Pharmaceutical dosage forms of stable amorphous rapamycin like compounds
The present invention provides a pharmaceutical dosage form comprising stable amorphous rapamycin like compounds and a pharmaceutically acceptable excipient and methods of making the pharmaceutical dosage form.
1 . A pharmaceutical dosage form comprising substantially amorphous rapamycin like compounds and a pharmaceutically acceptable excipient.
2 . The pharmaceutical dosage form of claim 1 wherein the substantially amorphous rapamycin like compound is sirolimus.
3 . The pharmaceutical dosage form of claim 2 wherein the substantially amorphous sirolimus contains less than 30 weight percent crystalline sirolimus.
4 . The pharmaceutical dosage form of claim 2 wherein the substantially amorphous sirolimus contains less than 10 weight percent crystalline sirolimus.
5 . The pharmaceutical dosage form of claim 2 wherein the substantially amorphous sirolimus contains less than 5 weight percent crystalline sirolimus.
6 . The pharmaceutical dosage form of claim 2 wherein the substantially amorphous sirolimus contains less than 1 weight percent crystalline sirolimus.
7 . The pharmaceutical dosage form of claim 2 wherein per unit dose the pharmaceutical dosage form contains from about 0.1 mg to about 2 mg of the sirolimus.
8 . The pharmaceutical dosage form of claim 2 per unit dose the pharmaceutical dosage form contains from about 0.5 mg to about 1 mg of the sirolimus.
9 . The pharmaceutical dosage form of claim 1 where the pharmaceutical dosage form is a solid dosage form.
10 . The pharmaceutical dosage form of claim 7 wherein the solid dosage form is selected from the group consisting of tablets, capsules, caplets, gelcaps, geltabs, powders and granules.
11 . The pharmaceutical dosage form of claim 8 wherein the solid dosage form is selected from the group consisting of tablets, capsules, gelcaps and geltabs.
12 . The pharmaceutical dosage form of claim 11 wherein the rapamycin like compound is sirolimus.
13 . The pharmaceutical dosage form of claim 1 wherein the dosage form is an oral dosage form.
14 . The pharmaceutical dosage form of claim 13 wherein the rapamycin like compound is sirolimus.
15 . The pharmaceutical dosage form of claim 1 wherin the dosage form is an injectable dosage form.
16 . The pharmaceutical dosage form of claim 15 wherein the like compound is sirolimus.
17 . The pharmaceutical dosage form of claim 1 wherein the pharmaceutical dosage form is a suspension containing amorphous rapamycin.
18 . A process for making a pharmaceutical dosage form comprising admixing a substantially amorphous rapamycin like compound with at least one pharmaceutically acceptable excipient.
19 . The pharmaceutical dosage form of claim 18 wherein the like compound is sirolimus.