Pharmaceutical compositions comprising iodine and steroid and uses thereof for sinus diseases
Inventors
Liang, Bo • Tessema, Belachew • Capriotti, Joseph A. • Samson, Michael C. • Song, Wei
Assignees
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Publication Number
US-11986491-B2
Publication Date
2024-05-21
Expiration Date
Abstract
The present invention provides pharmaceutical compositions comprising an iodine-containing compound and a steroid, useful for treating a clinical symptom in a patient's airway (e.g., nose, lung, and sinus), as well as methods for using the same.
Core Innovation
The invention relates to a pharmaceutical composition for treating a sinus inflammation or infection in a patient in need thereof. The composition consists of water as a carrier, an iodine-containing compound wherein the iodine-containing compound is povidone-iodine, and a steroid wherein the steroid is budesonide or a salt or ester thereof.
The povidone-iodine concentration in a fully constituted aqueous solution ranges from about 0.01% to about 15% by weight/weight or weight/volume percentage based on the total weight or volume of the pharmaceutical composition. At least 91% of steroid remains in the pharmaceutical composition after the pharmaceutical composition is stored at a temperature in the range of 5-40°C for a month.
Optionally, one or more agents are included selected from microcrystalline cellulose, carboxymethyl cellulose sodium, polysorbate 80, disodium edetate, sodium chloride, hydrochloric acid, and sodium hydroxide. The described formulation enables administration to the patient's sinus cavity for treating sinus inflammation or infection.
Claims Coverage
The document contains one independent claim, covering a pharmaceutical composition with three central inventive aspects: the defined aqueous carrier, a povidone-iodine concentration range, and a steroid (budesonide or salt/ester) with a specified stability requirement after storage. Dependent claims refine the povidone-iodine and optional-agent ranges, and a method claim narrows administration to the sinus cavity.
Aqueous povidone-iodine and budesonide composition for sinus inflammation or infection
A pharmaceutical composition for treating a sinus inflammation or infection of a patient in need thereof, consisting of water as a carrier, povidone-iodine as the iodine-containing compound at a defined concentration range in a fully constituted aqueous solution, and budesonide (or a salt or ester thereof) as the steroid.
Povidone-iodine concentration range in fully constituted aqueous solution
The concentration of povidone-iodine in a fully constituted aqueous solution ranges from about 0.01% to about 15% by weight/weight or weight/volume percentage based on the total weight or volume of the pharmaceutical composition.
Steroid stability at 5-40°C for one month
At least 91% of steroid remains in the pharmaceutical composition after the pharmaceutical composition is stored at a temperature in the range of 5-40°C for a month.
Optional excipients selected from specific agents
Optionally one or more agents selected from microcrystalline cellulose, carboxymethyl cellulose sodium, polysorbate 80, disodium edetate, sodium chloride, hydrochloric acid, and sodium hydroxide.
Administration to the sinus cavity
A method of treating sinus inflammation or infection by administering a pharmaceutical composition (as defined) to a patient's sinus cavity.
Overall claim coverage focuses on a defined aqueous pharmaceutical composition for sinus inflammation or infection combining water, povidone-iodine within a specified concentration range, and budesonide (or a salt/ester) with a required stability outcome after storage at 5-40°C for one month. Optional excipients are limited to a specified list, and a method claim further restricts administration to the sinus cavity.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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