Mitomycin-C bladder instillation syringe kit
The disclosure provides compositions, methods, and devices for use in delivering Mitomycin-C(MMC), an antineoplastic chemotherapy drug often used for bladder instillations to treat bladder cancer, which degrades in both acidic and alkaline environments. The disclosure provides a solution of buffered MMC (or a different drug) in 50% propylene glycol that maintains a pH from 7.0 to 8.0 when introduced into acidic solutions (pH of 5.0) and is stable when stored at 2-8° C. for greater than 134 days. This formulation can be produced in an FDA registered 503B Outsourcing facility in a pre-filled, ready-to-administer syringe kit with pre-attached closed system transfer device and accessories required for bladder instillation.
1. A Mitomycin-C formulation comprising:
0.9 mg/mL to 1.2 mg/mL Mitomycin-C;
300 mg/mL to 550 mg/mL propylene glycol;
0.1 mg/mL to 10 mg/mL sodium phosphate buffer;
and water.
2. The Mitomycin-C formulation of claim 1 , wherein the sodium phosphate buffer comprises a combination of sodium phosphate dibasic heptahydrate and sodium phosphate monobasic anhydrous.
3. The Mitomycin-C formulation of claim 2 , wherein the sodium phosphate dibasic heptahydrate has a concentration of 0.0862 mg/mL to 8.87 mg/mL.
4. The Mitomycin-C formulation of claim 2 , wherein the sodium phosphate monobasic anhydrous has a concentration of 0.0138 mg/mL to 1.42 mg/mL.
5. The Mitomycin-C formulation of claim 2 , wherein the sodium phosphate dibasic heptahydrate has a concentration of 0.0862 mg/mL to 8.87 mg/mL and the sodium phosphate monobasic anhydrous has a concentration of 0.0138 mg/mL to 1.42 mg/mL.
6. A bladder instillation syringe kit comprising:
a syringe;
a closed system transfer device connected to the syringe; and
a Mitomycin-C formulation comprising:
0.9 mg/mL to 1.2 mg/mL Mitomycin-C;
300 mg/mL to 550 mg/mL propylene glycol;
0.1 mg/mL to 10 mg/mL sodium phosphate buffer; and water.
7. The bladder instillation syringe kit of claim 6 , wherein in the Mitomycin-C formulation, wherein the sodium phosphate buffer comprises a combination of sodium phosphate dibasic heptahydrate and sodium phosphate monobasic anhydrous.
8. The bladder instillation syringe kit of claim 7 , wherein the sodium phosphate dibasic heptahydrate has a concentration of 0.0862 mg/mL to 8.87 mg/mL.
9. The bladder instillation syringe kit of claim 7 , wherein the sodium phosphate monobasic anhydrous has a concentration of 0.0138 mg/mL to 1.42 mg/mL.
10. The bladder instillation syringe kit of claim 7 , wherein the sodium phosphate dibasic heptahydrate has a concentration of 0.0862 mg/mL to 8.87 mg/mL and the sodium phosphate monobasic anhydrous has a concentration of 0.0138 mg/mL to 1.42 mg/mL.
11. A bladder instillation syringe kit comprising:
a syringe;
a closed system transfer device connected to the syringe; and
a Mitomycin-C formulation comprising;
0.9 mg/mL to 1.2 mg/mL Mitomycin-C;
300 mq/mL to 550 mq/mL propylene glycol;
0.1 mq/mL to 10 mg/mL sodium phosphate buffer; and water,
wherein the bladder instillation syringe kit is produced in a 503B Outsourcing Facility.