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ماجستير في الصيدلة الصناعية

ماجستير في الصيدلة الصناعية

 

وصف عام للبرنامج 

ماجستير الصيدلة الصناعية هو برنامج نوعي ومتخصص في مجال الصيدلة الصناعية وصناعة الدواء من حيث المحتوى العلمي، فقد تم العمل على تطوير هذا البرنامج لكي يتواكب مع أخر ما توصلت إليه أبحاث علوم الصيدلة الصناعية ومتطلبات سوق العمل في المملكة العربية السعودية، حيث يسهم هذا البرنامج في تطوير جيل متميز من الصيادلة في مجال الصيدلة الصناعية لسد حاجة الدولة في عدة مجالات متعلقة بصناعة الدواء وكذلك تلبية حاجة الدولة للكوادر البشرية المتخصصة في العديد من الجهات الحكومية والخاصة كوزارة الصحة، هيئة الغذاء والدواء، المصانع والشركات الدوائية، وكذلك المستشفيات والمراكز الطبية بأنحاء المملكة و بإتمام دراسة البرنامج سيكون الخريجين من الكوادر المؤهلة تأهيلا عاليا للعمل في كافة مراحل تصنيع وتطوير الصناعات الدوائية، والتحقق من صحة وتصنيع الأدوية الجديدة وضمان سلامتهم وجودتهم، وبذلك يكون خريجو البرنامج من الصيادلة ذو الأولوية للاستفادة من فرص العمل في جميع مراحل الصناعات الدوائية بالمملكة.

شروط القبول في البرنامج

 

1. ﻳﺠﺐ أن ﻳﻜﻮن اﻟﻤﺘﻘﺪم ﺣﺎﺻﻼً ﻋﻠﻰ درﺟﺔ دﻛﺘﻮر اﻟﺼﻴﺪﻟﺔ، أو درﺟﺔ اﻟﺒﻜﺎﻟﻮرﻳﻮس ﺑﺎﻟﻌﻠﻮم اﻟﺼﻴﺪﻻﻧﻴﺔ ﺑﻤﻌﺪل ﻻ ﻳﻘﻞ ﻋﻦ 2.75 ﻣﻦ 5.00، وﺑﺘﻘﺪﻳﺮ ﻻ ﻳﻘﻞ ﻋﻦ ﺟﻴﺪ ﺟﺪا ﻓﻲ ﻣﻘﺮرات اﻟﺼﻴﺪﻻﻧﻴﺎت. 
2. اﻟﺤﺼﻮل ﻋﻠﻰ درﺟﺔ ﻻ ﺗﻘﻞ ﻋﻦ 4.5 ﻓﻲ اﺧﺘﺒﺎر IELTS أو ﻣﺎ ﻳﻌﺎدﻟﻬﺎ ﻣﻦ اﺧﺘﺒﺎرات اﻟﻠﻐﺔ اﻹﻧﺠﻠﻴﺰﻳﺔ اﻟﻤﻌﺘﻤﺪة. 
3. اﺟﺘﻴﺎز اﻻﺧﺘﺒﺎر اﻟﺘﺤﺮﻳﺮي واﻟﻤﻘﺎﺑﻠﺔ اﻟﺸﺨﺼﻴﺔ. 
4. أﻻ ﺗﻘﻞ درﺟﺔ اﺧﺘﺒﺎر اﻟﻘﺪرات اﻟﻌﺎﻣﺔ ﻟﻠﺠﺎﻣﻌﻴﻴﻦ ﻋﻦ 60 درﺟﺔ.

 

لخطة الدراسية لبرنامج ماجستير الصيدلة الصناعية بكلية الصيدلة /قسم الصيدلانيات

 

مسمى المؤهل

ماجستير في الصيدلة الصناعية

Master of Industrial Pharmacy

Name of Degree Awarded

 

المستوى الأول

 

                     First Semester

م

رقم المقرر ورمزه

مسمى المقرر

عدد الوحدات

Course Code

No

Credit Hours

1

صيد ٦10

طرق البحث العلمي والاحصاء الحيوية التطبيقية

3(2+0+1)

RESEARCH METHODS & APPLIED BIOSTATISTICS

PHT 610

1

2

صيد 614

الصيدلة الفيزيائية واعتبارات ما قبل التصنيع

3(2+0+1)

PHYSICAL PHARMACY & PREFORMULATION CONSIDERATIONS

PHT 614

2

3

صيد ٦١5

أنظمة توصيل الدواء

4(3+0+1)

DRUG DELIVERY SYSTEMS

PHT 615

3

مجموع الوحدات

10(7+0+3)

Total Units

 

المستوى الثاني

 

                     Second Semester

م

رقم المقرر ورمزه

مسمى المقرر

عدد الوحدات

Course Code

No

Credit Hours

1

صيد 621

التحليل الصيدلاني التطبيقي

3(2+0+1)

APPLIED PHARMACEUTICAL ANALYSIS

PHT 621

1

2

صيد 622

ثابتية الدواء

3(2+0+1)

DRUG STABILITY

PHT 622

2

3

صيد ٦٢3

الصيدلة الحيوية المتقدمة

3(2+0+1)

ADVANCED BIOPHARMACEUTICS

PHT 623

3

4

صيد 627

الممارسة الجيدة لتصنيع المستحضرات الصيدلانية

3(3+0+0)

GOOD MANUFACTURING PRACTICE (GMP) OF PHARMACEUTICAL DOSAGE FORMS

PHT 627

4

مجموع الوحدات

12(9+0+3)

Total Units

 

المستوى الثالث

 

                     Third Semester

م

رقم المقرر ورمزه

مسمى المقرر

عدد الوحدات

Course Code

No

Credit Hours

1

صيد 631

التصنيع الدوائي المتطور

3(2+0+1)

 ADVANCED PHARMACEUTICAL TECHNOLOGY

 PHT 631

1

2

صيد 632

تقنيات تصعيد المستحضر من المعمل الى المصنع

3(3+0+0)

 SCALE-UP TECHNIQUIES & PILOT PLANT

 PHT 632

2

3

صيد 633

الشؤون التنظيمية للمستحضرات الصيدلانية

2(2+0+0)

REGULATORY AFFAIRS OF PHARMACEUTICAL DOSAGE FORMS

PHT 633

3

4

صيد 634

عمليات تطوير الدواء وتصديقه

2(2+0+0)

DRUG DEVELOPMENT & APPROVAL PROCESSESS

PHT 634

4

5

صيد 630

حلقة نقاش -1

1(0+0+1)

SEMINAR -1

PHT 630

5

مجموع الوحدات

11(9+0+2)

Total Units

 

المستوى الرابع

 

                     Fourth Semester

م

رقم المقرر ورمزه

مسمى المقرر

عدد الوحدات

Course Code

No

Credit Hours

1

 صيد 645

تسجيل المستحضرات الصيدلانية

2(2+0+0)

REGISTERATION OF PHARMACEUTICAL DOSAGE FORMS

PHT 645

1

2

صيد 646

مشروع بحثي

6(6+0+0)

RESEARCH PROJECT

PHT 646

2

3

صيد 640

حلقة نقاش -2

1(0+0+1)

SEMINAR -2

PHT 640

3

مجموع الوحدات

9(8+0+1)

Total Units

 

A. General information about the course:

1. Course Identificationn:

1. Credit hours: (3 (2,0,1) )

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: (First semester / first year)

4. Course general Description:

This course deals with ethics in scientific research and applied statistics in pharmaceutics.

This course will address research ethics as well as such topics as authorship and research misconduct. Also, it will emphasize principles of experimental design, methods of data collection, exploratory data analysis, and the use of graphical and statistical tools commonly used by scientists to analyze data. The course will include discussion about classical test theory (p values, scales of measurement, assumptions of analyses, etc.) and application of this theory for various statistical analyses, such as t tests, ANOVA, correlation, regression, and nonparametric analyses.

