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Capsules
Essentially a cookbook for making drugs, this title contains the recipes and process steps for over 2000 drugs. The author has painstakingly assembled this second volume from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and the BASF book of generic formulations.The second volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution and other similar products from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing uncompressed drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with the topics of cGMP considerations in liquid manufacturing, stability testing of new drugs substances and products, container closure systems, pre-approval inspection, in addition to providing quick tips on resolving the common problems in formulating liquid drugs. |
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| Author(s) : Safaraz Niazi | Format : Hardback Book |
| ISBN-10 : 0849317479 | ISBN-13 : 9780849317477 |
| RRP : £190.00 | Best available price : £ / $ |
| Prices as of : BST check live prices | |
Series Title : Handbook of Pharmaceutical Manufacturing Formulations
Country Publication : United States
Publication Date : 27/04/2004
Publisher : Taylor & Francis Ltd
Page Length : 224mm