PFT934 - Formulation of Solid Dosage Forms

Outline info
Last revision date 2018-07-20 11:50:07.798
Last review date 2018-07-20 11:50:41.492

Subject Title
Formulation of Solid Dosage Forms

Subject Description
This subject covers the physical and chemical factors considered important in the formulation of effective and safe solid dosage forms. (Lectures 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. Demonstrate an understanding of the development approach to solid dosage forms.

2. Determine the effect of the qualities and properties of materials on solid dosage forms.

3. Assess the effect of processing techniques on solid dosage forms.

4. Describe pharmaceutical manufacturing methods for solid dosage forms.

5. Explain the various types of process validation for solid dosage forms.

6. Explain stability evaluation requirements for solid dosage formulations.

7. Explain bio-availability and bio-equivalence requirements of a new solid dosage form.

8. Discuss regulatory requirements related to solid 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.

Pharmaceutical Manufacturing Methods I (PFT501)

It is the student's responsibility to ensure that the prerequisites are met.  If you do not have the required prerequisite subject or advanced standing for the prerequisite subject, you will be asked to withdraw with the risk of academic/financial penalty.

Topic Outline
Introduction: Overview of solid dosage forms & their formulation.

Physical properties affecting formulation:  physical form, particle size, crystal form, bulk control, solubility, wetting of solids, flow, cohesiveness, compressibility and organoleptic properties.

Chemical properties affecting formulation: hydrolysis, oxidation, racemization, polymerization, isomerization, decarboxylation, enzymatic decomposition.

Tablet ingredients and tablet characteristics: diluents, lubricants, disintegrators, coloring agents and flavoring agent.
Friability and abrasion, tablet hardness, thickness, weight, disintegration, dissolution and content uniformity.

Methods of tablet preparation: wet granulation method, dry granulation method, spheronization, spray-congealing, spray drying and molded tablets.

Tablet machines: single-punch machine, rotary tablet machine, high speed rotary tablet machine, multilayer rotary tablet machine.  Capping and splitting of tablets, contamination control.

Source of information: Internet, books, magazines.

Tablet Formulation:  wet granulation methods, dry granulation method, direct compression method.
A typical  format of master formula, manufacturing and packaging directions, SOP, C of A, and flow chart used in the Canadian pharmaceutical industry.

Tablet coating: coating equipment, coating pans,  ancillary pan-coating equipment.  Sugar coating of compressed tablets:  sugar coating formulations, sugar coating process, sugar coating problems.
Film coating of compressed tablets:  coating solution and suspension
Film Coating process.
Enteric Coating: coating process.

Manufacturing and characteristics of capsules: Hard gelatin capsules

Extemporaneous filling methods
Machine filling methods
Soft gelatin capsules
Plate process, rotary die process, Norton capsule machine, Accogel capsule machine, microencapsulation
Manufacturing of pills, preparation of mass, rolling the pills, pill making machine

Process validation, retrospective validation, stability, shelf life determination, cleaning validation.

Presentation of assignment by each student in the classroom with question and answer session.

Mode of Instruction
Research and written dissertations

Prescribed Texts
Instructor hand-outs

Reference Material
Remington's Pharmaceutical Sciences – Mack Publishing Co.
United States Pharmacopeia (USP) 

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 30%
In-Class Exercises 20%
Final Exam 50%

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