 

5. Pre-requirements for this course (if any):

 

 

 

6. Pre-requirements for this course (if any):

 

 

 

7. Course Main Objective(s):

- Help students understand how and why scientists use biostatistics

- Provide students with the knowledge necessary to critically evaluate statistical claims, and to develop skills that students need to utilize statistical methods in their own studies.

- Recognize the applying biostatistics in experimental design, analysis methods, and use of statistics in pharmaceutical data.

- Describe sampling procedures, outliers, correlation, and different statistical techniques.

- Interpret the basic concepts of fundamentals of research ethics, scientific misconduct, plagiarism, and conflicts of interest.

 

             

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

64

100

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

32

  1.  

Laboratory/Studio

32

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

64

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Know the fundamentals of scientific research and

K1

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

1.2

understand principles of experimental design

K1

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

1.3

Recognize the applying biostatistics in experimental design, analysis methods, and use of statistics in pharmaceutical data.

K2

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

2.0

Skills

2.1

Identify sampling procedures, outliers, correlation, and different statistical techniques.

S1

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

3.0

Values, autonomy, and responsibility

3.1

Appreciate the research ethics and Identify research misconduct

V2

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

 

C. Course Content:

No

List of Topics

Contact Hours

  1.  

Fundamentals of Scientific Research and Experiment Design

2

  1.  

Pharmaceutical Research Methodologies

2

3.

Experimental design and data collection methods

4

4.

Scientific Research Misconduct & Research Ethics

4

5.

Introduction to biostatistics

2

6.

Descriptive statistics

2

7.

Frequency Distributions

2

8.

Hypothesis testing

2

9.

Student t test (Paired)

2

10.

Student t test (unpaired)

2

11.

Analysis of Variance (ANOVA)

2

12.

Non parametric tests

2

13.

Correlation

2

14

Linear regression

2

 

 

 

 

List of lab Topics

 

  1.  

Fundamentals of Scientific Research and Experiment Design

2

  1.  

Pharmaceutical Research Methodologies

2

  1.  

Experimental design and data collection methods

2

  1.  

Scientific Research Misconduct & Research Ethics

2

  1.  

Introduction to biostatistics software (SPSS)

4

  1.  

Descriptive statistics

4

  1.  

Frequency Distributions

2

  1.  

Hypothesis testing

2

  1.  

Student t test (Paired)

2

  1.  

Student t test (unpaired)

2

  1.  

Analysis of Variance (ANOVA)

2

  1.  

Non parametric tests

2

  1.  

Correlation

2

  1.  

Linear regression

2

Total

64

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

Quizzes/assignment/ presentation and individual evaluation

Over the semester

15%

  1.  

Midterm Exam

8-9

20%

  1.  

Practical Assessment

Over the semester

25%

  1.  

Final Exam

17-19

40%

  1.  

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

Introduction to Research Methods 5th Edition: A Practical Guide for Anyone Undertaking a Research Project, C. Dawson

Supportive References

ABC of Research Methodology and Applied Biostatistics, M. N. Parikh, Nithya Gogtay,

Electronic Materials

The International Journal of Biostatistics

Statistical Methods in Medical Research: SAGE Journals

Other Learning Materials

 

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

Classroom

Technology equipment

(Projector, smart board, software)

Computers, internet data bases, Saudi digital library (SDL), Smart Boards

Other equipment

(Depending on the nature of the specialty)

 

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

A. General information about the course:

1. Course Identification:

1. Credit hours: 3( 2+1 )

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: First year/ level 1

4. Course general Description:

This course describes fundamentals of physical pharmacy, physical properties of drug molecules and excipients that can influence formulation performance. Topics include the state of matter, physicochemical properties of drug molecules (Ionic balance, surface chemistry and overall properties). An overview of pharmaceutical excipients used in formulations, polymorphism in drugs, methods used for determining a polymorphic state, morphology, hygroscopicity, complexation and protein binding, drug-excipient interaction, and the compatibility tests. in addition to applications of polymers as pharmaceutical excipients. The practical part of the course is designed to familiarize students with some relevant subjects belonging to certain topics covered within the context of the theoretical part

5. Pre-requirements for this course (if any):

 

6. Pre-requirements for this course (if any):

 

7. Course Main Objective(s):

  • Compare and contrast functions of different pharmaceutical excipients used in formulations.
  • Differentiate physicochemical properties of drug substances and excipients influencing the performance of the formulation.
  • Explain how the drug-excipient interaction and compatibility testing are carried out.
  • Evaluate physicochemical properties of drug molecules.
  • Choose proper pharmaceutical excipients that can influence formulation performance of any given drug candidate.to apply the rules of state of matter, phase equilibria, and colligative properties in dosage forms design.
             

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

64

100%

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

32

  1.  

Laboratory/Studio

32

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

64

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Understand the fundamentals of physics applied in the development of drug products. 

K1

Lecture and Lab

Midterm exams, quizzes and final exams of practical and theoretical parts.

1.2

An overview of pharmaceutical excipients used in formulations.

K2

Lecture

Presentation.

1.3

Recognize drug-excipient interaction, in addition to the compatibility tests.

K2

Lecture and Lab

Midterm exams, quizzes and final exams of practical and theoretical parts.

2.0

Skills

2.1

Demonstrate the skill to apply the physical pharmacy rules in dosage forms design.

S1

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

2.2

Compare methods and analysis used for drug-excipient interaction in pharmaceutical dosage and the application of  pre-formulation considerations.

S2

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

3.0

Values, autonomy, and responsibility

3.1

To appraise the ability to comprehend pharmaceutical issues.

V1

Lectures

Lab practical

Quiz

Exams

Lab exams

3.2

Demonstrate good communication with instructor and staff

V2

Lectures, Practical works, Group discussions, Home Works and assignment

Practical Preparations, group discussions, HomeWorks & assignments

 

C. Course Content:

No

List of Topics

Contact Hours

1       

The fundamentals of physical pharmacy

2

2

States of Matter

2

3

Plasma and its application

2

4

Distribution phenomenon

2

5

Thermodynamics

2

6

Types of drug stability, chemical, physical, and microbiological stability.

4

7

Reaction order

2

8

Influence of temperature on the reaction rate, collision theory, Arrhenius theory, activation energy (Ea), transition state theory.

2

9

The physical properties of drug molecules and drug excipients

2

10.

Influence of excipients on the formulation performance

2

11.

Micromeritics

2

12.

Polymorphism

2

13.

Drug-excipient interaction

2

14.

Compatibility evaluation study

4

 

List of Lab Topics

 

1

Determination of Solubility of Drugs in Single and Mixed Solvents

2

2

Construction of Ternary Phase Diagram

2

3

Determination of Partition Coefficient of Salicylic Acid between Benzene and Water

2

4

Interfacial Tension – Drop Number Method

2

5

Determination of Particle Size by Stoke’s Method

2

6

Accelerated Stability Testing

4

7

Determination of Order of a Reaction

2

8

Calibration of Eyepiece Micrometer

2

9

Determination of Globule Size in an Emulsion by Microscopy

2

10

Phenolphthalein - NaOH Kinetics

2

11

Micromeritics

2

12

Kinetics of Decomposition of Hydrogen peroxide

2

13

Determination of CMC of Tween 80

2

14

Evaluation of Physical Stability of Commercial Liquid Paraffin Emulsion

2

15

Influence of Suspending Agent on The Sedimentation Parameters in a Suspension

2

Total

 

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

 1

Quizzes/assignment/ presentation and individual evaluation

Over the semester

15%

 2

Midterm Exam

8-9

20%

 3

Practical Assessment

Over the semester

25%

4

Final Exam

17-19

40%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

  1. Physical Pharmacy, Martin A. 5th Edition, 2006, Lippincott Williams & Wilkins.
  2. Remington; The science and Practice of Pharmacy; 21st Edition, volume 1 & 2, 2005.
  3. Pharmaceutical Dosage Forms and Drug Delivery by H. C.Ansel, N. G. Popovich. 9th edition 2011.
  4. Pharmaceutical and Clinical Calculations, Mansoor A. Khan, Indra K. Reddy, 2nd Edition, 2000, CRC Press LLC
  5. Pharmaceutics, the Science of dosage form design, Miclael E. Aulton 2005.

