Case Study Of Preformulation Testing

1443 Words3 Pages

Preformulation Studies: (Deodatt A et al.,1980) Preformulation testing is the first step in rational development of dosage forms of drug substances. Prior to the development of the dosage form. It can be defined as investigation of physical and chemical properties of a drug substance alone and when combined with excipients. The overall objective of preformulation testing is to generate information useful to the formulator in developing stable and bioavailable dosage forms which can be mass produced. The goals of the program therefore are: 1. To establish the necessary physicochemical characteristics of new drug substances. 2. To determine its kinetics release rate profile. 3. To establish its compatibility with different excipients. Physical Characterization of Drug: (Indian Pharmacopoeia., 2007) The selected drug under investigation …show more content…

The physical studies were designed to ensure the stability of final formulation. The physical mixture of drug and lipids in the ratio of 1:1 was placed in glass vials, sealed and stored in 40ºc and 75% RH. The sample were withdrawn at pre determine time intervals of 15 and 21 day and examined for physical and chemical integrity of drug and Excipient. Parameter such as colour, odour or gas formation and aggregation were noted. The drug polymer compatibility was further confirmed by taking IR spectrum of drug, polymer and physical mixture of drug-lipid in ratio 1:1(Table:-) .The IR spectrum of physical mixture of drug-polymer was taken placing them in stability chamber at elevated temperature of 40ºC and 75% RH for 21 days. S.NO. Excipient Ratio 1 Tropicamide (drug) 1 2 Drug + Compritol 1:1 3 Drug + Stearic Acid 1:1 4 Drug + Glyceryl mono sterate 1:1 5 Drug +HPMC 1:1 Table:- Drug-Lipid Ratio for Compatibility Studies IR spectrum (Infra red

Open Document