Pharmacy

Handbook of Pharmaceutical Manufacturing Formulations, by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

The most important class of pharmaceutical formulations, comprising virtually two-thirds of all dosage varieties, compressed solids current many of the maximum demanding situations to formula scientists. the 1st quantity, Compressed sturdy items, tackles those demanding situations head on. Highlights from Compressed sturdy items, Volume One contain: formulations for greater than two hundred of the main commonplace medicines for all sorts of liberate profiles, supplying formulators a unprecedented chance to begin with an optimum composition the necessities of what try to be conscious of whilst setting up a producing procedure in keeping with the formulations offered id and inclusion of the most well-liked prescription items, a serious checklist for the choice of goods

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Additional info for Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 1: Compressed Solid Products

Example text

This geometric mean will be on the original scale of the measurement. It will be close to but not exactly equal to the mean obtained on the original scale of the measurement. The back-transformation of the confidence bounds is accomplished in the following way: Lower bound (expressed as a percentage) = (eL −1) × 100 Upper bound (expressed as a percentage) = (eU −1) × 100 Where L is the lower 90% confidence interval and calculated on the log-transformed data; U is the upper 90% confidence interval and calculated on the log-transformed data.

Mehta CR, Patel NR, Tsiatis AA (1984). Biometrics 40:819–825. Midha KK, Rawson MJ, Hubbard JW (2005). The bioequivalence of highly variable drugs and drug products. Int J Clin Pharmacol Ther 43(10):485–498. Parry GE, Dunn P, Shah VP, et al (1992). Acyclovir bioavailability in human skin. J Invest Dermatol 98:856–863. Pershing L, Silver BS, Krueger GG, et al (1992). Feasibility of measuring the bioavailability of topical betamethasone dipropionate in commercial formulations using drug content in skin and a skin blanching bioassay.

Although the use of the high alcoholic medium is not considered conventional, it has been found justifiable by the FDA for this drug substance. You may develop an alternate dissolution testing method for the drug product and submit the dissolution testing results when the application is filed. Azithromycin Tablets/Oral. Recommended studies: 2 studies. 1. Type of study: Fasting Design: single-dose, twoway crossover in vivo; Strength: 600 mg; Subjects: Normal, healthy males and females, general population.

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