Supportive References

  1. Comprehensive Pharmacy Review, Leon Shargel, 8th Edition, 2012 Lippincott Williams & Wilkins.
  2. Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5e, 2017

Electronic Materials

www.pharmacist.com (American Pharmacists Association)

www.ashp.org (American Society of Health-System Pharmacists)

www.phrma.org

www.emedicine.com

www.sciencedirect.com

www.pubmed.com

www.sdl.edu.sa

Other Learning Materials

  • Martindale (extra pharmacopeia).
  •  Handout of Lectures Delivered.

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

Pharmaceutics Lab, Classrooms with Smart Board; data show presentation

Technology equipment

(Projector, smart board, software)

Projector, Smart Board

Other equipment

(Depending on the nature of the specialty)

Regular Laboratory Instruments

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

A. General information about the course:

1. Course Identification:

1. Credit hours: 4 (3+1 )

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: ( 1/1 )

4. Course general Description:

This course aims to demonstrate the most recent drug delivery systems. In addition, to study and understand all biological factors affecting drug delivery, the physiochemical factors associated with it, advanced preparation techniques, drug formulations and the development of various drug delivery systems. This course also aims to study advanced preparation techniques, drug formulations, and the development of non-parenteral drug delivery systems that include various methods of use, including oral drug delivery, the oral cavity, the nose, the eye, transdermal, rectal, and vaginal delivery.

5. Pre-requirements for this course (if any):

 

6. Pre-requirements for this course (if any):

 

7. Course Main Objective(s):

  • Describe the biological factors that influence drug absorption.
  • Design the formulation of non-parenteral drug delivery systems with various routes of   administration including oral, buccal, nasal, ocular, transdermal, rectal, and vaginal route.
  • Describe the biological factors that influence drug absorption.
  • Demonstrate the physiochemical characteristics of the drug influence absorption from the GIT, mucosal membrane, and skin.
  • Define the bio-pharmaceutical considerations in dosage form design.

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

80

100%

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

48

  1.  

Laboratory/Studio

32

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

80

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Describe the fundamentals of drug delivery system design.

K1

Lectures and Practical

Midterm exams, quizzes and final exams of practical and theoretical parts.

1.2

Describe types, methods of preparations, rationales of uses, applications, advantages and drawbacks of advanced delivery systems.

K2

Lectures and Practical

Midterm exams, quizzes and final exams of practical and theoretical parts.

1.3

Know the pre-formulation considerations for advanced delivery systems.

K2

Lectures and Practical

Midterm exams, quizzes and final exams of practical and theoretical parts.

2.0

Skills

2.1

Compare and differentiate advanced delivery systems, their applications, advantages and drawbacks.

S1

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

2.2

Design and develop the pre-formulation considerations for advanced delivery systems.

S1

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

3.0

Values, autonomy, and responsibility

3.1

Interpretation and decision in the evaluation parameters results outcomes.

V1

Practical works, Group discussions, Home Works and assignment

Practical Preparations, group discussions, HomeWorks & assignments

...

 

 

 

 

 

C. Course Content:

No

List of Topics

Contact Hours

1

Introduction for advanced drug delivery systems

6

2

Advanced technique preparations, formulation, and development of parenteral and non-parenteral drug delivery systems

6

3

Advanced technique preparations, formulation, and development of oral drug delivery systems

6

4

Advanced technique preparations, formulation, and development of buccal drug delivery systems

3

5

Advanced technique preparations, formulation, and development of nasal drug delivery systems

3

6

Advanced technique preparations, formulation, and development of ocular drug delivery systems

3

7

Advanced technique preparations, formulation, and development of transdermal drug delivery systems

6

8

Advanced technique preparations, formulation, and development of vaginal drug delivery systems

3

9

Advanced technique preparations, formulation, and development of rectal drug delivery systems.

3

10

Advanced technique preparations, formulation, and development of vaginal drug delivery systems

3

11

Novel drug delivery systems

6

 

List of Lab Topics

 

  1.  

Orientation and Research lab visit for instruments – Operation & Applications.

2

  1.  

Instruments – Standard Operating Procedure Detailing

2

  1.  

Development of nanoparticles for oral – Sustained Release

2

  1.  

Characterization of nanoparticles for oral – Sustained Release

2

  1.  

Development of Nasal – gels/powders for brain delivery

2

  1.  

Characterization of Nasal – gels/powders for brain delivery

2

  1.  

Development of Buccal Patch for systemic delivery

2

  1.  

Characterization of Buccal Patch for systemic delivery

2

  1.  

Development of Ophthalmic Sol – gels/ Occuserts for glaucoma conditions

2

  1.  

Development of Ophthalmic Sol – gels/ Occuserts for glaucoma conditions

2

  1.  

Characterization of Vaginal – gels/pessaries

2

  1.  

Characterization of Vaginal – gels/pessaries

2

  1.  

Development of Rectal – gels/Suppositories  for systemic delivery

2

  1.  

Characterization of Rectal – gels/Suppositories  for systemic delivery

2

  1.  

Development of transdermal Patch for systemic delivery

2

  1.  

Characterization of transdermal Patch for systemic delivery

2

Total

80

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

1

Quizzes/assignment/ presentation and individual evaluation

Over the semester

15%

2

Midterm Exam

8-9

20%

3

Practical Assessment

Over the semester

25%

4

Final Exam

17-19

40%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

  1. Pharmaceutical Dosage Forms and Drug Delivery by H. C. Ansel, N. G. Popovich. 9th edition 2011.
  2. Comprehensive Pharmacy Review, Leon Shargel, 8th Edition, 2012 Lippincott Williams & Wilkins.
  3. Pharmaceutics, the Science of dosage form design, Miclael E. Aulton 2005.

Remington; The science and Practice of Pharmacy; 21st Edition, volume 1 & 2, 2005.

Supportive References

  1. International Journal of Pharmaceutics
  2. Advanced Drug Delivery Review
  3. Journal of Drug Delivery Sciences and Technology

Journal of Controlled Release

Electronic Materials

www.emedicine.com

www.sciencedirect.com

www.blackwell.com

www.ovid.com

www.pubmed.com

www.sdl.edu.sa

Other Learning Materials

 

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

Pharmaceutics Lab, Classrooms

Technology equipment

(Projector, smart board, software)

Projector

Other equipment

(Depending on the nature of the specialty)

 

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

G. Specification Approval Data:

Council /COMMittee

 

Reference No.

 

Date

 

 

A. General information about the course:

1. Course Identificationn:

1. Credit hours: (3 (2,0,1) )

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: (First semester / first year)

4. Course general Description:

This course gives in-depth knowledge concerning methodology for the analysis of pharmaceuticals in biological samples as well as in pharmaceutical preparations. It also deals with basic analytical techniques such as spectroscopic, chromatographic techniques, mass spectroscopy, and thermal analytical techniques.

5. Pre-requirements for this course (if any):

 

6. Pre-requirements for this course (if any):

 

7. Course Main Objective(s):

- Illustrate the theory of analytical techniques.

- Interpret analytical techniques such as spectroscopic, chromatographic techniques, mass spectroscopy, and thermal analytical techniques.

             

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

64

100

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

32

  1.  

Laboratory/Studio

32

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

64

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

List the basic analytical techniques such as spectroscopic, chromatographic techniques, mass spectroscopy, and thermal analytical techniques.

