New pharmaceutical excipients in solid dosage forms – A review

Abstract

The objective of a medicinal formulation development project is to deliver drug to the patient in the required amount, at the required rate, consistently within a batch, from batch to batch, and over the product’s shelf life. To produce a drug substance in a final dosage form requires pharmaceutical ingredients. In selecting excipients for pharmaceutical; dosage forms and drug products the development pharmacist should be certain that standards exist and are available to assure the consistent quality and functioning of the excipient from lot to lot. The development of new materials for use as pharmaceutical excipients requires the demonstration of the absence of toxicity and freedom from adverse reactions. The selection and testing of nonactive ingredients or excipient in the design of drug dosage form present to the formulator the challenge of predictive foresight. While the ability to solve problems when they occur is a valuable attribute, the ability to prevent the problem through adequate experimental design is a virtue. Newer excipients provide the means for simplifying formulation development, and improving overall operational costs while preserving the quality that is expected by the industry. The present review focus on such newer Excipients which have proved their potential in developing efficient solid dosage forms.