Development of Next Generation Excipient by Coprocessing:
The International Pharmaceutical Excipient Council (IPEC) classified pharmaceutical excipients based on safety data into two classes namely ‘new chemical excipients’ and ‘established excipients. The excipient class ‘new chemical excipients’ can be sub-divided into ‘modified excipients’ (i.e., existing excipients that are modified with respect to purity and/or physical properties such as particle size), ‘co-processed excipients’ (i.e., two or more existing excipients which are formulated into a new excipient with physical properties that cannot be obtained by a simple physical mixture and is produced through processes such as spray drying) and ‘novel excipients’ (i.e., new chemical entities used for the first time in a drug product which may include known excipients that are chemically modified). Development of new excipient entities and their evaluation is a costly procedure; modification of existing excipients is very easy, more economical and less time consuming. The development of ...