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Course Code: 
PHAR 308
Course Period: 
Spring
Course Type: 
Core
P: 
4
Lab: 
3
Credits: 
4
ECTS: 
6
Course Language: 
English
Course Objectives: 
The aim of this course is to introduce the students to the principles and technologies applied in the preparation of pharmaceutical dosage forms. This includes product design, formulation, manufacture, compounding, quality control, and clinical application of the various dosage forms.
Course Content: 

a)Therotical part

The course is to train the students to the formulation, manufacture and control of pharmaceutical dosage forms on the basis on the physicochemistry and bio-pharmacy knowledges acquired. The topics detailed in course include Sterile parenteral preparations, ophthalmic preparations, as well as solid dosage forms (powders , granules, tablets, capsules, lozenges  for oral route).The course also includes the formulation, manufacture and control of conventional solid and sterile  pharmaceutical dosage forms. The course will be taught in auditorium. A personal work of the student is required for the pharmaceutical calculations. For each form, the principles of the formulation, the excipients, the methods of preparation and controls are approached.

b)Laboratory applications

 Formulate and prepare pharmaceutically and physiologically acceptable Sterile parenteral preparations, ophthalmic preparations ,powders , granules, tablets, capsules, lozenges  and their related quality controls.

Course Methodology: 
1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study
Course Evaluation Methods: 
A:Written exam, B: multiple chose , C:Filing the blank D:False and troth, E: Oral Exam F: Portfolio, G: Contrabution of course activities H:Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes

Programme learning outcomes

Teaching Methods

Assessment Methods

1) Adequate knowledge in ‘Pharmaceutical Dosage Forms’ and capable of performing duties in areas related to pharmaceutical products and their manufacturing through properly understanding the design and factors leading to obtain  high quality, safe and efficacious Pharmaceutical products.

1,2,3,4,5,6,7,8, 14

1,2,3,4,5,6,7,8

A,B,C,D,E,F,G,H

2) To provide the seminars, workshops, conferences and pharmaceutical services to the pharmaceutical industry and the community.

7,8,9,10

1,2,3,4,5,6,7,8

A,B,C,D,E,F,G,H

3) To prepare pharmaceutical formulations and quality control of pharmaceutical dosage forms

11,12,13

1,2,3,4,5,6,7,8

A,B,C,D,E,F,G,H

 
 

Course Flow

Week

Teorical Topics                                      

Lab content

Study Materials

1

Isotonicity Calculation & Ophtalmic Preparation:Define buffers, buffer capacity, isotonicity, iso-osmoticity, osmotic pressure, hypertonicity, hypotonicity. Describe the use buffers in pharmaceutical solutions. Identify the range of solution pH considered safe for ophthalmic solutions. Formulate and analyze a buffer solution of desired pH and buffer capacity. Explain the importance of isotonicity in ophthalmic solutions. Explain the importance of sterility in ophthalmic solutions. Explain the role of preservatives in pharmaceutical solutions.

.

Formulate and prepare pharmaceutically and physiologically acceptable ophthalmic solutions, nasal solutions

Textbook, Course notes

2

Describe the Sources of Microbial Contamination, Explain the Practices to Reduce Contamination, Classify Pharmaceuticals by Microbiological Quality, Define Disinfectants, Antiseptics Sanitization & Sterilization, Describe Preservative Efficacy Test, Describe Microbial Inactivation Kinetics, Describe Steam Sterilization /Autoclaving Method, Describe Dry Heat Sterilization Method

Formulate and prepare pharmaceutically and physiologically acceptable ophthalmic solutions, nasal solutions

Textbook, Course notes

3

Describe the Method of Sterilization by Radiation, Describe the method of Sterilization by Filtration, Describe Chemical Method of Sterilization, Describe New Sterilization Technologies, How to Choose a Sterilization Method, Describe Sterility Assurance Systems Describe which the Sterile Substances/Dosage Form are used in Pharmacy, Definition and Short History of Parenterals, Advantages and Disadvantages of Pareteral Applications, Describe Parenteral Routes of Administration, Describe Environments and Techniques for Small-scale Parenteral Preparations (Compounding)

Formulate and prepare pharmaceutically and physiologically acceptable ophthalmic solutions, nasal solutions

Textbook, Course notes

4

Describe and demonstrate aseptic techniques required for the preparation of parenteral admixtures. Identify potential sources of instability or incompatibility in the preparation and packaging of admixtures.

Make calculations related to the administration of parenteral products (i.e. related to concentration, dose, rate of administration). Describe special precautions to be taken in handling nutritional, cytotoxic, antimicrobial, and radiopharmaceutical solutions for parenteral administration.

Techniques for Small-scale Parenteral Preparations (Compounding)

Textbook, Course notes

5

Describe the ingredients for manufactured parenteral preparations, Describe Clean Room Classified Area, Describe how to decide which Dosage Form to Manufacture as Parenteral Preparation, Describe their Manufacturing Processes, Describe Parenteral Product Testing and Evaluation- Sterility Test, Pyrogen  Test, Clarity Test, Particulate Analysis, Leaker Test.

Sterliztion process application:

(Steam sterilization, filtration sterilization vb)

Textbook, Course notes

6

Describe Clean Room Classified Area, Describe how to decide which Dosage Form to Manufacture as Parenteral Preparation, Describe their Manufacturing Processes, Describe Parenteral Product Testing and Evaluation- Sterility Test, Pyrogen  Test, Clarity Test, Particulate Analysis, Leaker Test.

