Abstract

Various hydrophilic polymers from synthetic origin such as methylcellulose, PEGs, HPMC as well as those from natural world such as guar gum, tragacanth, xanthan gum have been used to formulate oral sustained release formulations. Psyllium husk has the ability to swell 10-14 times of its original volume and form a hydrogel. It is biocompatible, inexpensive, inert, non-absorbable, environment friendly and easily available. However, its use as a release retardant has not been fully explored. Owing to large dose, high sensitivity to light, moisture and heat and also very short half-life of 1-2 h; formulation of sustained release dosage form of amoxicillin trihydrate is a challenge. Hence the present study has been undertaken to develop sustained release granules as well as matrix tablets of amoxicillin trihydrate using psyllium husk as a primary release retardant. The drug release of these formulations was compared with those containing HPMC K4M.The results showed insignificant difference in t80% value for drug release as assessed by student's t-test at 5% level of significance. Selected formulations were kept at controlled conditions of 40o/75% RH and 30o/65% RH for a period of 3 mo. Microbiological assay was used as a stability indicating method of assay. Sustained release granules and tablet formulations containing HPMC alone were found to be more stable than the similar formulations containing husk with percent drug content at the end of 3 mo at 40o/ 75% RH being 92.66%, 93.81%, 86.74%, 88.31% and the rate of degradation being 8.46×10^-4 d^-1, 7.1×10^-4 d^-1, 1.58×10^-3 d^-1 and 1.38×10^-3 d^-1, respectively. Thus it was concluded that psyllium husk can be effectively used as a hydrogel polymer in sustained release formulations. However, there is a need to keep moisture level under control during and after formulation.