Pharmaceutical excipients, handbook

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. 

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],... 

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). 

Anon. Handbook of Pharmaceutical Excipients. London Pharmaceutical Press, 1986. 

Handbook of Pharmaceutical Excipients, Vol. 1, American Pharmacetical Association, Washington, DC, 1986, p. 53. 

N. A. Armstrong and co-workers, in A. Wade and P. J. Weller, eds., Handbook of Pharmaceutical Excipients, 2nd ed., American Pharmaceutical Association, Washington, D.C. and The Pharmaceutical Press, Royal Pharmaceutical Society, London, 1994, pp. 500—505. 

Rowe RC, Sheskey PJ, Weller PJ. Handbook of Pharmaceutical Excipients. 4th ed. American Pharmaceutical Association and The Pharmaceutical Press, 2003. 

Many pharmaceutical excipients are food additives or GRAS substances that have been used in foods for many years. The Handbook of Excipients provides information in the regulatory status section for the accepted uses of excipients in foods (27). In addition, Appendix II of the Handbook lists the E number for excipients that are approved as food additives in the EU. 

Although spray-crystallized dextrose-maltose (EMDEX , J. Rettenmaier Sohne GmbH Co. KG, Germany) and compressible sugars are coprocessed, they are commonly considered as single components and are listed as such in the United States Pharmacopeia, while the third edition of the Handbook of Pharmaceutical Excipients has listed SMCC as a separate excipient (58). 

Monograph for Calcium Phosphate, Dibasic Dihydrate from Handbook of pharmaceutical excipients. London Pharmaceutical Press, 2004. 

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. 

Information about excipients is useful in the initial planning and interpretation of the excipient compatibility results. Important factors to consider for excipients include their physical-chemical properties. The Handbook of Pharmaceutical Excipients lists important information on structure, moisture content, melting point, pH, solubility, and equilibrium moisture at variable relative humidity for individual excipients (27). An example of relevant physical-chemical parameters for some select excipients is detailed in Table 1. A spectroscopic review of excipients (28) has been completed, and extensive reviews of some of the most common types of excipients (i.e., carbohydrate based) are published (29). 

Kibbe AH, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC American Pharmaceutical Association, 2000 665. 

Winfield AJ. 2006. Lactose, spray-dried. In Rowe RC, Sheskey PJ, Owen SC, editors. Handbook of pharmaceutical excipients, 5th ed. London and Washington, DC Pharmaceutical Press and American Pharmaceutical Association 396-401. 

Rowe R, Sheskey P and Owen S (2005) Handbook of Pharmaceutical Excipients Chlorofluorocarbons (CFC). London Pharmaceutical Press. Available at http //www. medicinescomplete.com/ [Accessed 4 July 2008],... 

Handbook of Pharmaceutical Excipients (1994) 2nd edn, American Pharmaceutical Association - The Pharmaceutical Press, London... 

---