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In vitro release study of brexpiprazole sustained release microspheres for injection
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Jin-mei SUN1, 2, Fei YU1, 2, 3, Zhi-hong XU1, 2, 3, Lian-qing ZHANG3, Feng-mei ZHOU3, Wan-hui LIU1, 2, 3
Chinese Journal of New Drugs | 2023, 32(16) : 1684 - 1689
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Chinese Journal of New Drugs | 2023, 32(16): 1684-1689
In vitro release study of brexpiprazole sustained release microspheres for injection
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Jin-mei SUN1, 2, Fei YU1, 2, 3, Zhi-hong XU1, 2, 3, Lian-qing ZHANG3, Feng-mei ZHOU3, Wan-hui LIU1, 2, 3
Affiliations
  • 1College of Pharmacy, Yantai University, Yantai 264005, China
  • 2Key Laboratory of Molecular Pharmacology and Drug Evaluation of Ministry of Education, Yantai University, Yantai 264005, China
  • 3State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co., Ltd., Yantai 264670, China
Published: 2023-08-30
Outline
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Objective:

To establish a method of accelerated release of brexpiprazole sustained release microspheres for injection in vitro and discuss the in vivo and in vitro relationship, so as to provide reference for prescription screening and quality control of this preparation.

Methods:

The effects of surfactant type, salt type and temperature on the release behavior were investigated by the method of constant temperature water bath. The in vitro accelerated release method was finally determined by the analysis of distinguishing ability and in vivo and in vitro relationship (IVIVR).

Results:

A method for accelerated release of pH 7.4 HEPES (containing 0.2% cetyltrimethylammonium bromide) at 45 ℃ in vitro was established, which showed a good correlation with in vivo release (r2>0.99).

Conclusion:

The method of accelerated release in vitro established in this paper can guide prescription screening and process modification in all stages of drug development, and it is of great significance for product quality control.

brexpiprazole  /  sustained release microspheres  /  in vivo and in vitro relationship  /  cetyltrimethylammonium bromide  /  accelerated release test in vitro
Jin-mei SUN, Fei YU, Zhi-hong XU, Lian-qing ZHANG, Feng-mei ZHOU, Wan-hui LIU. In vitro release study of brexpiprazole sustained release microspheres for injection[J]. Chinese Journal of New Drugs, 2023 , 32 (16) : 1684 -1689 .
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Year 2023 volume 32 Issue 16
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  • Online Date：2026-03-05
  • Published：2023-08-30
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History
  • Accepted：2023-03-28
Affiliations
    1College of Pharmacy, Yantai University, Yantai 264005, China
    2Key Laboratory of Molecular Pharmacology and Drug Evaluation of Ministry of Education, Yantai University, Yantai 264005, China
    3State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co., Ltd., Yantai 264670, China
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表12种不同金属材料的力学参数
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小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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