Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin

Handle URI:
http://hdl.handle.net/10754/561656
Title:
Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin
Authors:
Al-Talla, Zeyad; Akrawi, Sabah H.; Emwas, Abdul-Hamid M.
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 After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet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-∞, AUC 0-t, Cmax, Ke, tmax and t 1/2 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. ©2011 Dustri-Verlag Dr. K. Feistle.
KAUST Department:
Advanced Nanofabrication, Imaging and Characterization Core Lab; Analytical Core Lab; Core Labs
Publisher:
Dustri-Verlgag Dr. Karl Feistle
Journal:
Int. Journal of Clinical Pharmacology and Therapeutics
Issue Date:
2011
DOI:
10.5414/CP201478
PubMed ID:
21726499
Type:
Article
ISSN:
09461965
Appears in Collections:
Articles; Analytical Core Lab; Advanced Nanofabrication, Imaging and Characterization Core Lab

Full metadata record

DC FieldValue Language
dc.contributor.authorAl-Talla, Zeyaden
dc.contributor.authorAkrawi, Sabah H.en
dc.contributor.authorEmwas, Abdul-Hamid M.en
dc.date.accessioned2015-08-03T09:01:33Zen
dc.date.available2015-08-03T09:01:33Zen
dc.date.issued2011en
dc.identifier.issn09461965en
dc.identifier.pmid21726499en
dc.identifier.doi10.5414/CP201478en
dc.identifier.urihttp://hdl.handle.net/10754/561656en
dc.description.abstractObjective: 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-∞, AUC 0-t, Cmax, Ke, tmax and t 1/2 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. ©2011 Dustri-Verlag Dr. K. Feistle.en
dc.publisherDustri-Verlgag Dr. Karl Feistleen
dc.subjectBioequivalence studyen
dc.subjectClindamycinen
dc.subjectHPLCen
dc.subjectNMRen
dc.subjectPharmacokineticsen
dc.titleSolid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycinen
dc.typeArticleen
dc.contributor.departmentAdvanced Nanofabrication, Imaging and Characterization Core Laben
dc.contributor.departmentAnalytical Core Laben
dc.contributor.departmentCore Labsen
dc.identifier.journalInt. Journal of Clinical Pharmacology and Therapeuticsen
dc.contributor.institutionCollege of Pharmacy, Al-Ain University, Al-Ain, United Arab Emiratesen
kaust.authorAl-Talla, Zeyaden
kaust.authorEmwas, Abdul-Hamid M.en
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