Course : Pharmaceutical Manufacturing
Due Date : 18 July 2014
Lecturer(s) : Mr. M. Poka
TOPIC: Particle size analysis
1. Excipients used in tablet formulations
I. Diluents/ fillers
They act as bulking agents that is to make a tablet weight practical for the patient. The minimum tablet weight is typically 50mg. Actual pharmaceutical ingredients (API) can be as low as 20 micro-grams, for example for oral steroids.
They also act as compression aid that deforms and fragments readily to facilitate robust bonding in tablets compacts, e.g. microcrystalline cellulose.
Ideal diluents should have requirements such as; be chemically inert, be non-hygroscopic, be biocompatible, have acceptable taste, possess biopharmaceutical properties (e.g. water soluble or hydrophilic)
EXAMPLES OF DILUENTS
Lactose
Sucrose
Glucose
Mannitol
Sorbitol
Calcium phosphate
Calcium carbonate
Cellulose
II. Disintegrants
Disintegrants cause rapid break up of solid dosage forms upon exposure to liquids into small fragments, which promotes rapid drug dissolution. The disintegration process for a tablet occurs in two steps. Firstly, the liquids wet the solid and penetrates the pores of the tablets. Thereafter the tablet breaks into smaller fragments.
Disintegrants to be used in plain tablets are classified into:
Disintegrants that facilitate water uptake
-These disintegrants act by facilitating the transport of liquids into the pores of the tablet may break into fragments.
Disintegrants that will rupture the tablet.