Purpose: Direct compression is a mostly used and required process in the pharmaceutical industry. The co-processing is the most widely explored method for the preparation of directly compressible excipients. The present research work was targeted to develop a novel directly compressible co-processed excipient to prepare fast disintegrating tablets of Carvedilol.
Methods: From the preliminary trials, Lactose was selected as a directly compressible excipient and sodium starch glycolate was used as a super disintegrant. PEG 4000 was used as the binder from the preliminary batches. A melt agglomeration technique was selected to prepare the suitable co-processed excipient. Co-processed excipient was optimized by a central composite design where the concentration of binder (X1) and concentration of disintegrant (X2) was selected as independent variables from the preliminary studies. Carr’s index, wetting time, disintegration time, and Friability were selected as dependent variables as they were having the highest effect on co-processed excipient and tablet properties.
Results: The optimized co-processed excipient was characterized by Kawakita’s and Kuno’s analysis, Heckel plot analysis, granular friability index, and lubricant sensitivity ratio. Results of dilution potential revealed that poorly compressible drug; Carvedilol was sufficiently incorporated into co-processed excipient for the preparation of fast-disintegrating tablets. An in-vitro dissolution study showed faster disintegration of the drug compared to the conventional tablets. Instrumental studies like FT-IR and DSC proved the compatibility of various materials with each other.
Conclusion: The present investigation underlines the fact that co-processing may be adopted for the development of directly compressible adjuvant for the use in pharmaceuticals.