WANG Jing, WANG Yu, ZHU Junjun, et al. Preparation and in Vitro Release of Naloxone Hdrochloride Orodispersible Film[J]. 2020,20(7):808-811. DOI: 10.14009/j.issn.1672-2124.2020.07.011.
盐酸纳洛酮口腔速溶膜的制备及其体外释放研究
摘要
目的:制备盐酸纳洛酮口腔速溶膜(naloxone hydrochloride orodispersible film
OBJECTIVE: To prepare naloxone hydrochloride orodispersible film( NXH-ODF) and investigate dissolution behaviors in vitro.METHODS: Solvent casting method was applied to prepare the NXH-ODF
with film appearance
thickness and disintegration time as evaluation indexes.The type and dosage of NXH-ODF film-forming materials
plasticizers
surfactants and disintegrants were screened by single factor experiments.The content uniformity and in vitro release of NXH-ODF prepared with the best prescription were investigated.RESULTS: The NXH-ODF prepared by optimal formulation( NXH 1.8%
HPMC-E30 63.9%
propylene glycol 24.8%
CMS-Na 3.6%
tween 80 3.6%
aspartame 1.8%
lemon yellow 0.5%) could disintegrate within 40 s
the conformity of drug content was up to the standard( A+2.2 S<15.0)
and the cumulative release in vitro at 10 min reached( 97.44 ± 2.28) %.CONCLUSIONS: The prepared NXH-ODF has smooth appearance
rapid disintegration and significant in vitro release.
关键词
盐酸纳洛酮口腔速溶膜溶剂浇铸法单因素试验法体外释放
Keywords
Naloxone hydrochlorideSublingual fast dissolving filmsSolvent casting methodSingle factor test methodIn vitro release