Abstract
Objective: To formulate orally disintegrating taste masked tablets of drotaverine hydrochloride (HCl) by sublimation technique.Methods: Initially superdisintegrant was selected and its concentration was optimized by pre-compression and post-compression parametric evaluation. Camphor and menthol were used as sublimating agents alone and in combination to mask the taste of drotaverine hydrochloride. Prepared tablets were evaluated for physicochemical evaluation, in vitro dissolution studies and fourier transformation-infrared spectroscopy, differential scanning calorimetry and X-ray diffractometry studies.Results: The optimised formulation DCM2 prepared with a mixture of camphor and menthol was characterised by fourier transformation-infrared spectroscopy, differential scanning calorimetry and X-ray diffractometry studies and found no incompatibility and no major shifts were noticed.Conclusion: The results demonstrated that the prepared drotaverine HCl orally disintegrating tablets showed better taste masking. The present sublimation technique can be effectively used for taste masking and also for orally disintegrating tablets.
Highlights
Drotaverine hydrochloride (HCl) is a benzylisoquinoline derivative, which causes relaxation of smooth muscle that suppresses pain associated with spasm caused by smooth muscle contraction
Tablets prepared with a combination of menthol and camphor has shown faster dispersion and the values of in vitro dispersion time are given in table 7
By considering all the parameters like hardness, in vitro disintegration time, in vivo disintegration time, wetting time, dispersion time, and dissolution profile of all the tablets prepared, the batch DCM2 prepared using a combination of the sublimating agents i.e. camphor and menthol can be considered for optimization
Summary
Superdisintegrant was selected and its concentration was optimized by pre-compression and post-compression parametric evaluation. Camphor and menthol were used as sublimating agents alone and in combination to mask the taste of drotaverine hydrochloride. Prepared tablets were evaluated for physicochemical evaluation, in vitro dissolution studies and fourier transformation-infrared spectroscopy, differential scanning calorimetry and X-ray diffractometry studies
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