Handbook Of Pharmaceutical Excipients 8th Edition Pdf Free Download
Berniece Leonhardt
Handbook of Pharmaceutical Excipients is internationally recognised as the authoritative source of information on pharmaceutical excipients giving a comprehensive guide to uses, properties and safety. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity. All 380 monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names. The changes of this new edition are:
Pharmaceutical Press are currently offering a pre-publication offer price till 31 October 2012. Order your copy of the Handbook of Pharmaceutical Excipients now and get 10% discount off the published price. Order at www.pharmpress.com
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The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.
This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
The book describes the properties, analytical methods and the applications of different polyvinylpyrrolidone excipients (povidone, crospovidone, copovidone etc.) for use in pharmaceutical preparations. This group of excipients is one of the most important excipients used in modern technology to produce drugs. The book is intended for all persons working in the research, development and quality control of drugs. It gives a survey of all applications in solid, liquid and semisolid dosage forms including many drug formulation examples and more than 600 references to the literature.
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Fas discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
Excipients typically influence a variety of critical quality attributes and process parameters of a drug product and can often be used to enhance oral bioavailability, modifying both drug solubility and permeability; particularly for BCS (Biopharmaceutical Classification System) class III or IV compounds.2
Excipients endow formulations with stability or else allow a more effective and safe delivery option and are typically classified into functional categories, which are dependent on the medicinal product. For example, in tablets they are classified as diluents/fillers, binders, lubricants, glidants, etc. Excipients can also have multiple functions in a formulation or in different delivery systems. For example, hydroxypropylmethylcellulose (HPMC or hypomellose) can be used as a coating agent or binder in solid oral dosage forms; as a suspending agent in oral suspension products; and as a viscosity-enhancing, mucoadhesive in intra-nasal products.3 Innovation in drug products can also be driven by formulations with atypical levels of known excipients or using established oral excipients via a different delivery route or novel excipients. Regulators regard novel excipients as new substances and this constitutes an important barrier to development of innovative drug products.9
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The Handbook of Pharmaceutical Excipients is internationally recognised as the worlds most authoritative source of information on pharmaceutical excipients. It provides you with a one stop resource when researching an excipient for use. The 400+ monographs are also thoroughly cross referenced and indexed to allow their identification by chemical, non proprietary or trade names. Extensive content updates in the new edition include: - Over 420 fully referenced excipient monographs, many including IR, Raman, and NIR spectra - 13 new monographs including several amino acids and hydrated silicon dioxide - 250 existing monographs reviewed - New chapters include excipient selection for orally inhaled and injectable formulations Order your copy today and: Get the full picture on excipients - all the information you need on the physical properties of excipients Save research time - each monograph contains everything you need to ensure the correct excipient is selected Ease of use - monographs are thoroughly cross-referenced and indexed so that excipients can easily be identified by either a chemical, a non-proprietary or a trade name Get up to speed quickly on unfamiliar areas with educational chapters on topics such as the characteristics of excipients in formulations
CONTENTS:
Table of Contents
New Formulation Considerations and Related Information chapters on:
Functional Categories of Pharmaceutical Excipients
Pharmaceutical Excipients in Pediatric Formulations
The Selection of Excipients for Oral Solid Dosage Forms
The Selection of Excipients for Injectable Formulations
Formulation Considerations for Orally Inhaled Dosage Forms
Reactive Components in Pharmaceutical Excipients
Biological Effects of Pharmaceutical Excipients
The Use of Counter-ions and Co-formers in the Creation of Salt and Co-crystal Forms of Active Pharmaceutical Ingredients (APIs)
Over 400 Monographs benefiting from a standardized, easy-to-use template including:
pharmacopoeial information from the UK, Europe, Japan and the United States
non-proprietary names and synonyms
chemical name and structure, CAS Registry number, empirical formula, molecular weight
functional category, applications and incompatibilities
material description and typical excipient properties
safety, stability, storage and handling information
method of drug manufacture
related substances
primary references
editorial comments
author details and revision date
Appendices
Suppliers directory
List of Monographs by Functional Category
List of Related Substances
List of Excipients by E number
List of Excipients by EINECS number
List of Excipients by CAS number
Pharmaceutical Excipients Assessed by the FDA Select Committee on GRAS Substances (SCOGS)
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N2 - Nanomaterials are being explored intensely for applications in pharmaceutical sciences and nanomedicine. The same properties of these materials that make them interesting for the development of novel excipients, therapies and diagnostics are those which often make them potentially harmful. A thorough investigation of the interaction of any new nanomaterial with the immune system, coupled with both generic and specific toxicological information must hence be conducted. However, in many instances common toxicological assays and endpoints are not applicable and may need revising. Here, we highlight some of these barriers using mesoporous silica materials as an example and suggest some important material properties to be taken into account when performing a full toxicological appraisal.
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