PFT504 - Dissolution Testing of Pharmaceutical Products

Outline info
Semester
School
Last revision date 2017-05-29 00:41:45.803
Last review date 2017-07-17 00:16:29.464


Subject Title
Dissolution Testing of Pharmaceutical Products

Subject Description
Starting with the history of dissolution testing of pharmaceutical products, this subject takes the student through the theory and concepts such as bioavailability and bioequivalence and in vivo and vitro correlation. Experiments are designed with emphasis on thorough understanding of the working of the apparatus, the experimental variables and their control in order to achieve consistent results. Beginning with the USP Apparatus I and Apparatus II to test immediate release products this hands on subject leads the student through dissolution profiling and dissolution testing of modified release tablets such as enteric coated and sustained release tablets with strong emphasis on the requirements of the United States Pharmacopeia, FDA and Health Canada. (Lectures and Labs)

Credit Status
One credit toward the Pharmaceutical Instrumentation Analyst (PIA) Certificate Program

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

1. Describe the role of Bio-availability and bio-equivalency in dissolution testing.

2. Describe the in-vivo in-vitro correlations (IVIVC) and its importance.

3. Set up disintegration apparatus and perform disintegration test according to USP <701>.

4. Assess the impact of various factors affecting dissolution testing.

5. Clearly understand the requirement of USP general chapter <711>.

6. Set up dissolution apparatus and perform dissolution tests as per USP.

7. Explain the principle of dissolution profiling and perform dissolution profiling.

8. Apply F2 similarity factor.

9. Perform dissolution for sustained release tablets.

10. Explain dissolution principles, requirements and apparatus for various dosage forms.

11. Document and report results.

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 http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

Discrimination/Harassment
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 student.conduct@senecacollege.ca.

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.

Prerequisite(s)
Students should consult the Program Information Package each semester to ensure they have current information regarding program requirements. Packages are available from the continuing Education Office.

Topic Outline

  • Overview of the history of dissolution, dissolution theory, bioavailability and bioequivalence
  • Disintegration test
  • Dissolution and the USP: apparatus, control of parameters, test procedure, acceptance criteria
  • Dissolution test for immediate release tablets
  • Dissolution profiling
  • Dissolution profile #1
  • Dissolution profile #2
  • Multi-tiered dissolution
  • Apparatus other than basket and paddle and drug release from other dosage forms
  • Independent study
  • Review

Mode of Instruction
Lecture sessions combined with practical demonstrations and experiments and handouts on basic concepts are provided. 

Prescribed Texts
Handouts and Internet resources on dissolution testing

Reference Material
United States Pharmacopeia - current version

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.

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)
OR
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.


Modes of Evaluation
Assignments

  • 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:  http://library.senecacollege.ca

LAB COURSES
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:
Lab Report # 1 5%
Lab Report # 2 10%
Lab Report # 3 10%
Lab Report # 4 10%
Quiz 15%
Independent Study 10%
Final Exam  40%

Four lab reports are worth a total of 35% of the final mark. The reports are due one week after the work is completed.
The requirements for the reports are presented in writing at the beginning of the subject

*NOTE: TEST AND ASSIGNMENT DATES WILL BE CONFIRMED BY THE INSTRUCTOR

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.

PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS

Approved by: Denis Gravelle