K2

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

1.2

Outline the theory of analytical techniques.

K2

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

1.3

 

 

 

 

2.0

Skills

2.1

Summarize the analytical techniques such as spectroscopic, chromatographic techniques, mass spectroscopy, and thermal analytical techniques.

S1

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

2.2

Differentiate the theory of analytical techniques.

S2

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

…

 

 

 

 

3.0

Values, autonomy, and responsibility

3.1

Demonstrate good communication with instructors and staff.

V1

Lectures and practical

Midterm Exams, Final Exam of theoretical and practical

3.2

 

 

 

 

...

 

 

 

 

C. Course Content:

No

List of Topics

Contact Hours

  1.  

Fundamentals of basic pharmaceutical analytical techniques

2

  1.  

Quality control of biotechnology produced Drugs

2

3.

Physical and chemical properties of drug molecules

2

4

Trimetric and chemical analysis methods

2

5.

Spectroscopic pharmaceutical analytical techniques: Ultraviolet and visible spectroscopy

3

6.

Infrared spectroscopy

4

7.

Nuclear Magnetic Resonance (NMR) spectroscopy

3

8.

Mass spectroscopy

4

9.

Chromatography

4

10.

Gas chromatography

2

11.

High-performance liquid chromatography

2

12.

Extraction methods in pharmaceutical analysis

2

 

Lab – Experiment List

 

  1.  

Calibration of graduated glass apparatus

2

  1.  

Calibration of pH meter

2

  1.  

Colorimetry / UV / Visible, Spectroscopy, scanning of few compounds for UV-absorption, calculation of Assay / content uniformity / % of drug release ( Acetyl salicylic Acid)

2

  1.  

Colorimetry / UV / Visible, Spectroscopy, scanning of few compounds for UV-absorption, calculation of Assay / content uniformity / % of drug release (Ibuprofen)

2

  1.  

Colorimetry / UV / Visible, Spectroscopy, scanning of few compounds for UV-absorption, calculation of Assay / content uniformity / % of drug release (Paracetamol)

2

  1.  

To estimate simultaneously diclofenac and paracetamol sample by dual wavelength method by UV spectroscopy.

2

  1.  

Experiment based on HPLC (Isocratic and gradient) Techniques – (Experiments/Demonstration)

2

  1.  

Experiment/Data Interpretation/Demonstration of NMR

 

  1.  

Experiment/Data Interpretation/Demonstration of LC-MS

 

  1.  

Incompatibility studies, identification and functional groups – Determination by FTIR

2

  1.  

To interpret IR spectra of known compound (ibuprofen) by peak matching using FTIR

2

  1.  

To interpret IR spectra of Paracetamol by peak matching using FTIR

2

  1.  

Separation and calculation of Rf values by using paper chromatography, TLC,

2

  1.  

To determine the Rf value of Diclofenac sodium by TLC.

2

  1.  

Experiment/Data Interpretation/Demonstration of GC

 

  1.  

To determine the mp by DSC (Amorphous/crystal –identification)

2

Total

64

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

Quizzes/assignment/ presentation and individual evaluation

Over the semester

15%

  1.  

Midterm Exam

8-9

20%

  1.  

Practical Assessment

Over the semester

25%

  1.  

Final Exam

17-19

40%

  1.  

Total

 

100%

  1.  

 

 

 

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists 3rd Edition by D.G. Watson

Supportive References

 

Electronic Materials

 

Other Learning Materials

 

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

Classroom, Pharmaceutical analysis laboratory

Technology equipment

(Projector, smart board, software)

Projector, Computers, internet data bases, Saudi digital library (SDL), Smart Boards

Other equipment

(Depending on the nature of the specialty)

 

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

A. General information about the course:

1. Course Identification:

1. Credit hours:  3(2+1)

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: (First year/ Level 2)

4. Course general Description:

This course is designed to deal with the stability studies ensuring the maintenance of drug quality, safety, and efficacy throughout the shelf life, which are considered a pre-requisite for the acceptance and approval of any pharmaceutical product. These studies are required to be conducted in a planned way, following the guidelines issued by ICH and WHO and or other agencies.

5. Pre-requirements for this course (if any):

None

 

6. Pre-requirements for this course (if any):

PHT 614

7. Course Main Objective(s):

In depth knowledge and update information in the following areas with emphasis on research relevant issues:

  • Basic concepts of drug degradation and stability.
  • Physical and chemical degradation of pharmaceutical products and preventive measures.
  • Factors affecting drug degradation.
  • Accelerated stability testing and shelf-life calculation.
  • WHO and ICH stability testing guidelines.
             

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

64

100%

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

32

  1.  

Laboratory/Studio

32

  1.  

Field                                                                         

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

64

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

State the basic concepts of drug degradation and stability.

K1

Lectures, Lab and Presentation

Exam, quiz, and lab assessment

1.2

Describe, compare and apply analytical method for the degradation of drug substance, drug products and dosage forms.

K2

Lectures, Lab and Presentation

Exam, quiz, and lab assessment

1.3

Describe the drug stability studies as per ICH and WHO guidelines.

K3

Lectures, Lab and Presentation

Exam, quiz, and lab assessment

2.0

Skills

2.1

Summarize the basic concepts of drug degradation and stability.

S1

Lectures, Lab and Presentation

Exam, quiz, and lab assessment

2.2

Differentiate the chemical degradation mechanisms, physical drug degradation, rate of degradation.

S2

Lectures, Lab and Presentation

Exam, quiz, and lab assessment

2.3

Perform the degradation of drug/dosage form as per ICH/WHO guidelines.

S3

Lectures, Lab and Presentation

Exam, quiz, and lab assessment

3.0

Values, autonomy, and responsibility

3.1

Develop the capability to independently design, execute, and evaluate stability studies according to established guidelines from regulatory bodies such as the ICH and WHO

V1

Lectures, Lab and Presentation

Exam, quiz, and lab assessment

3.2

Cultivate self-directed learning skills to stay updated with emerging trends, regulations, and best practices in the field of pharmaceutical stability testing.

V2

Lectures, Lab and Presentation

Exam, quiz, and[A1] [A2]  lab assessment

3.3

Take responsibility for the accurate and reliable generation of stability data, ensuring adherence to protocols, standard operating procedures (SOPs), and regulatory requirements.

V3

Lectures, Lab and Presentation

Exam, quiz, and[A3] [A4]  lab assessment

 

C. Course Content:

No

List of Topics

Contact Hours

  1.  

Basic concepts of drug degradation and stability, Types of stability and Factors Influencing Stability.

2

  1.  

Chemical Kinetics

4

  1.  

Chemical drug degradation mechanisms

4

  1.  

Physical drug degradation mechanisms & Factors effecting physical stability.

4

  1.  

Photochemical degradation & Incompatibility.

2

  1.  

Prevention of degradation reactions and  Drug  stabilization

2

  1.  

Chemical and Photostabilization studies

2

  1.  

Forced Degradation studies

2

  1.  

Accelerated stability testing

2

  1.  

Stability-indicating assay methods

4

  1.  

ICH guidelines and WHO guidelines and stability protocols for dosage forms.

4

 

List of lab topics

 

 

  1.  

Determination of rate of, reaction, half life and Shelf life of drug.

2

 

  1.  

Study of the chemical stability of a drug: Hydrolysis and Oxidation.

2

 

  1.  

Photostability studiesof riboflavin

2

 

  1.  

Utilization of analytical techniques in the study of physical state of drug.

4

 

  1.  

Study of factors affecting physical stability of drug.

2

 

  1.  

Forced degradation studies in the development of drugs

2

 

  1.  

Accelerated stability studies

2

 

  1.  

Analytical techniques used in forced degradation studies

4

 

  1.  

Packaging effects on drug stability

2

 

  1.  

