Niacin formulation
The present invention provides a composition including an amphiphilic compound capable of self-assembling into a liquid crystalline phase; and a niacin compound. In another aspect, the present invention provides a method for the treatment of a disease state comprising administering a therapeutically effective amount of a pharmaceutical composition incorporating that composition.
1. A method for prolonging the release of niacin in a subject, comprising:
administering to the oral mucosa of a subject in need thereof a composition comprising an amphiphilic compound capable of self-assembling into a liquid crystalline phase upon contact with a hydrophilic solvent and a therapeutically effective amount of a niacin compound, and
prolonging release of the niacin compound in the subject for up to 12 hours.
2. The method of claim 1 , wherein release of the niacin compound is prolonged for 6 to 8 hours.
3. The method of claim 1 , wherein release of the niacin compound is prolonged for at least 4 to 6 hours.
4. The method of claim 1 , wherein the composition does not comprise prolonged release polymers.
5. The method of claim 1 , wherein administering the composition comprises sublingual administration.
6. The method of claim 1 , wherein the niacin compound comprises a unit dosage of 100 mg to 1,000 mg.
7. The method of claim 1 , wherein the weight of the amphiphilic compound in the composition when dry comprises at least 5% by weight of the combined weight of the dry niacin compound and the dry amphiphilic compound in the composition.
8. The method of claim 1 , wherein the weight of niacin compound when dry comprises at least 50% by weight of the combined weight of the dry niacin compound and the dry amphiphilic compound.
9. The method of claim 1 , wherein administering the composition comprises nighttime administration.
10. The method of claim 1 , wherein the niacin compound comprises nicotinyl alcohol tartrate, d-glucitol hexanicotinate, aluminium nicotinate, niceritrol, or d,l-alpha-tocopheryl nicotinate.
11. The method of claim 1 , wherein the niacin compound comprises niacin.
12. The method of claim 1 , wherein the amphiphilic compound comprises a monoglyceride of a fatty acid comprising a 6 to 24 carbon chain, a diglyceride of a fatty acid comprising a 6 to 24 carbon chain, or a combination thereof.
13. The method of claim 12 , wherein the carbon chain is unsaturated.
14. The method of claim 12 , wherein the amphiphilic compound comprises a mixture of monoacylglycerols, diacylglycerols, and glycerol.
15. The method of claim 12 , wherein the amphiphilic compound comprises a glycerol monooleate.
16. The method of claim 1 , wherein contacting the composition with excess PBS causes the composition to physically disintegrate and the amphiphilic compound to form a self-assembled structure detectable by small angle x-ray scattering (SAXS).
17. The method of claim 16 , wherein the detectable self-assembled structure comprises an inverse hexagonal bulk phase.
18. The method of claim 16 , wherein disintegration of the composition comprises 2 to 10 minutes.
19. The method of claim 1 , wherein the composition is a tablet.
20. The method of claim 1 , wherein the amphiphilic compound is self-assembled.
21. The method of claim 1 , wherein the composition is a colloidal dispersion, wherein the colloidal dispersion comprises a self-assembled amphiphilic compound in a continuous phase formed by one or more hydrophilic solvents.