Development of directly compressible co-processed excipients for solid dosage forms
By Rajendra Awasthi, Deepak, Garima Garg, Vivek Pawar, Gaurav Sharma, Giriraj T Kulkarni
The tablets manufactured by direct compression method using co-processed excipient showed relatively better disintegration time and in vitro drug release, with omission of number of laborious steps as compared to tablets manufactured by conventional wet granulation method. Melt granulation technique is a potential alternative for the development of directly compressible adjuvants. Lactose and mannitol blend (1:1, 1:2, 2:1, 1:3, 3:1; 90, 80 or 70 %) along with meltable binders PVP K – 30 and PEG 4000 (1:9, 1:1 or 9:1) were used in the formulation. The effect of addition of co-processed excipient in a formulation containing poorly compressible drug (paracetamol) was also studied. The micromeritic studies and bulk powder properties of the co-processed agglomerates were studied. It was observed that co-processed agglomerates exhibited much better flow properties as compared to individual excipients. The optimized formulation shows that the tensile strength was found to be inversely related with the percentage of acetaminophen. It might be due to the poor compressibility and elastic recovery of acetaminophen. Lower value of disintegration time may be attributed to decreased tensile strength. No capping and lamination of tablet was observed as usually associated with acetaminophen compression.
Key words: co-processing, excipients, lactose, mannitol, adjuvant, direct compression.
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