Liquid-filled hard gel capsule pharmaceutical formulations
View Patent ↗Embodiments of liquid-filled hard gel capsule pharmaceutical formulations comprise a non-emulsified mixture, wherein the non-emulsified mixture comprises about 0.1 to about 5% by weight of at least one active pharmaceutical ingredient, about 50 to about 95% by weight medium chain triglycerides, and about 5 to about 25% by weight medium chain mono/diglycerides, wherein the medium chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 5:1.
1. A liquid-filled hard gel capsule pharmaceutical formulation comprising a non-emulsified mixture disposed in a hard gelatin capsule shell, wherein the non-emulsified mixture comprises:
about 0.1% to about 0.2% by weight of dutasteride,
about 85% to about 95% by weight medium chain triglycerides,
about 5% to about 15% by weight medium chain mono/diglycerides, and
at least 0.1% to about 1% by weight of butylated hydroxytoluene,
wherein the medium chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 7:1.
2. The liquid-filled hard gel capsule pharmaceutical formulation of claim 1 further comprising tamsulosin.
3. The liquid-filled hard gel capsule pharmaceutical formulation of claim 1 , wherein the medium chain mono/diglycerides comprise mono/diglycerides of caprylic/capric acid.
4. The liquid-filled hard gel capsule pharmaceutical formulation of claim 1 , wherein the non-emulsified mixture is a substantially homogenous mixture.
5. A liquid-filled hard gel capsule pharmaceutical formulation comprising a non-emulsified mixture disposed in a hard gelatin capsule shell, wherein the non-emulsified mixture comprises:
about 0.1 to about 5% by weight of dutasteride,
about 87.5 to about 95% by weight long chain triglyceride,
about 5 to about 12.3% by weight medium chain mono/diglycerides, and
at least 0.1% to about 1% by weight of butylated hydroxytoluene,
wherein the long chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 7:1.
6. The liquid-filled hard gel capsule pharmaceutical formulation of claim 5 further comprising tamsulosin.
7. The liquid-filled hard gel capsule pharmaceutical formulation of claim 5 wherein the medium chain mono/diglycerides comprise mono/diglycerides of caprylic/capric acid.
8. The liquid-filled hard gel capsule pharmaceutical formulation of claim 5 wherein the long chain triglyceride comprises corn oil.
9. A liquid-filled hard gel capsule pharmaceutical formulation comprising a non-emulsified mixture disposed in a hard gelatin capsule shell, wherein the non-emulsified mixture comprises:
about 0.2% by weight dutasteride;
about 90.7% by weight medium chain triglycerides;
about 9.1% by weight medium chain mono/diglycerides; and
about 0.013% by weight butylated hydroxytoluene (BHT).
10. A liquid-filled hard gel capsule pharmaceutical formulation comprising a non-emulsified mixture disposed in a hard gelatin capsule shell, wherein the non-emulsified mixture comprises:
about 0.1% to about 0.2% by weight of dutasteride,
about 85% to about 95% by weight medium chain triglycerides,
about 5% to about 15% by weight medium chain mono/diglycerides, and
about 0.013% by weight of butylated hydroxytoluene,
wherein the medium chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 7:1.
11. A liquid-filled hard gel capsule pharmaceutical formulation comprising a non-emulsified mixture disposed in a hard gelatin capsule shell, wherein the non-emulsified mixture comprises:
about 0.1% to about 0.2% by weight of dutasteride,
about 85% to about 95% by weight medium chain triglycerides,
about 5% to about 15% by weight medium chain mono/diglycerides, and
about 0.01% by weight of butylated hydroxytoluene,
wherein the medium chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 7:1.