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THE PHARMA REVIEW
(AUGUST 2008) |
Effect of Dispersants on the
Dissolution of Amoxycillin Trihydrate from Capsule
Formulations
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P. V.Swamy, Prashant. A.
Borgaonkar, S. B. Shirsand |
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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.
Introduction
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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