Pharmaceutical dosage forms contain both pharmacologically active compounds and excipients added to aid the formulation and manufacture of the subsequent dosage form for administration to patients. Indeed, the properties of the final dosage form (i.e. its bioavailability and stability) are, for the most part, highly dependent on the excipients chosen, their concentration and interaction with both the active compound and each other. No longer can excipients be regarded simply as inert or inactive ingredients, and a detailed knowledge not only of the physical and chemical properties but also of the safety, handling and regulatory status of these materials is essential for formulators throughout the world. In addition, the growth of novel forms of delivery has resulted in an increase in the number of the excipients being used and suppliers of excipients have developed novel excipient mixtures and new physical forms to improve their properties. This database has been conceived as a systematic, comprehensive resource of information on all of these topics.
The first edition of the Handbook was published in 1986 and contained 145 monographs. This was followed by the second edition in 1994 containing 203 monographs, the third edition in 2000 containing 210 monographs, and the fourth edition in 2003 containing 249 monographs. Since 2000, the data has also been available on CD-ROM, updated annually, and from 2004 online. The fifth edition with its companion CD-ROM, Pharmaceutical Excipients 5, contains 300 monographs compiled by over 120 experts in pharmaceutical formulation or excipient manufacture from Australia, Europe, India and the USA. All the monographs have been reviewed and revised in the light of current knowledge. There has been a greater emphasis on including published data from primary sources although some data from laboratory projects included in previous editions have been retained where relevant. Variations in test methodology can have significant effects on the data generated (especially in the case of the compactability of an excipient), and thus cause confusion. As a consequence, the editors have been more selective in including data relating to the physical properties of an excipient. However, comparative data that show differences between either source or batch of a specific excipient have been retained as this was considered relevant to the behavior of a material in practice. The Suppliers Directory (Appendix I) has also been completely updated with many more international suppliers included.
In a systematic and uniform manner, Pharmaceutical Excipients collects essential data on the physical properties of excipients such as: boiling point, bulk and tap density, compression characteristics, hygroscopicity, flowability, melting point, moisture content, moisture-absorption isotherms, particle size distribution, rheology, specific surface area, and solubility. Scanning electron microphotographs (SEMs) are also included for many of the excipients. Pharmaceutical Excipients contains information from various international sources and personal observation and comments from monograph authors, steering committee members, and the editors.
All of the monographs in the electronic version are thoroughly cross-referenced and indexed so that excipients may be identified by either a chemical, a nonproprietary, or a trade name. Most monographs list related substances to help the formulator to develop a list of possible materials for use in a new dosage form or product. Related substances are not directly substitutable for each other but, in general, they are excipients that have been used for similar purposes in various dosage forms.
Pharmaceutical Excipients is a comprehensive, uniform guide to the uses, properties, and safety of pharmaceutical excipients, and is an essential reference source for those involved in the development, production, control, or regulation of pharmaceutical preparations. Since many pharmaceutical excipients are also used in other applications, Pharmaceutical Excipients will also be of value to persons with an interest in the formulation or production of confectionery, cosmetics, and food products.