Excipient category

More than 200 monographs of pharmaceutical excipients appear in the third edition of the Handbook of Pharmaceutical Excipients, published jointly by the American Pharmaceutical Association and the Pharmaceutical Press in the year 2000. In addition, more than 200 of the same pharmaceutical ingredients (excipients) are listed in NF 19 and cover more than 40 different excipient categories, from acidulants to wetting agents. It has been estimated that there are more than 1000 different pharmaceutical excipients in use worldwide at the present time. 

On the left part of the screen, you can select the active pharmaceutical ingredient or excipient category (in the case of the active pharmaceutical ingredients, a letter of the alphabet is also displayed) and open the desired spectra sheet by clicking on it. 

The USP/NF provides a listing of excipients by categories in a table according to the function of the excipient in a dosage form, such as tablet binder, disintegrant, and such. An excellent reference for excipient information is the APA s Handbook of Pharmaceutical Excipients (1994). 

Tests have been outlined for each exposure category to assure safe use of the time period designated. The tests for each exposure category assure the safe use of the new pharmaceutical excipient for the time frame specified for the specific exposure category. Additional tests are required for longer exposure times. 

Residual solvents are organic volatile chemicals that remain in active substances, excipients, and other pharmaceutical products after processing. In spite of their toxic properties, solvents play an important role in the production of pharmaceuticals, during the synthesis, separation, or purification, and their use cannot be avoided. Solvents in this category do not include those used as excipients. 

Materials that have had prior human use/exposure in food and cosmetics, or from the chemical industry, can be categorized as essentially new excipients. Such previous exposure is likely to be of help for oral and topical use excipient development. Excipients that have had established medicinal product use but are being used by a different dose route and/or chemically modified to enhance their properties are also likely to belong to this category. 

By this we mean interactions that occur after the medicine has been administered to the patient. For the most part, they are physical interactions. However, the major distinctions are that the interaction is between the medicine (including excipients) and the body fluids, primarily comprising aqueous solutions, and that they have the potential to influence the rate of absorption of the drug. They will vary depending on the route of administration. Because physiological and biopharmaceutical interactions are so important, and they are not specifically linked, for example, to the stability of the medicinal product, and also because they occur after the medicine has been administered to the patient, they have been included as a special category for the purposes of this discussion. The importance and potential impact of biopharmaceutical interactions of excipients has been recognized for some years (see for example Ref. 29). 

Intuitively such delivery systems or excipients would best achieve this objective if they were to be composed of natural products or their modifications an overwhelming presence of excipients under this category (discussed in Ref. 1) provides credence to this observation. The substitution of natural products comprising complex proteins, antibodies, chimera, or toxins in lieu of stand-alone simple inorganic molecules as excipients for parenteral drug delivery represents a paradigm shift in the introduction of emerging excipients in the therapeutic armamentarium. 

Annex II will contain those substances for which no MRL is necessary to protect public health. However, this does not necessarily mean that these substances do not require safety testing or are exempt from withdrawal periods. As indicated by the application form for an Annex II listing, this category was created with (among other substances) adjuvants and excipients in mind. It is expected that at least those excipients with a long history of safe use in humans will be listed in Annex II. 

Table 2 includes a broad category of excipients whose function in formulation could be as follows ... 

Many excipients used by the pharmaceutical industry in the last 15 years in sugar-free medical preparations probably come under the category of essentially new excipients. Pressure for their introduction has been encouraged by the definite relationship between the dietary consumption of sucrose and the incidence of dental caries. " "" These materials include intense sweeteners such as saccharin and cyclamate plus bulk sweeteners such as the polyols sorbitol, xylitol, and lactitol. These materials are all either approved for food use or have pharmacopoeia monographs in existence or in draft. Fiterature reviews show number of... 

The cyclodextrins (CDs) fall into the categories of new and essentially new excipients. CDs are enzymatically modified starches with many favorable properties as excipients. The use of CDs in food products in the late 1970s and 1980s, together with extensive preclinical testing, has resulted in the inclusion of these materials in marketed Various companies now... 

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