Stability of cyanocobalamin in sugar-coated tablets.
The purpose of this study was to clarify the stability of cyanocobalamin (VB(12)-CN) in sugar-coated tablets containing fursultiamine hydrochloride (TTFD-HCl), riboflavin (VB(2)), and pyridoxine hydrochloride (VB(6)), and to identify the factors affecting the stability of VB(12)-CN in these sugar-coated tablets. The stability of VB(12)-CN was investigated using high-performance liquid chromatography while decomposition was evaluated kinetically. The decomposition of VB(12)-CN in sugar-coated tablets with high equilibrium relative humidity (more than 60%) under closed conditions showed complex kinetics and followed an Avrami-Erofe'ev equation, which expresses a random nucleation (two-dimensional growth of nuclei) model. We showed that equilibrium relative humidity, the incorporation of VB(2) and VB(6), and sugar coating, are the main factors influencing decomposition and that these factors cause the complex decomposition kinetics.
Ohmori
Shinji
S
Health Science Laboratories, Consumer Healthcare Company, Takeda Pharmaceutical Company Limited, 17-85, Jusohonmachi 2-chome, Osaka 532-8686, Japan. Ohmori_Shinji@takeda.co.jp
Kataoka
Masumi
M
Koyama
Hiroyoshi
H
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D004339:Drug Compounding; D004355:Drug Stability; D005666:Fursultiamin / Q000737:chemistry; D006170:Gum Arabic / Q000737:chemistry*; D006813:Humidity; D007700:Kinetics; D008956:Models, Chemical; D011208:Powders; D011736:Pyridoxine / Q000737:chemistry; D012256:Riboflavin / Q000737:chemistry; D013549:Sweetening Agents / Q000737:chemistry*; D013607:Tablets; D014805:Vitamin B 12 / Q000737:chemistry*; D014803:Vitamin B Complex / Q000737:chemistry*; D014867:Water / Q000737:chemistry*
D004338:Drug Combinations; D011208:Powders; D013549:Sweetening Agents; D013607:Tablets; D014867:Water; D005666:Fursultiamin; D014803:Vitamin B Complex; D006170:Gum Arabic; D011736:Pyridoxine; D014805:Vitamin B 12; D012256:Riboflavin