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Preparation and in vitro-in vivo evaluation of suvorexant orodispersible films
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Peng ZHAO1, 2, Cong-hui LI2, Si-yi SHUAI2, Bing YANG2, Hui ZHANG2, Nan LIU2, Ai-ping ZHENG2, Yong-jun WANG1, *, Zeng-ming WANG2, *
Acta Pharmaceutica Sinica | 2024, 59(9) : 2659 - 2664
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Acta Pharmaceutica Sinica | 2024, 59(9): 2659-2664
Preparation and in vitro-in vivo evaluation of suvorexant orodispersible films
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Peng ZHAO1, 2, Cong-hui LI2, Si-yi SHUAI2, Bing YANG2, Hui ZHANG2, Nan LIU2, Ai-ping ZHENG2, Yong-jun WANG1, *, Zeng-ming WANG2, *
Affiliations
  • 1. Wuya College of Innovation, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2. State Key Laboratory of National Security Specially Needed Medicines, Academy of Military Medical Sciences, Beijing 100850, China
Published: 2024-09-12 doi: 10.16438/j.0513-4870.2024-0101
Outline
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Orodispersible films (oral dispersible films), a novel form of oral solid dosage forms, are widely used for patients with dysphagia and those with uncontrollable autonomic behavior. In this study, suvorexant orodispersible film was prepared by hot melt extrusion technology, and the disintegration time, mechanical properties, in vitro dissolution and pharmacokinetics were evaluated, compared with other orodispersible films and commercially available tablets Belsomra. All experiments were approved by the Committee on the Management and Use of Laboratory Animals of Academy of Military Medical Sciences (IACUC-DWZX-2024-504). The results showed that the dissolution rate of suvorexant orodispersible film was faster and the mechanical strength was better than that of other commercially available orodispersible film, which could meet the needs of storage and transportation. Differential scanning calorimetry and X-ray diffraction results showed that suvorexant was dispersed within the orodispersible film in an amorphous state. The in vitro dissolution of the film was observed to be four times faster than that of the commercial tablets, achieving complete dissolution within five minutes. Pharmacokinetic evaluations in Beagle dogs revealed that the self-formulated orodispersible film exhibited no significant differences in the area under the blood concentration-time curve when compared with Belsomra. However, the film showed a faster onset of action, with a peak time that was twice as rapid, and a maximum blood concentration that was twice as high as that of Belsomra. Leveraging hot melt extrusion technology, the suvorexant orodispersible film offers a straightforward, continuous production process with consistent quality. It serves as an excellent platform for the development of solvent-free film preparations tailored for patients with special needs.

orodispersible film  /  suvorexant  /  hot melt extrusion  /  mechanical strength  /  dissolution  /  pharmacokinetics
Peng ZHAO, Cong-hui LI, Si-yi SHUAI, Bing YANG, Hui ZHANG, Nan LIU, Ai-ping ZHENG, Yong-jun WANG, Zeng-ming WANG. Preparation and in vitro-in vivo evaluation of suvorexant orodispersible films[J]. Acta Pharmaceutica Sinica, 2024 , 59 (9) : 2659 -2664 . DOI: 10.16438/j.0513-4870.2024-0101
Year 2024 volume 59 Issue 9
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Article Info
doi: 10.16438/j.0513-4870.2024-0101
  • Receive Date:2024-01-31
  • Online Date:2025-11-24
  • Published:2024-09-12
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History
  • Received:2024-01-31
  • Revised:2024-06-13
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Affiliations
    1. Wuya College of Innovation, Shenyang Pharmaceutical University, Shenyang 110016, China
    2. State Key Laboratory of National Security Specially Needed Medicines, Academy of Military Medical Sciences, Beijing 100850, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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