Faes Farma has filed a patent for an aqueous pharmaceutical composition containing bilastine, benzalkonium chloride, and other preservatives. The composition has a pH between 3.5 and 5.5 and can be used for the treatment and prevention of certain disorders through nasal administration. The patent also includes a process for preparing the composition. 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 administration with bilastine
A recently filed patent (Publication Number: US20230181555A1) describes an aqueous pharmaceutical composition for the prevention and treatment of various disorders and diseases. The composition includes bilastine or a pharmaceutically acceptable salt or solvate thereof, benzalkonium chloride, and at least one additional preservative such as phenylethyl alcohol or benzyl alcohol. It also contains a suspending agent and 2-hydroxypropyl-ß-cyclodextrin, with a pH range of 3.5 to 5.5.
The composition may further include mometasone or an ester, ether, or ketonide of mometasone, with the content of 2-hydroxypropyl-ß-cyclodextrin being less than 8.5 wt %. The content of bilastine or its salt or solvate is between 0.2 wt % and 0.8 wt %, while the total content of preservatives ranges from 0.010 to 2 wt %. The content of 2-hydroxypropyl-ß-cyclodextrin is between 1 and 5 wt %.
The patent also describes a process for preparing the aqueous pharmaceutical composition, which involves preparing an aqueous solution containing 2-hydroxypropyl-ß-cyclodextrin, benzalkonium chloride with additional preservatives, bilastine or its salt or solvate, and a buffer agent to achieve the desired pH. This solution is then combined with an aqueous suspension of a suspending agent and homogenized under stirring. Optionally, a dispersion of mometasone or its derivative with a surfactant can be added before homogenization.
The method of prevention and/or treatment of disorders or diseases susceptible to antagonism of H1 histamine receptor and/or corticosteroid-responsive diseases involves administering the aqueous pharmaceutical composition to a patient in need. The disorders or diseases susceptible to amelioration 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.
The aqueous pharmaceutical composition can be administered intranasally using a nasal spray device. The patent also provides specific ranges for the content of preservatives, bilastine or its salt or solvate, and 2-hydroxypropyl-ß-cyclodextrin in different claims.
In summary, the patent describes an aqueous pharmaceutical composition and its preparation process for the prevention and treatment of various disorders and diseases. The composition includes specific ingredients and their concentrations, along with a range of pH. The method of administration involves intranasal use, and the patent also includes a nasal spray device containing the composition.
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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
