Controlled indomethacin release from mucoadhesive film: in vitro and clinical evaluations.
Yakugaku Zasshi
; 128(11): 1673-9, 2008 Nov.
Article
em En
| MEDLINE
| ID: mdl-18981703
ABSTRACT
To develop a film formulation allowing controlled release for long-term analgesia, we selected ethyl cellulose (EC) as a novel additive, prepared a film formulation using indomethacin (IM film), and evaluated it in vitro and clinically. In the in vitro experiments, the effects of the EC concentration on the release rate of IM and on the adhesion force to the mucous membrane were investigated. The addition of 10% EC resulted in more sustained slow release compared with no EC, and the adhesion of the film with 10% EC added was similar to that of films containing carboxyvinyl polymer, which we reported previously showed significantly increased adhesion. A two-layered film consisting of an adhesive layer with 2% or 1% IM and 10% EC and a nonadhesive layer with 2% polyethylene glycol as a softening agent, was investigated for clinical use. Film consisting of an adhesive layer with 2% IM and 10% EC exhibited rapid onset of potent analgesia and was expected to prolong the duration of analgesia. These results suggest that IM film with EC added may be useful clinically, since it shows both immediate analgesic effects and prolonged duration of release.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Dor
/
Celulose
/
Anti-Inflamatórios não Esteroides
/
Indometacina
/
Mucosa Bucal
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2008
Tipo de documento:
Article