Lyophilized formulations of Salinosporamide A
Lyophilized formulations comprising Salinosporamide A or analogs thereof are provided. In some aspects, lyophilized formulations comprising Salinosporamide A or analogs thereof and bulking agents are provided. Also provided are methods of lyophilizing Salinosporamide A or analogs thereof. In some aspects, a solvent or co-solvent system is utilized. Also provided are methods of administering Salinosporamide A or analogs thereof to patients.
1. A lyophilized formulation comprising Salinosporamide A and a bulking agent comprising sucrose.
2. A container comprising a lyophilate comprising Salinosporamide A and a bulking agent comprising sucrose.
3. The container of claim 2 comprising from about 0.2 mg to about 4 mg of Salinosporamide A.
4. The container of claim 2 , wherein the container is selected from the group consisting of a type 1 flint tubing vial, an amber tubing vial, a clear molded vial, and an amber molded vial.
5. A kit for administering Salinosporamide A comprising:
a first container comprising a lyophilate comprising Salinosporamide A or an analog thereof and a bulking agent comprising sucrose; and
a second container comprising a diluent.
6. The kit of claim 5 , wherein the bulking agent comprises from about 10 mg to 100 mg of sucrose.
7. The kit of claim 5 , wherein the first container comprises from about 0.2 mg to about 4 mg of Salinosporamide A.
8. The kit of claim 5 , wherein the first container is selected from the group consisting of a type 1 flint tubing vial, an amber tubing vial, a clear molded vial, and an amber molded vial.
9. The kit of claim 5 , wherein the diluent comprises a co-solvent system.
10. The kit of claim 5 , wherein the diluent comprises polyethylene glycol, ethanol, a buffer, or mixtures thereof.
11. The kit of claim 10 , wherein the buffer is a citrate buffer.
12. The kit of claim 5 , wherein the diluent comprises propylene glycol, ethanol, a buffer, or mixtures thereof.
13. The kit of claim 12 , wherein the buffer is a citrate buffer.
14. The kit of claim 5 , wherein the diluent comprises at least 50% propylene glycol, ethanol, and 40% citrate buffer (10 mM, pH 5.0).