Alfuzosin Hydrochloride ODTs with Risk Evaluation via Quality by Design

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 excipi- ent 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.



Today, it is generally accepted that quality cannot be tested or inspected into a  finished product, but rather that quality, safety and e effectiveness must be “designed” and built into a product and its manufacturing process. In the traditional approach, the production processes and process parameters are determined to be unchanged in order to avoid any variety in the quality of the product. Thus, required specifications are met and the product quality is measured by  nished product tests. In order to design quality into a product, the requirements for the product design and performance must be well understood in the early design phase. In pharmaceuticals, these product requirements can be justified as Quality Target Product Profile (QTPP) which is also de ned as “a prospective summary of … Continue reading in pdf-file


Acta Pharm. Sci. Vol 55 No: 2. 2017 DOI: 10.23893/1307-2080.APS.05512
Gözde Güncan1, Gizem Yeğen2, Burcu Mesut1, Buket Aksu2, Yıldız Özsoy1*
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.
Formulation Design of the Oral Disintegr
Adobe Acrobat Document 363.3 KB
Table with risk assessments of drug components
Risk assessment of formuation components

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