Excipients regulatory requirements

List the common excipients used and also the regulatory requirements for approving excipients. 

Tableting process, since being introduced in the early 1840s, has witnessed numerous changes in the form of stringent regulatory requirements for the excipients and product stability. Increasing regulatory pressure on purity, safety, and standardization of the excipients has catalyzed the formation of an international body, the International Pharmaceutical Excipients Council (IPEC) (13). IPEC is a tripartite council with representation from the United States, Europe, and Japan, and has made serious efforts to harmonize requirements for purity and functionality testing of excipients (14).

The selection of a drug delivery system suitable for the administration of a particular drug compound to human respiratory airways depends not only on the device performance, but also on many other factors such as drug properties, formulation excipient, intended site of action, marketing preference, and regulatory requirements. It is important to fully understand the drug properties during the formulation... 

In Japan, Uchiyama has recently published requirements for the safety evaluation of new excipients. These requirements include studies on acute, subacute, and chronic toxicity, mutagenicity, effects on reproduction, dependency, antigenicity, carcinogenicity, and local irritation (human patch test). The first five of these tests are mandatory. With the exception of the local irritation test, for which a domestic trial is required, non-Japanese data are acceptable for these studies. Even if a material has been used in a pharmaceutical product outside Japan, the material is treated as a new excipient if there has been no prior use in Japan, although relevant overseas data for the material are acceptable for regulatory submission. A material is treated as a new excipient when the route of administration differs or the dose level exceeds that of prior use even after approval for the Japanese market.f ... 

Although the subject of their own chapter in this book, it should be emphasized here that there is no regulatory requirement for innovative and generic drugs to have identical excipients. Exemption from demonstration of efficacy for generic products is obtained only when bioequivalence with a prototype, approved product is demonstrated. 

The multidose formulation will be tested to determine its efficacy according to the Antimicrobial Effectiveness Test required by the USP.39 If the results support the USP requirements, international requirements must then be met. International markets require different preservatives, different concentrations, and different excipients of the formulation. In addition, the period required for the inhibition and/or killing of the challenge microorganisms may be different. International regulatory requirements for compliance should be well researched and understood by the scientific and the management staff. 

Monkhouse DC. Excipient compatibility possibilities and limitations in stability prediction. In stability testing in the EC, Japan and the USA. In Crim W, Krummen K, eds. Scientific and Regulatory Requirements, Paperback APV 32. Stuttgar Wissenschaftlidie Verlassgellschaft... 

Labeling requirements for excipient packages are subject to applicable national and international regulatory requirements, which may include transportation and safety measures. Procedures must be employed to protect the quality and purity of the excipient when it is packaged, and to assure that the correct label is applied to all containers. A good system of labeling should have, at a minimum, the following features ... 

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