Dymista Description

DYMISTA nasal spray is a fixed combination product containing the following active ingredients: azelastine hydrochloride and fluticasone propionate. Each g of suspension contains 1 mg azelastine hydrochloride and 0.365 mg fluticasone propionate. One spray (137 mg) contains 125 μg of azelastine (as the base) and 50 μg of fluticasone propionate.
The chemical name for azelastine hydrochloride is (R,S)-4[(4-Chlorophenyl)methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-phthalazin-1(2H)-one hydrochloride.
C₂₂H₂₄ClN₃O·HCl Molecular weight: 418.37 g mol^-1.
CAS Registry No: 79307-93-0.
The chemical name for fluticasone propionate is 6α,9-Difluoro-17-[[(fluoromethyl) sulphanyl]-carbonyl]-11β-hydroxy-16α-methyl-3-oxoandrosta-1,4-dien-17α-yl propanoate.
C₂₅H₃₁F₃O₅S Molecular weight: 500.6 g mol^-1.
CAS Registry No: 80474-14-2.
It is available as a metered-spray suspension for intranasal administration.
DYMISTA nasal spray contains the following inactive ingredients: disodium edetate, glycerol, microcrystalline cellulose, carmellose sodium, polysorbate 80, benzalkonium chloride, phenethyl alcohol and purified water.
Physical and Chemical Properties: Azelastine hydrochloride occurs as a white, odourless, crystalline powder with a bitter taste. It is sparingly soluble in water, and soluble in ethanol and dichloromethane. Azelastine hydrochloride is slightly hygroscopic.
Fluticasone propionate is a white or almost white powder. It is practically insoluble in water, sparingly soluble in dichloromethane and slightly soluble in alcohol.