EVALUATION OF REPEATED DOSE-90-DAY ORAL TOXICITY STUDY OF L-DOPA AND HYOSCINE HYDRBROMIDE COMBINATION IN RATS

  • Sabir Husain Attar Institute of Chemical Technology, N. P. Marg, Matunga
  • Dharmendra Kumar Khatri Institute of Chemical Technology, N. P. Marg, Matunga
  • Jayant Sancheti Institute of Chemical Technology, N. P. Marg, Matunga
  • Archana Ramesh Juvekar Pharmacology Research Laboratory-1, Department of Pharmaceutical Sciences and Technology (DPST), Institute of Chemical Technology, N. P. Marg, Matunga, Mumbai 400019, India

Abstract

Objective: The present study was done to evaluate repeated-dose 90-day oral toxicity studies of l-dopa and hyoscine hydrbromide combination in rats.

Methods: Repeated-dose 90-day oral toxicity study was performed according to the Organisation for Economic Co-operation and Development (OECD) guidelines 408. In the present study, combination of L-dopa and hyoscine hydrobromide was administered at 5 times the upper limit of therapeutic dose of each drug which is 1200 mg per day for L-dopa and 0.75 mg per day for hyoscine hydrobromide for adult human being and which was converted to required dose for Wistar rats (5 males and 5 females).

Results: The combination of L-dopa and hyoscine hydrobromide at 5 times the upper therapeutic dose produced no treatment-related signs of toxicity or mortality in any of the animals tested during 90 d of the study. The subchronic administration of the combination of L-dopa and hyoscine hydrobromide did not produce any significant difference in any of the assigned parameters between the control and all treatment groups.

Conclusion: It is established that the combination of L-dopa and hyoscine hydrobromide therapy is safe on repeated dose 90-day oral toxicity at 5 times the upper limit of therapeutics dose of each drug.

 

Keywords: Parkinson’s, Toxicity, L-dopa, Hyoscine hydrobromide

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Attar, S. H., D. K. Khatri, J. Sancheti, and A. R. Juvekar. “EVALUATION OF REPEATED DOSE-90-DAY ORAL TOXICITY STUDY OF L-DOPA AND HYOSCINE HYDRBROMIDE COMBINATION IN RATS”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 7, no. 11, Oct. 2015, pp. 241-5, https://innovareacademics.in/journals/index.php/ijpps/article/view/7506.
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