Defense Date

11-21-2008

Graduation Date

Spring 2009

Availability

Immediate Access

Submission Type

thesis

Degree Name

MS

Department

Pharmaceutics

School

School of Pharmacy

Committee Chair

Moji Christianah Adeyeye

Committee Member

Hideki Ichikawa

Committee Member

Wilson Meng

Keywords

Nano-emulsions, zeta potential, z-average, trifluoperazine, oil-in-water, Thin layer hydration method

Abstract

Objectives: 1.) To develop and characterize an optimal formulation of oil-in-water nano-emulsions of trifluoperazine for parenteral delivery. 2.) To perform short term stability testing of the optimal formulation and monitor the potency using high performance chromatography (HPLC).

Materials and Methods: Emulsions containing soybean oil, water, trifluoperazine hcl as an amphiphilic drug, phospholipon 90 and Tween 80 as surfactant blend were prepared using the Thin-layer hydration method. Z-average, polydispersity index, zeta potential of emulsions were determined. A fully randomized 2X2X2X2X2 statistical design was developed using JMP software. Optimal formulation was selected based on desirable properties of low z-average and polydispersity index, and high zeta potential. Stability of optimal formulation was determined using HPLC analysis and based on ICH specifications.

Results: Z-average of optimal formulation was 72.9nm with zeta potential value of 25.59 mV and polydispersity index 0.2. After storage for 3 months, z-average values were below 200nm indicating optimal formulation was not physically degraded. Drug content analysis showed chemical degradation due to reduction of potency.

Conclusions: Trifluoperazine nano-emulsions formulations had acceptable values of low z-average, low polydispersity index and high zeta potential and were physically stable but not chemically stable over 3 months.

Format

PDF

Language

English

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