Prevention of degradation reactions

4

 

  1.  

Chemical and photostabilization studies

2

 

  1.  

Development of stability-indicating assay methods

4

 

TOTAL

64

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

Quizzes/assignment/ presentation and individual evaluation

Over the semester

15%

  1.  

Midterm Exam

8-9

20%

  1.  

Practical Assessment

Over the semester

25%

4.

Final Exam

17-19

40%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

Drug Stability, Revised, and Expanded Principles and Practices, Jens T. Carstensen, Christopher Rhodes, CRC Press (2000).

Supportive References

Drug Stability for Pharmaceutical Scientists 1st Edition, Thorsteinn Loftsson, Academic Press (2014).

Electronic Materials

 

Other Learning Materials

 

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

Classrooms, laboratories

Technology equipment

(Projector, smart board, software)

Internet access

Other equipment

(Depending on the nature of the specialty)

Laboratory room

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

A. General information about the course:

1. Course Identification:

1. Credit hours: ( 2+1 )

 

2. Course type

A.

☐ University

College

☒Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: (First year, Level 2)

4. Course general Description:

This course deals with advanced concepts of biopharmaceutics and pharmacokinetics. Absorption, distribution, metabolism and excretion of drugs will be explained that include one compartment and multiple compartment models, calculations of pharmacokinetic parameters and their relevance, bioavailability and bioequivalence, biopharmaceutical considerations in drug product design, in vitro drug product performance, and the relationship between obtained results from in vitro and in vivo models (IVIVC).

5. Pre-requirements for this course (if any):

NONE

6. Pre-requirements for this course (if any):

N/A

7. Course Main Objective(s):

  • Define the concepts of biopharmaceutics and pharmacokinetics.
  • Illustrate the absorption, distribution, metabolism and excretion of drugs that include one compartment and multiple compartment models.
  • Describe the pharmacokinetic parameters and their relevance.
  • Define bioavailability and bioequivalence.
  • Interpret biopharmaceutical considerations in drug product design.
  • Analyze the in vitro drug product performance, and the relationship between obtained results from in vitro and in vivo models.
             

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

64

100

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

32

  1.  

Laboratory/Studio

32

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

64

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Define the advanced concepts of biopharmaceutics and pharmacokinetics.

K1

Lectures and Practical

Midterm exams, quizzes and final exams of practical and theoretical parts.

1.2

Outline the absorption, distribution, metabolism and excretion of drugs that include one compartment and multiple compartment models.

K2

Lectures and Practical

Midterm exams, quizzes and final exams of practical and theoretical parts.

1.3

Recognize the pharmacokinetic parameters and their relevance, bioavailability and bioequivalence, biopharmaceutical considerations in drug product design.

K1

Lectures and Practical

Midterm exams, quizzes and final exams of practical and theoretical parts.

1.4

Describe the in vitro drug product performance, and the relationship between obtained results from in vitro and in vivo models.

K3

Lectures

Quizzes

2.0

Skills

2.1

Summarize the advanced concepts of biopharmaceutics and pharmacokinetics.

S2

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

2.2

Differentiate the absorption, distribution, metabolism and excretion of drugs that include one compartment and multiple compartment models.

S2

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

2.3

Compare the pharmacokinetic parameters and their relevance, bioavailability and bioequivalence, biopharmaceutical considerations in drug product design.

S2

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

2.4

Evaluate the in vitro drug product performance, and the relationship between obtained results from in vitro and in vivo models.

S2

Lectures and Practical works

Quizzes, Exams (theoretical and practical), HomeWorks, group discussions & assignments.

3.0

Values, autonomy, and responsibility

3.1

Follow the ethics if using PK studies in animal/volunteers 

V1

Lectures, Practical works, Group discussions, HomeWorks and assignments.

Practical Preparations, group discussions, HomeWorks & assignments.

3.2

Demonstrate good communication with during presentation of the data, results, BA/BE concepts – results.

V3

Lectures, Practical works, Group discussions, HomeWorks and assignments.

Practical Preparations, group discussions, HomeWorks & assignments.

C. Course Content:

No

List of Topics

Contact Hours

  1.  

Advanced concepts of biopharmaceutics and pharmacokinetics.

2

  1.  

 Mechanism   of the drug Absorption

2

  1.  

Factors influencing the Absorption of drugs (Physicochemical and  Pharmaceutical)

2

  1.  

Factors influencing the Absorption of drugs (Physiological)

2

  1.  

Concepts of drug distribution

2

  1.  

Concepts of drug Metabolism

2

  1.  

Concepts of drug Excretions

2

  1.  

Pharmacokinetic Concepts and type of models

2

  1.  

One compartment compartment models

2

  1.  

Multiple compartment models 

2

  1.  

Methods applied to enhance dissolution and absorption of drugs through the oral route

2

  1.  

Evaluation methods of dissolution and absorption of drug through oral route

2

  1.  

Bioavailability and bioequivalence

2

  1.  

Biopharmaceutical considerations in drug product design

2

  1.  

In vitro drug product performance of drug delivery systems

2

  1.  

Relationship between in vitro and in vivo models (IVIVC) of drug product pharmacokinetics parameters.

2

No

List of Lab

Contact Hours

  1.  

Determination of partition coefficient and dissociation constant.

2

  1.  

Kinetic study of dissolution of drug.

2

  1.  

In vitro dissolution of compressed tablet

2

  1.  

In vitro dissolution of Sustained Release tablet

2

  1.  

Effect of pH on dissolution behavior of drug

2

  1.  

In vitro permeation study using Franz diffusion cell

2

  1.  

Effect of permeation enhancers on diffusion of drug

2

  1.  

Diffusion  of drug from various ointment bases

2

  1.  

Protein binding study using equilibrium  dialysis method

2

  1.  

Calculation of various pharmacokinetic parameters after IV bolus injection

2

  1.  

Calculation of urinary excretion rate constant and elimination rate constant

2

  1.  

Calculation of various pharmacokinetic parameters after IV Infusion

2

  1.  

Calculation of area under curve by Trapezoidal rule

2

  1.  

Calculation of absorption rate constant by method of residuals

2

  1.  

Calculation of various pharmacokinetic parameters after extravascular administration

2

  1.  

Lab Exam/ Revisions

2

Total

64

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

Quizzes/assignment/ presentation and individual evaluation

Over the semester

15%

  1.  

Midterm Exam

8-9

20%

  1.  

Practical Assessment

Over the semester

25%

4.

Final Exam

17-19

40%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

  • Shargel and A.B.C. Yu., Applied Biopharmaceutics and Pharmacokinetics, 4th edition 1999. Appleton & Lange/MacGraw-Hill, New York.
  • Milo Gibaldi, Biopharmaceutics and Pharmacokinetics, 4th Ed., 2006, Pharma Book Syndcate.
  • V. Venkateswarlu,  Biopharmaceutics and Pharmacokinetics, 4th Ed. , 2006., Pharma Book Syndcate

Supportive References

  • International Journal of Pharmaceutics
  • Journal of Pharmaceutical Sciences
  • European Journal of Pharmaceutics and biopharmaceutics
  • Biopharmaceutics and drug disposition

Electronic Materials

  • http://www.boomer.org/c/p1/
  • http://www.icp.org.nz/
  • http://pharmacyonline.creighton.edu/pha443/pdf/default.htm
  • http://pharmacyonline.creighton.edu/pha443/
  • http://accp1.org/pharmacometrics/index.html
  • http://www.uiowa.edu/~c046138/KINETICS_HOMEPAGE.htm

Other Learning Materials

 

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

  • The classroom utilizes lecture rooms with Smart Board; data show presentation, and animated simulations of topics under discussion.
  • A questions and answers approach centered on enhancing student critical thinking is used.
  • Laboratory emphasis is placed on individual and group study designed to enhance and augment, in a practical manner, the theoretical portion of the course.

