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| Study about preparation and release rate in vitro of Potassium chloride wax matrix sustained-release tablets |
| BAO Yusheng, MA Chong, YUAN Xiaoli, TAO Li YE Hai |
| Nanjing Heron Pharmaceutical Science Technology Co.,Ltd,Nanjing 211100,P.R.China |
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Abstract Objective To prepare the wax matrix sustained-release tablets of potassium chloride baseing on the hot-melt extrusion technology,and investigate the in-vitro release consistency between homemade and reference preparation,which will provide eference for domestic enterprises to carry out the consistency evaluation of this product.Methods Hydrogenated vegetable oil was used as a wax skeleton material,and Pharma 16 hot-melt extruder was used to prepare a potassium chloride sustained-release tablet by a hot melt granulation process.In addition,an in vitro release curve was examined.Results When the amount of hydrogenated vegetable oil was 25%, the release profile was similar to the reference formulation, and the f2 factor in the aqueous medium was 76. The extrudate obtained by the extruding operation with the extrusion temperature parameter setting between 60～65°C had good melting effect.Conclusion The main prescription factor affecting on the in vitro release of potassium chloride was the amount of hydrogenated vegetable oil.The main process factor was the size of the granules after the crushed whole extrudate.
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Received: 25 May 2018
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