Optimization of Process Parameters for Formulation of Fluvastatin Tablet by Using Dry Granulation Method
Abstract
The manufacturing process of the tablet is a very complex process; it can be affected by the several process parameters or variables. The aim of this study was to understand and optimize the process parameters such as mixing, granulation, lubrication and tablets compression processes using quality by design (QbD) approach for a model Anti- Hyperlipidemic drug Fluvastatin sodium. During the processes there are several parameters which may influence or affect product quality. So the main objective of present work was to identify various process parameters and optimize this parameter, for the formulation of good quality product which needs to optimize Blending time, Roller force, Compression force and machine speed. A scale up batch was taken to evaluate and optimize the parameters. Critical quality attributes (CQA) such as flow behavior, granules parameters, Blend uniformity, tablet appearance, effect on tablet quality like physical appearance (surface, weight etc.) and tablet dissolution time as well as drug release. The test results of following parameters at various in-process phases are complies with the specified limits and finished product sample results were found to be within specified limits. This study results assures the manufacturing process is reproducible, robust and will yield consistent product, which meets specification.
Keywords: Process Parameters, Quality by Design, Fluvastatin, Granulation, Blending, Compression etc,.
Keywords:
Process Parameters, Quality by Design, Fluvastatin, Granulation, Blending, CompressionDOI
https://doi.org/10.22270/jddt.v10i5-s.4347References
EMA, 2014. Human Regulatory, Quality by Design, Guidance Documents. Accessed on 2016.06.13
Pallagi E, Ambrus R, Szabó-Révész P, Csóka I. Adaptation of the quality by design concept in early pharmaceutical development of an intranasal Nanosized formulation. International Journal of Pharmaceutics. 2015; 491:384 – 392.
Reddy BV, Navaneetha K, Reddy KVR. International Journal of Pharmacy and Pharmaceutical Sciences.2014; 6(4):312 – 317.
Kaur G, Sridhar DB, Gera M. Optimization of Roll Compaction/Dry Granulation Process for Poorly Flowable Antiviral Formulation. Am. J. PharmTech Res. 2012; 2(4):544 – 557.
Khorasani M et al., Process optimization of dry granulation based tableting line: Extracting physical material characteristics from granules, ribbons and tablets using near-IR (NIR) spectroscopic measurement
Hwang R, Noack RM. Application of design of experiments to pharmaceutical formulation development; 2(1):58 – 65.
Sutton S. Optimizing Tableting Processes with Quality by Design. Pharmaceutical Technology. 2012; 36(5).
Belic A, Skrjanc I, Bozic DZ, Vrecer F. Tableting process optimisation with the application of fuzzy models. International Journal of Pharmaceutics. 2010; 389(1-2):86-93.
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