Technology equipment

(Projector, smart board, software)

  • Computers, Data Show, internet data bases, Saudi digital library (SDL), Smart Boards

Other equipment

(Depending on the nature of the specialty)

 

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

A. General information about the course:

1. Course Identification:

1. Credit hours: ( 3+0 )

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: ( 2/1)

4. Course general Description:

This course deals with basic requirements for pharmaceutical and manufacturing quality management. Topics will cover GMP, total quality management, quality costs, and manufacturing quality management, in addition, regulatory aspects, design and performance qualification and documentation. Also, quality control, quality assurance and assessment of various dosage forms. Moreover, validation of pharmaceutical formulation processes and evaluation of dosage forms according to USP, BP, FDA regulations will be covered.

 

5. Pre-requirements for this course (if any):

 

PHT 615

 

6. Pre-requirements for this course (if any):

 

7. Course Main Objective(s):

- Define the basic requirements for pharmaceutical and manufacturing quality management.

- Outline the GMP, total quality management and quality costs.

- Describe regulatory aspects of GMP.

- Define performance qualification and documentation.

- Recognize quality control and quality assurance of various dosage forms.

- Describe the validation of pharmaceutical formulation processes and evaluation of dosage forms according to USP, BP, FDA regulations.

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

48

100

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

48

  1.  

Laboratory/Studio

 

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

48

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Recognize the quality control, quality assurance and assessment of various dosage forms.

K1

Lectures and tutorial,

Student Seminars

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

 

1.2

Outline the GMP, total quality management, quality costs, and manufacturing quality management. In addition, describing the regulatory aspect and defining performance qualification and documentation.

K2

Lectures and tutorial,

Student Seminars

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

 

1.3

Describe the validation of pharmaceutical formulation processes and evaluation of various dosage forms according to USP, BP, FDA regulations.

K3

Lectures and tutorial,

Student Seminars

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

 

2.0

Skills

2.1

Differentiate the GMP, total quality management, quality costs, and manufacturing quality management, In addition, realize the regulatory aspect and recognize performance qualification and documentation.

 

S1

Lectures and tutorial,

Student Seminars

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

 

2.2

Evaluate the validation of pharmaceutical formulation processes and evaluation of dosage forms according to USP, BP, FDA, PIC/S regulations.

S3

Lectures and tutorial,

Student Seminars

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

 

…

 

 

 

 

3.0

Values, autonomy, and responsibility

3.1

Evaluate the quality control, quality assurance and assessment of various dosage forms.

V1

Theories, tutorial, Seminars.

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

 

3.2

Illustrate the GMP, total quality management, quality costs, and manufacturing quality management, In addition, realize the regulatory aspect and recognize performance qualification and documentation.

 

V3

Group discussions, HomeWorks and assignments.

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

 

 

C. Course Content:

No

List of Topics

Contact Hours

  1.  

Basic requirements for pharmaceutical and manufacturing quality management.

4

  1.  

GMP, total quality management, quality costs, and manufacturing quality management.

4

  1. ---

Regulatory aspects of GMP for various dosage forms USP, BP, FDA , PIC/S regulations

4

  1.  

Case Study

4

  1.  

Design, performance qualification and documentation of dosage forms.

4

  1.  

Quality control of various dosage forms.

4

  1.  

Quality assurance of various dosage forms.

4

  1.  

Case Study

4

  1.  

Validation of pharmaceutical formulation processes.

8

  1.  

Evaluation of dosage forms according to USP, BP, FDA regulations..

8

 

 

 

Total

48

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

Quizzes/assignment/ presentation and individual evaluation

Over the semester

20%

  1.  

Midterm Exam

8-9

30%

3.

Final Exam

17-19

50%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

  • Pharmaceutical Manufacturing Handbook, Production and Processes by Shayne Cox Gad, 2008.
  • Bentley’s Textbook of Pharmaceutics, An Adaption, 1st Edition, 2012.

Supportive References

  • Theory And Practice Of Industrial Pharmacy By Leon Lachman, H.A. Liberman, Verghese Publication House, 3rd Edition, Dader, Bombay
  • Laboratory Manual by Pamposh Kumar; V.P.S. Tomer; CBS Publishers and Distributors, Ist edition, 2005.
  • Documentation Basics That Support GMP By Carol Desain, Advanstar Communications, 1993.
  • Good Manufacturing Practices for Pharmaceuticals, 7th Edition, Taylor and Francis group.
  • Good Manufacturing Practices for Pharmaceuticals, A Plan for Total Quality Control, 3rd edition, west publishing company.
  • CGMP for Pharmaceuticals by Manohar A. Potdar.
  • GMP for Pharmaceuticals, Fifth edition, by Sidney H. Willing.
  • Pharmaceutical Industrial Management, by G.Vidyasagar.
  • WHO, 1997. Joint training on GMP for biological products in Thailand, 2-11 September, 1997
  • Chung Keel Lee, 2003. GMP and related topics, 13-15 October, 2003.
  • Chung Keel Lee, 2004. Current GMP for biological products and its practical implementation, 22-23 March, 2004.
  • FDA and WHO, 2004. GMP inspection workshop, 21-29 June, 2004.

Electronic Materials

www.GMP-quality.com

U.S. Food and Drug Administration (fda.gov)

www.pharmacist.com (American Pharmacists Association)

www.ashp.org (American Society of Health-System Pharmacists)

www.phrma.org

www.emedicine.com

www.sciencedirect.com

www.blackwell.com

www.ovid.com

www.pubmed.com

Other Learning Materials

British Pharmacopeia (B.P.).

United States Pharmacopeia (U.S.P).

British Pharmaceutical Codex (B.P.C).

Martindale (extra pharmacopeia).

Handout of Lectures Delivered.

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

  • The classroom utilizes lecture rooms with Smart Board; data show presentation, and animated simulations of topics under discussion.
  • A questions and answers approach centered on enhancing student critical thinking is used.
  • Laboratory emphasis is placed on individual and group study designed to enhance and augment, in a practical manner, the theoretical portion of the course.

Technology equipment

(Projector, smart board, software)

Computers, Data Show, internet data bases, Saudi digital library (SDL), Smart Boards

 

Other equipment

(Depending on the nature of the specialty)

 

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

 

A. General information about the course:

1. Course Identificationn:

1. Credit hours: (1 (0,0,1))

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: Level 3 (First semester / II year)

4. Course general Description:

Seminar - I offers an enriching platform for students to transcend conventional coursework boundaries. This coursework propels students into the realm of advanced topics, fostering exploration of cutting-edge developments and specialized fields within pharmaceutical science and technology. Covering a diverse spectrum, subjects include research methods, physical pharmacy, drug delivery systems, pharmaceutical analysis, drug stability, biopharmaceutics, good manufacturing practice (GMP), regulatory affairs, pharmaceutical technology, scale-up techniques, drug development and approval processes. Additionally, students will undertake concise reviews on selected topics or specialized articles pertinent to industrial pharmacy and engage in critical evaluation of scientific papers specific to this domain. Through this comprehensive approach, students refine their analytical skills, deepen their understanding of industrial pharmacy, and significantly contribute to the advancement of pharmaceutical science and technology.

5. Pre-requirements for this course (if any):

NA

6. Pre-requirements for this course (if any):

NA

7. Course Main Objective(s):

  1. To explore advanced topics in industrial pharmacy beyond regular coursework.
  2. To improve critical thinking by analyzing cutting-edge developments.
  3. To understand industrial pharmacy practices through practical applications.
  4. To develop analytical skills by reviewing and evaluating scientific literature.
  5. To enable students to contribute effectively to the field of industrial pharmacy.

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

32

100

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

32

  1.  

Laboratory/Studio

 

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

32

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Develop knowledge and understanding of advanced topics in industrial pharmacy beyond regular coursework.

