By Ashok Katdare, Mahesh Chaubal
To facilitate the improvement of novel drug supply structures and biotechnology-oriented medications, the necessity for brand new excipients to be constructed and authorized keeps to extend. Excipient improvement for Pharmaceutical, Biotechnology, and Drug supply platforms serves as a complete resource to enhance knowing of excipients and forge new avenues for regulatory overview and allowance to exploit. This booklet offers designated, updated details on a variety of features of excipient improvement, trying out, and technological issues for his or her use. It addresses particular info akin to old point of view, preclinical trying out, protection, and toxicology evaluate, in addition to regulatory, caliber, and software elements. The textual content additionally describes top practices to be used of assorted useful excipients and vast literature references for all issues.
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Extra info for Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems
Thus, it is crucial to clarify the excipient impurity proﬁle as even established pharmacopeia-listed materials such as the commonly used magnesium stearate has had questions raised on the safety and toxicity of its impurities (72). Various materials have recently been evaluated in extensive preclinical programs to allow for regulatory ‘‘approval’’ as stand alone excipients. These include the cyclodextrins (CDs) and the hydroﬂuoroalkanes (HFAs) (46,47,73). Published literature on preclinical studies performed for other excipient materials under development is not extensive (presumably as developers do not want to aid competitors by allowing them to reference the available data), but information on some materials is available.
Japanese Pharmaceutical Excipient Council (JPEC), ed. Tokyo: Yakuji Nippon Ltd, 1996. 7. Rowe RC, Sheskey PJ, Weller PJ. Handbook of Pharmaceutical Excipients. 4th ed. American Pharmaceutical Association and The Pharmaceutical Press, 2003. 8. Shangraw R. Developments in tablet excipients since 1960. Manufact Chem 1986; 22. 9. International Pharmaceutical Excipients Council (IPEC). The proposed guidelines for the safety evaluation of new excipients, The IPEC Europe Safety Committee. Eur Pharm Rev 1997.
Lifesaving therapy), it may be acceptable to have reduced toxicity data (17). Similarly, the extent of studies needed to support the safe use of essentially new excipients, and indeed well-known materials, needs careful consideration based on available knowledge. REFERENCES 1. Baldrick P. Pharmaceutical excipient development: the need for preclinical guidance. Reg Tox Pharm 2000; 32:210. 2. Baldrick P. Pharmaceutical excipient testing—a regulatory and preclinical perspective. In: Swarbrick J, Boylan JC, eds.
Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems by Ashok Katdare, Mahesh Chaubal