Design and development of multilayered tablets as platform technology for fixed dose combination therapy

Abstract

The aim was to prepare a stable fixed dose combination unit dosage form of Incompatible drugs. newlineChemical incompatibility between drug-drug and drug-excipient is most observed challenge during newlineformulation of FDC s. To avoid such problems, layered tablets are prepared as a novel drug newlinedelivery system. Multilayered tablet is a very effective technology for sequential release of two or newlinemore drugs in combination, separates two incompatible drug or excipients and provides multi drug newlinerelease profile of tablet. newlineIn current research work, two incompatible drugs were selected, and the techniques used to design newlineboth the drug in single unit dosage form is the layered tablet. Layered tables prepared by newlineincorporating the middle inactive separating layer in between the two active layer. The final Trilayered newlinetablet prepared was evaluated for all in-process parameters and charged for accelerated newlinestability studies. newlineThe model drug selected for developing the platform technology of tri-layered tablet are 1) newlineIbuprofen and Famotidine Immediate release tablet, 2) Ibuprofen (Immediate Release) and newlineFamotidine Sustained release floating tablets and 3) Metformin HCl Sustained release and newlineVildagliptin HCl immediate release tablet. All the three formulations were prepared as a tri-layered newlinetablet with different release criteria. Tri-layered tablets of all the formulation were kept on newlineaccelerated stability study for 6 months. newlineTo develop a platform technology of Tri-layered Tablets, the first strategy used is to design an newlineimmediate release layer for Ibuprofen and Famotidine as a model drug. There are many rationales newlinefor Ibuprofen and Famotidine fixed dose combination. Ibuprofen is NSAIDs and widely indicated newlinefor wide range of arthritis and non-arthritic condition. Chronic therapy of NSAIDs is linked with newlinemajor side effects like gastritis, dyspepsia, gastric and duodenal ulceration. Gastric and duodenal newlineulceration is a consequence of impaired mucosal integrity. This risk can be reduced by co-therapy newlinewith Famotidine. Famotidine is a histamine type-I