Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine

a fixed dose, mometasone technology, applied in the direction of pharmaceutical non-active ingredients, organic active ingredients, medical preparations, etc., can solve the problems of sneezing, nasal itching, headache, fatigue, and cognitive impairment, and achieve the effects of reducing the risk of side effects, reducing the effect of side effects, and improving the effect of drug

Inactive Publication Date: 2018-01-04
GLENMARK SPECIALTY
View PDF6 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Rhinitis may cause additional symptoms, such as sneezing, nasal itching, coughing, headache, fatigue, malaise, and cognitive impairment.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

examples 1-2

Suspension Compositions Containing Mometasone Furoate, Olopatadine HCl and Carboxymethylcellulose Sodium

[0121]

Example 1Example 2SN Ingredient(% w / w)(% w / w) 1Mometasone Furoate monohydrate0.0500.025Eq. to Mometasone furoate 2Olopatadine Hydrochloride0.6650.665 3Avicel RC 591 (Microcrystalline Cellulose1.2001.200and Carboxymethylcellulose Sodium) 4Benzalkonium chloride (50% solution)0.0400.040 5Carboxymethylcellulose Sodium0.5000.500(Cekol 2000 P) 6Sodium chloride0.4100.410 7Edetate disodium0.0100.010 8Dibasic sodium phosphate heptahydrate0.9400.940 9Polysorbate 800.0100.01010Sodium HydroxideQ.S.Q.S.11Hydrochloric acidQ.S.Q.S.12Water for injectionQ.S.Q.S.ObservationsPhysical observation on standing No phaseNo phasefor 24 hoursseparationseparationobservedobservedMean Particle size by microscopyBelow Below 15 μm.15 μm.

Manufacturing Procedure

[0122]1. Avicel RC-591 was added in water for injection with homogenization and allowed to hydrate.[0123]2. Carboxymethylcellulose Sodium was disper...

examples 3-4

Suspension Compositions Containing Mometasone Furoate, Olopatadine HCl and Xanthan Gum

[0133]

Example 3Example 4SNIngredient(% w / w)(% w / w) 1Mometasone Furoate monohydrate0.0500.025Eq. to Mometasone furoate 2Olopatadine HCl0.6650.665 3Avicel RC 591 (Microcrystalline Cellulose 1.0001.000and Carboxymethylcellulose Sodium) 4Benzalkonium chloride (50% solution)0.0400.040 5Xantural 75 (Xanthan Gum)0.3000.300 6Sodium chloride0.4100.410 7Edetate disodium0.0100.010 8Dibasic sodium phosphate heptahydrate0.9400.940 9Polysorbate 800.0100.01010Sodium HydroxideQ.S.Q.S.11Hydrochloric acidQ.S.Q.S.12Water for injectionQ.S.Q.S.ObservationsPhysical observation on standing No phaseNo phasefor 24 hoursseparationseparationobservedobservedMean Particle size by microscopyBelow Below 15 μm.15 μm.

Manufacturing Procedure

[0134]1. Avicel RC-591 was added in Water for injection with homogenization and allowed to hydrate.[0135]2. Xanthan gum was dispersed in Water for injection and added to step -1.[0136]3. Dibasic...

example 5

Pharmacokinetics of Olopatadine in a Fixed Dose Combination of Mometasone Furoate and Olopatadine Hydrochloride Nasal Spray

[0149]The pharmacokinetics of olopatadine in a fixed dose combination of mometasone furoate and olopatadine hydrochloride nasal spray was evaluated in a clinical trial. The clinical trial was a randomized, single-center, single-dose, open-label, three-period, six-sequence, cross-over study to evaluate three treatments administered as a nasal spray. The three treatments included a combination of mometasone furoate and olopatadine hydrochloride nasal spray, olopatadine hydrochloride nasal spray and PATANASE® nasal spray.

[0150]Subjects were randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio with all subjects receiving single doses of a fixed dose combination of mometasone furoate and olopatadine hydrochloride nasal spray, olopatadine hydrochloride nasal spray, and PATANASE® nasal spray. The study consisted of a screening visit, 3 single-dose treatment ...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
mean particle sizeaaaaaaaaaa
osmolalityaaaaaaaaaa
mean particle sizeaaaaaaaaaa
Login to View More

Abstract

The present invention relates to a stable fixed dose aqueous pharmaceutical composition (e.g., contained in a container) for nasal administration to a human, comprising mometasone or its salt, olopatadine or its salt. The composition may further include a hydrocolloid. The invention also relates to a process for preparing the pharmaceutical composition, and the use of the pharmaceutical composition in the treatment of rhinitis in a subject.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This patent application is a continuation of U.S. patent application Ser. No. 15 / 210,692, filed Jul. 14, 2016, which is a continuation-in-part of U.S. patent application Ser. No. 15 / 183,534 (now U.S. Pat. No. 9,750,754), filed Jun. 15, 2016, which is a continuation of U.S. patent application Ser. No. 14 / 662,128 (now U.S. Pat. No. 9,370,483), filed Mar. 18, 2015, which is a continuation-in-part of U.S. Pat. application Ser. No. 14 / 483,837 (now U.S. Pat. No. 9,078,923), filed Sep. 11, 2014, which claims the benefit of (1) Indian Provisional Patent Application No. 2975 / MUM / 2013, filed Sep. 13, 2013, and (2) International Patent Application No. PCT / IB2014 / 064251, filed Sep. 4, 2014, each of which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The present patent application relates to a stable fixed dose, aqueous pharmaceutical composition for nasal administration to a human comprising mometasone or its salt an...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/58A61K31/335A61K9/00A61K9/10A61K47/38A61K47/36
CPCA61K9/10A61K47/36A61K31/58A61K47/38A61K9/0043A61K31/335A61K2300/00
Inventor DHUPPAD, ULHAS R.KATKURWAR, ASHOKGUPTA, YASHWANTANKAM, RAJESHDHATRAK, CHANDRAKANT
Owner GLENMARK SPECIALTY
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com