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COLLEGE OF PHARMACY BATCH 2024

DOSAGE FORMS, DRUG DELIVERY SYSTEMS, AND MEDICAL DEVICES
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ADAPTED FROM: POWERPOINT/LECTURE

COURSE OUTLINE: PRELIMS - combination of a drug entity and

1. Introduction to Dosage Forms, Drug Delivery drug additives
Systems, and Medical Devices o Drug Product
2. New Drug Development and Approval - finished dosage form that
Process/PreFormulation Studies contains a drug substance,
generally, but not, necessarily, in
3. Liquid Dosage Forms - Solutions association w/ inactive
ingredients
4. Liquid Dosage Forms - Dispersed Systems
- also includes a finished dosage
REFERENCE BOOK form that is intended to be used
Allen, L., & Ansel, H. (2015). Ansel’s Pharmaceutical as a placebo
Dosage Forms and Drug Delivery Systems. Philadelphia:
Wolters Kluwer IMPORTANCE OF DOSAGE FORMS

1. To protect the drug substance from the destructive

Introduction to Pharmaceutical Dosage influences of atmospheric oxygen or humidity

Forms, Drug Delivery Systems, and 2. To protect the drug substance from the destructive
influence of gastric acid after oral administration
Medical Devices
3. To conceal the bitter, salty, or offensive taste or
INTRODUCTION TO DRUGS odor of a drug substance

DRUG 4. To provide liquid preparations of drug substances,

● Article intended for and having as their main use in either as dispersions or as clear preparations
the diagnosis, cure, mitigation, treatment, or
5. To provide rate-controlled drug action
prevention of disease.
● Article recognized by a monograph in a 6. To provide optimal drug action from topical
compendia administration sites
● Article (other than food) used to affect the structure
or any function of the body of man or other 7. To provide for insertion of a drug into one of the
animals body’s orifices
● Article used as a component in any of the 8. To provide for placement of drugs directly in the
previously mentioned definitions bloodstream or body tissues

ACTIVE INGREDIENT 9. To provide for optimal drug action through

● Any component that is intended to furnish inhalation therapy
pharmacological activity or other direct effect in
the diagnosis, cure, mitigation, treatment or CATEGORIES OF DOSAGE FORMS
BASED ON THE DELIVERY ROUTE
prevention of disease or to affect the structure or
function of the body of man or other animals Gastrointestinal ● oral
Tract ● oropharyngeal
● rectal
substances where you expect a pharmacologic axn/ effect
would come from Tissues or Body ● IV
Fluids ● IA
● IC
INTRODUCTION TO DOSAGE FORMS ● IM
● SC
DOSAGE FORMS ● ID
● Means of administering drugs as formulated ● IT
preparations
o Pharmaceutical Preparations Mucosal ● otic
Membrane ● nasal
o Pharmaceuticals
● ophthalmic
o Dosage Forms ● vaginal
● urethral

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INSERT YOUR UNIVERSITY NAME & LOGO HERE
COLLEGE OF PHARMACY BATCH 2024
DOSAGE FORMS, DRUG DELIVERY SYSTEMS, AND MEDICAL DEVICES
INSERT PROF HERE
ADAPTED FROM: POWERPOINT/LECTURE

Skin Surface ● topical 1. Harmless in amounts used

● transdermal
2. Does not exceed the minimum quantity required to
Lungs ● inhalational provide their intended effect
3. Does not impair the bioavailability or therapeutic
efficacy of the dosage form
BASED ON THE GENERAL TYPE OF DOSAGE FORM
4. Does not interfere with the assays and tests
Liquids ● solutions prescribed for determining their compliance with
● emulsions official standards
● suspensions

Semisolids ● ointments CATEGORIES OF PHARMACEUTICAL EXCIPIENTS

● creams
● gels 1. Those added for Stability
● pastes - enhances stability & shelf-life
● foams - e.g. preservatives
● collodions
2. Those added for In Vivo Absorption
Solids ● powders - for extravascular route
● tablets - ↑ absorption
● capsules
● patches 3. Those added for manufacturability
● gauzes - solubilizers
● tapes - emulsifiers
● sticks - diluents
- binders
- suspending agents (↓ rate of solubility)
BASED ON THE RELEASE PATTERN OF DRUG
Conventional Release 4. Those added for acceptability
(CR) - for aesthetic
- flavorants, sweeteners
Modified Release ● extended - colorants
(MR) ● delayed - viscosity enhancers
● targeted
● pulsatile PACKAGING, LABELLING,
● orally AND STORAGE OF PHARMACEUTICALS
disintegrating
● orally dispersing PACKAGING
An economical means of providing:
PHARMACEUTICAL EXCIPIENTS ● Presentation
● Protection (and preservation)
EXCIPIENT ● Identification/information
● Any component other than the active ingredient in a ● Containment
drug product ● Convenience
● Inactive Ingredient ● Compliance
● Provides the drug or active therapeutic agent in a for a product during storage, carriage, display, and use until
form suitable for administration to a patient with the such time as the product is used or administered
assurance that the optimum effects will result
ROLE: TYPES OF PACKAGE SYSTEM
● bulk production
Primary Secondary
● suspension
● dilution ● Immediate ● Outer packaging
● tabulation Container ● Additional physical
● solubilizer ● Direct contact with protection
● flavorant the product ● Ensure safe
● colorant ● Direct effect on the storage in
product shelf-life warehouses and
● Prevent product delivery of the
QUALITIES OF AN IDEAL EXCIPIENT

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INSERT YOUR UNIVERSITY NAME & LOGO HERE
COLLEGE OF PHARMACY BATCH 2024
DOSAGE FORMS, DRUG DELIVERY SYSTEMS, AND MEDICAL DEVICES
INSERT PROF HERE
ADAPTED FROM: POWERPOINT/LECTURE

deterioration product

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