FORMULATION OF A TOPICAL PRODUCT CONTAINING BROMELAIN AND TESTING ITS EFFECT TOWARDS INFLAMMATION
Bromelain, an extract from pineapple (Ananas comosus Mem) is known to have many beneficially potential therapeutic effects that have been applied for both traditional and conventional medicine to treat various diseases. The main aim of this study was to formulate a topical product containing bromelain and to determine its release profile from the dosage form, as well as its ability in combating acute inflammation. In this research, bromelain was firstly formulated into different types of topical dosage forms such as o/w cream and w/o cream both of which consisted of cetostearyl alcohol and sodium lauryl sulphate as the emulsifying agent in a ratio of 9:1. A gel dosage form was also formulated using hydroxypropyl methylcellulose (HPMC) as the gelling agent. These formulas were later further optimized by adding either of the 2 types of penetrating enhancers, i.e. urea and DMSO. The physical stability and organoleptic properties of the topical formulations were then evaluated for a period of 2 month. The formulations were also tested in both in- vitro and in-vivo model. The in-vitro test was performed using the static type Franz diffusion cell, where samples collected at specific time were then pre-treated by the Lowry assay method and analyzed using UV-spectrophotometer. The in-vivo test however was performed using an animal model, in which the animals were firstly divided into control, standard and test groups. Acute inflammation was then induced by injecting 1% X¬carrageenan solution into the paw of the rat. Each group, except control, was given treatment and edema volume was measured for a duration of 5h using Plethysmometer. The physical evaluation test conducted on both cream and gel remained stable throughout the research where the pH (5.9+0.005, 5.80.003) and viscosity (7920±0.1, 3021±0.1) cp was constant throughout the evaluation period. There were also no changes in terms of its color, odor, texture as well as no microbial growth observed. The in-vitro test showed that 1% urea and 15% DMSO when incorporated into the dosage form did improved penetration of drug but did not show any significant differences when compared to each other (p>0.05, Anova). The bromelain gel dosage form, however, showed a better result when compared to the cream in both in-vitro and in-vivo test. The diffusion test of bromelain from gel achieved the highest percentage of drug release at the 6th hour (44.08%). In the pharmacodynamic study, standard (1% diclofenac gel) and test drug when compared against the control group showed a significant difference (p<0.05, Anova). The maximum percentage of edema inhibition of standard drug and the bromelain gel was 75.49% and 76.62%, respectively, observed at 4h. Test drug compared against standard group, however, showed no significant differences (p>0.05, Anova). The bromelain HPMC gel dosage form with 1% urea gave the best result in both in-vitro and in-vivo study, as well showed almost an equivalent pharmacodynamic effect when compared to the standard commercial Diclofenac gel (p >0.05, Anova).