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Encountered granule flow in gemfibrozil tablet USP 600mg using novel technology
Corresponding Author(s) : Golla Nirmala
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
Abstract
The aim of this study was to formulate solid dosage form of Gemfibrozil and the scope of the study to design of experiment for Gemfibrozil tablet using 600mg using Roll compaction method is to increase the flow of the blend which resolved the die filling problem during compression and useful for granule flow. Die fill problem is encountered in production batches if the flow of the blend is not optimum. The flow of the blend is related to the characteristics of granules..Gemfibrozil is a waxy, crystalline, hydrophobic material that results in prolongation of disintegration time during storage in stability studies. Because of the fluffy nature of API flow problem was also encountered. Product and process characteristics important to desired performance must be derived from combination of prior knowledge and experimental assessment during product development, which is required to achieve objectives of Quality by Design (QbD). From prior knowledge and experimental data, a multivariate model linking product and process measurements and desired attributes was constructed. Flow of Gemfibrozil blend was improved by addition of colloidal silicone dioxide, selecting microcrystalline cellulose of higher particle size and by producing granules of sufficient strength. Since the major portion of the tablet was Gemfibrozil, the role of particle characteristics was also investigated
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- SchneiderLCR, Sinka IC,Cocks ACF. Characterisation of the flow behaviour of pharmaceutical powd-ers using a model die-shoe filling system. Powder Technol. 2007;173(1):59-71. doi: 10.1016/j.powtec.2006.11.015.
- Sinka IC, Schneider LCR, Cocks ACF.Measurement of the flow prop-erties of powders with special reference to die fill.IntJPharm.2004;280(1-2):27-38. doi: 10.1016/j.ijpharm.2004.04.021, PMID 15265544.
- Sinka IC, Motazedian F, Cocks ACF, Pitt KG.The effect of processing parameters on pharmaceutical tablet properties.Powder Technol.2009;189(2):276-84. doi: 10.1016/j.powtec.2008.04.020.
- Wu CY, Cocks ACF.Numerical and experimental investigations of theflow of powder into a confined space.Mech Mater. 2006;38(4):304-24. doi: 10.1016/j.mechmat.2005.08.001.
- [citedApr28, 2010]Available from: http://en.wikipedia.org/wiki/Gemfibrozil. Wikipedia.http://www.rxlist.com/script/main/srchcont_rxlist.asp?src=gemfibrozil.
- HuangQP, WangJX, ChenGZ, ShenZG, ChenJF, Yun J. Micronization of gemfibrozil by reactive precipitation process.IntJPharm.2008;360(1-2):58-64. doi: 10.1016/j.ijpharm.2008.04.026, PMID 18502064.
- United States Pharmacopeia31.NF 26;I:639-40.
- WuC-Y, Cocks ACF.Flow beha-viour of powders during die filling.Powder Metall. 2004;47(2):127-36. doi: 10.1179/003258904225015617.
- Rasenack N, Müller BW.Crystal habit and tableting behavior.IntJPharm.2002;244(1-2):45-57. doi: 10.1016/s0378-5173(02)00296-x, PMID 12204564.
References
SchneiderLCR, Sinka IC,Cocks ACF. Characterisation of the flow behaviour of pharmaceutical powd-ers using a model die-shoe filling system. Powder Technol. 2007;173(1):59-71. doi: 10.1016/j.powtec.2006.11.015.
Sinka IC, Schneider LCR, Cocks ACF.Measurement of the flow prop-erties of powders with special reference to die fill.IntJPharm.2004;280(1-2):27-38. doi: 10.1016/j.ijpharm.2004.04.021, PMID 15265544.
Sinka IC, Motazedian F, Cocks ACF, Pitt KG.The effect of processing parameters on pharmaceutical tablet properties.Powder Technol.2009;189(2):276-84. doi: 10.1016/j.powtec.2008.04.020.
Wu CY, Cocks ACF.Numerical and experimental investigations of theflow of powder into a confined space.Mech Mater. 2006;38(4):304-24. doi: 10.1016/j.mechmat.2005.08.001.
[citedApr28, 2010]Available from: http://en.wikipedia.org/wiki/Gemfibrozil. Wikipedia.http://www.rxlist.com/script/main/srchcont_rxlist.asp?src=gemfibrozil.
HuangQP, WangJX, ChenGZ, ShenZG, ChenJF, Yun J. Micronization of gemfibrozil by reactive precipitation process.IntJPharm.2008;360(1-2):58-64. doi: 10.1016/j.ijpharm.2008.04.026, PMID 18502064.
United States Pharmacopeia31.NF 26;I:639-40.
WuC-Y, Cocks ACF.Flow beha-viour of powders during die filling.Powder Metall. 2004;47(2):127-36. doi: 10.1179/003258904225015617.
Rasenack N, Müller BW.Crystal habit and tableting behavior.IntJPharm.2002;244(1-2):45-57. doi: 10.1016/s0378-5173(02)00296-x, PMID 12204564.
