ISOLATION AND EVALUATION OF DISINTEGRATING PROPERTIES OF BASELLA ALBA Linn. LEAF MUCILAGE IN TABLET FORMULATIONS

Abstract

There are number of synthetic polymers are available in market for pharmaceutical formulations, but these synthetic polymers have certain disadvantages such as high cost, toxicity, environmental pollution during synthesis, non-renewable sources, side effects, and poor patient compliance. Because of these disadvantages natural polymers such as natural gums and mucilage are preferred to semi synthetic and synthetic excipients because of the following advantages: Low cost and natural origin, Free from side effects, Biocompatible and bio-acceptable, Renewable source, Environmental friendly processing, Local availability etc. Because of this demand for these substances are increasing and new sources are being developed Basella alba is a wildly cultivated, cool season vegetable with climbing growth habit. Malabar spinach is high in vitamin A, vitamin C, iron and calcium. It is low in calories by volume, but high in protein per calorie. The succulent mucilage is a particularly rich source of soluble fiber. Literature survey reveals that comprehensive physicochemical characterization and exploration of BAM as versatile pharmaceutical excipients in pharmaceutical formulations has not been done. Hence, the present study was aimed to enhance the use of BAM as a natural plant based excipients to develop various pharmaceutical formulations and it will encourage cultivation and use of this mucilage in the pharmaceutical industry. In the present work, an attempt was made to develop fast dissolving tablets of diclofenac using natural disintegrant isolated from Basella alba leaves and its efficiency was compared with other synthetic superdisintegrants like Crosscarmellose sodium and Crosspovidone.
Fast dissolving tablets of diclofenac were prepared by direct compression method comprising of three different superdisintegrants-BAM, Crosscarmellose sodium and Crosspovidone (1%, 2%, 3% and 4%). Fifteen formulations were prepared and evaluated for hardness, thickness, friability, weight variation, drug content, in vitro disintegration time, in vitro dispersion time, wetting time, water absorption ratio and in vitro dissolution studies. The results obtained in this study established for the first time, the fundamental characteristics of BAM. The present investigation was a primary platform to indicate the suitability of BAM as a pharmaceutical excipients Phytochemical tests carried out on BAM confirmed the absence of alkaloids, steroids, flavanoids, saponins, tannins, phenols and glycosides. On treatment of mucilage with ruthenium red, it showed red colour confirming the obtained product was mucilage and it confirmed the purity of the mucilage obtained. The toxicity studies of extracted mucilage revealed no behavioral changes, no changes in body weight, no mortality; no toxic syndromes were reported, indicating the safety of the mucilage. The results from the physicochemical parameters of the mucilage manifested all the characteristics of a good pharmaceutical excipient that can be used for the formulation of various pharmaceutical formulations. FTIR studies revealed that there was no chemical interaction between the drug and the excipients. Formulation F2 was found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release the formulation F2 containing BAM (2%) was found to be the optimized combination. Stability studies were carried out at 250C ± 20C / 60% ± 5% RH and 400C ± 20C / 75% ± 5% RH for formulation F2 for 60 days. The results of stability studies indicated no significant changes with respect to physicochemical properties, in vitro disintegration time, wetting time and in vitro drug release.
Keywords: Fast dissolving tablets, diclofenac, Basella alba mucilage, Superdisintegrant, Direct compression, Crosscarmellose sodium, Crosspovidone.