Title: Quality by Design approach and development of Process Analytical Technology for a matrix type sustained–release product.
Acronym: QbD-PAT-SR
Abstract: The aim of the project is to apply the Quality by Design (QbD) approach in development of the manufacturing technological process of matrix type sustained–release products and to use near infrared spectroscopy (NIRs) in association with chemometry as an adequate tool for Process Analytical Technology (PAT). The main factors affecting the release of drugs from hydrophilic matrix systems are re lated to drug characteristics (particle size, polymorphism), polymer (type, substituents of the side chain, particle size, intrinsic viscosity, percentage), formulation factors (other excipients, air trapped in the porosity, resistance to breakage) and technological factors (homogeneity of powder blend, compression force). Currently those factors are not monitored during the manufacturing process and variability affects product consistency (drug’s release profile/bioavailability) with consequences on quality of the final product. The project propose a scientific approach to overcome this difficulty by applying QbD order to define the Design Space in granulation, mixing and compression septs and development and validation NIRs methods for on-line monitoring of these steps. Therefore, the proposed project aims to find solutions for overcoming the problems of manufacturing high quality sustained release products by developing the innovative solution of applying enhanced process understanding via QbD in product development and NIRs as PAT tool for continuous process monitoring.
Project budge: 500.000 lei
2015: 90.000 lei
2016: 262.637 lei
2017: 147.363 lei
Project duration: 01.10.2015 – 30.09.2017
Financial support: the project is supported by a grant of the Romanian National Authority for Scientific Research and Innovation, CNCS – UEFISCDI, project number PN-II-RU-TE-2014-4-1862 (contract 134 din 01/10/2015)
Key words: Quality by Design, Design Space, Process Analytical Technology, NIR – spectroscopy, Chemometry, Multivariate data analysis
QbD-PAT MatrixRS 