SAFETY ASSESSMENT OF L-DOPA AND HYOSCINE HYDROBROMIDE IN COMBINATION: ACUTE AND SUB-ACUTE ORAL TOXICITY STUDIES

Authors

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

Keywords:

Nil, Toxicity, L-dopa, Hyoscine hydrobromide

Abstract

Objective: To evaluate the safety of L-Dopa and hyoscine hydrobromide combination by determining its potential toxicity after acute and sub-acute oral administration in rats.

Methods: The acute and sub-acute toxicity study was performed according to the Organisation for Economic Co-operation and Development (OECD) Guideline 423 and 407 respectively. The 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/d for L-dopa and 0.75 mg/d for hyoscine hydrobromide for adult human being and which was converted to required dose for Wistar rats (3 males and 3 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 14 d of the study. In the repeated dose 28 d oral toxicity study, there was no significant difference in any of the assigned parameters between the control and all treatment groups.

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

 

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Author Biography

Archana Juvekar, Pharmacology Research Laboratory-1, Department of Pharmaceutical Sciences and Technology (DPST), Institute of Chemical Technology, N. P. Marg, Matunga, Mumbai 400019, India

Professor in Pharmacology and Physiology, Dept. of Pharmaceutical Sciences and Technology

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Published

01-07-2015

How to Cite

Attar, S. H., D. K. Khatri, D. Nagmoti, and A. Juvekar. “SAFETY ASSESSMENT OF L-DOPA AND HYOSCINE HYDROBROMIDE IN COMBINATION: ACUTE AND SUB-ACUTE ORAL TOXICITY STUDIES”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 7, July 2015, pp. 226-30, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/6119.

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