Dosage Form Development

Question 1

It is a finished formulation of a drug preparation designed

to contain a specific amount of a medication.

Answer 1

Dosage Form

Question 2

Reasons for the need of Dosage Forms

Answer 2

Protection of drug substance from the destructive
influences at atmospheric oxygen or moisture.

Protection of the drug from the destructive
influence of gastric acid after oral administration
Conceal the salty, bitter, offensive taste
or odor of a drug substance.
Provide liquid dosage forms of substances soluble in the desired vehicle.
Provide liquid preparations of
substances that are either insoluble or
unstable in the vehicle.
Make minute or small dose of a drug larger enough to be picked up with the fingers.

Question 3

Physicochemical Parameters

Answer 3

• Melting point
• Phase Rule
• Polymorphism
• Particle size
• Solubility
• Membrane permeability
• Partition coefficient
• Dissociation constant

Question 4

Capability of a particular
formulation in a specific container or
closure system to remain with in its
physical, chemical, microbiological,
therapeutic and toxicological specifications.

Answer 4

Stability

Question 5

Limits the time during
which the product may be dispensed by the
pharmacist or used by the patient.

Answer 5

Expiration Date

Question 6

the duration of time
during which a drug preparation will
remain physically, chemically,
therapeutically, toxicology and
microbiology stable (possessing NLT 90%
of the labeled potency).

Answer 6

Shelf life

Question 7

Types of Stability

Answer 7

• Chemical
• Physical
• Microbiologic
• Therapeutic
• Toxicologic

Question 8

Stability study conducted under the usual or normal conditions
of the environment, transport and storage
expected during product distribution.

Answer 8

Long-term or actual

Question 9

Stability studies designated to increase the rate of
chemical or physical degradation of a drug
substance or product by using exaggerated
storage conditions.

Answer 9

Accelerated

Question 10

The shelf-life of extemporaneous Preparations of Non-aqueous liquids and solids of a manufactured product

Answer 10

6 months, or not later than 25% of the time

remaining

Question 11

The shelf-life of extemporaneous Preparations from the USP/NF active of Non-aqueous liquids and solids

Answer 11

6 months

Question 12

The shelf-life of extemporaneous Preparations of Aqueous products from a manufactured solid form

Answer 12

14 days stored at cold temp

Question 13

The shelf-life of extemporaneous Preparations of Non-Aqueous products from a manufactured solid form

Answer 13

30 days