PILGAONKAR PRATIBHA S.,RUSTOMJEE MAHARUKH T.,GANDHI ANILKUMAR S.
申请号：
NZ62298513
公开号：
NZ622985A
申请日:
2013.03.27
申请国别(地区):
NZ
年份:
2015
代理人:
摘要：
The disclosure relates to a stable solid tablet formulation of vitamin D3 (also called cholecalciferol) comprising: (a) a tablet core comprising 5000 - 75000 IU vitamin D3, at least one lipophilic dispersant, one or more antioxidants, at least one adsorbent and one or more pharmaceutically acceptable excipients and (b) at least one barrier coating. The lipophilic dispersants are a fatty acid, wax, a long chain monohydric alcohol, a fat or combinations thereof. The antioxidant are tocopherol, tocopherol acetate, tocopherol acid succinate, &bgr-carotene, propyl gallate, butylated hydroxytoluene (BHT), butylated hydroxyanisole, vitamin E, ascorbic acid, sodium ascorbate, calcium ascorbate, ascorbic palmitate, 2,4,5- trihydroxybutyrophenone, 4-hydroxymethyl-2,6-di-tert-butylphenol, erythorbic acid, gum guaiac, thiodipropionic acid, dilauryl thiodipropionate, tertbutylhydroquinone or combinations thereof. The adsorbent is be mannitol, dibasic calcium phosphate, dicalcium phosphate dihydrate, calcium hydrogen phosphate dihydrate, calcium phosphate tribasic, or combinations thereof. The pharmaceutically acceptable excipient may be a diluent, binder, disintegrant, lubricant, colorant, coating agent, anti-adherent, glidant, or combinations thereof. The barrier coating comprises hydroxypropyl methylcellulose, polyvinyl alcohol, polyvinyl acetate, sodium carboxymethyl cellulose, pullulan, polyvinyl alcohol and vinyl alcoholethylene glycol copolymer copolymer comprising methyl methacrylate and diethylaminoethyl methacrylate, poylmethacrylic acids, polymethacrylates or combinations thereof. The vitamin D3 is substantially uniformly dispersed throughout the tablet core and the formulation comprises less than about 2% by weight of total impurities after 6 months at 40°C and 75% relative humidity. The disclosure also relates to processes of preparing these formulations and the use of these formulations in the manufacture of a medicament for treating or preventing conditions associa
