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ISSN 2063-5346
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SELECTION OF PACKAGING IN GENERIC PRODUCT DEVELOPMENT

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Jailani. S , C. K. Dhanapal , Noohu Abdullah Khan
» doi: 10.31838/ecb/2023.12.si5.057

Abstract

The present study aimed to develop suitable packaging material for the generic formulation of Rivaroxaban tablets by packaging material characterization and reverse engineering study of the marketed reference product. The packaging material of the marketed reference product was characterized by description, thickness, total grammage, and an individual grammage of PVC and PVDC layers. The components of the foil were identified using Attenuated total reflection (ATR) assembly and compared with standards. The degradation profile of generic Rivaroxaban tablets was performed by forced degradation study as well as using a photostability study. The packaging material was evaluated for vapour permeation study as per the modified USP method. Based on a short-term stability study and cost-effectiveness of European and Asian source packaging material was proposed. As per ICH guidelines stability study of Rivaroxaban, tablets was performed at accelerated and stress conditions for 6 months. Based on these stability results, the shelf life of the product was predicted. Through the ATR study, it was confirmed that the packaging material was PVC-PVDC. This forced degradation study confirmed that humidity has a high impact on the stability of the product. It has been observed that drug products are light stable and not light sensitive as the directly exposed tablets themselves are stable. It has been observed that among all the packaging materials tested, PVC-PVDC 250/60 showed minimum MVRT and was classified as Class A material. Based on short-term stability testing and cost-effectiveness Asian source PVCPVDC 250 µ/60 g/m2 was proposed as the final packaging material and the generic product was packed in blisters made with PVC-PVDC and aluminum foil for Climatic zone III and IV. In both accelerated and stress stability testing the product was found to be stable over 6 months. Overall, 24 month's shelf life is predicted based on the predicted value of assay and impurity levels.

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