Development of M3 as Improved Functionality Composite Excipient for Direct Compression

Abstract

Introduction: Direct compression is the most preferred method of formulations of a compressed solid dosage form, but the poor compressibility of most of the active pharmaceutical ingredients limits the use of the direct compression technique.   Methodology: The present research study involves the development of M3 with improved functionality composite excipient used for direct compression. The aqueous dispersion of Maltose and Mannitol was co-processed with Maize Starch by using the co-drying technique. The dried composite was assessed for excipient functionalities such as Flowability, Compressibility, Mechanical Strength, Dilution Potential and Lubricant Sensitivity.  Results: The results of the study showed that composite excipient prepared by co-drying of maltose and mannitol with Maize Starch provides desired flowability, good compressibility and better mechanical strength. The study also revealed that the developed composite excipient exhibited better dilution potential and almost remain unaffected by the addition of a hydrophobic lubricating agent. Conclusion: The developed excipient composite M3, can be used as directly compressible filler binder for a compressed solid dosage form containing poorly compressible active pharmaceutical ingredients.