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KMID : 0369820150450020237
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Jorunal of Korean Pharmaceutical Sciences
2015 Volume.45 No. 2 p.237 ~ p.247
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Formulation and comparative pharmacokinetic evaluation of orodispersible tablets and films of nebivolol hydrochloride
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Vijayanand P.
Patil J. S.
Venkata Reddy M.
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Abstract
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Objective of the present research work was to prepare orodispersible tablets and orodispersible films of nebivolol hydrochloride for dysphagic patients. Nebivolol hydrochloride, an anti-hypertensive agent, was chosen as a model drug in this study. Oral bioavailability of Nebivolol hydrochloride is only 12 % in humans due to extensive first pass hepatic metabolism by Cytochrome P450 2D6 enzyme. Orodispersible tablets of Nebivolol hydrochloride were prepared using different sublimating agents like camphor, menthol and thymol. The orodispersible tablet formulation containing 10 % w/w of menthol showed a disintegration time of 11 s with more than 98 % drug release within 14 min. The orodispersible films of Nebivolol hydrochloride were prepared using xanthan gum, guar gum and sodium alginate as polymers by solvent casting method. Formulation containing 1.5 % w/v of sodium alginate had disintegration time of 14 s with 99 % drug release within 10 min. In-vivo studies of both orodispersible tablets and orodispersible films in rabbits showed significantly better pharmacokinetic profile (AUC, Tmax, Cmax) compared to marketed conventional tablets of Nebivolol hydrochloride. From this study, it was concluded that both orodispersible tablets and films of Nebivolol hydrochloride may prove to be more efficacious in the treatment of hypertension in dysphagic patients.
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KEYWORD
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Orodispersible tablets, Orodispersible films, Nebivolol HCl, Dysphagia, Super-disintegrants, Sublimation
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