Lubrication properties of potential alternative lubricants, glycerin fatty acid esters, to magnesium stearate.
To study the usefulness of glycerin fatty acid ester Poem TR-FB (TR-FB) and Poem TR-HB (TR-HB) as lubricants, pressure transmission ratio, ejection force, disintegration time, and tensile strength were measured at different concentrations and mixing times for granules and tablets. When each lubricant was mixed at 0.1-3.0%, the increase in the pressure transmission ratio that was equal to or greater than that of Mg-St as well as the reduction in the ejection force was observed at a low concentration in both TR-FB and TR-HB, proving that they have excellent lubrication performance. The granules that were lubricated with TR-FB and TR-HB at even low concentration of 0.4% showed a more stable and sufficiently lower ejection force than with Mg-St from the first tablet after the start of compression. When they were mixed for 5-60 min, while the mixture with Mg-St showed a low pressure transmission ratio of 82% and a high ejection force of 500 N in the first tablet even when the mixing time was 60 min, a high pressure transmission ratio and a low ejection force were observed in TR-FB and TR-HB from the first tablet after mixing for 5-60 min, and these were maintained thereafter. As for the disintegration time and the tensile strength, a prolonged disintegration time and a decreased tensile strength, which are disadvantages of Mg-St, were not observed in TR-FB and TR-HB. Based on these results, it was concluded that TR-FB and TR-HB are useful as alternative lubricants to Mg-St.
Uchimoto
Takeaki
T
Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.
Iwao
Yasunori
Y
Ikegami
Yuki
Y
Murata
Takashi
T
Sonobe
Takashi
T
Miyagishima
Atsuo
A
Itai
Shigeru
S
D002626:Chemistry, Pharmaceutical; D005227:Fatty Acids / Q000737:chemistry*; D005990:Glycerol / Q000031:analogs & derivatives / Q000737:chemistry*; D006244:Hardness; D007700:Kinetics; D054327:Lubricants / Q000737:chemistry*; D008956:Models, Chemical; D011312:Pressure; D012995:Solubility; D013229:Stearic Acids / Q000737:chemistry*; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods; D013718:Tensile Strength
D005227:Fatty Acids; D054327:Lubricants; D013229:Stearic Acids; D013607:Tablets; C031183:stearic acid; D005990:Glycerol