ZELSUVMI Topical gel Ref.[107468] Active ingredients: Berdazimer

ZELSUVMI (berdazimer) topical gel, 10.3%, a nitric oxide releasing agent, contains the drug substance berdazimer sodium, a white to off white powder with the chemical name poly[{[3-(methylamino)propyl]silasesquioxane}co{[3-(1-methyl-2-nitroso2-oxidohydrazin-1-yl)propyl]silasesquioxane}-co-silicate (1:3:6 x)], partially hydrolyzed (Si:OH ~10:5), and the following structural and empirical formula:

Structural Formula:

^* Denotes shared oxygen atom between bonded constituents; resulting bonds are Si-O-Si or Si‑OH

Empirical formula: [(C₄H₉N₃NaO_3.5Si)₃(C₄H₁₀NO_1.5Si)₁(SiO₂)₆(HO_0.5)₅]_0.1n

Due to the insoluble nature of berdazimer sodium, the molecular formula, molecular mass, and average molecular weight range cannot be determined.

ZELSUVMI (berdazimer) topical gel is an opaque white to off-white gel containing 10.3% berdazimer (equivalent to 10.9% berdazimer sodium). ZELSUVMI is supplied as two gel components that are mixed before administration:

• Tube A (14 g): an opaque white to off-white gel containing 240 mg of berdazimer sodium per gram of gel and the inactive ingredients cyclomethicone, hexylene glycol, hydroxypropyl cellulose, and isopropyl alcohol.
• Tube B (17 g): a translucent to opaque white to off-white gel containing the inactive ingredients benzoic acid, carboxymethylcellulose sodium, cyclomethicone, ethanol (13% v/v), glycerin, potassium phosphate monobasic, and purified water.