Development and evaluation of an oral fast disintegrating anti-allergic film using hot-melt extrusion technology.
Eur J Pharm Biopharm
; 119: 81-90, 2017 Oct.
Article
em En
| MEDLINE
| ID: mdl-28596037
ABSTRACT
The main objective of this novel study was to develop chlorpheniramine maleate orally disintegrating films (ODF) using hot-melt extrusion technology and evaluate the characteristics of the formulation using in vitro and in vivo methods. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and the last zone of the barrel was opened to discharge water vapors, which helped to manufacture non-sticky, clear, and uniform films. The film formulations demonstrated rapid disintegration times (6-11s) and more than 95% dissolution in 5min. In addition, the films had characteristic mechanical properties that were helpful in handling and storage. An animal model was employed to determine the taste masking of melt-extruded films. The lead film formulation was subjected to a human panel for evaluation of extent of taste masking and disintegration.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Portadores de Fármacos
/
Clorfeniramina
/
Tecnologia Farmacêutica
/
Antialérgicos
/
Temperatura Alta
Tipo de estudo:
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Animals
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Eur J Pharm Biopharm
Ano de publicação:
2017
Tipo de documento:
Article