In situ gel-forming pharmaceutical compositions and uses thereof for sinus diseases
Inventors
Assignees
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Publication Number
US-11547659-B2
Publication Date
2023-01-10
Expiration Date
Abstract
The present invention provides pharmaceutical compositions comprising an antiseptic and a steroid, useful for treating a clinical symptom in a patient's airway (e.g., nose, lung, and sinus), wherein a gel containing the antiseptic is formed in situ upon instillation of the compositions onto a body cavity of a subject, as well as methods for using the same.
Core Innovation
The invention concerns aqueous in situ gelling pharmaceutical compositions for sinonasal or sinus cavity administration. The compositions comprise an antiseptic, a steroid, and a biocompatible polysaccharide that forms a gel in situ upon instillation into a sinonasal cavity of a subject in need thereof. The antiseptic comprises povidone-iodine (PVP-I).
The steroid comprises mometasone, fluticasone, or budesonide, or a salt, an ester, or any combination thereof. The polysaccharide comprises deacetylated gellan gum (DGG). The composition can include the antiseptic at 0.1% to 5.0%, the steroid at 0.02% to 0.1%, and the polysaccharide at 0.1% to 2.0%.
The compositions are directed to treating clinical sinus symptoms and improving a lung condition of a cystic fibrosis patient by washing a sinus cavity with the aqueous pharmaceutical composition. The composition forms a gel in situ upon instillation, and the treated condition is addressed through the combined presence of an antiseptic, an anti-inflammatory steroid, and a gel-forming polysaccharide matrix.
Claims Coverage
The provided claims include three independent claims. Across them, the independent inventive features are the combination of an antiseptic, a steroid, and a biocompatible gel-forming polysaccharide that forms a gel in situ in a sinus or sinonasal cavity, with specified concentration ranges for each component.
Aqueous in situ gel-forming sinonasal composition with PVP-I, steroid, and DGG
An aqueous pharmaceutical composition comprising an antiseptic, a steroid, and a biocompatible polysaccharide as a gel-forming material, wherein the composition can form a gel in situ upon instillation into a sinonasal cavity of a subject in need thereof, the antiseptic comprises povidone-iodine (PVP-I), the steroid comprises mometasone, fluticasone, or budesonide, or a salt, an ester, or any combination thereof, and the polysaccharide comprises deacetylated gellan gum (DGG); wherein the antiseptic is contained in the composition at a concentration of 0.1% to 5.0%, the steroid is contained in the composition at a concentration of 0.02% to 0.1%, and the polysaccharide is contained in the composition at a concentration of 0.1% to 2.0%.
Treating a clinical sinus symptom by administering a PVP-I/steroid/DGG in situ gelling composition
A method for treating a clinical sinus symptom of an airway of a subject in need thereof, comprising administering to a sinus cavity of the subject an aqueous pharmaceutical composition comprising an antiseptic, a steroid, and a biocompatible polysaccharide, wherein the composition can form a gel in situ upon instillation into the sinus cavity, wherein the antiseptic comprises povidone-iodine (PVP-I), the steroid comprises mometasone, fluticasone, or budesonide, or a salt, an ester, or any combination thereof, and the polysaccharide comprises deacetylated gellan gum (DGG); wherein the antiseptic is contained in the composition at a concentration of 0.1% to 5.0%, the steroid is contained in the composition at a concentration of 0.02% to 0.1%, and the polysaccharide is contained in the composition at a concentration of 0.1% to 2.0%.
Improving a cystic fibrosis lung condition by washing with a PVP-I/steroid/DGG in situ gelling composition
A method for improving a lung condition of a cystic fibrosis patient, comprising washing a sinus cavity of the patient with an aqueous pharmaceutical composition comprising an antiseptic, a steroid, and a biocompatible polysaccharide, wherein the composition can form a gel in situ upon instillation into the sinus cavity, wherein the antiseptic comprises povidone-iodine (PVP-I), the steroid comprises mometasone, fluticasone, or budesonide, or a salt, an ester, or any combination thereof, and the polysaccharide comprises deacetylated gellan gum (DGG); wherein the antiseptic is contained in the composition at a concentration of 0.1% to 5.0%, the steroid is contained in the composition at a concentration of 0.02% to 0.1%, and the polysaccharide is contained in the composition at a concentration of 0.1% to 2.0%.
Across the independent claims, the core claim coverage is directed to an aqueous composition combining PVP-I, a specified steroid class, and deacetylated gellan gum that forms a gel in situ in a sinonasal or sinus cavity, and to methods that use that composition either to treat clinical sinus symptoms or to improve a lung condition in a cystic fibrosis patient by washing the sinus cavity with the in situ gelling composition.
Stated Advantages
Documented Applications
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