 K1 & K2

Lectures and Seminars

Assignments, Project, Presentation, Group discussion

 

 

 

 

 

2.0

Skills

2.1

Apply appropriate research methodologies to investigate and support seminar arguments.

 S1

Lectures and Seminars

 Assignments, Project, Presentation, Group discussion

 2.2

Apply pharmaceutical interpersonal and management skills to communicate with a large group of employees to accomplish various pharmaceutical technology tasks in the industrial environment.

S1

Lectures and Seminars

 Assignments, Project, Presentation, Group discussion

2.3

Integrate technical programs specialized in pharmaceutical technologies in planning future industrial pharmacy projects

S2

Lectures and Seminars

Assignments, Project, Presentation, Group discussion

3.0

Values, autonomy, and responsibility

3.1

Practice solving complex problems arising in industrial pharmacy fields.

 V1

Lectures and Seminars, Problem-solving workshops, case analyses, debates

 Assignments, Project, Presentation, Group discussion

 

C. Course Content:

No

List of Topics

Contact Hours

  1. 1.

Course Overview and Expectations

2

  1.  

Basic knowledge of pharmaceutics and pharmaceutical industry.

4

  1.  

Assess different sources of publications relevant.

4

  1.  

Appraise and criticize journal articles in the interest topics.

4

  1.  

Primary Presentation.

6

  1.  

Group Journal Club.

6

  1.  

Final Presentation of research Proposal.

6

Total

32

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

In class Activity

Over the semester

10%

  1.  

Assignment / quizzes

Over the semester

15%

  1.  

Oral test

 

15

  1.  

Journal Club evaluation

 

20

  1.  

Final Presentation

15-16

40%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

Theory And Practice Of Industrial Pharmacy By Leon Lachman, H.A. Liberman, Verghese Publication House, 3rd Edition, Dader, Bombay

Laboratory Manual by Pamposh Kumar; V.P.S. Tomer; CBS Publishers and Distributors, Ist edition, 2005.

Documentation Basics That Support GMP By Carol Desain, Advanstar Communications, 1993.

Good Manufacturing Practices for Pharmaceuticals, A Plan for Total Quality Control, 3rd edition, west publishing company.

CGMP for Pharmaceuticals by Manohar A. Potdar.

GMP for Pharmaceuticals, Fifth edition, by Sidney H. Willing.

Pharmaceutical Industrial Management, by G.Vidyasagar.

WHO, 1997. Joint training on GMP for biological products in Thailand, 2-11 September, 1997

Chung Keel Lee, 2003. GMP and related topics, 13-15 October, 2003.

Chung Keel Lee, 2004. Current GMP for biological products and its practical implementation, 22-23 March, 2004.

FDA and WHO, 2004. GMP inspection workshop, 21-29 June, 2004.

Supportive References

International Journal of Pharmaceutics

Journal of Pharmaceutical Sciences

AAPS PharmSciTech

Drug development and Industrial Pharmacy

Electronic Materials

The International Journal of Biostatistics

Statistical Methods in Medical Research: SAGE Journals

Other Learning Materials

www.pharmacist.com (American Pharmacists Association)

www.ashp.org (American Society of Health-System Pharmacists)

www.phrma.org

www.emedicine.com

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

Classroom

Technology equipment

(Projector, smart board, software)

Blackboard, Saudi digital library (SDL), Smart Boards

Other equipment

(Depending on the nature of the specialty)

NA

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

 

A. General information about the course:

1. Course Identification:

1. Credit hours: ( 2+1 )

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: (Second year, Level 1)

4. Course general Description:

This course provides an overview of the processes that occur in the pharmaceutical industry, with specific reference to the tablets manufacturing and the instruments used for that, including the processes of reducing and enlarging the size of particles, mixing, freeze-drying, spray-drying, tablet manufacturing , coating, and the modern technologies used.

 

5. Pre-requirements for this course (if any):

 

PHT 627

 

6. Pre-requirements for this course (if any):

 

None

 

7. Course Main Objective(s):

- Understand the basic knowledge of advanced manufacturing of pharmaceutical preparation.

- Assess and understand the processes used in the pharmaceutical industry.

- Operate the instruments used in pharmaceutical manufacturing.

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

64

100%

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

32

  1.  

Laboratory/Studio

32

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

64

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Define the basic knowledge of advanced manufacturing of dosage forms

K.1

Lecture and lab

Exam, quiz, and lab assessment

1.2

Describe the different manufacturing process include reducing and enlarging the size of particles, mixing, freeze-drying, spray-drying, tablet manufacturing , coating.

K.2

Lecture and lab

Exam, quiz, and lab assessment

…

 

 

 

 

2.0

Skills

2.1

Summarize the basic knowledge of advanced manufacturing of dosage forms.

S.1

Lecture and lab

Exam, quiz, and lab assessment

2.2

Differentiate the manufacturing process in the pharmaceutical industry.

S.2

Lecture and lab

Exam, quiz, and lab assessment

2.3

Operate the instruments used in pharmaceutical manufacturing.

S.2

Lecture and lab

Exam, quiz, and lab assessment

3.0

Values, autonomy, and responsibility[A5] [A6] 

3.1

Develop the skills and proficiency to independently operate and troubleshoot various instruments and equipment used in pharmaceutical manufacturing processes.

V.1

Lecture and lab

Exam, quiz, and lab assessment

3.2

Acknowledge the importance of environmental sustainability and safety in pharmaceutical manufacturing and assume responsibility for minimizing environmental impact and ensuring workplace safety.

V.3

Lecture and lab

Exam, quiz, and lab assessment

 

C. Course Content:

No

List of Topics

Contact Hours

  1.  

Introduction to pharmaceutical technology

2

  1.  

Mixing

4

3.

Particle size reduction

4

4.

Particle size enlargement

4

5.

Lyophilization

2

6.

Spray drying

2

7.

Tablet manufacturing

6

8.

Coating

4

9.

Modern manufacturing technologies

4

Total

32

 

 

List of lab topics

 

 

  1.  

Course introduction

2

 

  1.  

Concept and process of mixing

4

 

  1.  

Concept and process of size reduction

4

 

  1.  

Particle size analysis

2

 

  1.  

Preparation and evaluation of granules

4

 

  1.  

Preparation and evaluation of tablets

4

 

  1.  

Tablet coating; process and principles

2

 

  1.  

Preparation and evaluation of a freeze dried formulation.     

2

 

  1.  

Preparation and evaluation of a spray dried formulation

2

 

  1.  

Preparation of nanoformulation and particle size analysis

4

 

  1.  

Practical final exam

2

 

Lab Total

32

 

Total

64

 

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

Quizzes/assignment/ presentation and individual evaluation

Over the semester

15%

  1.  

Midterm Exam

8-9

20%

  1.  

Practical Assessment

Over the semester

25%

4.

Final Exam

17-19

40%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

  • Ansel’s Pharmaceutical Dosage Forms and Drug Delivery System
  • Aulton's Pharmaceutics: The Design and Manufacture of Medicines

•   Developing oral solid dosage forms ‘pharmaceutical theory and practice

•   Tutorial Pharmacy; Cooper and Gunn's, Ed. S J Carter

Supportive References

 

Electronic Materials

 

Other Learning Materials

 

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

Classrooms, laboratories

Technology equipment

(Projector, smart board, software)

Internet access

Other equipment

(Depending on the nature of the specialty)

Laboratory room

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

A. General information about the course:

1. Course Identification:

1. Credit hours: (3+0)

 

2. Course type

A.

☐ University

☐ College

☒ Department

☐ Track

 

B.

