Improvement of content uniformity of d-alpha-tocopheryl acetate as an oily drug in granules by emulsification.
To elucidate the effects of an oily drug emulsification on its content uniformity in granules obtained by wet granulation with a high-shear mixer, d-alpha-tocopheryl acetate (VE) was emulsified with hydroxypropylcellulose (HPC-L) solution (mean diameter of the VE droplets was 1.3 microm). When VE was added to the mixing powder as the emulsion, nuclei rich in VE were not formed and then the content of VE was fairly uniform throughout the granules even at 2 min granulation. We found that the oily drug poor content uniformity could be improved significantly by adding an emulsified drug to the powder in granulation process.
Kato
Yoshiteru
Y
Formulation Research Laboratories, Eisai Co. Ltd, Takehaya, Kakamigahara, Gifu 501-6195, Japan. y-3-kato@hhc.eisai.co.jp
Takeno
Masaki
M
D004655:Emulsions; D007202:Indicators and Reagents; D010316:Particle Size; D011208:Powders; D024505:Tocopherols; D024502:alpha-Tocopherol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry / Q000592:standards
D004655:Emulsions; D007202:Indicators and Reagents; D011208:Powders; D024502:alpha-Tocopherol; D024505:Tocopherols