Claims for Patent: 12,303,635

Summary for Patent: 12,303,635

Title:	Dispensing device and pharmaceutical composition for the treatment of rhinitis
Abstract:	A nasal dispensing device and pharmaceutical composition includes a container; a dispenser head having at least a pump, a dispensing channel, and a dispensing orifice; a dip tube; and a pharmaceutical composition comprising mometasone, an ester thereof (e.g., mometasone furoate), or a salt thereof and olopatadine or its salt (e.g., olopatadine hydrochloride). The container can have a conically shaped internal bottom, angled downwardly toward a center, and a further angularly deepened well, centrally located, with the dip tube extending into the well. An optional cap is provided that includes a sealing sleeve communicating in a seal tight manner with a perimeter of a lateral wall of the dispenser head.
Inventor(s):	Ulhas R. DHUPPAD, Ashok Katkurwar, Yashwant Gupta, Rajesh Ankam, Chandrakant Dhatrak, Neelima Khairatkar-Joshi, Abhay Kulkarni, Dinesh Pradeep WALE, Vikram Mansingh BHOSALE, Piyush Agarwal, Patrick Keohane, Sudeesh K. TANTRY, Chad OH
Assignee:	Glenmark Specialty SA
Application Number:	US18/309,963
Patent Claims:	1. A dispensing device containing an aqueous suspension for nasal administration to a human subject, comprising: (a) about 0.025% w/w mometasone furoate in particulate form; and (b) about 0.665% w/w olopatadine hydrochloride in dissolved form, wherein the suspension has a pH between 3.3 to 4.1, and the suspension contains not more than 1% of (21-chloro-9β,11β-epoxy-17α-hydroxyl-16α-methyl pregna-1,4-diene-3,20-dione) and not more than 1% of α-hydroxy olopatadine after 12 months of storage at 25±2° C. and 60% ±5% relative humidity in the dispensing device. 2. The dispensing device of claim 1, wherein the suspension has a pH in the range of 3.5 to 3.9. 3. The dispensing device of claim 1, wherein the suspension further comprises a hydrocolloid in an amount of at least 0.1% w/w of the suspension. 4. The dispensing device of claim 3, wherein the hydrocolloid is selected from xanthan gum and carboxymethyl cellulose sodium. 5. The dispensing device of claim 4, wherein xanthan gum is present in an amount of at least 0.3% w/w of the suspension. 6. The dispensing device of claim 5, wherein xanthan gum is present in an amount of 0.3% w/w to 3% w/w of the suspension. 7. The dispensing device of claim 4, wherein carboxymethyl cellulose sodium is present in an amount of at least 0.1% w/w of the suspension. 8. The dispensing device of claim 7, wherein the carboxymethyl cellulose sodium is present in an amount of 0.1% w/w to 3% w/w of the suspension. 9. The dispensing device of claim 1, wherein the suspension comprises 0.025% w/w mometasone furoate, 0.665% w/w olopatadine hydrochloride, 0.5% w/w carboxymethyl cellulose sodium, 1.2% w/w mixture of microcrystalline cellulose and carboxymethyl cellulose sodium, 0.02% w/w benzalkonium chloride, 0.4% w/w sodium chloride, 0.01% w/w di-sodium edetate, 0.94% w/w sodium phosphate heptahydrate, and 0.01% w/w polysorbate 80. 10. The dispensing device of claim 1, wherein the dispensing device comprises (a) a container for the aqueous suspension; (b) a dispenser head for dispensing the aqueous suspension from the container, the dispenser head including at least a pump or valve mechanism, a dispensing channel, and a dispensing orifice; and (c) a dip tube extending along the longitudinal axis of the container, the dip tube having a proximal end communicating with the dispenser head and an open distal end extending into the container and in communication with the aqueous solution.