Comparative Chemical Stability Studies Of The Solubilized And Suspension Liquid Dosage Forms Of Paracetamol

Abstract

The formulation option of solubilizing the poorly water soluble Paracetamol powder B.P. was compared to the suspension option in which the chemical stabilities of the following three preparations were studied:

1. Co-solvent solubilized fonn (Elixir)
2. Surfactant solubilizcd form (SodiumLauryl sulphate used)
3. Suspension form.

Accelerated stability studies were carried out on the preparations at the elevated temperatures of 40°C, 60°C and 80°C. The results were extrapolated to room temperature (25"C) by the use of the Arrhenius plot to obtain the degradation rate constants at room temperature from which shelf and half life were calculated. The study showed that at storage temperature of about 40°C and below, the Elixir was the most stable of the three preparations showing very little deterioration at those temperatures as given by the  Arrhenius plot. This thus suggests that the Elixir should be the preferred liquid dosage form of paracetamol: However it must be stored at low temperature since its deterioration rate rapidly increase with-increase in storage teniperature. attaining a maximum at about 60°C above which deterioration rate was seen to decrease again. The suspension form was found to be more Stable than the surfactant solubilized form.