Strength, efficacy and tolerability of morphine solution with and without added preservatives: A comparative study

Rawshan Ara Perveen,Md Sayedur Rahman

doi:10.3329/bjp.v10i1.21754

Abstract

Cancer patients having moderate to severe pain need immediate pain relief. Immediate release formulation of morphine is not available in Bangladesh. This open label randomised two phase crossover clinical trial was conducted to compare strength, efficacy, and tolerability of oral morphine solution prepared from morphine sulfate injectable formulation and sustained release tablet with and without added preservatives. Concentration of morphine in solutions both with and without added preservative was highest on the first day and then gradually decreased. No difference between two storage temperatures on first day, but highly significant difference afterwards. Rate of degradation of morphine in solution with added preservative was significantly slower. The present study revealed that the solutions prepared from sustained release tablets and injectable formulation with added preservative could be an option to control severe pain in cancer patients. To introduce the present research finding in clinical practice, this has to be accepted institutionally.

Highlights

Morphine has been accepted as gold standard drug of choice to treat moderate to severe pain in advanced cancer (WHO, 1996)
Cheaper than injectable formulation and modified both formulations by adding more preservative. This open label randomised two phase crossover clinical trial was conducted to compare the strength, efficacy, and tolerability of oral morphine solution prepared from morphine sulfate injectable formulation and sustained release tablet with and without added preservatives in cancer patients
Pain intensity marked as baseline, before administration of solution prepared by sustained release tablets without added preservative was highest, after 1.5 hours of 1st dose of morphine solution administration was decreased, when patient received solution just after preparation

Summary

Introduction

Morphine has been accepted as gold standard drug of choice to treat moderate to severe pain in advanced cancer (WHO, 1996). Aqueous solutions of morphine sulfate or hydrochloride salt and tablet or capsule preparation is recommended for oral administration. Immediate release formulation of morphine either as tablet or as solution is not available in Bangladesh (Dehgan et al, 2010). In the background of this prevailing reality in Bangladesh, Centre for Palliative Care, Bangabandhu Sheikh Mujib Medical University prepared an immediate release morphine solution from injectable formulation of morphine sulfate with distilled water. Cheaper than injectable formulation and modified both formulations by adding more preservative This open label randomised two phase crossover clinical trial was conducted to compare the strength, efficacy, and tolerability of oral morphine solution prepared from morphine sulfate injectable formulation and sustained release tablet with and without added preservatives in cancer patients

Materials and Methods

Result

Findings

Discussion