Accelerated stability study of Jawarish Jalinoos

Abstract

Background and Objective: Jawarish Jalinoos (JJ) is a sugar based semisolid formulation used in Unani system of medicine to treat chronic debilitating disorders, geriatric problems, to strengthen the digestive power, etc., since ancient time. Shelf life/stability evaluation of this valuable compound formulation has not been carried out till date. Therefore, authors aim to evaluate the shelf life of JJ under the accelerated stability condition. Materials and Methods: Finished product was manufactured in the institute’s in-house pharmacy and packed in four air tight polyethylene terephthalate containers. One container was analyzed at baseline and remaining three containers were kept in stability chamber at 40±2°C/75±5% relative humidity. At each pre decided time point, i.e., 1, 3, and 6 months, one container was taken out from stability chamber and evaluated for organoleptic, physicochemical, microbiological parameters, and high performance thin layer chromatography (HPTLC) fingerprinting to assess any changes. Results: No significant changes were observed in organoleptic characters. All physicochemical parameters showed <5% change, HPTLC showed minimum difference, microbial load, and specific pathogenic bacteria counts were within WHO guideline’s prescribed limit. Conclusion: The shelf life of JJ was calculated as minimum 20 months using Grimm’s statement. This was in accordance to the drug and cosmetic rule, 1945–161B, Government of India that states the shelf life of Jawarish dosage form as 2 years.