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Comparative bioavailability of slow release diclofenac (Voveran SR) with enteric coated tablet and internationally used Voltaren Retard.
J Assoc Physicians India. 1991 Jul; 39(7):546-8.JA

Abstract

The objective of the study was to compare the enteric coated diclofenac sodium (Voveran), the slow release formulation developed in India (Voveran SR) and the internationally marketed formulation Voltaren Retard. Ten healthy volunteers were administered 100 mg each of the three formulations in a three-way crossover fashion. Blood samples were collected over 24 hours following administration of the drug; plasma levels of unchanged drug were determined by gas chromatography. Pharmacokinetic parameters for the three formulations were compared. The extent of the drug available from the three formulations was the same as the mean AUC values were not significantly different. Cmax and MRT values for the two slow release formulations were comparable but were significantly different from the values obtained with the enteric coated formulation. Tmax values for the two slow release formulations were similar while the enteric coated tablet had faster time to peak. Voveran SR is comparable to Voltaren Retard and has the distinct advantage of a slow release formulation in that its Cmax is much lower and levels are maintained over 12 hours and detectable upto 24 hours. This slow release formulation will offer clinical advantages of better compliance, relief of early morning symptoms and better tolerability over long term usage.

Authors+Show Affiliations

Sahajwalla CG
Research Centre and Medical Department, Hindustan Ciba-Geigy Ltd.
Bhatt AD
No affiliation info available
Bhatia SC
No affiliation info available
Bakshi R
No affiliation info available
Doshi KJ
No affiliation info available
Banavalikar MM
No affiliation info available
Bharucha ED
No affiliation info available
Marthak KV
No affiliation info available
Shah NN
No affiliation info available
Gupta KC
No affiliation info available

MeSH

AdultBiological AvailabilityDelayed-Action PreparationsDiclofenacHumansMaleMiddle AgedTablets, Enteric-CoatedTime Factors

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

1800501

Citation

Sahajwalla, C G., et al. "Comparative Bioavailability of Slow Release Diclofenac (Voveran SR) With Enteric Coated Tablet and Internationally Used Voltaren Retard." The Journal of the Association of Physicians of India, vol. 39, no. 7, 1991, pp. 546-8.
Sahajwalla CG, Bhatt AD, Bhatia SC, et al. Comparative bioavailability of slow release diclofenac (Voveran SR) with enteric coated tablet and internationally used Voltaren Retard. J Assoc Physicians India. 1991;39(7):546-8.
Sahajwalla, C. G., Bhatt, A. D., Bhatia, S. C., Bakshi, R., Doshi, K. J., Banavalikar, M. M., Bharucha, E. D., Marthak, K. V., Shah, N. N., & Gupta, K. C. (1991). Comparative bioavailability of slow release diclofenac (Voveran SR) with enteric coated tablet and internationally used Voltaren Retard. The Journal of the Association of Physicians of India, 39(7), 546-8.
Sahajwalla CG, et al. Comparative Bioavailability of Slow Release Diclofenac (Voveran SR) With Enteric Coated Tablet and Internationally Used Voltaren Retard. J Assoc Physicians India. 1991;39(7):546-8. PubMed PMID: 1800501.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative bioavailability of slow release diclofenac (Voveran SR) with enteric coated tablet and internationally used Voltaren Retard. A1 - Sahajwalla,C G, AU - Bhatt,A D, AU - Bhatia,S C, AU - Bakshi,R, AU - Doshi,K J, AU - Banavalikar,M M, AU - Bharucha,E D, AU - Marthak,K V, AU - Shah,N N, AU - Gupta,K C, PY - 1991/7/1/pubmed PY - 1991/7/1/medline PY - 1991/7/1/entrez SP - 546 EP - 8 JF - The Journal of the Association of Physicians of India JO - J Assoc Physicians India VL - 39 IS - 7 N2 - The objective of the study was to compare the enteric coated diclofenac sodium (Voveran), the slow release formulation developed in India (Voveran SR) and the internationally marketed formulation Voltaren Retard. Ten healthy volunteers were administered 100 mg each of the three formulations in a three-way crossover fashion. Blood samples were collected over 24 hours following administration of the drug; plasma levels of unchanged drug were determined by gas chromatography. Pharmacokinetic parameters for the three formulations were compared. The extent of the drug available from the three formulations was the same as the mean AUC values were not significantly different. Cmax and MRT values for the two slow release formulations were comparable but were significantly different from the values obtained with the enteric coated formulation. Tmax values for the two slow release formulations were similar while the enteric coated tablet had faster time to peak. Voveran SR is comparable to Voltaren Retard and has the distinct advantage of a slow release formulation in that its Cmax is much lower and levels are maintained over 12 hours and detectable upto 24 hours. This slow release formulation will offer clinical advantages of better compliance, relief of early morning symptoms and better tolerability over long term usage. SN - 0004-5772 UR - https://www.unboundmedicine.com/medline/citation/1800501/Comparative_bioavailability_of_slow_release_diclofenac__Voveran_SR__with_enteric_coated_tablet_and_internationally_used_Voltaren_Retard_ DB - PRIME DP - Unbound Medicine ER -