Comments: tocopherols excipient is described in the USPNF XVII as a vegetable oil solution containing not less than 50.0% of total tocopherols, of which not less than 80.0% consists of varying amounts of alpha, beta, delta and gamma tocopherols. The Handbook of Pharmaceutical Excipients collects together essential data on the physical properties of excipients as well as providing information on their safe use and applications. All of the 400+ monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.

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Sheskey, Paul J; Cook, Walter G; Cable, Colin G
Eighth Edition

The Handbook of Pharmaceutical Excipients contains essential data on the physical properties of excipients, their..

RPS Member Price£311.25

Rowe, Raymond C; Sheskey, Paul J; Quinn, Marian E
Online via MedicinesComplete

A comprehensive guide to the uses, properties and safety of pharmaceutical excipients. Available online..

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Novel excipients – which this Working Group define as “a material or a composition that has not been previously used in an approved drug product in the US (i.e. not listed in FDA Inactive Ingredient Database (IID)) or that has been previously used in an approved drug product but which it is desired to employ for a new route of administration, or a higher level of use than has been previously listed in the IID, or a new co-processed excipient made from two or more previously approved excipient” - can enhance pharmaceutical safety and efficacy (e.g., by modifying drug plasma profiles), and may present opportunities for accelerating new therapeutic mechanisms (e.g., by enabling low solubility candidates) to create valuable new drug products for patients. They can also play an important role in addressing patient needs by extending uses and presentations of existing medicines.

In light of current challenges in drug development, IQ and IPEC-Americas have established a collaboration to assess challenges to novel excipient use, and identify potential solutions to facilitate use of novel excipients. IQ and IPEC are currently exploring regulatory pathways to enable the use of novel excipients.

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