Pre-formulation

Question 1

What is pre-formulation?

Answer 1

The first stage of formulation developmental process is known as pre-formulation

Question 2

What are the THREE prerequisites for pre-formulation?

Answer 2

Synthesis

Pharmacology

Toxicology

Question 3

What methods are used to identify active drug compound?

Answer 3

NMR, UV & mass spectroscopy

Question 4

Finish the sentence:
Analytical methods should be

Answer 4

Sensitive

Selective

Reproducible

Question 5

How are analytical methods validated?

Answer 5

Molecular weight

Purity

Chemical structure

Solubility

pKa

Question 6

Name FOUR factors that particle size influence

Answer 6

Solubility & dissolution

Content uniformity

Flow characteristics

Sedimentation rate

Question 7

What is solubility?

Answer 7

The maximum amount of drug that be dissolved in a selected solvent at equilibrium

Question 8

What factors impact salt selection in the pre formulation process?

Answer 8

Hygroscopic nature

Solubility & bioavailability

Stability

Question 9

What is pKa?

Answer 9

Acid dissociation constant and measures the strength of an acid or base, lower values indicate stronger acidity & greater proton donation ability

Question 10

Name the FOUR classes of biopharmaceutics

Answer 10

Class I: High solubility, high permeability

Class II: Low solubility, high permeability

Class III: High solubility, low permeability

Class IV: Low solubility, low permeability

Question 11

What factors must be considered in relation to dosage form of medicines?

Answer 11

Route of administration

Drug absorption

Physicochemical properties

Question 12

What is the definition of an excipient?

Answer 12

An inert substance that is used as a diluent or vehicle for preparing a drug product

Question 13

Name THREE factors that affect excipient usage

Answer 13

Concentration of the drug

Compability with the drug

Stability

Question 14

Give an example of a chemical incompatibility

Answer 14

Interactions of preservatives with non-ionic surfactants, reducing its antimicrobial properties

Question 15

Particle size will directly influence all of the following
factors with the exception of:

a. Drug toxicity
b. Solubility and dissolution
c. Content uniformity
d. Flow characteristics of powders
e. Sedimentation rate

Answer 15

A. Drug toxicity

Question 16

Discuss the importance of developing a validated
analytical technique

Answer 16

If your analytical method is wrong →your results are wrong →
your product quality decisions are wrong →patients are at risk

Ensures accuracy

Ensures quality & consistency

Detects impurities & degradation