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Pharmacokinetic and bioequivalence studies of immediate release diclofenac potassium tablets (50mg) in healthy volunteers.
Ali, Huma; Shoaib, Muhammad Harris; Zafar, Farya; Hanif, Muhammad; Bushra, Rabia; Naz, Asia; Khursheed, Raheela.
Afiliación
  • Ali H; Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan / Faculty of Pharmacy, Ziauddin University, Karachi, Pakistan.
  • Shoaib MH; Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
  • Zafar F; Faculty of Pharmacy, Ziauddin University, Karachi, Pakistan.
  • Hanif M; Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
  • Bushra R; Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
  • Naz A; Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
  • Khursheed R; Faculty of Pharmacy, Ziauddin University, Karachi, Pakistan.
Pak J Pharm Sci ; 29(5): 1671-1679, 2016 Sep.
Article en En | MEDLINE | ID: mdl-27731828
This study was conducted with the aim to determine the pharmacokinetic and bioequivalence of diclofenac potassium 50 mg test (F4) tablet formulation with reference product (Caflam). Present study was single dose, randomized, two phase cross over design, conducted in 12 healthy Pakistani volunteers and planned in accordance with FDA guidelines. In this study a simple, selective, sensitive and reproducible HPLC procedure was developed and validated for the estimation of diclofenac potassium in plasma. The process was validated in the range of 50 - 0.05 µg.mL-1 and used in bioequivalence trial of two products. Multiple blood samples were collected at various time points (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 14 hr after treating volunteers with test (F4) and marketed reference brand. Plasma separation and deproteination were carried out with acetonitrile; samples (20µL) were injected using the validated HPLC method. Various pharmacokinetic parameters (compartmental and noncompartmental) were estimated using KineticaTM 4.4.1 (Thermo Electron Corp. USA). Bioequivalence among the products was established by calculating the 90% CI with log and non log transformed data for Cmaxcalc, Tmaxcalc, AUC0-∞, AUCtot and AUClast using two way ANOVA and Schirmann's Two one sided t- test. No significant difference was found between log and non-log data. The 90% confidence interval values using log transformed data for AUC0-∞ (0.997-1.024), AUCtot (1.004-1.031), AUClast (0.997 -1.024), Cmaxcalc (0.994-1.007) and Tmaxcalc (0.996-1.013) for the trial and reference products were found within the FDA acceptable limits of 0.8-1.25. Results were further verified by the Schirmann's one-sided t test. Results showed the bioequivalence of test and reference formulations. Both the products were well tolerated.
Asunto(s)
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diclofenaco / Inhibidores de la Ciclooxigenasa Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans País/Región como asunto: Asia Idioma: En Revista: Pak J Pharm Sci Asunto de la revista: FARMACIA / FARMACOLOGIA / QUIMICA Año: 2016 Tipo del documento: Article País de afiliación: Pakistán Pais de publicación: Pakistán
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diclofenaco / Inhibidores de la Ciclooxigenasa Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans País/Región como asunto: Asia Idioma: En Revista: Pak J Pharm Sci Asunto de la revista: FARMACIA / FARMACOLOGIA / QUIMICA Año: 2016 Tipo del documento: Article País de afiliación: Pakistán Pais de publicación: Pakistán