Tags

Type your tag names separated by a space and hit enter

A comparative bioavailability study on two sustained-release formulations of diclofenac sodium following a single dose administration.
Int J Clin Pharmacol Ther Toxicol. 1993 Aug; 31(8):387-91.IJ

Abstract

A single dose comparative bioavailability study and an in vitro evaluation were conducted on two sustained-release formulations of diclofenac sodium (Voltaren "V" and Diclogesic "D"). The two products were found similar in weight and content uniformity. The in vitro dissolution, however, revealed that product D has a significantly faster rate of drug release compared to product V. The bioavailability study was carried out on 15 healthy male volunteers, who received a single oral dose (100 mg tablet) of each product according to a randomized crossover design. Blood samples were obtained over a 12 h period, and drug concentrations were determined by an HPLC assay. The two products were not found to be statistically different with respect to the lag time between dosing and appearance of the drug in the serum (0.8 +/- 0.2 and 0.6 +/- 0.1 h for V and D, respectively), or in the time needed to attain the peak concentrations (4.5 +/- 0.8 and 4.1 +/- 0.9 h for V and D, respectively). The two products, however, varied in the peak serum concentration (736 +/- 125 and 536 +/- 63 ng.ml-1 for V and D, respectively), but this difference was not statistically significance. In terms of the extent of absorption, assessed by estimating the area under the concentration-time curve over 12 h, the two products were not significantly different (3,340 +/- 270 and 3,045 +/- 294 ng.h.ml-1 for V and D, respectively). These in vitro and in vivo findings indicate that Diclogesic is characterized by sustained-release properties which are comparable to Voltaren.

Authors+Show Affiliations

Department of Pharmacology, Faculty of Medicine, Jordan University of Science and Technology, Irbid.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8225684

Citation

Hasan, M M., et al. "A Comparative Bioavailability Study On Two Sustained-release Formulations of Diclofenac Sodium Following a Single Dose Administration." International Journal of Clinical Pharmacology, Therapy, and Toxicology, vol. 31, no. 8, 1993, pp. 387-91.
Hasan MM, Najib NM, Muti H. A comparative bioavailability study on two sustained-release formulations of diclofenac sodium following a single dose administration. Int J Clin Pharmacol Ther Toxicol. 1993;31(8):387-91.
Hasan, M. M., Najib, N. M., & Muti, H. (1993). A comparative bioavailability study on two sustained-release formulations of diclofenac sodium following a single dose administration. International Journal of Clinical Pharmacology, Therapy, and Toxicology, 31(8), 387-91.
Hasan MM, Najib NM, Muti H. A Comparative Bioavailability Study On Two Sustained-release Formulations of Diclofenac Sodium Following a Single Dose Administration. Int J Clin Pharmacol Ther Toxicol. 1993;31(8):387-91. PubMed PMID: 8225684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative bioavailability study on two sustained-release formulations of diclofenac sodium following a single dose administration. AU - Hasan,M M, AU - Najib,N M, AU - Muti,H, PY - 1993/8/1/pubmed PY - 1993/8/1/medline PY - 1993/8/1/entrez SP - 387 EP - 91 JF - International journal of clinical pharmacology, therapy, and toxicology JO - Int J Clin Pharmacol Ther Toxicol VL - 31 IS - 8 N2 - A single dose comparative bioavailability study and an in vitro evaluation were conducted on two sustained-release formulations of diclofenac sodium (Voltaren "V" and Diclogesic "D"). The two products were found similar in weight and content uniformity. The in vitro dissolution, however, revealed that product D has a significantly faster rate of drug release compared to product V. The bioavailability study was carried out on 15 healthy male volunteers, who received a single oral dose (100 mg tablet) of each product according to a randomized crossover design. Blood samples were obtained over a 12 h period, and drug concentrations were determined by an HPLC assay. The two products were not found to be statistically different with respect to the lag time between dosing and appearance of the drug in the serum (0.8 +/- 0.2 and 0.6 +/- 0.1 h for V and D, respectively), or in the time needed to attain the peak concentrations (4.5 +/- 0.8 and 4.1 +/- 0.9 h for V and D, respectively). The two products, however, varied in the peak serum concentration (736 +/- 125 and 536 +/- 63 ng.ml-1 for V and D, respectively), but this difference was not statistically significance. In terms of the extent of absorption, assessed by estimating the area under the concentration-time curve over 12 h, the two products were not significantly different (3,340 +/- 270 and 3,045 +/- 294 ng.h.ml-1 for V and D, respectively). These in vitro and in vivo findings indicate that Diclogesic is characterized by sustained-release properties which are comparable to Voltaren. SN - 0174-4879 UR - https://www.unboundmedicine.com/medline/citation/8225684/A_comparative_bioavailability_study_on_two_sustained_release_formulations_of_diclofenac_sodium_following_a_single_dose_administration_ DB - PRIME DP - Unbound Medicine ER -