PREFORMULATION

Question 1

Aspirin requires a filler - TRUE or FALSE

Answer 1

FALSE - Aspirin has good compression properties so a filler need not be present

Question 2

Is dibasic calcium phosphate a disintegrant?

Answer 2

NO - Dibasic calcium phosphate is a filler used to at as a bulking agent to increase physical size of a dosage form and aid in binding

Question 3

Disintegrants such as cross linked povidone, sodium starch glycolate and cross linked sodium carboxymethycellulose work by shrinking TRUE OR FALSE

Answer 3

FALSE - most disintegrants work by swelling and are present to reduce the cohesive strength of the compressed tablet

Question 4

Pregelitinised starches are fillers that additionally increase flowability and compressibility

Answer 4

FALSE - pregelitinised starches are DISINTEGRANTS that have good flow and compressibility properties

Question 5

What type of excipient reduces friction at the die wall and reduces adhesion at the punch face

Answer 5

Lubricants

Question 6

Name an appropriate excipient for use in an effervescent tablet that will reduce friction at the die wall and reduce adhesion at the punch face

Answer 6

Mixture of a water soluble, high molecular weight polymer such as Polyethylene Glycol, with Sodium benzoate

Question 7

Name a lubricant that interferes less with inter-particulate bonding and may be preferred over alkaline metallic stearate for chemical stability

Answer 7

Stearic acid

Question 8

Name two metallic stearates

Answer 8

Magnesium stearate and Calcium stearate - used in tablets but not EFFERVESCENT or DISPERSIBLE tablets

Question 9

What is Preformulation?

Answer 9

• Physiochemical characterisation of the properties of the compound
• Provides critical info for formulation development and scale up

Question 10

For a dosage form, there must be a clear understanding of:

1) The stability and solubility of the active pharmaceutical ingredient (API) AND
2) …

Answer 10

2) An awareness of means of inhibiting decomposition and increasing shelf life of product

Question 11

Drugs need a shelf life of a minimum of _ years

Answer 11

2 years

Question 12

What type of packaging is used if the product is unstable?

Answer 12

Foil/Foil to keep water out

Question 13

If a compound has an aqueous solubility of less than 1mg/ml what does this indicate the need for?

Answer 13

A salt as it may have dissolution related absorption problems otherwise due to it’s low solubility

Question 14

Why does an amorphous form of drug require less energy for dissolution and why is the bioavailability of the amorphous form greater than that of the crystalline form?

Answer 14

• Because the amorphous form of a drug has no crystalline lattice and less energy is required for dissolution