PFT501 - Pharmaceutical Manufacturing Methods I

Outline info
Last revision date 2018-07-20 11:49:12.777
Last review date 2018-07-20 11:49:21.475

Subject Title
Pharmaceutical Manufacturing Methods I

Subject Description
This subject is an introduction to the methods related to the production of pharmaceuticals. Several dosage forms such as solids, liquids, semi-solids, and parenterals are discussed. In each, the merits of the type, composition, handling, processing, testing and equipment used are discussed to provide a foundation from which more specific training can be undertaken. Regulatory requirements which serve as controls, as well as the rationale which support their application are discussed and applied to areas of plant operations. (Lecture only)

Credit Status
One credit toward the Industrial Pharmaceutical Technology Certificate Program

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Analyze the use of materials, equipment, and facilities for manufacture of pharmaceutical products.

2. Demonstrate an understanding of the regulatory requirements and control of variability of manufacturing processes (process validation).

3. Demonstrate familiarity with the merits, composition, and handling of various dosage forms.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on for further information regarding cheating and plagiarism policies and procedures.

All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.


Topic Outline

  • Drug
  • New drug development
  • New Drug approval process
  • Standards - USP, NF

Dosage Form Design
  • Biopharmaceutic consideration
  • Drug absorption metabolism and excretion processes
  • Routes of drug administration

Dosage Form Design
  • General formulation considerations
  • Pharmaceutic ingredients, packaging labeling and storage of pharmaceuticals

Solid Dosage Form I
  • Powders and granulation technology
  • Capsulation technology
  • Capsulation equipments

Solid Dosage Form II
  • Compression technology
  • Tabletting equipment

Solid Dosage Form III
  • Coating technology
  • Modified release

  • Equipment
  • Components
  • Labeling

Quality assurance and control / Good manufacturing practices (GMP, cGMP)

Liquid Oral Dosage Form
  • Water system
  • Oral solutions, syrups and elixirs
  • Oral suspensions

Semisolid Manufacturing Technology
  • Emulsions, parenterals
  • Method of sterilization
  • Manufacturing and packaging of parenterals
  • Biologicals
  • Ointments, creams and lotions
  • Transdermal
  • Suppositories
  • Gels
  • Ophthalmic, nasal, otic, and oral preparations applied topically
  • Stability and process validation
  • Aerosols
  • Inhalations
  • Sprays

Mode of Instruction
Lectures combined with group and individual assignments, guest speakers, and practical demonstrations (subject to available facilities) along with the possibility of a field trip to a manufacturing plant (if available by all students). Students will be expected to meet reading assignments and submit reports word processed (unless otherwise stated by instructor). 

Prescribed Texts
Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, 10th Edition; Howard C. Ansel, Lloyd V. Allen Jr. and Nicholas G. Popovich; Publisher: Lea Febriger Moseby Publisher; ISBN: 9781451188769

Reference Material
Remington's Pharmaceutical Sciences, Mack Publishing Co.  

Required Supplies

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online ( or at Seneca's Registrar's Offices.

Modes of Evaluation

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:

Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed. 

Grading is based on the following marking scheme:
Mid Term Examination 30%
Assignments 30%
Final Exam 40%

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.


Approved by: Denis Gravelle