Components of Pharmaceutical Dosage Forms
Session 8: Components of Pharmaceutical Dosage Forms
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
|Step |Time |Activity/ |Content |
| | |Method | |
|1 |05 minutes |Presentation |Introduction, Learning Tasks |
|2 | |Presentation |Major Components of Pharmaceutical |
| |10 minutes |Brainstorming |Dosage Forms |
|3 |20 minutes |Presentation |Definition and General Uses of |
| | |Buzzing |Pharmaceutical Excipients |
|4 | |Presentation |Classes of Pharmaceutical Excipients|
| |70 minutes |Small Group | |
| | |Discussion | |
|5 |05 minutes |Presentation |Key Points |
| 6 |10 minutes |Presentation |Evaluation |
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing
STEP 2: Major Components of Pharmaceutical Dosage Forms (10 minutes)
|Activity: Brainstorming (5 minutes) |
| |
|Ask students to brainstorm on the following question: |
| |
|What are the major components of any pharmaceutical dosage form? |
| |
|ALLOW few students to respond |
| |
|WRITE their responses on the flip chart/ board |
| |
|CLARIFY and SUMMARISE by using the content below |
o Active Pharmaceutical Ingredient (API)
o Excipient
API for various purposes
STEP 3: Definition and General Uses of Pharmaceutical Excipients (20
minutes)
o Is usually an inert substance added to the drug to give suitable
consistency or definite form to the drug
o It is a pharmacologically inactive (inert) substance that is
formulated with the active pharmaceutical ingredient
o Pharmaceutical excipients are also known as pharmaceutical necessity
or aids
|Activity: Buzzing (5 minutes) |
| |
|ASK students to pair up and buzz on the following question for 2 |
|minutes |
| |
|What are the general uses of pharmaceutical excipients? |
| |
|ALLOW few pairs to respond and let other pairs to add on points not |
|mentioned |
| |
|WRITE their response on the flip chart/board |
| |
|CLARIFY and SUMMARIZE by using the content below |
o Pharmaceutical excipients are added for various purposes including:
during manufacturing
intended route
including protection from degradation
STEP 4: Classes of Pharmaceutical Excipients (70 minutes)
|Activity: Small Group Discussion ( 30 minutes) |
| |
|DIVIDE students into small manageable groups |
| |
|ASK students to discuss on the following question |
|What are the classes of pharmaceutical excipients? |
| |
|ALLOW students to discuss for 15 minutes |
| |
|ALLOW few groups to present and the rest to add points not mentioned |
| |
|CLARIFY and SUMMARIZE by using the contents below |
depending on the role that they are intended to play in the dosage form
o Antioxidants
o Preservatives
o Humectants
o Buffering agents (Acidifying and alkalizing agents)
o Chelating agents
o Colouring agents
o Flavouring agents
o Surface Active Agents
o Solvents and co-solvents
o Are substances that are added into pharmaceutical dosage forms for the
purpose of inhibiting oxidation in products that are subject to
deterioration by oxidation processes
o Common antioxidants include Ascorbic acid and Alpha Tocopherol
o Are substances that prevent or inhibit growth of microorganisms
o They are added to avoid spoilage of pharmaceutical preparations by
microorganisms
o Common preservatives include methyl paraben, ethyl paraben, propyl
paraben, benzoic acid, sodium benzoate, Benzalkonium chloride, Benzyl
alcohol, Chlorobutanol and Phenol
o Minimize water loss from pharmaceutical preparations i.e. they prevent
drying out of a pharmaceutical preparation to
closure of a container after first opening
o Examples of humectants are Propylene glycol, Glycerol and
Polyethylene glycol
o Are substances that are added in oral liquid preparations in order to
increase palatability of the therapeutic agent i.e. to mask unpleasant
taste of the medicine
o Are substances used in liquid preparations to provide acidic medium
for the product stability
o Are substances that are used in liquid preparations to provide
alkaline medium of product stability
o Are molecules with ability to bind metal ions and hence prevent auto-
oxidation phenomena frequently catalysed by metal ions
o Added to prevent auto-oxidation of drug molecules by metallic ions
such as Iron ions
o These are substances added to impart desired colour to pharmaceutical
preparations
o Are substances that are added to increase patient acceptance to oral
pharmaceutical dosage formulations. They mask unpleasant flavours of
some medications
o Solvents are substances that can dissolve a solute
o Co-solvents are water-miscible organic solvents that are used in
liquid pharmaceutical preparations to increase solubility of poorly
soluble drug substance or to enhance the chemical stability of the
drug
STEP 5: Key Points (5 minutes)
Pharmaceutical Ingredient (API) and excipients
properties as well as therapeutic outcome of the medicines
intended use, such classes include antioxidants, colouring agents,
solvents and co-solvents, chelating agents, humectants, preservatives,
anti-oxidants, sweetening agents and flavouring agents
STEP 6: Evaluation (10 minutes)
References
Aulton, M.E.,Taylor, M.K. (2001). Pharmaceutics: The Science of dosage form
design
(2nd ed.). USA: Churchill Livingstone
.
Cooper, J.W., Gunns, C., & Carter, S.J. (2008). Dispensing for
Pharmaceutical Students
(12th end). Delhi, India: CBS Publishers and Distributors.
Rawlins, E.A. (2001).Bentley’s Textbook of Pharmaceutics (8th ed.). London,
UK:
Bailliere Tindall.
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