Latest Edition Of Handbook Of Pharmaceutical Excipients
Maureen Quartaro
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.
At the end of August 2009, the 6th Edition of the Handbook of Excipients appeared in print (both hard copy and interactive CD ROM). Containing 340 monographs on pharmaceutical excipients, the handbook presents a collection of essential physical and chemical data, and other data of interest. It is divided into 22 sections covering: nonproprietary names, synonyms, chemical name and chemical abstract service (CAS) registration number, empirical formula and molecular weight, structural formula, functional category, applications in pharmaceutical formulation or technology, description, pharmacopoeial specifications, typical properties, stability and storage conditions, incompatibilities, methods of manufacture, safety, handling precautions, regulatory status, related substances, comments, specific and general references. In the last section, the authors responsible for the monograph are named and the date of revision of the monograph is recorded. A suppliers' directory for the various excipients is provided in Appendix I: first sorted in view of the excipients listed in the Handbook; and second, listing the addresses and contact information for each supplier mentioned. Appendix II provides a list of the 'EN-umbers' for the various excipients and Appendix III summarises the 'EINECS-Numbers' for the excipients. The molecular weight of the excipients is compared in Appendix IV.
The information collected originates from various international sources, and compendial data are extracted from the British Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia and the US Pharmacopeia/National Formulary. This makes the Handbook of Excipients a standard reference book for worldwide use in the pharmaceutical and cosmetic industries, in governmental departments involved in the regulation and licensing of pharmaceutical products, as well as in academia.
The Handbook of Excipients should be on the desk of anybody involved in the development or manufacture of pharmaceutical products in Europe, the US and Japan. Development of pharmaceutical dosage forms and drug delivery devices is increasingly undertaken by nonpharmacists, and even in academia, it is the Departments of Chemical and Mechanical Engineering that get more and more involved in novel pharmaceutical developments. In these research groups, however, excipients are often used that are unacceptable in pharmaceutical products and the Handbook of Excipients is unknown and usually unavailable to these scientists; a shortage that the publishers should be able to address. Manufacturers of nutraceuticals, cosmetics and health foods should also consider obtaining at least one copy for the library. Even manufacturers of machinery (particularly capsule filling and tabletting) might find this book occasionally useful. In addition to commercial use, this book provides essential information on excipients for students and lecturers of pharmacy or pharmaceutical sciences; yet for the latter clientele, to purchase the book would require special discounts and subsidized access through their science libraries.
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.
Excipients have been defined in many ways, including as inert substances used as vehicles and diluents for drugs. The problem with this definition is that in recent years excipients have proved to be anything but inert, not only possessing the ability to react with other ingredients in the formulation, but also to cause adverse and hypersensitivity reactions in patients. These range from a mild rash to a potentially life-threatening reaction. Different brands of the same drug may contain different excipients, especially preservatives and colourants. The Consumer Medicines Information provides a list of excipients, and information on the safety of individual excipients can be found in drug reference guides.
The word excipient is derived from the Latin excipere, meaning 'to except', which is simply explained as 'other than'. Pharmaceutical excipients are basically everything other than the active pharmaceutical ingredient. Ideally, excipients should be inert, however, recent reports of adverse reactions have suggested otherwise.
The best new therapeutic entity in the world is of little value without an appropriate delivery system.1 Today, medicines are available in many dosage forms including tablets, capsules, oral liquids, topical creams and gels, transdermal patches, injectable products, implants, eye products, nasal products, inhalers and suppositories. Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action, but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability. They may also assist in product identification and enhance the overall safety or function of the product during storage or use.2
The list of purposes for which excipients are used, as defined in international pharmacopoeias, is extremely long. Many excipients have more than one use, which can be an advantage since it reduces the number of excipients needed and minimises the risk of interactions between them.
Tablets are the most widely used dosage form. Their manufacture can be a complex process and considerable ingenuity and formulation expertise are required to produce a product that will be stable during storage, transport and handling, yet will release its active pharmaceutical ingredient as required once ingested.4 Various excipients are used to achieve this (Table 1).2
Ideally, an excipient is pharmacologically inactive, non-toxic, and does not interact with the active ingredients or other excipients. However, in practice few excipients meet these criteria. Toxicity may relate to compounds used as excipients in the final dosage form, or to residues of compounds (such as solvents) used during the manufacturing process.2 Table 2 shows examples of adverse reactions that have occurred with excipients.
Owing to their widespread and relatively large use in food, a number of colours in current use have been associated with adverse effects, although in a relatively small number of people.5 The role of food additives in hyperactive behaviour has been debated for many years. In 2007 a study was published linking the use of six colours (tartrazine, quinoline yellow, sunset yellow, carmoisine, ponceau 4R and allura red) with behavioural problems in children. However, after reviewing the results of the study, the European Food Standards Agency concluded that no change in legislation was needed.5
When presented with a patient who has an adverse reaction, it is important to be aware that reactions may not always be due to the active ingredient (Fig. 1). They are more likely to occur if the patient has an existing sensitivity to similar ingredients, or is on multiple medicines, or when the quantity of excipients may be high relative to body weight, for example in premature babies.6 Excipients present in their current and past medication history should also be considered. This will help to rule out which ingredients may be causing the adverse effects.
Similar action to glidants, however, they may slow disintegration and dissolution. The properties of glidants and lubricants differ, although some compounds, such as starch and talc, have both actions.
Protect tablet from the environment (air, light and moisture), increase the mechanical strength, mask taste and smell, aid swallowing, assist in product identification. Can be used to modify release of the active ingredient. May contain flavours and colourings.
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