ABSTRACT
PURPOSE: The arabinoxylan from Ispaghula (Plantago ovata) husk has been proven scientifically as potential excipient. However, toxicity study of the arabinoxylan is still lacking. The present study was done to investigate the acute toxicity of arabinoxylan in two animal species. METHODS: The mice were exposed to (1 g/kg, 5 g/kg, 10 g/kg) and rabbits (2.5 g/kg, 5 g/kg) of arabinoxylan orally and observed for a period of 14 days. On day 15 hematology, serum biochemistry and necropsy was performed in mice relative organ weight calculated and histological examination was carried out. Primary dermal and eye irritation tests were carried out. Cardiac effects of isolated arabinoxylan were studied on frog heart. RESULTS: The acute administration of the arabinoxylan did not produce mortality or significant changes in, water and food consumption however body weights of mice and rabbits decreased initially with a gradual increase till day 14. Internal organs relative weights were found to be normal. Hematological biochemical and histopathological examination did not show any significant (p < 0.05) change. Primary dermal and eye irritation was not observed in treated rabbits. No change in heart rate and vascular contraction was observed in frog heart. CONCLUSION: This study has shown that acute administration of arabinoxylan may be safe.
Subject(s)
Excipients/toxicity , Plant Extracts/toxicity , Plantago/toxicity , Toxicity Tests, Acute , Xylans/toxicity , Animals , Anura , Excipients/isolation & purification , Female , Male , Mice , Phytotherapy , Plant Extracts/isolation & purification , Plantago/chemistry , Plants, Medicinal , Rabbits , Risk Assessment , Seeds , Time Factors , Xylans/isolation & purificationABSTRACT
The purpose of this study is to evaluate the use of arabinoxylan as potential suspending agent, an effective alternative to commercially used excipients for the preparation of pharmaceutical suspensions. Alkali extraction was done to separate arabinoxylan from ispaghula (Plantago ovata) seed husk by alkali extraction its physicochemical characterization was done and the suspending properties of arabinoxylan isolated were evaluated comparatively with those of bentonite at different concentration ranges of 0.125,0.25,0.5 and 1% in Zinc oxide suspension. The parameters employed for evaluation were sedimentation volume, degree of flocculation, flow rate, density, pH, redispersibility, microbiological evaluation and particle size analysis. Physicochemical characterization of arabinoxylan indicates its suitability as excipient as it has fair flow properties, low moisture content and almost neutral pH. Arabinoxylan at low conc. 0.125% showed sedimentation volume comparable to commercially used suspending agents such as bentonite 1% while suspensions containing higher concentrations such as 0.25% (sedimentation volume 92%), 0.5% (sedimentation volume 94%) and 1% conc. (sedimentation volume 98%) of arabinoxylan remained almost completely suspended during study period of 7 days. Formulations containing 0.125% and 0.25% arabinoxylan as suspending agents are easily redispersible as compared to bentonite containing formulation while formulation containing 0.5% arabinoxylan are moderately redispersible while formulation containing 1% suspending agent gel upon storage and was not redispersible. Furthermore arabinoxylan produces stable, highly flocculated suspension, which fulfilled microbiological, and particle size specifications, however the formulations containing higher arabinoxylan 1% concentration gel upon storage. So it is concluded that arabinoxylan could be used as effective suspending agent at low concentrations in Zinc oxide suspension.
