Patent GB-799068-A (GB)
Title: A stabilized vitamin-d composition and a process for the production thereof
IPC: A61K31/59
Filed: 1956-12-28
Abstract: A stabilized Vitamin D composition comprises at least one vitamin of the Vitamin D group, 2,6-di-(t-butyl)-4-methyl-phenol, ethylenediamine-tetraacetic acid or an alkali metal salt thereof, and 2-(t-butyl)-4-hydroxy-anisole and/or 3 - (t - butyl) - 4 - hydroxy - anisole.  A preferred composition contains Vitamin D2 and/or D3, the butylated hydroxy-anisole and the 2,6-di-(t-butyl)-4-methyl-phenol in a proportion of about 5 mg. to 20 mg. of each, e.g. about 10 mg. of each, per one million International Units of said vitamin, and about 0.1 to 0.5 per cent, preferably about 0.2 per cent, by weight of ethylenediamine-tetraacetic acid or the alkali metal salt thereof based on the weight of the final composition.  In the examples stabilized compositions are prepared in which a commercial mixture of 2- and 3-(t-butyl)-4 - hydroxy - anisole, 2.6 - di - (t - butyl) - 4-methyl-phenol, the disodium salt of ethylenediaminetetraacetic acid and Vitamin D2 or D3 are used.ALSO:An animal food supplement containing a stabilized vitamin D composition consisting of at least one vitamin of the vitamin D group, 2, 6-di-(t-butyl)-4-methyl-phenol, ethylenediamire-tetraacetic acid or an alkali metal salt thereof, and 2-(t-butyl)-4-hydroxy-anisole and/or 3-(t-butyl)-4-hydroxy-anisole.  The composition may also include a vegetable oil such as corn oil, sesome oil or coconut oil, and may be in a protective matrix of gelatin and sucrose.ALSO:A therapeutic composition comprises a mixture of at least one vitamin of the Vitamin D group, 2,6 - di - (t - butyl) - 4 - methyl - phenol, ethylene - diamine - tetraacetic acid or an alkyl metal salt thereof and 2-(t-butyl)-4-hydroxy - anisole and/or 3 - (t - butyl) - 4 - hydroxy-anisole, or free-flowing dry granules containing in finely dispersed form at least one vitamin of the Vitamin D group, 2,6-di-(t-butyl)-4 - methyl - phenol, ethylenediamine - tetraacetic acid or an alkali metal salt thereof, 2-(t - butyl) - 4 - hydroxy - anisole and/or 3 p  - (t-butyl) - 4 - hydroxy - anisole and a vegetable oil in a protective matrix of gelatin and sucrose.  The composition may be prepared by dissolving at least one vitamin of the Vitamin D group, the butylated hydroxy-anisole and 2,6-di - (t - butyl) - 4 - methyl - phenol in a vegetable oil, adding ethylenediamine-tetraacetic acid or an alkali metal salt thereof to the solution, emulsifying the resulting mixture in a solution of gelatin and sucrose, spraying the emulsion into a mass of pre-dried free-flowing starchy powder, separating the beadlets thus formed from the starchy powder, and drying the beadlets by heating.  Suitable vegetable oil are corn oil, sesame oil and coconut oil.  The compositions may be blended with other dry vitamins and minerals. The preferred compositions contain Vitamin D2 and/or D3, the butylated hydroxy-anisole and the 2,6-di-(t-butyl)-4-methyl-phenol in a proportion of about 5 mg. to 20 mg. of each, e.g. about 10 mg. of each, per one million International Units of said vitamin, and about 0.1 to 0.5 per cent, preferably about 0.2 per cent, by weight of ethylenediamine-tetraacetic acid or the alkali metal salt thereof based on the weight of the final composition.  The gelatin, sucrose and vegetable oil are conveniently employed in proportions of approximately 50 per cent, 10 per cent and 12 per cent. respectively, based on the total weight of composition.  The compositions may be incorporated in flavoured drinks or formed into tablets with or without other vitamins and minerals for use in the baking industry. In the examples, compositions are formed containing the disodium salt of ethylenediamine - tetraacetic acid, 2,6 - di - (t - butyl) - 4 - methyl - phenol, a commercial mixture of 2- and 3-(t-butyl)-4-hydroxy-anisole and corn oil with Vitamin D2 and with Vitamin D3, the compositions being in the form of particles protected by a matrix of gelatin and starch.