By Sarfaraz K. Niazi
The most important type of pharmaceutical formulations, comprising virtually two-thirds of all dosage varieties, compressed solids current a number of the maximum demanding situations to formula scientists. the 1st quantity, Compressed good items, tackles those demanding situations head on. Highlights from Compressed sturdy items, Volume One comprise: formulations for greater than two hundred of the main everyday medications for all sorts of liberate profiles, delivering formulators a unprecedented chance firstly an optimum composition the necessities of what you should be conscious of while setting up a producing strategy according to the formulations provided identity and inclusion of the most well-liked prescription items, a severe checklist for the choice of goods
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Additional resources for Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 1: Compressed Solid Products
Bioequivalence based on (90% CI): Amoxicillin and clavulanic acid. 5 mg, based on acceptable (i) bioequivalence studies on the 400-mg/ 57-mg strength, (ii) proportional similarity of the formulations, and (iii) acceptable in vitro dissolution testing of all strengths. r Anastrozole Tablets/Oral. Recommended studies: 2 studies. 1. Type of study: Fasting Design: single-dose, two-way crossover in vivo; Strength: 1 mg; Subjects: Please conduct the studies in postmenopausal subjects or surgically sterile females.
25 mg; Subjects: Normal, healthy males and females, general population. Additional comments: Analytes to measure: Bisoprolol and Hydrochlorothiazide in plasma. Bioequivalence based on (90% CI): Bisoprolol and Hydrochlorothiazide. 25-mg strength, (ii) proportionally similar across all strengths, and (iii) acceptable in vitro dissolution testing of all strengths. r Bisoprolol Fumarate Tablets/Oral. Recommended studies: 2 studies. 1. Type of study: Fasting Design: singledose, two-way crossover in vivo; Strength: 10 mg; Subjects: Normal, healthy males and females, general population.
Equivalence studies for complex active ingredients and dosage forms. AAPS J 7(4):E786–E812. Byron PR, Notari RE (1976). Critical analysis of “flip-flop” phenomenon in two-compartment pharmacokinetic model. J Pharm Sci 65:1140–1144. Caron D, Queille-Roussel C, Shah VP, et al (1990) Correlation between the drug penetration and the blanching effect of topically applied Bioequivalence Testing Rationale and Principles hydrocortisone creams in human beings. J Am Acad Dermatol 23:458–462. Chen ML, Shah V, Patnaik R, et al (2001).
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 1: Compressed Solid Products by Sarfaraz K. Niazi