Syllabus(Manufacturing Pharmacy)

A Syllabus for the Proposed Pharmacy Curriculum SY 2005-2006

Course Title : Manufacturing Pharmacy
Course Number : Pharmaceutics II
Credit Units : 3 units (lecture) / 2 units (laboratory)
Course Description : This course presents the basic principles, methods and technology involved in the production of various drug dosage forms and delivery systems, from the initial design of the dosage forms to their actual manufacture, including the requirements for packaging, equipment and facilities.
Prerequisite(s) : Pharmaceutics I and Physical Pharmacy
Placement : 3rd year, 2nd semester
General Objectives : At the end of the course, the students should be able to:
1. enumerate and discuss the requirements for facilities, equipment, methods and processes, organization and personnel as specified in the Current Good Manufacturing Practices (CGMPs);
2. outline the different pharmaceutical unit operations;
3. describe the principles and technology involved in the design, formulation, manufacture and packaging of the various drug dosage forms and delivery systems;
4. discuss how adjuvant ingredients, technological procedures, and material physical and chemical properties affect the formulation, design and production of the various drug dosage forms.

Course Outline :

First Grading Period
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
At the end of the chapter, the students should be able to:
1. identify and describe the functions of the different departments/sections in a pharmaceutical firm;

A. Organizational structure of a pharmaceutical company
B. Current Good Manufacturing Practices (CGMPs)
C. Preformulation Process 15 hours Lecture with audio-visual presentation

Class discussion

Written examinations, assignments, quizzes, graded recitation
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
2. discuss the importance of CGMPs;
3. explain the importance of preformulation in the production of medicines;
4. describe the general pharmaceutical plant design conforming to the provisions of the CGMPs;
discuss the proper system in handling pharmaceutical materials. A. General pharmaceutical plant design and construction, room classification based on air particle density, environmental control (humidity, temperature and air-conditioning), and industrial hazards and safety.
B. Material handling systems for solids, liquids and gas

Second Grading Period
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool

At the end of the chapter, the students should be able to:
1. cite and discuss the different unit operations and equipment for pharmaceutical production;
2. identify and describe the specific production facilities, raw materials used in the formulations and methods of manufacturing the various dosage forms;
3. integrate CGMP in the manufacture of pharmaceutical dosage forms. C. Pharmaceutical unit operations and equipment: milling, granulation and size separation; mixing; filtration; drying
D. Facilities, materials, methods and technology in the design, formulation and production of various dosage forms:
1. Solid dosage forms:
a. Tablets (immediate release and controlled release)
b. Capsules
2. Non-sterile liquid dosage forms:
a. solutions
b. suspensions and lotions
c. emulsions
3. Semi-solid dosage forms and other topical products:
a. ointments
b. creams
c. gel 15 hours Lecture with audio-visual presentation

Class discussion

Written examinations, assignments, quizzes, graded recitation
Final Grading Period
At the end of the chapter, the students should be able to:
1. identify and describe the specific production facilities, raw materials used in the formulations and methods of manufacturing the various dosage forms;
2. describe different methods of sterilization;
3. explain the importance of depyrogenation in the preparation of sterile products;
4. discuss the formulation and production technology of cosmetics;
5. discuss the packaging principles and technology in cosmetics. 6. Aerosols and inhalations
7. Sterile products and ophthalmic preparations
8. Implantable preparations
9. Transdermal drug delivery systems
G. Cosmetics
1. Lipstick
2. Shampoo
3. Face powder
4. Soap
5. Toothpaste 15 hours Lecture with audio-visual presentation

Class discussion

Written examinations, assignments, quizzes, graded recitation
References : H. Ansel, L. Allen Jr., N. Popovich. Pharmaceutical Dosage Forms and Drug Delivery Systems
WHO’s Good Manufacturing Practice and Inspection
A. Wade and P.J. Walker. Handbook of Pharmaceutical Excipients
A. Gennaro. Remington: the Science and Practice of Pharmacy. Latest Edition.
S. Turco. Sterile Dosage Form. 4th Edition
L. Lachman, et.al. The Theory and Practice of Industrial Pharmacy. 3rd Edition.
G.S. Banker and C.T. Rhodes. Modern Pharmaceutics. 4th Edition.