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Course Code: 
PHAR 303
Course Period: 
Autumn
Course Type: 
Core
P: 
4
Lab: 
4
Credits: 
4
ECTS: 
6
Course Language: 
English
Course Objectives: 
This course teaches the scientific background and technical aspects important in dosage form design, basic dosage forms and their therapeutic applications. This course will focus on the biopharmaceutical considerations and physicochemical foundation of various dosage forms. Discussion will include preformulation factors (melting point, solubility, viscosity, dissolution, particle and solid state properties), rheology, pharmaceutical solutions, colloids and dispersions, suspensions, emulsions,ointments, suppositories. The course is also 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 purpose of this course is to provide a foundation in the basic concepts of pharmaceutics that are the foundation of drug delivery. The course begins by presenting the molecular basis for aqueous and lipid solubility of drugs, pharmacokinetic principles that are related to dosage forms, mechanisms by which excipients or manufacturing processes affect bioavailability, and chemical kinetics applied to the shelf-life of dosage forms. The pharmaceutics principles are then applied to successively more complex liquid dosage forms: solution, emulsion, and suspension. The excipients that are required to prepare the dosage forms: buffers, preservatives, emulsifiers, suspending agents, wetting agents, etc. and the method of preparing each dosage form in both a compounding and manufacturing setting are covered

b)Laboratory applications

Formulate and prepare pharmaceutically and physiologically acceptable solutions, colloids and dispersions, suspensions, emulsions,ointments, suppositories and  methods of formulations  and their 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 choose , 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 all 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

Teoritical Topics                                     

Lab content

Study Materials

1

Define Drugs, Dosage Forms and Describe their Necessity, Describe New Drug Discovery &Approval Process and Role of Pharmaceutical Technology in the Process, Explain Factors Considered in Design of Dosage Forms, Explain Scale of Preparation of Dosage Form, Describe Drug Standards, Harmonization of Standards and Registration Procedure

Formulate and prepare pharmaceutically and physiologically acceptable topical solutions

Textbook, Course notes

2

Explain Water as a Key Pharmaceutical Utility  and Types of Pharmaceutical Waters, Explain Why municipal Water is not Suitable for Pharmaceuticals, Describe Water Purification Systems, Describe Storage and Distribution System for  Pharmaceutical Water, Describe Validation Process of Water Systems, Describe Quality Control Tests for Pharmaceutical Waters

Formulate and prepare Physiologically acceptable topical solutions

Textbook, Course notes

3

Define pharmaceutics and pharmaceutical dosage forms (i.e., medications used by patients). List different routes for administration of medications.

Discuss types of dosage forms and administration routes in relation with therapeutic outcomes. Apply physicochemical and biopharmaceutic concepts to interpret dosage form design.

Techniques for Small-scale Syrup Formulation Preparations (Compounding)

Textbook, Course notes

4

Explain physicochemical principles relevant to pharmaceutical dosage forms.

Describe biopharmaceutic considerations in the pharmaceutical dosage form design and discuss how

this consideration is applied to the selection of different dosage forms, design and composition of

pharmaceuticals.

 

Techniques for Small-scale Syrup Formulation Preparations (Compounding)

Textbook, Course notes

5

Give Examples of Marketed Solution Preparations, Definition,  Explain Advantages and Disadvantages of Solution, Explain Various Types of Solutions, Describe Formulation Ingradients for Solutions, Describe Aqueous and Nonaqueous Solvents, Approaches to Improve Drug’s Aqueous Solubilty, Describe Method of Preparation of Solution, Describe Quality Control and Stability Tests for  Solutions

Formulate and prepare Topical Suspension Formulation

Textbook, Course notes

6

Theory of Disperse Systems A study of disperse systems including small particle technology, interfacial phenomena, electrokinetic and rheological properties of materials in colloidal and coarse dispersions. To learn pharmaceutical colloidal and dispersion formulations, and to understand the basic concepts of colloid and surface chemistry and their application to design of good pharmaceutical

products.

Formulate and prepare Oral Suspension Formulation

Textbook, Course notes

7

MIDTERM I

-

Textbook, Course notes

8

Define and describe the physical characteristics of pharmaceutical suspensions. Define flocculation and aggregation. Identify a stable (flocculated) suspension, by visual inspection or by verbal description of its appearance and physical characteristics. Describe the effect of viscosity on the sedimentation rate of suspensions. Identify/describe the role of formulation aids in the preparation of suspensions. (e.g., electrolytes, viscosity enhancers).

Prepare, label, and dispense an oral  suspension. Characterize the desired rheological behavior of suspensions.

 

Textbook, Course notes

9

Define and/or identify emulsions and emulsifying agents. Identify two factors that determine emulsion type (o/w vs. w/o). Describe the levels of instability to which emulsions are subject. Describe 3 mechanisms by which emulsions are stabilized. Classify emulsifying agents by type and describe their uses, advantages, limitations. Define and calculate HLB for any nonionic surfactant system. Identify pharmaceutical uses of emulsions.

Describe and/or demonstrate 3 methods of emulsion

Textbook, Course notes

10

Classify an ointment base formulation as 1 of 5 types. Describe the physical properties of ointment bases and determine the purposes for which they are best suited.

Describe and/or demonstrate different  methods of ointment preparation.

 

Textbook, Course notes

11

Extemporaneously prepare each type of ointment base and incorporate a solid drug into it. Relate the composition and type of ointment base to the release of a drug contained therein.

Prepare and dispense ointment preparations.

 

Textbook, Course notes

12

Midterm II

-

Textbook, Course notes

13

Give Examples of Marketed Suppository Preparations, Definition,  Explain Size and Shapes,  Routes of Application of Suppositories, Explain Advantages and Disadvantages, Explain Suppositories for local and Systemic Action, Explain Factors affecting drug absorption for Systemically Acting Suppositories, Describe Ingredients for suppositories/ formulation, Describe Methods for Preparation, Packaging and Storage of Suppositories, Describe Quality Control Tests for Suppositories, Give Advice to Patients for Proper Use of Suppositories

Prepare and dispense suppository formulations 

Textbook, Course notes

14

Give Examples of Marketed Aerosol Preparations, Definition,  Explain Types of Aerosol, Explain Advantages and Disadvantages of Pharmaceutical Aerosols, Describe Components of Aerosols: Container, Valve, Propellant, Product concentrate, Explain Mode of Aerosol Operation and Quality Control Tests, Describe Aerosol Filling Methods, Describe Packaging, Labeling, and Storage for Aerosol, Give Advice to the Patients on Proper Administration of Aerosol

Stability tests

Textbook, Course notes

15

Descrbe the ‘Transdermal Dosage Forms’ and  explain the advantages and disadvantages of trandermal patch system and components.

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  Exam s

2

40

Short Exam

1

20

Lab.

1

20

Lab Final

1

20

Total

 

100

CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE

 

40

CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE

 

60

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

0,5

8

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

2

2

Lab. Final

1

5

5

Homework

1

1

1

Final

1

6

6

Total Work Load

 

 

128

Total Work Load / 25 (h)

 

 

5,12

ECTS Credit of the Course

 

 

5