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US 9,801,821 B2Granted
Stabilized vitamin D formulations
AssigneePSM Healthcare Limited
InventorsAnilkumar S. Gandhi, Pratibha S. Pilgaonkar, Maharukh T. Rustomjee
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Abstract
The present invention relates to stable solid formulations of vitamin D3 and to processes for preparation of the same. The present invention provides stabilized compositions comprising vitamin D3 at least one lipophilic dispersant, one or more antioxidants, at least one adsorbent and one or more pharmaceutically acceptable excipients and further coated with a barrier coating.
Claims19
A stable solid tablet formulation of vitamin D3 comprising:
- (a) a tablet core comprising:
- i) about 1,000 IU to about 65,000 IU of vitamin D3, about 7,000 IU of vitamin D3, about 40,000 IU to about 65,000 IU of vitamin D3, or about 50,000 IU of vitamin D3,
- ii) at least one lipophilic dispersant,
- iii) one or more antioxidants,
- iv) at least one adsorbent, and
- v) one or more pharmaceutically acceptable excipients;
- and
- (b) at least one barrier coating;
- wherein the vitamin D3 is substantially uniformly dispersed throughout the tablet core;
- and
- wherein the formulation comprises less than about 2% by weight of total impurities after 6 months at 40° C. and 75% relative humidity.
8 more elements
Dependencies are inferred from the claim text.