Guidelines

How do you cite a pharmaceutical excipient handbook?

How do you cite a pharmaceutical excipient handbook?

Citation Data

  1. MLA. Handbook of Pharmaceutical Excipients. London : Washington, DC :Pharmaceutical Press ; American Pharmaceutical Association, 2003.
  2. APA. Handbook of pharmaceutical excipients. ( 2003).
  3. 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.

What are the types of excipients?

Excipients by Origin: Organic Chemicals

  • Fillers & Diluents.
  • Binders.
  • Suspension & Viscosity Agents.
  • Coatings.
  • Flavoring Agents.
  • Disintegrants.
  • Colorants.
  • Lubricants & Glidants.

Do excipients need to be GMP manufactured?

The excipient starting materials may not be required to be manufactured in accordance with Good Manufacturing Practice (GMP) requirements for excipients (for example as in the IPEC-PQG GMP Guide1) because these other uses of the material do not demand the adoption of GMP.

What is the Handbook of pharmaceutical excipients used for?

Rowe 2005 The Handbook of Pharmaceutical Excipients is a comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential reference for those involved in the development, production, control or regulation of pharmaceutical preparations; The handbook collects together essential …

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 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.

What is the role 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 excipients PPT?

Excipient  An excipient is an inactive substance formulated alongside the active ingredient of a medication, for the purpose of bulking-up formulations that contain potent active ingredients.  Drug products contain both drug substance (commonly referred to as active pharmaceutical ingredient or API) and excipients.

Do excipients need FDA approval?

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 …

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 NF monograph?

What is USP-NF? USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.

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 the purpose of excipient?

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.

How do you calculate excipients?

  1. Measure the average weight of your preparation by taking 20 tablets (or as recommended). Let, it is “X” mg.
  2. Finely ground those using mortar and pestle…
  3. Now, minus the value “Y” from “X” i.e. Z = X – Y ; where Z represents the average weight of excipients (in mg) of your tablet preparation.

How are pharmaceutical excipients classified?

On the basis of their functions, excipients can be categorized as binders, cosolvents, fillers, disintegrates, lubricants, surfactants, emulsifying agents, suspending agents, antimicrobials, preservatives, etc.

What is the difference between DMF and dossier?

As I know, Drug master file has information of the manufactured product while dossier is an application submitted to the regulatory agencies. Drug Master file is part of 3.2. S of the dossier which contains information regarding API only where as the dossier is submitted for the finished pharmaceutical product.

Do excipient manufacturers have to register with FDA?

Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products.

What is the Handbook of pharmaceutical excipients?

The Handbook of Pharmaceutical Excipients has been point, moisture content, moisture-absorption isotherms, particle conceived as a systematic, comprehensive resource of information size distribution, rheology, specific surface area, and solubility. on all of these topics.

What are the best sources for excipients in pharmaceutical formulation?

An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs.

What is included in the 4th edition of excipients?

It collects in a systematic and unified manner, the essential data on the physical and chemical properties of excipients. The fourth edition has been completely revised and updated, and includes 40 new excipient monographs and many more excipients included as “related substances”.

What is Eur J Pharm Biopharm 1994?

Eur J Pharm Biopharm 1994; calcium sulfate. 40 (5): 289–293. 9 Kiyoshi T et al. Novel preparation of free-flowing spherically 18 Comments granulated dibasic calcium phosphate anhydrous for direct tabletting. Chem Pharm Bull 1996; 44 (4): 868–870. Anhydrous dibasic calcium phosphate is one of the materials that 10 Ayorinde JO et al.