Granted Patent B2

US 12,303,635 · App. 18/309,963 · Granted May 20, 2025

Inventors: Ulhas R. Dhuppad (Maharashtra, IN); Ashok Katkurwar (Maharashtra, IN); Yashwant Gupta (Maharashtra, IN); Rajesh Ankam (Maharashtra, IN); Chandrakant Dhatrak (Maharashtra, IN); Neelima Khairatkar-Joshi (Maharashtra, IN); Abhay Kulkarni (Maharashtra, IN); Dinesh Pradeep Wale (Maharashtra, IN); Vikram Mansingh Bhosale (Maharshtra, IN); Piyush Agarwal (Maharshtra, IN); Patrick Keohane (London, GB); Sudeesh K. Tantry (Jamison, PA); Chad Oh (San Francisco, CA)

Assignee: GLENMARK SPECIALTY S.A.

A61M11/007A61K9/0043A61K31/335A61K31/58A61K47/02A61K47/183A61K47/186A61K47/24A61K47/26A61K47/36A61K47/38A61M15/0065A61M15/08A61M31/00A61P37/08B05B15/30A61M2210/0618B05B11/0037

Abstract

Claims (17)

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.

Assignments (2)

Priority Claims (1)

Continuity (2)

References Cited (102)

Cited By (1)

US 12,605,728