Dosing regimens for echinocandin class compounds
The invention features pharmaceutical compositions, methods, and kits featuring dosing gimens and oral dosage formulations for administration of echinocandin class compounds.
1. A method of treating or preventing a fungal infection in a subject comprising reconstituting a lyophilized composition to form an aqueous solution, wherein the lyophilized composition comprising compound 22 having the formula
or a pharmaceutically acceptable salt thereof, and formulated for immediate release of compound 22 or a pharmaceutically acceptable salt thereof; and
subcutaneously administering two or more doses of the aqueous solution to the subject, wherein the aqueous solution having an effective amount of compound 22 or a pharmaceutically acceptable salt thereof,
wherein the lyophilized composition loses less than 5% potency when stored for three months and wherein stabilizers are not present in the lyophilized composition.
2. The method of claim 1 , wherein the aqueous solution is administered at an interval of one dose every 5 to 8 days.
3. The method of treating a fungal infection of claim 2 , wherein the interval is one dose every 7 days.
4. The method of claim 1 , comprising subcutaneously administering for at least two intervals over a period of at least two weeks.
5. The method of claim 1 , comprising subcutaneously administering 25 ml to 500 ml of the aqueous solution.
6. The method of claim 1 , comprising subcutaneously administering 1 ml to 10 ml of the aqueous solution.
7. The method of claim 1 , comprising subcutaneously administering 0.05 ml to 2.0 ml of the aqueous solution.
8. The method of claim 1 , comprising subcutaneously administering 0.05 ml to 1.0 ml of the aqueous solution.
9. The method of claim 1 , wherein the subject is infected with a pathogenic fungus.
10. The method of claim 1 , wherein the lyophilized composition comprises an acetate salt of compound 22.
11. The method of claim 1 , wherein the lyophilized composition further comprises a bulking agent.
12. The method of claim 11 , wherein the bulking agent is mannitol.
13. The method of claim 11 , further comprising a buffer.
14. The method of claim 1 , further comprising a buffer.
15. The method of claim 1 , wherein the fungal infection is selected from a group consisting of tinea capitis, tinea corporis, tinea pedis, onychomycosis, perionychomycosis, pityriasis versicolor, oral thrush, vaginal candidiasis, respiratory tract candidiasis, biliary candidiasis, eosophageal candidiasis, urinary tract candidiasis, candidemia, mucocutaneous candidiasis, aspergillosis, mucormycosis, paracoccidioidomycosis, North American blastomycosis, histoplasmosis, coccidioidomycosis, sporotrichosis, fungal sinusitis, and chronic sinusitis.
16. The method of claim 1 , wherein the subject is being prepared for an invasive medical procedure, the subject is immunocompromised, or the subject is undergoing long term antibiotic therapy.
17. The method of claim 16 , wherein the invasive medical procedure is a transplant.