Treatment options for multiple myeloma
Patent Information
- Application Number
- RU2025108416
- Authority / Receiving Office
- RU · RU
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-12-04
- Filing Date
- 2025-04-04
- Publication Date
- 2026-10-05
Claims
1. A liquid pharmaceutical composition containing (a) isatuximab at a concentration of 5-20 mg / ml; (b) a buffering agent selected from the group consisting of histidine, acetate and phosphate; (c) an excipient selected from the group consisting of sucrose and mannitol, and (d) polysorbate 80 (PS80).
2. The liquid pharmaceutical formulation of claim 1, wherein isatuximab is present at a concentration of 5 mg / mL, wherein the buffering agent is histidine, and wherein histidine is present at a concentration of 10 mM, wherein the excipient is sucrose, and wherein sucrose is present at a concentration of 10% (w / v), wherein PS80 is present at a concentration of 0.005% (w / v), and wherein the pharmaceutical formulation is characterized by a pH of about 6.0 or about 6.
5.
3. The liquid pharmaceutical composition according to claim 2, wherein the pH is approximately 6.
5.
4. The liquid pharmaceutical formulation of claim 1, wherein isatuximab is present at a concentration of 20 mg / mL, wherein the buffering agent is histidine, and wherein histidine is present at a concentration of 20 mM, wherein the excipient is sucrose, and wherein sucrose is present at a concentration of 10% (w / v), wherein PS80 is present at a concentration of 0.02% (w / v), and wherein the pharmaceutical formulation is characterized by a pH of approximately 6.
0.
5. The liquid pharmaceutical formulation of claim 1, wherein isatuximab is present at a concentration of 20 mg / ml, wherein the buffering agent is histidine, and wherein histidine is present at a concentration of 1.46 mg / ml, wherein the excipient is sucrose, and wherein sucrose is present at a concentration of 100 mg / ml, wherein PS80 is present at a concentration of 0.2 mg / ml, and wherein the pharmaceutical formulation further comprises histidine hydrochloride monohydrate at a concentration of 2.22 mg / ml.