Steroid hormone compositions in medium chain oils
This disclosure provides a novel pharmaceutical composition capable of forming micelles upon exposure to the gastric environment. The pharmaceutical composition is suitable for delivering steroid hormones, and progesterone in particular, to a subject in need thereof.
1. A method of treating a disease or condition associated with reduced progesterone levels, the method comprising administering to a subject in need thereof a pharmaceutical composition comprising:
about 6 weight percent progesterone,
from about 1 weight percent to about 15 weight percent of a polysorbate, and
from about 70 weight percent to about 90 weight percent of a medium chain oil,
wherein
the medium chain oil comprises at least about 50 weight percent of a predominantly medium chain monoglyceride and up to about 10 weight percent of a complex medium chain diglyceride; and
the progesterone is fully solubilized.
2. A method of treating a disease or condition associated with reduced progesterone levels, the method comprising administering to a subject in need thereof an oral, fully-solubilized progesterone pharmaceutical composition comprising:
a polysorbate and about 6 weight percent progesterone, wherein the progesterone and the polysorbate are present in a weight ratio of from about 1:2 to about 2:1; and
a medium chain oil comprising at least about 50 weight percent of a predominantly medium chain monoglyceride and up to about 10 weight percent of a complex medium chain diglyceride, the medium chain oil not containing more than about 10 weight percent triglycerides.
3. The method of claim 1 , wherein the disease or condition associated with reduced progesterone levels is selected from the group consisting of menopause, endometrial hyperplasia; secondary amenorrhea; prevention of preterm birth; and osteoporosis.
4. The method of claim 2 , wherein the disease or condition associated with reduced progesterone levels is selected from the group consisting of menopause, endometrial hyperplasia; secondary amenorrhea; prevention of preterm birth; and osteoporosis.
5. The method of claim 1 wherein the predominantly medium chain monoglyceride and the progesterone are present at a weight ratio of about 10:1 to about 15:1.
6. The method of claim 1 , wherein the medium chain oil comprises at least about 70 weight percent of a predominantly medium chain monoglyceride.
7. The pharmaceutical composition of claim 6 , wherein the polysorbate is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, and polysorbate 80.
8. The method of claim 1 , wherein the pharmaceutical composition provides an oral bioavailability of at least about 150 percent as measured by an increase in AUC when compared to a reference product.
9. The method of claim 1 , wherein the pharmaceutical composition further comprises at least one of a polyoxyethylene hydrogenated castor oil, a D-α-Tocopherol polyethylene glycol succinate derivative, or a terpene.
10. The method of claim 9 , wherein the predominantly medium chain monoglyceride comprises at least about 90 weight percent of the medium chain oil.
11. The method of claim 10 , wherein the polysorbate is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, and polysorbate 80.
12. The method of claim 9 , wherein the pharmaceutical composition provides an oral bioavailability of at least about 150 percent as measured by an increase in AUC when compared to a reference product.
13. The method of claim 2 , wherein the polysorbate is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, and polysorbate 80.
14. The method of claim 2 , wherein the pharmaceutical composition provides an oral bioavailability of at least about 150 percent as measured by an increase in AUC when compared to a reference product.
15. The method of claim 2 , further comprising at least one of a polyoxyethylene hydrogenated castor oil, a d-α-tocopherol polyethylene glycol succinate derivative, or a terpene.