Question

Answer four drug formation questions

（i）what potential issues arise when formulating a micronized active into a capsule or tablet formulation?

(ii) Why is it desirable to have a narrow particle size distribution of an active and excipients used in a tablet formulation?

(iii) What other physical factors are important to consider in order to produce homogeneous powder mixes?

（iv）Why is it often necessary to incorporate a granulation step in the tablet manufacturing process?

invilved tablets, capsules and powder

Answer 1

a) micronized active when tablet punching may stick to the walls of the punch and the flow property is also not good. So granulation method is used to improve the flow property.

b) Particle size reduction is a fast and cost effective method to improve the bioavailability of poorly soluble oral drugs. As the size of particle is reduced, the surface area increases and thereby improving the dissolution rate.

c) The main physical factors to concider inorder to produce homogeneous powder mixtures include:

• Particle size and distribution

• Material density

• Particle shape

• Wettability

• Stickiness

d) Granulation is the process in which the primary powder particles are made adhere to form larger multi particles.

Granulation prevents segregation of the constituents of the powder mix and also improves the flow property and compressibility of the powder mass while tablet punching.