abstract |
The present invention relates to compositions and dosage forms that allow high drug loading for highly lipophilic drugs, while maintaining excellent oral availability. The pharmaceutical compositions and unit dosage forms described herein may reduce the pill load for hydrophobic drugs such as (8R, 9S, 10R, 13S, 14S, 17S) - 10, 13-dimethyl-3-oxo-1 tridecanoate. , 2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclope nta [a] phenanthren-17-yl or tetradecanoate (8R, 9S, 10R, 13S, 14S, 17S, ) -10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydro cyclopenta [a] phenanthren-17-yl, and may be formulated at advantageous drug loads (for example, more than 23%) while providing adequate bioavailability (for example, capable of treating a hypogonadal male with less than 10 unit dosage forms per day) that allows the reduction in pill load and therefore, improved patient adherence or compliance. Additionally, the composition (eg, dosage form) has a release profile that is suitable for providing bioavailable API and the release profile is stable over time (for example, under storage conditions). |