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Control strategy of generic loratadine orally disintegrating tablets 10 mg during scalable manufacturing

Volume No : (2016) Volume: 04 Issue : 22 Year : 2016 Page No: 189-195

Authors : Biswajit Bhunia, Sajari Biswajit Bhunia, Swati Rawat

Abstract :

Loratadine is a second-generation peripheral histamine H1-receptor blocker used to treat allergies. The designing and formulation is key factor to commercial any product. Quality by Design (QbD) is increasingly becoming an important and widely used technique in pharmaceutical product development. The present work aims to propose control strategy for commercial manufacturing of Loratadine as an ODT. The control strategies including proposal of different parameters including strategies for raw materials, mixing time, speed of impeller and chopper, inlet temperature, screen size and mill speed, blending and lubrication time, and tablet compression.

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