☒ Required

☐ Elective

3. Level/year at which this course is offered: (Second year, Level 3)

4. Course general Description:

This course deals with the development of scale-up manufacturing processes of pharmaceuticals. Plant design/plant layout of large-scale manufacturing unit for sterile and nonsterile products will be covered. Pilot plant/scale-up techniques, technology transferring procedures from R&D results to a pilot plant, and then to production scale will be determined. The dimensional analysis and scale up in theory and industrial application of pharmaceutical products will be discussed. Finally, the engineering aspects of scale up processes and pilot plant design of various pharmaceutical dosage forms such as tablets, capsules and liquid dosage forms will be described.

5. Pre-requirements for this course (if any):

 

None

 

6. Pre-requirements for this course (if any):

 

None

 

7. Course Main Objective(s):

  • Define various scale-up approaches for pilot plants.
  • Describe the plant design and layout for a large-scale manufacturing facility for sterile and nonsterile products.
  • Explain the processes for transferring R&D results from the lab to the pilot plant, and then to the production scale.
  • Identify the dimensional analysis and scale-up process of several pharmaceutical dosage forms, including tablets, capsules, and liquid dosage forms.
  • Elucidate the engineering aspects of scale-up processes and pilot plant design.
             

2. Teaching Mode: (mark all that apply)

No

Mode of Instruction

Contact Hours

Percentage

1

Traditional classroom

48

100

2

E-learning

 

 

3

Hybrid

  • Traditional classroom
  • E-learning

 

 

4

Distance learning

 

 

 

 

3. Contact Hours: (based on the academic semester)

No

Activity

Contact Hours

  1.  

Lectures

48

  1.  

Laboratory/Studio

 

  1.  

Field

 

  1.  

Tutorial 

 

  1.  

Others (specify)……

 

 

Total

48

 

 

B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods:

Code

Course Learning Outcomes

Code of CLOs aligned with program

Teaching Strategies

Assessment Methods

1.0

Knowledge and understanding

1.1

Solve the encountered production problems for improved large-scale manufacturing of pharmaceuticals. 

K1

Lectures

 

Midterm exams, quizzes, and final exams of theoretical parts.

1.2

Illustrate theory and practice to solve qualitative and quantitative problems of a familiar and unfamiliar nature.

K2

Lectures

Midterm exams, quizzes, and final exams of theoretical parts.

1.3

Demonstrate the critical thinking through their differentiation, contrast, and criticism of the presented information.

K3

Lectures

Midterm exams, quizzes, and final exams of theoretical parts.

2.0

Skills

2.1

Compare the information will be given in a seminar style.

S1

Lectures

 

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

2.2

Assess the students during presentation

S2

Lectures

 

Quizzes, Exams (theoretical), HomeWorks, group discussions & assignments.

3.0

Values, autonomy, and responsibility

3.1

Demonstrate good communication with instructors and staff.

 

V1

Lectures, Practical works, Group discussions, HomeWorks and assignments.

Practical Preparations, group discussions, HomeWorks & assignments.

3.2

Questions and illustrate the topics in large-scale manufacturing of pharmaceuticals as per the specific situations.

V2

Lectures, Practical works, Group discussions, HomeWorks and assignments.

Practical Preparations, group discussions, HomeWorks & assignments.

3.3

Organize group work, manage a project, and respond to class discussions on a regular basis.

V3

Lectures, Practical works, Group discussions, HomeWorks and assignments.

Practical Preparations, group discussions, HomeWorks & assignments.

C. Course Content:

No

List of Topics

Contact Hours

  1.  

Dimensional analysis and scale-up in theory and industrial application.

3

  1.  

Development of large-scale manufacturing of pharmaceuticals.

3

  1.  

Plant design, pilot plant scale-up techniques, and plant layout of large-scale manufacturing unit of pharmaceutical products (solutions, semisolid products)

3

  1.  

Plant design, pilot plant scale-up techniques, and plant layout of large-scale manufacturing unit of pharmaceutical products (Solid, Sterile products)

3

  1.  

Technology transfer from R&D to a pilot plant then plant scale.

3

  1.  

Parenteral and nonparenteral pharmaceutical products scale-up.

3

  1.  

Scale-up considerations for biotechnology-derived products.

3

  1.  

Practical aspects of tableting scale-up. (part 1)

3

  1.  

Practical aspects of tableting scale-up. (part 2)

3

  1.  

Batch size increase in dry blending, mixing and powder handling.

3

  1.  

Scale-up in the field of granulation and drying.

3

  1.  

Scale-up of the compaction of tablet and film coating process.

3

  1.  

Dimensional analysis of the tableting process.

3

  1.  

Engineering aspects of process scale-up and pilot plant design.

3

  1.  

A collaborative search for efficient methods of ensuring unchanged product quality and performance during scale-up of immediate-release solid oral dosage forms.

3

  1.  

A collaborative search for efficient methods of ensuring unchanged product quality and performance during scale-up of sustained-release solid oral dosage forms.

3

Total

48

 

D. Students Assessment Activities:

No

Assessment Activities *

Assessment timing

(in week no)

Percentage of Total Assessment Score

  1.  

Quizzes/assignment/ presentation and individual evaluation

Over the semester

20%

  1.  

Midterm Exam

8-9

30%

4.

Final Exam

17-19

50%

 

Total

 

100%

*Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.)

E. Learning Resources and Facilities:

1. References and Learning Resources:

Essential References

  • Pharmaceutical Process Scale-up, 3rd Edition by Michael Levin
  • PILOT PLANTS AND SCALE-UP OF (Special Publications) (Vol 2) 1st Edition by W. HOYLE 
  • Bentley's Textbook of Pharmaceutics - E-Book By Sanjay Kumar Jain, Vandana Soni
  •  Pharmaceutical Dosage Forms and Drug Delivery by H. C. Ansel, N. G. Popovich. 9th edition 2011.
  • Comprehensive Pharmacy Review, Leon Shargel, 8th Edition, 2012 Lippincott Williams & Wilkins.
  • Remington; The science and Practice of Pharmacy; 21st Edition, volume 1 & 2, 2005.

Supportive References

  • International Journal of Pharmaceutics
  • Journal of Pharmaceutical Sciences
  • AAPS PharmSciTech
  • Drug development and Industrial Pharmacy

Electronic Materials

  • www.pubmed.com
  • www.sciencedirect.com
  • www.emedicine.com
  • www.blackwell.com
  • www.ovid.com

Other Learning Materials

 

 

2. Educational and Research Facilities and Equipment Required:

Items

Resources

facilities

(Classrooms, laboratories, exhibition rooms, simulation rooms, etc.)

  • The classroom utilizes lecture rooms with Smart Board, data show presentation, and animated simulations of topics under discussion.
  • A questions and answers approach centered on enhancing student critical thinking is used.
  • Laboratory emphasis is placed on individual and group study designed to enhance and augment, in a practical manner, the theoretical portion of the course.

Technology equipment

(Projector, smart board, software)

  • Computers, Data Show, internet data bases, Saudi digital library (SDL), Smart Boards.

Other equipment

(Depending on the nature of the specialty)

 

 

F. Assessment of Course Quality:

Assessment Areas/Issues 

Assessor

Assessment Methods

Effectiveness of teaching

Students, Faculty members, QA members, Program and Course Coordinators

Surveys, Peer Assessment

Effectiveness of students assessment

Faculty

Direct, indirect

Quality of learning resources

Students, Faculty, Peer Reviewer

Peer evaluation, Student feedback survey

The extent to which CLOs have been achieved

Faculty

Direct, indirect

Other

 

 

Assessor  (Students, Faculty, Program Leaders, Peer Reviewer, Others (specify)

Assessment Methods (Direct, Indirect)

 


 [A1]Its not a Values, autonomy, and responsibility

 [A2]Changed as required

 [A3] [A3]Its not a Values, autonomy, and responsibility

Ypu can delete it

 [A4]Changed as required

 [A5]Need to change, these domains could be matched with knowledge not with values and responsibility

 [A6]Changed as required

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