Pharmaceutical Technology I+ Lab.I

Course Code:

PHAR 303

Course Period:

Autumn

Course Type:

Core

P:

4

Lab:

0

Credits:

6

ECTS:

6

Course Language:

English

Course Coordinator:

Çetin TAŞ

Courses given by:

Çetin TAŞ

Gülengül DUMAN

Juste BARANAUSKAITE ORTASÖZ

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, transdermal systems and aerosol dosage forms. 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 true, E: Oral Exam F: Portfolio, G: Contribution 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 all 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	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	Demonstration on the formulation and preparation of topical and oral solutions	Textbook, Course notes
2	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.	Demonstration on the formulation and preparation of topical and oral suspensions	Textbook, Course notes
3	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.	Formulate and prepare topical solutions	Textbook, Course notes
4	Provide fundamentals of the preformulation studies and how the physicochemical, physicomechanical, and biopharmaceutical properties data generated during these studies can impact candidate selection, formulation design, choice of drug delivery technology, drug product manufacturing process	Formulate and prepare topical solutions	Textbook, Course notes
	MIDTERM I	Formulate and prepare oral solutions & Techniques for Small-scale Syrup Formulation Preparations (Compounding	Textbook, Course notes
5	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 topical and oral suspensions	Textbook, Course notes
6	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 and oral suspensions & Characterize the desired rheological behavior of suspensions.	Textbook, Course notes
7	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	Lab Midterm-	Textbook, Course notes
8	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.	Demonstration on the formulation and preparation of emulsions	Textbook, Course notes
9	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).	Formulate and prepare emulsions & Describe and/or demonstrate 3 methods of emulsion & Perform Quality Control process for emulsions	Textbook, Course notes
10	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.	Formulate and prepare creams and ointments & Perform Quality Control process for creams and ointments	Textbook, Course notes
11	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.	Formulate and prepare in situ gels	Textbook, Course notes
12	Proper preparation of all kinds of ointment bases and solid drug integration into ointment base. Establishing the relationship between the content and type of ointment base and the release of the contained drug.	Prepare and dispense suppository formulations	Textbook, Course notes
13	Descrbe the ‘Transdermal Dosage Forms’ and explain the advantages and disadvantages of trandermal patch system and components	Prepare and dispense pastes	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	Lab Final	Textbook, Course notes
	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	Midterms, Lab Midterm, Final Exam

Assessment

IN-TERM STUDIES	NUMBER	PERCENTAGE
Midterm Exam	1	25
Lab.	1	25
Lab Final	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
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.			X
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.				X
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.				X
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.					X

ECTS

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION
Activities	Quantity	Duration (Hour)	Total Workload (Hour)
Course Duration	14	4	56
Hours for off-the-classroom study (Pre-study, practice)	14	1	14
Midterm Exams	1	2	2
Lab. Applications	14	4	56
Hours for off-the-Lab. study (Pre-study, practice)	14	1	14
Lab. Midterm Exam	1	4	2
Lab. Final	1	4	2
Homework	1	1	1
Final	1	2	2
Total Work Load			149
Total Work Load / 25 (h)			5,96
ECTS Credit of the Course			6

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