FORMULATION AND EVALUATION OF FLOATING OSMOTIC DELIVERY SYSTEM OF CARVEDILOL
Shubham Kundu, Gangadharappa H.V.* and Adithya Pramod
Abstract
Floating osmotic delivery system is a combination of floating and
osmotic systems that provides site specific and controlled drug release.
Carvedilol is non- selective β blocker under bio pharmaceutical
classification system (BCS) class II is widely used in the treatment of
hypertension. Half-life of model drug is 6-8 h. The model drug showed
promising pharmacokinetics and physico - chemical properties
required for controlled releases dosages. Therefore this drug was
selected for present investigation. Floating drug delivery system was
developed initially by formulating the osmotic core tablet followed by
multilayer coating for floating the system. Core tablet comprised of
Carvedilol, Mannitol, and sodium bicarbonate which was coated with
cellulose acetate (osmotic layer), followed by coating of floating layer
with Hydroxyl propyl Methyl cellulose (E15 / E50) and sodium bicarbonate and further
coated with entrapment layer composed of Eudragit RL30D.The drug and polymers were
characterized by DSC and pre-compression like bulk density, tapped density and Hausner’s
ratio. The prepared tablets were evaluated for physical properties like floating lag time,
duration of floatation. Invitro studies revealed that drug release depends on concentration of
polymer, agitation speed and pH of the medium. From the results, it indicated that
formulation were intact. Floating lag time and floating time were dependent on hydroxyl
propyl methyl cellulose grade used in floating layer and coating percentage on entrapment
layer. Drug release was controlled by changing the amount of mannitol in the core tablets.
Keywords: Sustained release, Matrix tablets, Model drug, Sodium bicarbonate, Hydroxy propyl Methyl cellulose, Eudragit RL 30D,Mannitol, talc.
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