Pharmaceutical Technology II+Lab.II

Course Code:

PHAR 308

Course Period:

Spring

Course Type:

Core

P:

4

Lab:

0

Credits:

6

ECTS:

7

Course Language:

English

Course Coordinator:

Çetin TAŞ

Courses given by:

Çetin TAŞ

Gülengül DUMAN

Juste BARANAUSKAITE ORTASÖZ

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.	1,2,3,4,6,7,10	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.	1,2,3,4,5,6,7,8,9,10	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	1,3,5,10	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...	Demonstration on pharmaceutically and physiologically acceptable ophthalmic and nasal solutions	Textbook, Course notes
2	Describe the use buffers in pharmaceutical solutions. Identify the range of solution pH considered safe for ophthalmic and nasal solutions. Formulate and analyze a buffer solution of desired pH and buffer capacity. Explain the importance of isotonicity in ophthalmic and nasal solutions. Explain the importance of sterility in ophthalmic solutions.	Demonstration on pharmaceutically and physiologically acceptable parenteral 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	Formulate and prepare pharmaceutically and physiologically acceptable ophthalmic solutions and nasal solutions	Textbook, Course notes
4	Make calculations related to the administration of small and large volume parenteral products (i.e. related to concentration, dose, rate of administration). Describe special precautions for producing, sterilization and quality conrol managements.	Formulate and prepare pharmaceutically and physiologically acceptable ophthalmic solutions and nasal solutions	Textbook, Course notes
5	Describe Total Parenteral Nutrition (TPN), calculations, incompatibility issues and clean room requirements for production of TPN.	Techniques for Small-scale Parenteral Preparations (Compounding) Sterliztion process application: (Steam sterilization, filtration sterilization vb)	Textbook, Course notes
	MIDTERM		Textbook, Course notes
6	Describing mean diameters for particle sizes, sieving standard, particle size reduction and surface activity, surface area pore size measurements	Formulate and prepare parenteral admixtures	Textbook, Course notes
7	Powders, Granules definitions and describing thier properties and list variety of types of powders and granules. Describe appropriate uses of pharmaceutical powders and granules.	Lab Midterm	Textbook, Course notes
8	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	Demonstration on powders and granule and effervescent granules	Textbook, Course notes
9	Describe the advantages and limitations of tablets as dosage forms. Describe three methods of tablet preparation.	Compound and dispense divided and bulk powders and granule and effervescent granules.	Textbook, Course notes
10	Describe the official USP tests required of tablets. Evaluate tablets as a unit dosage form by performing and analyzing data from official USP tests.	Prepare and dispense capsule formulations Prepare and dispense hard and soft Lozenge formulations	Textbook, Course notes
11	Describe dosage forms having drug release features based on time, course, and/or location which are designed to accomplish therapeutic or convenience objectives not offered by conventional or immediate release forms	Evaluate tablet coating process	Textbook, Course notes
12	This course is intended to provide a basic to advanced level understanding on developing a stability program to support the expiration dating of pharmaceutical products. Content will focus on different aspects from development to commercial to understand the stability profile of drug substance and drug products.	Prepare and dispense tablet formulations	Textbook, Course notes
13	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	Evaluate tablet finished product controls	Textbook, Course notes
14	Industrial production design, facilities of pharmaceutical plants, GMP, GLP and quality assuarance of pharmaceutical products	Lab Final	Textbook, Course notes
15	FINAL EXAM		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	Midterm, Lab Midterm, Final Exam

Assessment

IN-TERM STUDIES	NUMBER	PERCENTAGE
Midterm Exams	1	25
Lab.	1	25
Final Exam	1	50
Total		100

COURSE CATEGORY

√Compulsary/Elective

Course’s Contribution to Program

No	Program Learning Outcomes	Contribution
No	Program Learning Outcomes	1	2	3	4	5
1	Has national and international up-to-date, theoretical and applied knowledge in the field of pharmacy.					X
2	Defines problems related to the profession, collects data, evaluates its accuracy and reliability, develops evidence-based solutions, shares them with healthcare professionals, makes necessary explanations to other people.					X
3	Communicates accurately and effectively in accordance with cultural and ethical values with all relevant professional groups, especially those working in the field of health, and all segments of society, using information and communication technologies.				X
4	Takes into account the law and ethics when dealing with public health issues.			X
5	Acts as a pharmacist with high career awareness, self-confidence, leadership spirit, who is prone to teamwork, entrepreneurial, productive and able to manage financial resources.			X
6	Based on the principle of pharmaceutical care, Acts as an easily accessible health consultant with a patient-oriented approach and plays an active role in constantly informing the society.					X
7	Improves his/her knowledge by participating in in-service training and activities in line with the needs of the century and society, takes part in the professional development of colleagues and adopts the lifelong learning principle				X
8	Suggests and manages multidisciplinary / interdisciplinary research and development projects related to pharmaceuticals, cosmetics, medical devices and shares their results.			X
9	Applies knowledge and skills for the benefits of the society taking part in social responsibility projects.				X
10	Fulfills the requirements of quality management systems using the theoretical and applied knowledge acquired in the field.				X

ECTS

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION
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	2	32
Midterm Exams	2	5	10
Lab. Applications	16	1	16
Hours for off-the-Lab. study (Pre-study, practice)	16	2	32
Lab. Midterm Exam	1	4	4
Lab. Final	1	5	5
Homework	1	2	2
Final	1	6	6
Total Work Load			171
Total Work Load / 25 (h)			6,84
ECTS Credit of the Course			7

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