PFT907 - Production Formulation

Outline info
Last revision date 2018-07-20 11:50:02.293
Last review date 2018-07-20 11:50:34.761

Subject Title
Production Formulation

Subject Description
This advanced subject focuses on the theoretical and practical aspects of formulation of solid, semi-solid, and liquid pharmaceutical products. New dosage form development is discussed in terms of: new drug development and approval process; dosage form design; manufacturing methods; development of stability programs. (Lectures and Labs)

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. Describe in detail the formulation and process development of a wide range of pharmaceutical dosage forms.

2. Recognize efficacy, safety and stability as being the three key elements in the development of new drug products.

3. Investigate the effect of raw and packaging materials on the physical and chemical stability of finished products.

4. Describe various methods employed to manufacture solid, liquid and semi-solid dosage forms.

5. Apply experimental techniques to evaluate properties of powders including flow and density.

6. Apply experimental techniques to determine the type of emulsifying agents required to form micro and macroemulsions.

7. Demonstrate a knowledge of pharmaceuticals development using small-scale, pilot scale and large-scale study techniques.

8. Be cognizant of analytical techniques used to evaluate the stability of a new formulation.

9. Explain the role played by Health Canada and the FDA in the approval of a new pharmaceutical product to the market place.

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.

PFT501 Pharmaceutical Manufacturing Methods I

Topic Outline
Orientation and Introduction, Test and Assignment Dates
Laboratory Safety and WHMIS overview
New Drug Development and Approval Process
Concept of Dosage Form Design:

1. General Considerations - Pre-Formulation, Formulation and scale up
2.  Biopharmaceutic Considerations
3. Dosage and Pharmaceutical Ingredients
Solid Dosage Forms:
Formulation Development and Manufacturing - Powders, Blends, Granules (Wet and Dry Granulation).
Micromeritics (The Science of Small Particles)
PRACTICAL:  Preparation of Direct Blends and Granule Blends.
Physical Characterization of Blend Including Particle Size Distribution, Density and Flow Test

Solid Dosage Forms:
Formulation Development and Manufacturing - Tablets and Capsules Dosage Forms
PRACTICAL:  Preparation of Tablets and Determination of Tablets Properties (Weight Variation, Hardness, Thickness, Friability and Disintegration)

Liquid Dosage Forms:
Formulation and Manufacturing of Solutions, Syrups and Suspensions
PRACTICAL:  Medicated Syrup and/or Suspension is Formulated and Prepared

Semi-Solid Dosage Forms:
The formulation and Manufacturing methods of Emulsion, Creams, Ointments and Pastes
PRACTICAL:  A Hydrocarbon Base Ointment and Cream is Formulated and Prepared

Product Stability:
Chemical and Physical Factors Contributing to Drug and/or Finished Product Stability
Regulatory Requirements for a Stability Program
Design and Implementation of an In House Stability Program
PRACTICAL: A Topical Cream is Formulated and Prepared

Mode of Instruction

  • Lectures on subject matter
  • Audio-visual presentations
  • Research and written dissertations
  • Practical lab work

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: Lippincot, Williams &  Wilkins; ISBN: 9781451188769

Reference Material

Required Supplies
All students must wear a laboratory coat and safety glasses while in the lab.  This requirement is mandatory and consistent with safe practice.  Anyone not having the mandatory requirements will be asked to leave the lab.

Metric Ruler, Calculator, Graph Paper, Laboratory Coat, Safety Glasses

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 (Theory) 20%
Assignment: (Practical) 20%
Final Exam (Theory 30% and Practical (30%) 60%


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