Development and Characterization of Novel co-processed excipients to enhance compressibility profile for Formulation of Tablet Dosage Form

Abstract

The present work deals with the development of a novel co-processed excipients using melt- granulation technique that would serve as an inbuilt multifunction adjuvant and can be used for the preparation of tablet as solid dosage form with poorly compressible drugs like Paracetamol, Diclofenac, and Ibuprofen etc. by direct compression method. In the formulation DCP (Dicalcium phosphate) and Potato Starch were used as a filler in 2:1 ratio; Croscarmellose as a superdisintegrant and 20% w/v PEG 6000 (polyethylene glycol) as a binder, to develop the co-processed excipient. This resulted in formation of co-processed agglomerates, which had exhibited better flowability, compressibility and compaction properties when compared to an individual excipient and/or the physical mixture of compounds. Being a poorly compressible drug, PCM (Paracetamol) was used as a model drug to prepare tablets. The finally developed tablet dosage form of PCM along with co-processed excipient, were subjected to Fourier Transform Infra-Red (FTIR) study to ensure the absence of any drug-excipient interaction. The dosage form was also evaluated for capping and lamination to assure the better compressibility profile. The surface characteristics of developed co-processed agglomerated mass was characterised using Scanning Electron Microscopy (SEM). From the results obtained, it was concluded that the co-processed excipient is superior in flowability and compression characteristics in comparison to the physical mixture of excipients and individual components both. FTIR studies explained that there is no drug-excipient interaction and SEM also shown the spherical shapes of the agglomerated mass proving the better flowability properties of co-processed excipients.