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What is the Handbook of Pharmaceutical Excipients used for?
The Handbook of Pharmaceutical Excipients is internationally recognised as the world’s most authoritative source of information on pharmaceutical excipients. It provides you with a one stop resource when researching an excipient for use.
How do you cite a pharmaceutical excipient handbook?
Citation Data
- MLA. Handbook of Pharmaceutical Excipients. London : Washington, DC :Pharmaceutical Press ; American Pharmaceutical Association, 2003.
- APA. Handbook of pharmaceutical excipients. ( 2003).
- Chicago. Handbook of Pharmaceutical Excipients.
What is excipients in pharmaceuticals?
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.
Why are excipients important?
Excipients are used to facilitate the manufacture and use of medicines. Without excipients, it would not be feasible to formulate some drugs into appropriate medicinal products. For others the removal of excipients would reduce the shelf life and make them uneconomic to produce or too expensive for users to purchase.
What is the role of excipients?
Specialty excipients are used to produce dosage forms that can reduce the number of doses by modifying the rate of drug release or improve drug delivery by targeting drug release in a specific region in the gastrointestinal tract where drug absorption is the highest.
What is excipient monograph?
A monograph includes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification. The specification consists of a series of tests, procedures for the tests, and acceptance criteria.
What are the roles of excipients?
The intended function of an excipient is to act as the carrier (vehicle or basis) or as a component of the carrier of the active substance(s) and, in so doing, to contribute to product attributes such as stability, biopharmaceutical profile, appearance and patient acceptability and to the ease with which the product …
What are the properties of excipients?
Generally, an excipient has no medicinal properties. Its standard purpose is to streamline the manufacture of the drug product and ultimately facilitate physiological absorption of the drug. Excipients might aid in lubricity, flowability, disintegration, taste and may confer some form of antimicrobial function.
Why excipients are important in a drug product?
How are excipients regulated?
Under U.S. law, an excipient, unlike an active drug substance, has no regulatory status and may not be sold for use in food or approved drugs unless it can be qualified through one or more of the three U.S. Food and Drug Administration (FDA) approval mechanisms that are available for components used in food and/or …
What is USP monograph?
USP Monographs for Bulk Drug Substances and Other Ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations. These monographs appear in the USP–NF.
What is difference between drug and excipient?
APIs are bulk drugs that are pharmaceutically active and generate a desired pharmacological effect, whereas, excipients are pharmacologically inactive substances that are generally used as a carrier of the API in the drug.
What is the importance of pharmaceutical excipients?
Pharmaceutical Excipients are crucial to drug delivery within the body. Generally, an excipient has no medicinal properties. Its standard purpose is to streamline the manufacture of the drug product and ultimately facilitate physiological absorption of the drug.