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Development of Medicated Chewing Gum Formulations for the Delivery of a Poorly Soluble Drug

Paul Bahl

University of Huddersfield Repository (University of Huddersfield), 2015

2 citations

Abstract

The concept of chewing gum for medical purposes provides discrete, convenient administration, the potential for buccal absorption and the avoidance of first pass metabolism or gastrointestinal degradation. This work contributes to the limited information available on the release of poorly soluble drugs from medicated chewing gum formulations. Lansoprazole was chosen as a model drug due to its poor solubility and instability (under acidic conditions), thus a chewing gum formulation would be of particular benefit avoiding gastrointestinal degradation. \nThe solubility and stability of lansoprazole in artificial saliva was found to be dependent on the pH of the solution. An increase in pH caused an increase in solubility with a significant increase between pH 9 and pH 10. At pH 6, concentrations decreased over time confirming the acid instability of lansoprazole. The use of cyclodextrins as solubilisers and stabilisers for lansoprazole were investigated; complexed lansoprazole (with Mβ-CD, 1:1) resulted in a 9 fold increase in solubility compared to free lansoprazole and remained stable at pH 6. \nChewing gum formulations incorporating lansoprazole were prepared and the following excipients were investigated: Revolymer‟s® hydrophilic polymer Rev7, buffering excipients and complexed lansoprazole (with Mβ-CD, 1:1). Drug diffusion from gum surfaces was found to be limited, highlighting the need for effective mastication to ensure the timely release of the drug. In vitro release…

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