Co-Processed Excipients: A Patent Review
Nidhi Garg, Harish Dureja and Deepak Kaushik
Affiliation: Department of Pharmaceutical Sciences, M.D. University, Rohtak, India.
Keywords: Co-processed excipients, co-processing, direct compression, directly compressible adjuvants, high functionality
The introduction of high speed tableting machines and the preference of direct compression as a method of tableting
have increased the demands on the functionality of excipients mainly in terms of flowability and compressibility.
Co-processed excipients, where in, excipients are combined by virtue of sub-particle level interaction have provided an attractive
tool for developing high functionality excipients. The multifold advantages offered by co-processed excipients
such as production of synergism in functionality of individual components, reduction of company’s regulatory concern
because of absence of chemical change during co-processing and improvement in physico-chemical properties have expanded
their use in the pharmaceutical industry. In the recent years, there has been a spurt in the number of patents filed
on co-processed excipients. Hence, the present review focuses on co-processed excipients and their application in pharmaceutical
industry. The worldwide databases of European patent office (http://ep.espacenet.com) and United States patent
office (www.uspto.gov) were employed to collect the patents and patent applications. The advantages, limitations, basis
for the selection of excipients to be co-processed, methods of co-processing and regulatory perspective of co-processed
excipients are also briefly discussed.
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