The gum of ipil-ipil seeds was investigated for its use as an excipient in pharmaceutical liquid dosage forms.
The specifications followed during the quality control of Leucaena gum (supplied by 9402.1) were based on that of Guar gum found in the USP/NF (1995). It conformed to all limits set except for one test -- Ash content. After RMQC, a compatibility study was then done to determine the stability of Leucaena gum with drugs (Aluminum Hydroxide, Magnesium Trisilicate, Isoniazid) and other excipients. This was followed by the trial formulation stage wherein based on the results from the compatibility study, several preparations were formulated using the gum as a suspending agent in suspension (Aluminum Hydroxide and Magnesium Trisilicate Antacid suspension) and as a thickener in syrup (Isoniazid syrup). These formulations were exposed to different temperatures (5 degrees, RT,40 degrees,50 degrees,60 degrees) and changes in physical properties were observed (color,odor,taste,PH,viscosity). The most stable formulation for each dosage form was then produced on laboratory scale. These were then subjected to Accelerated Stability Study to determine the expiration date (shelf-life) of the said products. The resulting shelf-lives according to the drug content are as follows:Aluminum Hydroxide content-21 weeks; Magnesium Trisilicate content-69 weeks; Isoniazid content-63 weeks). In all these studies, results suggested that Leucaena gum is an effective excipient in pharmaceutical liquid dosage forms. (Author)