Tablet regulatory

Toxicology Essentially nontoxic Uses Sweetener for pharmaceuticals diluent, excipient in tablets and capsules Features May be compressed directly into selfbinding tablets Regulatory NF compliance Manuf./Distrib. AMRESCO http //www.amresco-inc.com, Adept Sol ns. Ashland http //www.ashchem.com, Avebe Am. http //www.avebe.com] Barrington http //WWW. barringtonchem. com CarboMer http //www.carbomer.com, Cerestar USA Corn Prods. 

Uses Dissolution enhancer for actives in tablets and capsules polishing agent for fi Im-coaled tablets water-soluble lubricant for effervescent tablets Regulatory USP/NF, EP, JPE... 

A tablet containing two drug compounds, A and B, is being scaled up from kilogram to half-ton batches in preparation for a regulatory submission. The applicable specifications and sample work-up methods are... 

An MEKC method for the determination of ibuprofen, codeine phosphate hemihydrate, their nine potential degradation products, and impurities in a commercial tablet formulation was developed, optimized, and fully validated according to ICH guidelines and submitted to the regulatory authorities. The optimized system containing ACN as organic modifier allowed baseline separation of ibuprofen, codeine, and nine related substances within 12 min. 

The decision to approve a new drug is made by a national regulatory body (Food Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK Europe, Australia) to which manufacturers are required to submit their appUca-tions. AppUcants must document by means of appropriate test data (from predinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control. 

In addition to these regulatory issues there are some homemade limitations to common quality documentation (e.g. normally, pharmaceutical companies prefer to market tablets in polyethylene bottles in the United States, in contrast to blister packs for the European market and different trade names, colours or pack sizes are also unavoidable in certain cases). The consequence of these differences is the fact that a common Module 3 (Quality) and therefore a common Quality Summary in Module 2 cannot be compiled. 

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 government is currently in the process of attempting to regulate ephedrine use in pep pills and supplements. The proposal is the FDA s first regulatory major initiative under the 1994 Act. According to the FDA, more than 800 adverse reactions, including seizures, strokes, and heart attacks, have been linked to ephedrine capsules, tablets, and teas since 1994. The FDA puts the ephedrine-related death toll at 18 since then. 

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