Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin
Z.A. Al-Talla1, S.H. Akrawi2, A.-H.M. Emwas3
1 Analytical Core Lab, King Abdullah University of Science and Technology, KAUST, Thuwal, Kingdom of Saudi Arabia, 2 College of Pharmacy, Al-Ain University, Al-Ain, United Arabs Emirates, and 3 NMR Core Lab, King Abdullah University of Science and Technology, KAUST, Thuwal, Kingdom of Saudi Arabia
DOI 10.5414/CP201478
Abstract
Objective: The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a reference formulation (Dalacin C® 150 mg capsule) in healthy adult male volunteers. Methods: A single-dose, open-label, 2-period crossover study was conducted. Healthy male volunteers were randomly assigned to oral administration of a single treatment of the reference and test formulations. The same groups were given the alternate formulation. After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet detection. Pharmacokinetic parameters, including AUC0–∞, AUC0–t, Cmax, Ke, tmax and t1/2 were determined from the serum concentrations for both formulations (test and reference). The products were tested for bioequivalence after log-transformation of the data. Results: 24 healthy adult male volunteers from Jordan (mean [SD] age, 28.8 (7.7) years (range 19 – 45 years); height, 175.8 (10.6) cm (range 159.0 – 192.0 cm); weight, 75.6 (11.0) kg (range 58 – 101 kg); and body mass index, 24.4 (1.8) kg/m2 (range 21.3 – 28 kg/m2)) were enrolled in and completed the study. The 13C NMR spectra for both Dalacin C® and Clindox® showed 18 distinct lines associated with the 18 different carbon atoms. Conclusion: The statistical comparison suggested that Clindox® capsules are bioequivalent to Dalacin C® capsules. The 13C CPMAS results confirmed that the two drugs exhibit typical clindamycin spectra.
Author Details
Authors
Departments
- 1 Analytical Core Lab, King Abdullah University of Science and Technology, KAUST, Thuwal, Kingdom of Saudi Arabia,
- 2 College of Pharmacy, Al-Ain University, Al-Ain, United Arabs Emirates, and
- 3 NMR Core Lab, King Abdullah University of Science and Technology, KAUST, Thuwal, Kingdom of Saudi Arabia
Address
Z.A. Al-Talla, PhD
Analytical Chemistry and NMR Core Labs
King Abdulla University of Science and Technology
KAUST, Thuwal 23955-6900
Kingdom of Saudi-Arabia
Email:
[email protected]
Citation
Z.A. Al-Talla, S.H. Akrawi and A.-H.M. Emwas.Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin. 2011; 49: 469-476. doi: 10.5414/CP201478.
