Leaky enteric coating on ranitidine hydrochloride beads: dissolution and prediction of plasma data

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V
Ehab R Bendas, James W Ayres

Abstract

The present research is based on the hypothesis that leaky enteric-coated pellets formulations are able to provide sustained input for drugs that have an absorption window, such as ranitidine hydrochloride, without jeopardizing their bioavailability. Leaky enteric-coated pellets formulations are defined as enteric-coated pellets that allow some of the drug to be released from the formulation in gastric fluid. Different approaches to making leaky enteric-coated pellets were investigated using extrusion-spheronization followed by spray coating. Leaky enteric coats were formulated using a commonly used enteric polymer, Eudragit L 30 D-55, combined with soluble compounds including lactose, PEG 8000 and surfactants (Span 60 (hydrophobic) or Tween 80 (hydrophilic)). The rate of drug release from the formulations in simulated gastric fluid can be tailored by varying the additive's amount or type. All leaky enteric-coated formulations studied completely released the drugs within 30 min after changing dissolution medium to phosphate buffer, pH 6. Predictions of plasma concentration-time profiles of the model drug ranitidine hydrochloride from leaky enteric-coated pellets in fasted conditions and from immediate-release formulations were ...Continue Reading

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Citations

Jun 16, 2010·Drug Development and Industrial Pharmacy·Ghanshyam V JoshiHari C Bajaj
Apr 3, 2009·Journal of Pharmaceutical Sciences·Rahul Dixit, Shivanand Puthli
Jul 21, 2011·Pharmaceutical Development and Technology·Umesh Nandkumar KhatavkarKishor Dattatraya Deo

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