ACTA Pharmaceutica Sciencia 2017 , Vol 55 , Num 2
Formulation Design of the Oral Disintegrating Tablets Including Alfuzosin Hydrochloride with Risk Evaluation via Quality by Design
Gözde Güncan 1 Gizem Yeğen 2 Burcu Mesut 1 Buket Aksu 2 Yıldız Özsoy 1
1 Department of Pharmaceutical Technology, Faculty of Pharmacy, Istanbul University, 34116, Istanbul, Turkey
2 Department of Pharmaceutical Technology, Faculty of Pharmacy, Istanbul Kemerburgaz University, 34145, Istanbul, Turkey
DOI : 10.23893/1307-2080.APS.05512 In this study, within the framework of Quality by Design which is a systematically scientific approach which enables to understand and control the production and formulation variables during the process design and development, different parameters in the formulation and production process were detected and critical process parameters and critical material attributes were determined via risk evaluation methods. Then, different oral disintegrating tablet formulations were prepared and tested by changing the usage of co-formulated disintegrating excipient and other disintegrant combined with sodium starch glycolate and mannitol. Powder flow characteristics were examined. Suitable formulations compressed via direct compression method at two different pressure levels. Compressed tablets were tested physically and chemically. The results thus obtained were evaluated in the Artificial Neural Network and Gene Expression Programming modules. Keywords : Oral Disintegrating Tablets, Alfuzosin Hydrochloride, Quality by Design, Artificial Neural Network, Gene Expression Programming

Istanbul Medipol University