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Improvement of in vitro dissolution and physical stability for spironolactone solid dispersion formulated with Soluplus
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Hang SONG1, Li-fang GAO1, Qiang FU1, *, Jue WANG2, *, Zhong-gui HE1
Acta Pharmaceutica Sinica | 2019, 54(1) : 14 - 21
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Acta Pharmaceutica Sinica | 2019, 54(1): 14-21
• Special Reports: Promoting the Dissolution of Poorly Soluble Drugs •
Improvement of in vitro dissolution and physical stability for spironolactone solid dispersion formulated with Soluplus
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Hang SONG1, Li-fang GAO1, Qiang FU1, *, Jue WANG2, *, Zhong-gui HE1
Affiliations
  • 1. Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2. Institute of Packaging Materials and Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2019-01-12 doi: 10.16438/j.0513-4870.2018-0958
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Spironolactone, a class Ⅱ drug of the biopharmaceutics classification system, has low oral bioavailability due to poor solubility. Spironolactone solid dispersions were prepared using the solvent method in order to improve its aqueous solubility. Optimization studies of spironolactone solid dispersions were performed using in vitro dissolution tests. Differential scanning calorimetry, X-ray diffraction and Fourier transform infrared were used to investigate the physical state of the drug in carrier materials and to detect the possible interactions between the drug and carrier materials in the solid dispersions. In addition, stress tests were employed to elucidate the key factors which have influence on the stability of the spironolactone solid dispersions. Results showed that spironolactone in the solid dispersions formulated with Soluplus and HPMC-E5 were both in amorphous state and the hydrogen bonds between the drug and carrier materials were formed in the solid dispersion. Therefore, the in vitro dissolution of spironolactone was also significantly enhanced. Stress tests demonstrated that the physical stability of spironolactone solid dispersions prepared with Soluplus was greatly improved compared to those formulated with HPMC-E5. Thus, spironolactone solid dispersion formulated with Soluplus using the solvent method could be used to improve the in vitro dissolution and stability of poorly soluble drugs.

spironolactone  /  solvent method  /  solid dispersion  /  carrier material  /  physical stability
Hang SONG, Li-fang GAO, Qiang FU, Jue WANG, Zhong-gui HE. Improvement of in vitro dissolution and physical stability for spironolactone solid dispersion formulated with Soluplus[J]. Acta Pharmaceutica Sinica, 2019 , 54 (1) : 14 -21 . DOI: 10.16438/j.0513-4870.2018-0958
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Article Info
doi: 10.16438/j.0513-4870.2018-0958
  • Receive Date：2018-10-22
  • Online Date：2026-01-26
  • Published：2019-01-12
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History
  • Received：2018-10-22
  • Revised：2018-11-23
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Affiliations
    1. Shenyang Pharmaceutical University, Shenyang 110016, China
    2. Institute of Packaging Materials and Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
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表12种不同金属材料的力学参数
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Family		 属数
Number of
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Number of
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Percentage of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
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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