Preparation and in vitro-in vivo evaluation of suvorexant orodispersible films
10.16438/j.0513-4870.2024-0101
- VernacularTitle:苏沃雷生口溶膜的制备及体内外评价
- Author:
Peng ZHAO
1
,
2
;
Cong-hui LI
3
;
Si-yi SHUAI
3
;
Bing YANG
3
;
Hui ZHANG
3
;
Nan LIU
3
;
Ai-ping ZHENG
3
;
Yong-jun WANG
1
;
Zeng-ming WANG
3
Author Information
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
3. State Key Laboratory of National Security Specially Needed Medicines, Academy of Military Medical Sciences, Beijing 100850, China
- Publication Type:Research Article
- Keywords:
orodispersible film;
suvorexant;
hot melt extrusion;
mechanical strength;
issolution;
pharmacokinetics
- From:
Acta Pharmaceutica Sinica
2024;59(9):2659-2664
- CountryChina
- Language:Chinese
-
Abstract:
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.
