Dymista Description

DYMISTA is formulated as a white, homogeneous and redispersible suspension. It is available as a metered-spray suspension for intranasal administration.
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.
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.
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.
Excipients/Inactive Ingredients: DYMISTA nasal spray contains the following inactive ingredients: disodium edetate, glycerol, microcrystalline cellulose, carmellose sodium, polysorbate 80, benzalkonium chloride, phenethyl alcohol and purified water.
DYMISTA contains the antimicrobial preservatives benzalkonium chloride and phenethyl alcohol.