Sequential statistical optimization of a positively-charged submicron emulsion of miconazole

Pharmaceutical Development and Technology
P WehrleS Benita

Abstract

A positively charged oil/water (O/W) emulsion containing an antifungal agent was developed for ophthalmic use. An attempt was made using a sequential statistical methodology to optimize the O/W emulsion by varying both formulation and process parameters to obtain the smallest droplet size emulsion that can remain stable for a long period of time. During the first step of the study, not less than 7 parameters were found to be important--drug content, amount of lipophilic phase, poloxamer concentration, quantity of the phospholipids-stearylamine couple, pH adjustment, time of coarse emulsification and time of high pressure homogenization. A screening approach based on Hadamard's matrix was used to select the parameters displaying the most significant effects on response parameters. A first set of 8 experiments proved efficient enough to define the concentration of poloxamer and the quantity of the couple phospholipids-stearylamine, which confer the overall positive charge to the emulsified droplet, as the most significant parameters affecting the final droplet size of the emulsions formed. A 2k-type experimental design was then built with the two main factors in order to evaluate a first-order polynomial model with interaction. P...Continue Reading

References

Jan 1, 1992·Biomaterials, Artificial Cells, and Immobilization Biotechnology : Official Journal of the International Society for Artificial Cells and Immobilization Biotechnology·G K HannaT A Sklenar
Jun 1, 1986·Acta Ophthalmologica·S K DharmaG A Peyman
Sep 1, 1984·Survey of Ophthalmology·J W Shell
Nov 1, 1994·Journal of Pharmaceutical Sciences·J Li, K D Caldwell

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Citations

May 27, 2009·Drug Development and Industrial Pharmacy·Yan LiuXing Tang
Mar 19, 2005·Drug Development and Industrial Pharmacy·D AttiviP Maincent
Aug 7, 2004·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Shunmugaperumal Tamilvanan, Simon Benita

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