HIGH SHEAR GRANULATION PROCESS: ASSESSING IMPACT OF FORMULATION VARIABLES ON GRANULES AND TABLETS CHARACTERISTICS OF
Abstract:
High shear wet granulation is a significant component procedure in the pharmaceutical industry. The objective of the study was to investigate the influence of two independent formulation variables; polyvinypyrrolidone (PVP) as a binder (X,) and croscarmellose sodium (CCS) as a disintegrant (X2) on the crit- ical quality attributes of acetaminophen granules and their corresponding tablets using design of experiment (DoE) approach. A two factor, three level (32) full factorial design has been applied; each variable was investi- gated at three levels to characterize their strength and interaction. The dried granules have been analyzed for their density, granule size and flowability. Additionally, the produced tablets have been investigated for: break- ing force, friability, disintegration time and t. of drug dissolution. The analysis of variance (ANOVA) showed that the two variables had a significant impact (p < 0.05) on granules and tablets characteristics, while only the binder concentration influenced the tablets friability. Furthermore, significant interactions (p < 0.05) between the two variables, for granules and tablets attributes, were also found. However, variables interaction showed minimal effect for granules flowability as well as tablets friability. Desirability function was carried out to opti- mize the variables under study to obtain product within the USP limit. It was found that the higher desirability (0.985) could be obtained at the medium level of PVP and low level of CCS. Ultimately, this study supplies the formulator with beneficial tools in selecting the proper level of binder and disintegrant to attain product with desired characteristics.
Related Concept Videos
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Cartesian Form for Vector Formulation
Resultant Moment: Vector Formulation
The resultant moment of a system of forces can be calculated through vector formulation. For example, if we consider...
Couples: Scalar and Vector Formulation
A couple moment is a rotational force that tends to rotate the steering wheel. The wheel's rotation can either be in a clockwise or anticlockwise direction. The right-hand rule is a helpful method for determining the direction of a couple moment....
Formulating and Validating Nursing Diagnosis I
There are thirteen domains...
Formulating and Validating Nursing Diagnosis II
Risk nursing diagnoses represent clinical judgments of an individual, family, or community more vulnerable to developing the health problem than others...