Formulate and prepare parenteral admixtures

Textbook, Course notes

7

Large Volume parenteral solution, Admixtures, Total Parenteral Nutritition, Irrigation Solutions

Formulate and prepare parenteral admixtures

Textbook, Course notes

8

Midterm I

-

Textbook, Course notes

9

Powders, Granules and and Micromeritics:

understand the properties of particles and pharmaceutical powders List and describe a variety of types of powders and granules. Describe appropriate uses of pharmaceutical powders and granules.

Compound and dispense divided and bulk powders and granule abd effervescent granules.

Textbook, Course notes

10

Describe the advantages and limitations of tablets as dosage forms. Describe the official USP tests required of tablets. Describe three methods of tablet preparation. Evaluate tablets as a unit dosage form by performing and analyzing data from official USP tests.

Prepare and dispense tablet formulations 

Textbook, Course notes

11

Describe quality controls and pharmacopeia requirements, tablets as a unit dosage form by performing and analyzing data from official USP tests.

Evaluate tablets as a unit dosage form by performing and analyzing data from official USP tests.

 

Textbook, Course notes

12

Midterm II

-

Textbook, Course notes

13

Describe the advantages and limitations of capsules as dosage forms. Describe the official USP tests required of capsules. Describe methods of hard and soft capsule preparation.

Prepare and dispense capsule formulations 

Textbook, Course notes

14

Define, Give example of, Formulate hard and soft Lozenges and Pastille, Define, Give example of,

Prepare and dispense hard and soft Lozenge formulations 

Textbook, Course notes

15

Define Packs, Primary & Secondary Packs, Describe the Role of the Packs, Explain the Factors Influencing Choice of Pack, Describe Various Types of Pharmaceutical Containers, Describe various Packaging Materials used for Pharmaceuticals

Lab Midterm

Textbook, Course notes

 
 

Recommended Sources

Textbook

Ansel, H.C., Pharmaceutical dosage forms and drug delivery systems. Lea and Febiger, Philadelphia

Additional Resources

Remington: The Science and Practice of Pharmacy, Mack Publishing Co: Easton, PA, USA, Handbook of Excipients
 

 
 

Material Sharing

Documents

Course Notes, Textbook

Assignments

Projects and Presentations

Exams

Midterms (I and II), Lab Midterm, Final Exam

 
 

Assessment

IN-TERM STUDIES

NUMBER

PERCENTAGE

Midterm  Exams

2

40

Short  Exams

1

20

Lab.

1

20

Lab. Final

   

Total

 

100

CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE

 

60

CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE

 

40

Total

 

100

 

 

COURSE CATEGORY

Compulsary/Elective

 
 

Course’s Contribution to Program

No

Program Learning Outcomes

Contribution

1

2

3

4

5

1

Acquire skills needed to practice the profession of pharmacy in either a Turkish or an English language setting.

       

2

Being equipped to access current theoretical and applied knowledge, keeping abreast of new developments, and possessing the critical faculties enabling an accurate and reliable interpretation and assessment of this information.

       

3

Having the capacity to apply the skills acquired in the field of pharmaceutical science. Possessing the ability to harness his/her acquired knowledge in order to function as a highly accessible health counsellor, providing a ready source of clinically relevant, health-related information to the general public.

       

4

Keeping abreast of and being equipped to apply the fundamental pharmaceutical and health science principles which guide future developments in modern technology, and being able to share these experiences and skills with colleagues through participatation in professional development education seminars.

   

   

5

Knowing how to assess risks arising from the use of drugs and other chemicals and those risks potentially encounterd during laboratory practice.

     

 

6

Acquiring the skills and knowledge needed to interpret findings obtained through quantative and qualitative measurements, and thus reach valid, scientific conclusions based on this data. 

       

7

Being able to compound pharmaceutical products while being knowledgable about their clinical application, interactions, side effects and risks  and apply in proper manner .

       

8

Being competent to conduct and manage research and development projects, and share experimental outcomes.

   

   

9

Be competent to accurately and intelligibly communicate clincally relevant information to patients concerning prescription items and other pharmaceutical products.  

     

 

10

Being able to function in a multidisciplinary environment. Possessing the skill to collaborate and establish lines of communication with other professionals, while developing their own professional competency through participation in relevant continuing education activities.

   

   

11

Being able to play a role in projects which fulfills the profession’s societal responsibilities. Participating in professional activities and undertaking duties in a manner which reflects an awareness of and sensitivity to environmental issues.

   

   

12

Being capable of opening a community pharmacy, practicing in a hospital pharmacy setting, and offering service in any field related to drugs, cosmetics, medical  and/or plant-derived products. Able to play an active role in his/her own personal professional development, as well as that of colleagues and pharmaceutical students.

     

 

13

Able to play a role in issues related to public health as a member of the health care team while being cognizant of and able to fulfill legal and professional requirements and maintain ethical standards. 

     

 

14

Is knowledgable of and equipped to manage the planning, development, compounding and quality control analysis of naturally occuring and synthetic medicines, while also being aware of the processes related to these products’ absorption, distribution, metabolism and excretion from the body.

       

 
 

ECTS

Activities

Quantity

Duration
(Hour)

Total
Workload
(Hour)

Course Duration (Including the exam week: 16x Total course hours)

16

4

64

Hours for off-the-classroom study (Pre-study, practice)

16

1

16

Midterm Exams

2

5

10

Lab. Applications

16

1

16

Hours for off-the-Lab. study (Pre-study, practice)

16

1

16

Lab. Midterm Exam

1

4

4

Lab. Final

1

5

5

Homework

1

2

2

Final

1

6

6

Total Work Load

 

 

139

Total Work Load / 25 (h)

 

 

5,56

ECTS Credit of the Course

 

 

6