コンテンツへスキップ
Merck
  • Non-destructive monitoring of creaming of oil-in-water emulsion-based formulations using magnetic resonance imaging.

Non-destructive monitoring of creaming of oil-in-water emulsion-based formulations using magnetic resonance imaging.

Drug development and industrial pharmacy (2013-05-02)
Yoshinori Onuki, Akihiro Horita, Hideto Kuribayashi, Yoshihide Okuno, Yasuko Obata, Kozo Takayama
要旨

A non-destructive method for monitoring creaming of emulsion-based formulations is in great demand because it allows us to understand fully their instability mechanisms. This study was aimed at demonstrating the usefulness of magnetic resonance (MR) techniques, including MR imaging (MRI) and MR spectroscopy (MRS), for evaluating the physicochemical stability of emulsion-based formulations. Emulsions that are applicable as the base of practical skin creams were used as test samples. Substantial creaming was developed by centrifugation, which was then monitored by MRI. The creaming oil droplet layer and aqueous phase were clearly distinguished by quantitative MRI by measuring T1 and the apparent diffusion coefficient. Components in a selected volume in the emulsions could be analyzed using MRS. Then, model emulsions having different hydrophilic-lipophilic balance (HLB) values were tested, and the optimal HLB value for a stable dispersion was determined. In addition, the MRI examination enables the detection of creaming occurring in a polyethylene tube, which is commonly used for commercial products, without losing any image quality. These findings strongly indicate that MR techniques are powerful tools to evaluate the physicochemical stability of emulsion-based formulations. This study will make a great contribution to the development and quality control of emulsion-based formulations.

材料
製品番号
ブランド
製品内容

Sigma-Aldrich
ステアリン酸, Grade I, ≥98.5% (capillary GC)
Sigma-Aldrich
1-ヘキサデカノール, ReagentPlus®, 99%
Sigma-Aldrich
ステアリン酸, ≥95%, FCC, FG
USP
ステアリン酸, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
ステアリン酸, SAJ first grade, ≥90.0%, powder
Sigma-Aldrich
ステアリン酸, reagent grade, 95%
Sigma-Aldrich
1-ヘキサデカノール, ≥99%
USP
セチルアルコール, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
1-ヘキサデカノール, 95%
Supelco
ステアリン酸, analytical standard
Supelco
ステアリン酸, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
セチルアルコール, analytical standard
Supelco
セチルアルコール, Pharmaceutical Secondary Standard; Certified Reference Material
ステアリン酸, European Pharmacopoeia (EP) Reference Standard
Supelco
ステアリン酸, certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
セチルアルコール, European Pharmacopoeia (EP) Reference Standard