Confirming the pharmaceutical equivalence of Oral Solid Dose (OSD) products using MDRS and the Morphologi 4-ID

Introduction

According to FDA definition, a generic drug is "a drug product which is comparable to a reference listed drug (RLD) product in dosage form, strength, route of administration, quality, performance characteristics, and intended use" [1]. Rigorous rules and regulations pertaining to abbreviated new drug application (ANDA) submissions are complex and the generic drug industry strives to meet these in their efforts to obtain approval for a product. Generics companies must be highly skilled and disciplined in product development and critically, establishing bioequivalence, to have a chance of being first to file.

In this application note we discuss the use of Malvern Panalytical’s Morphologi^® 4-ID and Morphologically-Directed Raman Spectroscopy (MDRS^®), a physicochemical technique which is rapidly gaining acceptance for application in bioequivalence studies. Using MDRS, two orally-administered cold and ‘flu remedies were analyzed and compared. One of the products was the RLD, and the other a generic (test) version of the product. Both products are licensed from the same Marketing Authorization holder, so although they are packaged and priced differently, the two formulations should be comparable.

The particle size and shape distributions and the overall compositions of the two products were compared. Then, further comparison was made between the individual components within the two formulations.