4.2 PREFORMULATION STUDIES PREFORMULATION STUDIES Preformulation testing is an investigation of physical and chemical properties of a drug substance alone and when combined with excipients. It is the first step in the rational development of dosage forms. Preformulation commences when a newly synthesized drug shows sufficient pharmacologic promise in animal models to warrant evaluation in man. These studies should focus on those physicochemical properties of the new compound that could affect drug performance and development of an efficacious dosage form. A thorough understanding of these properties may ultimately provide a rationale for formulation design, or support the need for molecular modification. OBJECTIVE: The overall objective of preformulation testing is to generate information useful to the formulation in developing …show more content…
For this purpose 0.1N HCl, pH 4.6 buffer, pH 6.8 buffer and purified water were used. Highest dose of the drug i.e., 400mg was dissolved in 250 mL of medium and was kept untouched for 6 hrs. Later on the insoluble drug was filtered off and the solution was analysed by HPLC technique to find out the solubility. Based on the solubility calculated the D/S ratios were calculated. The FDA guidance on “Dissolution Testing of Immediate Release Solid Oral Dosage Forms” says that a drug substance is considered highly soluble when the dose/solubility volume of solution are less than or equal to 250 mL. 4.2.3 DRUG-EXCIEPIENT COMPATIBILITY STUDY DRUG-EXCIPIENT COMPATIBILITY STUDY The compatibility of drug and formulation components is important prerequisite before formulation. It is therefore necessary to confirm that the drug does not react with the polymers and excipients under experimental conditions and affect the shelf life of product or any other unwanted effects on the formulation.