Preparation and quality evaluation of orodispersible film containing ginkgolide B novel nanosuspension lyophilized powder.
10.19540/j.cnki.cjcmm.20200819.306
- Author:
Jing WANG
1
;
Jun-Jun ZHU
1
;
Bao-De SHEN
2
;
Ting ZHANG
2
;
Bo DAI
2
;
Ya-Ning ZHU
3
;
Hai-Long YUAN
2
Author Information
1. College of Pharmacy, Chengdu University of Traditional Chinese Medicine Chengdu 611137, China Department of Pharmacy,Air Force Medical Center, PLA Beijing 100142, China.
2. Department of Pharmacy,Air Force Medical Center, PLA Beijing 100142, China.
3. College of Pharmacy, Chengdu University of Traditional Chinese Medicine Chengdu 611137, China.
- Publication Type:Journal Article
- Keywords:
cumulative dissolution;
freezedrying;
ginkgolide B;
nanosuspension;
orodispersible film;
quality evaluation
- MeSH:
Ginkgolides;
Lactones;
Nanoparticles;
Particle Size;
Powders;
Solubility;
Suspensions
- From:
China Journal of Chinese Materia Medica
2020;45(22):5504-5510
- CountryChina
- Language:Chinese
-
Abstract:
To prepare a new dosage form that can improve the drug loading of the film--ginkgolide B nanosuspension lyophilized powder orodispersible film(GB-NS-LP-ODF) and to evaluate its quality. Firstly, ginkgolide B nanosuspension(GB-NS) was prepared by media milling method, and then ginkgolide B nanosuspension lyophilized powder(GB-NS-LP) was prepared with freeze-drying method. The mannitol was used as lyoprotectant and its dosage was also investigated. GB-NS-LP-ODF was prepared by solvent casting method and its formulation was screened by single factor test method and optimized by orthogonal test. The appearance, mechanical properties, content uniformity and in vitro dissolution of the optimized GB-NS-LP-ODF were investigated. The particle size of prepared GB-NS was about 201 nm, and the optimal dosage of mannitol was 8%. According to the optimal formula, the GB-NS-LP-ODF was prepared with GB-NS-LP 35.6%, PVA 0588 49.4%, PEG 400 10.7% and CMS-Na 4.3%, and completely disintegrated in about 30 s, and the particle size of reconstituted GB nanoparticles from ODF was about 210 nm. The film with smooth appearance and good mechanical properties was stable within 30 days and the content uniformity(A+2.2 S<15) conformed to the regulations. Scanning electron microscope(SEM) showed that GB-NS-LP-ODFs were evenly distributed and the particle size was about 200 nm. X-rays diffraction(XRD) showed that its crystallinity was significantly lower than that of GB raw drug and GB-ODF. The results of in vitro release test showed that the drug film was completely dissoluted within 10 minutes. These results indicated that nanosuspension lyophilized powder was prepared by freeze drying of nanosuspensions, and then loaded into the orodispersible film to effectively increase the drug loading of the ODF and have broad application prospects.
