Faes Farma has been granted a patent for an aqueous pharmaceutical composition that includes bilastine, mometasone, a suspending agent, and 2-hydroxypropyl-ß-cyclodextrin. The composition is designed for nasal administration and can be used to treat or prevent disorders or diseases that can be improved by antagonism of H1 histamine receptor and/or corticosteroid-responsive diseases. The pH of the composition should be between 3.5 and 5.5, and the content of 2-hydroxypropyl-ß-cyclodextrin should be less than 8.5% by weight. GlobalData’s report on Faes Farma gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Faes Farma, nanoparticle drug conjugates was a key innovation area identified from patents. Faes Farma's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
Aqueous pharmaceutical composition for nasal treatment of disorders
A recently granted patent (Publication Number: US11642309B2) discloses an aqueous pharmaceutical composition for the treatment and prevention of disorders or diseases that can be improved by antagonism of H1 histamine receptor and/or corticosteroid-responsive diseases. The composition comprises bilastine or a pharmaceutically acceptable salt or solvate thereof, mometasone or a pharmaceutically acceptable derivative thereof, a suspending agent, and 2-hydroxypropyl-ß-cyclodextrin. The pH of the composition is between 3.5 and 5.5, and the content of 2-hydroxypropyl-ß-cyclodextrin is less than 8.5% by weight.
The aqueous pharmaceutical composition described in the patent contains specific components and parameters to ensure its effectiveness. Bilastine or its salt or solvate is present in the composition at a content ranging from 0.2 wt % to 0.8 wt. %. Mometasone or its derivative, specifically mometasone furoate, is included in the composition. The content of 2-hydroxypropyl-ß-cyclodextrin, a solubilizing agent, is less than 8.5% by weight, and preferably less than 5 wt. %. The pH of the composition is maintained between 3.5 and 5.5, with a preferred range of 4.0 to 5.0. The suspending agent used can be cellulose or cellulose derivatives, such as cellulose ether derivatives, or a mixture thereof.
The patent also discloses a process for preparing the aqueous pharmaceutical composition. The process involves preparing an aqueous solution of 2-hydroxypropyl-ß-cyclodextrin with a content of less than 8.5% by weight, adding bilastine or its salt or solvate to the solution along with a buffer agent to adjust the pH, preparing a dispersion of mometasone or its derivative with a surfactant in purified water, preparing an aqueous suspension of the suspending agent, and finally combining the solutions and homogenizing the mixture under stirring.
The patent further claims a nasal spray device comprising the aqueous pharmaceutical composition and a method for the treatment and prevention of disorders or diseases susceptible to improvement by antagonism of H1 histamine receptor and/or corticosteroid-responsive diseases. The method involves administering an effective amount of the aqueous pharmaceutical composition to patients. The disorders or diseases that can be treated include allergic disorders such as rhinitis, conjunctivitis, and rhinoconjunctivitis, as well as corticosteroid-responsive diseases like asthma, allergic and non-allergic rhinitis, and non-malignant proliferative and inflammatory diseases.
Overall, this patent presents a specific aqueous pharmaceutical composition and its preparation process, which can be used for the treatment and prevention of various disorders and diseases. The composition's specific components and parameters ensure its effectiveness and suitability for use in nasal spray devices.
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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
