simvastatin formulation lecture 5

Question 1

list 4 physical properties of simvastatin

Answer 1

White to off-white

Non-hygroscopic crystalline powder

Practically insoluble in water

Freely soluble in chloroform, methanol and ethanol

Question 2

what is the standard dose of simvastatin?

Answer 2

Film-coated tablets for oral administration
Taken in evening
Taken with or without food
5 mg start dose

Question 3

what are the two types of excipients used in formulating simvastatin tablet

Answer 3

Inactive core excipients and Inactive coating excipients

Question 4

list 8 inactive core excipients of simvastatin tablet and their function.

Answer 4

-Butylated hydroxyanisole
(2-tert-Butyl-4-hydroxyanisole and 3-tert-butyl-4-hydroxyanisole, mixture) as an: (Antioxidant whichtraps free radicals: diene and OH group susceptible to oxidation)

Ascorbic acid as an: (Antioxidant as above)

Citric acid monohydrate as an: (Antioxidant as above)

Microcrystalline cellulose (refined wood pulp) as a: (Binder and filler hard and adds compressibility)

Pregelatinized maize starch as a: (Filler and disintegrant)

Lactose monohydrate as a: (Binder adds compressibility)

Colloidal anhydrous silica as an: (Anti-caking agent)

Magnesium stearate (Octadecanoic acid, Magnesium salt) as a: (Lubricant, to avoid sticking/ binding in the tabletting process)

Question 5

List the inactive coating excipient used in Simvastatin

and their purpose

Answer 5

1.Hydroxypropyl methyl-cellulose, HPMC) hypromellose - Film-forming polymer: can control drug delivery rate

2.Titanium dioxide- Pigment
3.Talc - Lubricant and disintegrant
(Hydrated magnesium silicate)
4.Iron oxide yellow - Colourant (for 10 and 20 mg*)

5. Iron oxide red - Colourant (for 10, 20, 40 and 80 mg)
6. Hydroxy propyl cellulose - Film-forming polymer: can control drug delivery rate

Question 6

What is the purpose of Hypromellose

(Hydroxypropyl methyl-cellulose?

Answer 6

Film-forming polymer: can control drug delivery rate

Question 7

What is the purpose of Hydroxy propyl cellulose

Answer 7

Film-forming polymer: can control drug delivery rate

Question 8

What is the purpose of Titanium dioxide

Answer 8

pigment

Question 9

What is the purpose of Talc

Hydrated magnesium silicate

Answer 9

Lubricant and disintegrant

Question 10

what is the purpose of Iron oxide yellow

Answer 10

Colourant (for 10 and 20 mg*)

Question 11

What is the purpose of Iron oxide red

Answer 11

Colourant (for 10, 20, 40 and 80 mg)