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Side by Side Layers Freeze Dried Orally Disintegrating Tablets

Author(s): Abdullah Alghamdi*and Geoff Smith

This study aimed to develop methodologies for the fabrication and testing of side by side layers freeze dried (lyophilized) orally disintegrating tablets (ODT) for same or different phase formulation. These side by side layers tablets will provide opportunities for combination therapies for patients who experience swallowing difficulty (e.g. geriatrics and paediatrics) and might enhance the bioavailability and incompatibility of some drugs. Two different solutions (A and B) were prepared separately and each solution was to create a different formulated layer to obtain different release profiles. The first layer was fabricated by injecting the solution A to an empty tablet blister to the half and freezing at -80°C for one hour in an external freezer. After the first layer was completely frozen, the solution B was injected into the rest half of the tablet blister and frozen at -80°C for one hour in an external freezer to create the second layer. Then, frozen side by side layers tablet was freeze dried and the resulting multilayer tablets were investigated. The study has shown that side by side layers freeze dried orally disintegrating tablets can be fabricated and formulated for same or different phase and with different disintegrating time for each layer to provide different release profiles. The optimization of adhesion between layers is required. The study has also shown that concentrations of gelatin and mannitol can affect the formulation characteristics.

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