Effect of Dispersants on the Dissolution of Amoxycillin Trihydrate from Capsule Formulations

P. V.Swamy, Prashant. A. Borgaonkar, S. B. Shirsand

Abstract: Amoxycillin trihydrate capsules were formulated using super-disintegrants such as cros-carmellose sodium, crospovidone and sodium starch glycolate in different concentrations 2-8% w/w. All the formulations were evaluated for drug content, and influence of super-disintegrants on the dissolution rate. Formulation containing cros-carmellose sodium (2% w/w) showed better dissolution rate (96% in 60 minutes) and also better dissolution efficiency compared to marketed product, fulfilling USP XXV dissolution requirements. No appreciable increase in the dissolution rate was observed with further increase in the concentration of croscarmellose sodium. The formulations containing crospovidone and sodium starch glycolate did not show any appreciable increase in the dissolution rate compared with pure drug (81% in 60 minutes). The promising formulation has displayed a dissolution efficiency value (DE30min) almost double that of the commercial formulation, and it has shown a t90% value of 44 minutes when compared to the commercial formulation, which gave a t90% value of > 90 minutes. Short-term stability studies over a period of 3 weeks on the promising formulation have shown no significant changes in the drug content and t50% value, which gave ‘t’ values of 0.75 and 4.02 respectively against the table value of 4.30 (p<0.05). Drug excipient interactions were ruled out by means of IR spectroscopic studies.

In recent years much attention has been focussed on the problem of drug bioavailability. The dissolution rate of drug from its dosage form is now considered as an important parameter in bioavailability. Dissolution is the rate limiting step in the absorption of a drug from dosage form, especially when the drug is poorly soluble in aqueous fluids.

Amoxycilin1 is an antibacterial agent used in the treatment of respiratory tract infections, infections of ear and gonococcal infections of urinary tract etc. Its trihydrate form, which is more commonly used in the capsule formulation is slightly soluble in water and hence its absorption is dissolution rate limited.


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