Question

Why the higher strength formulation of Humira (i.e. 80 mg/0.8 mL) did not contain buffering agents and other salts like the lower strength formulation ( i.e. 40 mg/0.8 mL)?

Answer 1

Each higher strength Humira (80 mg / 0.8 mL) injection delivers 0.8 mL (80 mg) of drug. Each 0.8 mL of Humira contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and water for Injection. Each lower strength 40 mg/0.8 mL injection delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Humira delivers adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and water for Injection. Sodium hydroxide is added as necessary as a buffering agent to adjust pH. A buffering agent (a weak acid or base) prevents a sudden change in pH when bases or acids are added to the solution, which is present in low concentration Humira (40 mg/0.8 mL).