Ryaltris Description

RYALTRIS is a nasal spray containing an isotonic aqueous white homogenous suspension in a metered dose manual spray unit. It has a pH approximately 3.7.
Physiochemical Properties: Olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6, 11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride, a dibenzoxepine derivative. The empirical formula is C21H23NO3·HCl. Olopatadine hydrochloride is a white, crystalline, water-soluble powder. It has a molecular weight of 373.88 and a melting point of ~245°C (decomp).
Mometasone furoate monohydrate is 9, 21-Dichloro-11ß, 17-dihydroxy-16α-methylpregna-1, 4-diene-3, 20-dione 17-(2-furoate) monohydrate. The empirical formula is C27H30Cl2O6·H2O. It has a molecular weight of 539.45. Mometasone furoate is a white to off white powder and it is practically insoluble in water; slightly soluble in methanol, ethanol and isopropanol; soluble in acetone.
CAS number: Mometasone furoate monohydrate: 141646-00-6.
Olopatadine hydrochloride: 140462-76-6.
Each spray delivers a volume of 0.1 mL suspension containing 600 microgram (0.6% w/v) of olopatadine equivalent to 665 micrograms of Olopatadine hydrochloride and 25 micrograms (0.025% w/v) of mometasone furoate equivalent to 25.86 micrograms of mometasone furoate monohydrate (600 micrograms/25 micrograms).
Excipient with known effect: Polysorbate 80 and benzalkonium chloride.
Excipients/Inactive Ingredients: The nasal spray also contains Benzalkonium Chloride, Carmellose sodium, Dibasic sodium phosphate heptahydrate, Disodium edetate, Hydrochloric acid, Dispersible Cellulose, Polysorbate 80, Sodium Chloride, Sodium hydroxide, and Water for injection.