Claims
1. An oral emulsion formulation of abiraterone comprising:
(i) abiraterone,
(ii) one or more emulsifying agents,
(iii) an oil phase,
(iv) an aqueous phase, and
(v) optionally additional excipients
2. The emulsion formulation of claim 1, wherein abiraterone is dissolved or
dispersed in the oil phase
3. The emulsion formulation of claim 1 , wherein the globule size is not more than 800nm when stored at 40°c for 3 months
4. The emulsion formulation of claim 1, wherein the D50 of the globule size is not more than 400nm when stored at 40°c for 3 months
5. The emulsion formulation of claim 1, wherein the one or more emulsifying agents are selected from the group comprising polysorbates, lecithin, sorbitan esters of fatty acids and polyethoxylated oils.
6. The emulsion formulation of claim 5, wherein the concentration of the
emulsifying agents ranges from l-10%w/v
7. The emulsion formulation of claim 1 wherein the oils for the oil phase are selected
from the group comprising medium chain triglycerides (MCT's), soya bean oil, com
oil, safflower oil, sunflower oil, castor oil, including medium chain fatty acids (i.e.,
caprylic acid, capric acid, lauric acid) and combinations.
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8. The emulsion formulation ol claim 1 additionally comprising flavoring agents, coloring agents, buffering agents and stabilizers.
9. An oral emulsion fomiulation of abiraterone comprising: (i) abiraterone,
(ii) polysorbate-80,
(iii) lecithin,
(iv) an oil phase,
(v) an aqueous phase, and
(vi) optionally additional excipients
10. The oral emulsion formulation of claim 9, wherein the concentration of
polysorbate and lecithin ranges from 1-10% w/v