Critical Quality Attributes (CQA)

A two level four factor partial factorial design was adopted, composite of experiment design was applied to optimize a tablet formulation of Tetrabenazine (TBZ) Tablets 25mg containing high percentage of Lactose Anhydrous, Sodium starch Glycolate, Magnesium Stearate and Starch/Lactose Ratio. The particle size distribution of Lactose Anhydrous is used as dependent variable and  Sodium starch Glycolate, Magnesium Stearate and Starch/Lactose Ratio were used as independent variables for optimizing some tablets response parameters. Reponses parameters for final TBZ Tablets were percentage of TBZ dissolve at thirty minutes. Design of Experiments (DOE) is an organized approach to determine the relationship between independent process variables and their effect on the response variable.24 partial factorial design were applied in this research work. The models were validated for accurate prediction of response characteristics and use to identify the optimum formulation. The results that an optimum TBZ 25mg tablets having a volume similar to commercial products can be produced by dry granulation process utilizing Lactose Anhydrous.

Quality by design is an essential part of the modern approach to pharmaceutical quality. Quality by design (QbD) is more scientific, risk based, holistic and proactive approach in pharmaceutical development for FDA and pharmaceutical industry in drug development. Quality by Design (QbD) is everything you do to directly to promote,  prove safety,  efficacy  and  quality  of your product from proof of concept to the point at which costumer are buying on regular basics.  This novel concept of QbD promotes industries in understanding product and manufacturing process starting with product development which aims basically building quality in product, not by testing it. A company needs to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA) under this concept of QBD during designing and development of a product. On the basis of information obtained company can build consistent product quality by monitoring and updating its manufacturing processes. This systematic approach to product development and manufacturing has received a great deal from traditional approach. The purpose of present article is to discuss the concept of pharmaceutical Quality by Design (QbD) and describe how it can be help to ensure pharmaceutical quality.