Comparison between lipolysis and compendial dissolution as alternative techniques for the in vitro characterization of alpha-tocopherol self-emulsified drug delivery systems (SEDDS).
Int J Pharm
; 352(1-2): 104-14, 2008 Mar 20.
Article
em En
| MEDLINE
| ID: mdl-18065173
ABSTRACT
In vitro characterization of alpha-tocopherol SEDDS formulations was performed by (1) lipolysis in bio-relevant media, and (2) physical assessment by dissolution, particle size, and turbidity analyses. Both methods were statistically correlated using a 25-run, five-factor multiple-level d-optimal mixture design. Independent variables were SEDDS composition [vitamin E (12.5-25%), Tween 80 (10-40%), labrasol (0-10%), alcohol (0-10%), and captex 355 (20-50%)]. Measured responses were percent lipolysis, percent vitamin E retained in the aqueous layer of the digestion medium, and percent vitamin E dissolved in the dissolution medium. Percent lipolysis ranged from 0% to 66.3%. Percent vitamin E retrieved in the aqueous layer of the digestion and dissolution media ranged from 3% to 29.3% and from 25.9% to 101.7%, respectively. Turbidity ranged from 28 to 403JTU and the average droplet size was >1.0 microm. All formulation ingredients had significant (p<0.05) effect on percent lipolysis. Only two factors, Tween and vitamin E had significant effect on vitamin retention in the aqueous layer post-lipolysis. Tween, labrasol, and captex 355 had significant effect on vitamin E dissolution. Poor correlation was observed between the responses. Formulation ingredients influenced each response differently; and therefore, each method can only reveal distinctive characteristics of the SEDDS formulation and may not be used interchangeably.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vitaminas
/
Portadores de Fármacos
/
Tecnologia Farmacêutica
/
Alfa-Tocoferol
/
Lipídeos
/
Lipólise
Tipo de estudo:
Prognostic_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Int J Pharm
Ano de publicação:
2008
Tipo de documento:
Article
País de afiliação:
Estados Unidos