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Comparison between lipolysis and compendial dissolution as alternative techniques for the in vitro characterization of alpha-tocopherol self-emulsified drug delivery systems (SEDDS).
- Source :
-
International journal of pharmaceutics [Int J Pharm] 2008 Mar 20; Vol. 352 (1-2), pp. 104-14. Date of Electronic Publication: 2007 Oct 26. - Publication Year :
- 2008
-
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.
- Subjects :
- Chemistry, Pharmaceutical
Drug Compounding
Emulsions
Ethanol chemistry
Glycerides
Kinetics
Lipase chemistry
Models, Statistical
Nephelometry and Turbidimetry
Organic Chemicals chemistry
Particle Size
Polysorbates chemistry
Solubility
Triglycerides chemistry
Water chemistry
Drug Carriers
Lipids chemistry
Lipolysis
Technology, Pharmaceutical methods
Vitamins chemistry
alpha-Tocopherol chemistry
Subjects
Details
- Language :
- English
- ISSN :
- 0378-5173
- Volume :
- 352
- Issue :
- 1-2
- Database :
- MEDLINE
- Journal :
- International journal of pharmaceutics
- Publication Type :
- Academic Journal
- Accession number :
- 18065173
- Full Text :
- https://doi.org/10.1016/j.ijpharm.2007.10.023