PFT505 - Fundamentals of Physical Testing

Outline info
Semester
School
Last revision date 2017-05-29 00:41:45.141
Last review date 2017-07-17 00:16:29.54


Subject Title
Fundamentals of Physical Testing

Subject Description
This subject provides a theoretical and practical study of some of the most commonly used, but critical physical testings in the pharmaceutical industry of solid, semi-solid and liquid dosage forms. Such testing is mandatory as per regulations and critical from a quality point of view and includes in-process testing of bulk product, finished product and raw-material. in recent years, testing also focused on pre-formulation studies and physical characterization of pharmaceutical active ingredients. Students practice using instruments such as a microscope, particle size analyzer, viscometer, moisture analyzer and various tabletting in-process test instruments including disintegration tester, hardness tester and friability tester. Students gain theoretical knowledge of x-ray diffraction, particle size analysis by laser defraction and differential scanning calorometry (DSC). Students also learn about applying these various techniques for analytical and formulation purposes. (Lecture and Labs)

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

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

1. Demonstrate basic understanding of a variety of physical characterization techniques used in pharmaceutical industry in analytical and formulation areas.

2. Apply the principles of physical testing for an understanding of drug physical properties.

3. Identify various physical testing to be performed on a drug from regulatory and quality point of view.

4. Assess the physical properties of bulk product, finished product and raw material for quality assurance and release purposes.

5. Prepare method development and validation protocols for physical testing.

6. Analyze and interpret the results of various physical testing obtained from an outside lab to support in process release testing, pre-formulation and stability studies etc.

7. Use basic laboratory equipment to characterize basic physical properties of solid, semi-solid and liquid 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 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)
None

Topic Outline
Introduction to Physical Testing in Pharmaceutical Industry

  • Introduction to Physical Testing in pharmaceutical industry
  • Overview of major physical characterization techniques
Particulate Characterization for Pharmaceutical Applications
  • Quiz #1: Overview of Physical Testing Methods
  • Overview of different methods of particulate characterization
  • Parameters to be characterized for particulates in pharmaceutical applications
  • Evaluation of particle size distribution for solid powders using laser diffraction
  • Characterization of particulate matter in injectables using light obscuration
  • Basics of surface area testing using BET method
  • Particle size testing using analytical sieving
Other phenomena and techniques: Water-solid interactions, Optical rotation
  • Viscosity
  • Water-solid interactions, hygroscopicity, water activity
  • Refractive index
  • Optical rotation
Optical Microscopy and Scanning Electron Microscopy
  • Quiz #2: Particle characterization
  • Light and polarizing microscopy
  • Basic principles of SEM: electron beam generation and focusing, interactions of electron beam, image formation
  • Basic principles of Energy Dispersive Spectroscopy
  • Application SEM and EDS in pharmaceutical industry
X-ray Diffraction: Polymorphism of Pharmaceutical Solids
  • Basic principles of X-ray diffraction
  • PXRD diffractometer: X-ray source, detector, slits etc.
  • Application of powder XRD for polymorph characterization
  • Qualitative and quantitative compound analysis
  • Sample preparation: powder and final dosage (tablets and suspensions)
Thermal Analysis: DSC and TGA
  • Quiz #3: Principles and applications of XRD
  • Basic principles of TGA and DSC techniques
  • Application of TGA and DSC in pharmaceutical industry
Lab experiments:
  • Lab Experiment #1: In process physical testing of solid dosage forms: tablet hardness, friability and disintegration
  • Lab Experiment #2: Evaluation of density and particle size of excipients
  • Lab Experiment #3: Study of the viscous behavior of some liquids preparations using a Brookfield viscometer
  • Lab Experiment #4: Identification of HPMC
  • Lab Experiment #5: Determination of melting point

Mode of Instruction
Lecture, labs, interactive quizzes and case studies

Prescribed Texts
None

Reference Material

  • Solid-State Chemistry of Drugs, 2nd Edition, Stephen R. Byrn, Ralph R. Pfeiffer, Joseph G. Stowell, SSCI, Inc., ISBN: 0-967-06710-3 (or 0-967-06711-1 – paperback student edition only)

  • Physical Characterization of Pharmaceutical Solids, Drugs and The Pharmaceutical Science, Volume 70, H.G.Brittain, Marcel Dekker, Inc., ISBN: 0-8247-9372-2 

  • Physical Characterization of Pharmaceutical Solids, Pharmaceutical Research, Vol.8, No.8 (1991) pp.963-973; H.G.Brittain, S.J.Bogdanowich, D.E.Bugay, J.DeVincentis, G.Lewen and A.W.Newman:

U.S. Pharmacopoeia: General Chapters (latest edition):
<429> Light Diffraction Measurement of particle Size
<701> Disintegration
<776> Optical Microscopy
<786> Particle Size Distribution Estimation by Analytical Sieving
<831> Refractive Index
<891> Thermal Analysis
<911> Viscosity
<941> X-Ray Diffraction
<1181> Scanning Electron Microscopy
<1216> Tablet Firability
<1217> Tablet Breaking Force

Required Supplies
None

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 Notes 10%
Quizzes (Q1: 10%, Q2: 15%, Q3: 10%) 35%
Project 15%
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.

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

Approved by: Denis Gravelle