Hypertonic pharmaceutical compositions containing an anti-platinum chemoprotectant agent
Hypertonic pharmaceutical compositions are disclosed. The hypertonic pharmaceutical compositions contain an anti-platinum chemoprotectant agent and a gelling agent. Also disclosed are methods of medical use of the hypertonic pharmaceutical compositions.
1. A method of preventing or mitigating platinum-induced ototoxicity in a subject to whom a platinum-based anti-neoplastic agent is administered, the method comprising administering to the round window of the subject an effective amount of a hypertonic pharmaceutical composition having a calculated osmolarity of 1,500-7,000 mOsm/L and comprising 0.5M-2.0M of an anti-platinum chemoprotectant agent, a gelling agent, and an optional tonicity agent; wherein the calculated osmolarity is calculated based on the chemoprotectant agent and the tonicity agent, if present, wherein the hypertonic pharmaceutical composition is administered prior to administration of the platinum-based anti-neoplastic agent.
2. The method of claim 1 , wherein the effective amount of the hypertonic pharmaceutical composition is administered intratympanically or transtympanically.
3. The method of claim 1 , wherein the hypertonic pharmaceutical composition is administered by a route different from the platinum-based antineoplastic agent.
4. The method of claim 1 , wherein 50 μL to 1 mL of the hypertonic pharmaceutical composition are administered to the round window of the subject.
5. The method of claim 1 , wherein the hypertonic pharmaceutical composition is administered within 1 hour prior to administration of the platinum-based antineoplastic agent.
6. The method of claim 1 , wherein the hypertonic pharmaceutical composition is administered within 2 hours prior to administration of the platinum-based antineoplastic agent.
7. The method of claim 1 , wherein the hypertonic pharmaceutical composition is administered within 3 hours prior to administration of the platinum-based antineoplastic agent.
8. The method of claim 1 , wherein the hypertonic pharmaceutical composition is administered within 4 hours prior to administration of the platinum-based antineoplastic agent.
9. The method of claim 1 , wherein the hypertonic pharmaceutical composition is administered within 5 hours prior to administration of the platinum-based antineoplastic agent.
10. The method of claim 1 , wherein the hypertonic pharmaceutical composition is administered within 6 hours prior to administration of the platinum-based antineoplastic agent.
11. A method of preventing or mitigating platinum-induced ototoxicity in a subject to whom a platinum-based anti-neoplastic agent is administered, the method comprising administering to the round window of the subject an effective amount of a hypertonic pharmaceutical composition having a calculated osmolarity of 1,500-7,000 mOsm/L and comprising 0.5M-2.0M of an anti-platinum chemoprotectant agent, a gelling agent, and an optional tonicity agent; wherein the calculated osmolarity is calculated based on the chemoprotectant agent and the tonicity agent, if present, wherein the hypertonic pharmaceutical composition is administered after administration of the platinum-based agent.
12. The method of claim 11 , wherein the effective amount of the hypertonic pharmaceutical composition is administered intratympanically or transtympanically.
13. The method of claim 11 , wherein the hypertonic pharmaceutical composition is administered by a route different from the platinum-based antineoplastic agent.
14. The method of claim 11 , wherein 50 μL to 1 mL of the hypertonic pharmaceutical composition are administered to the round window of the subject.
15. The method of claim 11 , wherein the hypertonic pharmaceutical composition is administered within 1 hour after administration of the platinum-based antineoplastic agent.
16. The method of claim 11 , wherein the hypertonic pharmaceutical composition is administered within 2 hours after administration of the platinum-based antineoplastic agent.
17. The method of claim 11 , wherein the hypertonic pharmaceutical composition is administered within 3 hours after administration of the platinum-based antineoplastic agent.
18. The method of claim 11 , wherein the hypertonic pharmaceutical composition is administered within 4 hours after administration of the platinum-based antineoplastic agent.
19. The method of claim 11 , wherein the hypertonic pharmaceutical composition is administered within 5 hours after administration of the platinum-based antineoplastic agent.
20. The method of claim 11 , wherein the hypertonic pharmaceutical composition is administered within 6 hours after administration of the platinum-based antineoplastic agent.