Preliminary health risk assessment of two exudate gums as pharmaceutical excipients

Abstract

Some exudate gums such as acacia and tragacanth gums have been certified to be used in pharmacy as excipients. In this study exudate gums, obtained from two local trees in Ghana: Cussonia arborea and Cordia mellinii, were assessed for their safety for use as pharmaceutical excipients. The crude gums were purified using water and 96% ethanol and digested by di-acid procedure using 65% HNO3 and 37% HCl (2:3) at 95 °C for elemental analysis. Quantification of Ca, Fe, Mg, Cu, Zn, Mn, Ni, Hg, Cd, Pb and As ions was done using AAS 400; Na and K using the single channel flame photometer; and P using Spectronic 20 spectrophotometer. Microbial quality of the purified gums was also determined by the British Pharmacopoeia method. Toxicity of the purified gums was evaluated using acute and sub chronic murine toxicity models. Quantities of elemental ions detected in both purified gums were not significantly high to affect the utilization of these gums as pharmaceutical excipients even in large dose and high dosing frequency drugs. Total aerobic viable counts of the gums were within the acceptable Pharmacopoeial specification and no harmful microorganisms were detected. Acute and sub-chronic toxicity tests of the gums showed that they are safe for use even in long term dosage regimen medications. Thus, when these gums are included in even long term use medicines as excipients, may not cause any harm to the patient. The gums are therefore safe and qualified for use as pharmaceutical excipients when purified.