Development and evaluation of the tablets coated with the novel formulation termed thin-layer sugarless coated tablets.
The purpose of this study was to develop and evaluate the thin-layer sugarless coated tablets containing Vitamin C, Vitamin E, Vitamin B2, calcium pantothenate, and L-cysteine. As a result of the formulation study, three coating layers, 2% under coating (UC), 38% build-up coating (BC), and 5% syrup coating (SC) were necessary for sufficient impact toughness, elegant appearance, and improvement of appearance stability after storage at 25 degrees C/75% RH for 6 months under open conditions. We demonstrated that the thin-layer sugarless coated tablets are superior to the sugar-coated tablets in terms of small tablet size and stability of calcium pantothenate. It was due to the coating method, the continuous spray mist method, which can minimize the thicknesses of coating layers and the moisture content in the tablets. We also demonstrated that the thin-layer sugarless coated tablets are superior to the film-coated tablets in terms of masking ability of the unpleasant odor and the appearance, stability of the appearance, and low hygroscopicity. It was due to the dense, opaque, and stable coating layers mainly consist of erythritol. We revealed that thin-layer sugarless coated tablets have both advantages of film-coated tablets and sugar-coated tablets.
Ohmori
Shinji
S
Healthcare Research Laboratories, Consumer Healthcare Company, Takeda Chemical Industries Ltd., 17-85, Jusohonmachi 2-Chome, Yodogawa-ku, Osaka 532-8686, Japan. ohmori_shinji@takeda.co.jp
Ohno
Yasuo
Y
Makino
Tadashi
T
Kashihara
Toshio
T
D019587:Dietary Supplements; D004355:Drug Stability; D004896:Erythritol / Q000737:chemistry*; D013549:Sweetening Agents / Q000737:chemistry*; D013607:Tablets; D013678:Technology, Pharmaceutical
D013549:Sweetening Agents; D013607:Tablets; D004896:Erythritol