Abstract

PROSPECTIVE STUDY OF EXCIPIENTS & METHODS OF EVALUATION OF DRUG-EXCIPIENT INTERACTIONS

Abhijeet H. Patil*, Mahesh G. Kamble, Asmita D. Pandit, Pranali R. Pangam, Vivek D. Savairam and Pooja A. Pukale

ABSTRACT

Active pharmaceutical ingredient (API) that is nothing but drug is a chemical entity which is designed to treat or prevent any diseased condition. Excipients are the non-API natural or synthetic components that are added in pharmaceutical dosage form with API as functional or non-functional agents. A dosage form is said to be complete when these both components are present in it. It is impossible to make a formulation only with drug or without excipients. So, excipients have their own importance in formulating a dosage form. Different excipients have different functions and accordingly they are added in the formulation. The aim of a pharmaceutical company is to design and prepare an effective and safer dosage form. So, to fulfil this aim, compatibility should be taken in consideration while preparing a dosage form. API and the excipients must be compatible with each other. They should not cause any unwanted reaction which can cause deterioration of product. Hence, prior to formulate a dosage form the compatibility of API is tested with different excipients and accordingly the excipients are selected. For this prior study, different techniques and methods can be used. Accelerated stability testing study can be performed. Apart from this, different methods like DSC, TGA, XRPD, FTIR, HPLC can be used. These methods will give an idea of compatibility between drug and excipients so that a proper, safer and effective formulation can be prepared.

Keywords: API, Excipients, Preformulation.