Excipients, pharmaceutical

Handbook of Pharmaceutical Excipients American Pharmaceutical Association/The Pharmaceutical Society of Great Britain, Washington, D.C. and London, 1986, pp. 19, 99, 101, 145, 240, 333. 

The US. Pharmacopeia (USP XXII) or National Formula (NFXVII) (20) also provide a similar description however, the peroxide value is not defined (Table 9). These specifications are also given in the Handbook of Pharmaceutical Excipients (HPE), pubhshed jointiy by the American Pharmaceutical Association and The Pharmaceutical Society of Great Britain (21), which defines lecithins both from plants and eggs. The Merck Index (22) specifies a slightiy lower acid value. The Japanese Monograph (ISCI-II) (23) specifies a slightiy lower acetone-insoluble matter and a lower heavy-metal content. 

Lecithia," Handbook of Pharmaceutical Excipients., American Pharmaceutical Association, Washiagton, D.C., 1986, p. 165. 

Papaverine, used to treat heart diseases as a vasodilator, is a dmg that was originally made from vanillin but has since been made from veratrole and (9f2v (9-l,2-dimethoxybenzene. Vanillin is also used as a pharmaceutical excipient. 

A. Candolfi, R. De Maesschalk, D.L. Massart, P.A. Hailey and A.C.E. Harrington, Identification of pharmaceutical excipients using NIR spectroscopy and SIMCA. J. Pharm. Biomed. Anal., in prep. 

JA Ranucci, IB Silverstein. Polymeric pharmaceutical excipients. In HA Lieberman, MM Rieger, GS Banker, eds. Pharmaceutical Dosage Forms Disperse Systems, Vol. 3, 2nd ed. New York Marcel Dekkter, 1998, pp 243-289. 

In many products it seems highly probable that there exists a narrow range of optimum moisture contents that should be maintained. More specifically, the effect of moisture on MCC-containing tablets has been the subject of an investigation that demonstrates the sensitivity of this important excipient to moisture content [10]. These researchers found that differences exist in both the cohesive nature and the moisture content to two commercial brands of MCC. A very useful report on the equilibrium moisture content of some 30 excipients has been compiled by a collaborative group of workers from several pharmaceutical companies and appears in the Handbook of Pharmaceutical Excipients [11,12],... 

Principles of Good Manufacturing Practices for Bulk Pharmaceutical Excipients... 

Pharmaceutical Excipients Characterization by IR, Raman, and NMR Spectroscopy, David E. Bugay and W. Paul Findlay... 

The comprehensive profiling of drug substances and pharmaceutical excipients as to their physical and analytical characteristics remains at the core of pharmaceutical development. As a result, the compilation and publication of comprehensive summaries of physical and chemical data, analytical methods, routes of compound preparation, degradation pathways, uses and applications, etc., has always been a vital function to both academia and industry. 

Plastic deformation is the permanent change in shape of a specimen due to applied stress. The onset of plastic deformation is seen as curvature in the stress—strain curve. Plastic deformation is important because it allows pharmaceutical excipients and drugs to establish large true areas of contact during compaction that can remain on decompression. In this way, good, intact, tablets can be prepared. 

Amidon and Houghton [48] completed a comparative study of several common methods of characterizing powder flow. Table 2 contains experimental results for a number of commonly used pharmaceutical excipients. Compressibility index, angle of repose, flow rate through an orifice, and shear cell data are presented. 

Table 5 Wm Values for Various Pharmaceutical Excipients Obtained from BET Analysis of Moisture Uptake Isotherms...

International Pharmaceutical Excipients Council (IPEC) guidelines, 21 168, 169 International Programme on Chemical Safety (IPCS), 18 540-541 International Society of Blood Transfusion (ISBT), 12 151... 

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. 

TABLE 13.10. Summary of Toxicological Studies Recommended for New Pharmaceutical Excipients Based on Route of Exposure3... 

Acute inhalation toxicity To determine the potential acute toxicity-lethality following a single 4-h inhalation exposure to a test atmosphere containing the new pharmaceutical excipient (aerosol, vapor or particles)... 

Yapp, F. S., Adams, M. J., Seville, J. P. K., Zhang, Z. Single and bulk compression of pharmaceutical excipients Evaluation of mechanical properties. Powder Technol., 185, 2008, 1-10. 

Different food components (e.g., fruit extracts) and commonly used pharmaceutical excipients (e.g., Tween 80) can interfere with secretory transport systems, leading to drug-food interactions [31, 43, 46, 167], As for CYPs, inhibition and induction of efflux transporters have been reported as possible... 

Hugger ED, Novak BL, Burton PS, Audus KL, Borchardt RT (2002) A comparison of commonly used polyethoxylated pharmaceutical excipients on their ability to inhibit P-glycoprotein activity in vitro. J Pharm Sci 91 1991-2002. 

Lo Y-L (2003) Relationships between the hydrophilic-lipophilic balance values of pharmaceutical excipients and their multidrug resistance modulating effect in Caco-2 cells and rat intestines. J Control Release 90 37 -8... 

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