clindamycin hydrochloride

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clindamycin hydrochloride preparations Absorption kinetic

Number of visits:1058 Date:2015/12/15 5:41:04
Absorption kinetics of topical clindamycin hydrochloride preparations.

Abstract Systemic clindamycin hydrochloride absorption was examined in 12 male Caucasians without acne who received 1 ml of Cleocin-T and 1 ml of 1 per cent clindamycin hydrochloride HCl in Vehicle-N (Neutrogena) applied topically the face every 12 h for 4 days according to a crossover design. In a separate phase clindamycin hydrochloride phosphate was administered by an IV infusion of 300 mg over 10 min. Systemic absorption was much higher with clindamycin hydrochloride in Vehicle-N than with Cleocin-T. Absolute bioavailability calculated from cumulative urinary excretion and serum AUCs were in good agreement and averaged 1.7 per cent and 7.5 per cent for Cleocin-T and clindamycin hydrochloride in Vehicle-N, respectively. Peak serum concentrations ranged from less than 0.5 ng ml-1 to 6 ng ml-1 for Cleocin-T and from 4-20 ng ml-1 for clindamycin hydrochloride in Vehicle-N. Absorption profiles indicated zero order absorption with Cleocin-T. No appreciable systemic accumulation from the repeated topical applications was noted. Systemic exposure to clindamycin hydrochloride from these formulations is minimal.

Bioavailability and selected pharmacokinetic parameters of clindamycin hydrochloride hydrochloride after administration of a new 600 mg tablet formulation.

The study was conducted to investigate the pharmacokinetics and relative bioavailability of clindamycin hydrochloride after administration of two oral clindamycin hydrochloride HCl formulations. A new tablet preparation containing 600 mg clindamycin hydrochloride (Clinda-saar 600, test) was compared to a marketed capsule containing 300 mg clindamycin hydrochloride (Sobelin 300, reference). Both preparations revealed comparable in vitro dissolution profiles with high batch conformity and homogeneity. Twenty healthy male volunteers received single doses of 600 mg clindamycin hydrochloride (test: 1 tablet, reference: 2 capsules) in an open, randomized, two-period crossover design. Blood samples were drawn up to 14 h p.a. and clindamycin hydrochloride plasma concentrations were measured using a sensitive and specific HPLC-UV method. Pharmacokinetic characteristics were similar for both preparations, arithmetic mean values (standard deviation) were computed as: AUC(0-infinity) 12.2 (4.2) and 13.1 (4.6) microg x h/ml, Cmax 3.1 (0.8) and 3.4 (0.8) microg/ml, t(max) 0.83 (0.24) and 0.85 (0.34) h, t(1/2) 2.3 (0.4) and 2.3 (0.6) h for test and reference, respectively. Mean relative bioavailability (point estimate) was 93% for AUC and 91% for Cmax. 90% confidence intervals for AUC and Cmax were within the predefined bioequivalence acceptance limits. Bioequivalence of test and reference preparations could be demonstrated. Single doses of 600 mg clindamycin hydrochloride orally were well tolerated without relevant differences between both preparations.
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