بررسي تاثير تنظيم كننده هاي تونيسينه بر پايداري شيميايي محلول تزريقي پروپرانولول هيدروكلرايد

The effect of tonicity adjusting agents on chemical stability of propranolol hydrochloride injectable solution

Propranolol hydrochloride intravenous solution, as a non-selective beta-adrenergic receptor blocking agent, is exclusively used for treatment of the cardiac arrhythmias. It should be evoked that such formulations should contain minimal Na ions, whose presence is contradictory with the objectives of treatment and may exacerbate the illness. In this study, buffered propranolol hydrochloride solutions were formulated using two isotonic agents (i.e., NaCl and sorbitol) in order to investigate their effects on chemical stability of the drug. Exploiting the well known Husa hemolysis methodology, two isotonic injectable solutions of the drug were formulated using NaCl and sorbitol as tonicity adjusting agents and their chemical stability were determined according to the classic Arrhenius approach. The shelf lives of the two solutions were nearly equal indicating that the stability of the drug was identical in the presence of two tonicity adjusting agents. As sorbitol resulted in similar isotonicity to that of NaCl, hence it is suggested that sorbitol should be used in the propranolol hydrochloride formulation as a replacement for NaCl, by which patients will receive minimal amount of Na ions.