| abstract |
Pharmaceutically active derivatives of vitamin D2 and vitamin D3 in a solid state composition are stabilized by the presence of effective amounts of pharmaceutically acceptable antioxidant and polyoxyalkyl stabilizer. Specified antioxidants are butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), vitamin E, propyl gallate, beta -carotene and ascorbic acid, while specified stabilizers are polyethyleneglycols, polyethyleneglycol ethers, polyethyleneglycol esters, polyoxyethylated castor oil, polyoxyethylated hydrogenated castor oil, polyoxyethylated sorbitan fatty acid esters and polyoxyethylated glycerol fatty acid esters. Suitable proportions of these ingredients by weight lie within the ranges 0.00003 to 0.8 vitamin D2 or D3 derivative: 0.01 to 0.1 antioxidant: 0.03 to 30 polyoxyalkyl stabilizer. Compared with similar non-stabilized compositions, the inventive compositions are particularly stable at elevated temperatures and/or humidities. |