Karuna Therapeutics has filed a patent for an oral pharmaceutical composition that includes xanomeline beads and trospium beads. The composition aims to provide a convenient and effective treatment option for certain medical conditions. GlobalData’s report on Karuna Therapeutics 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 Karuna Therapeutics, peptide pharmacophores was a key innovation area identified from patents. Karuna Therapeutics'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.
Oral pharmaceutical composition comprising xanomeline and trospium beads
A recently filed patent (Publication Number: US20230181470A1) describes an oral pharmaceutical composition for the treatment of schizophrenia. The composition consists of xanomeline beads containing xanomeline or a salt thereof, and trospium beads containing trospium chloride. The dosage strength of the composition can be chosen from three options: 50 mg xanomeline free base and 20 mg trospium chloride, 100 mg xanomeline free base and 20 mg trospium chloride, or 125 mg xanomeline free base and 30 mg trospium chloride.
The patent claims that the composition has a dissolution rate where at least 80% of the xanomeline or a salt thereof and trospium chloride is released within 20 minutes in a pH 6.8 buffer solution, or more than about 95% is released within the first 45 minutes in an aqueous solution. When administered to a patient, the composition is expected to provide an in-vivo plasma profile with a median Tmax (time to reach maximum concentration) of 2 hours for xanomeline and 1 hour for trospium.
The oral pharmaceutical composition can have different dosage strengths, including 50 mg xanomeline free base and 20 mg trospium chloride, 100 mg xanomeline free base and 20 mg trospium chloride, or 125 mg xanomeline free base and 30 mg trospium chloride. The composition is also required to have total impurities no greater than 5% after 12 months at various temperature and humidity conditions, or after 6 months. Additionally, the composition should contain less than 0.5 wt. % of Impurity A after being stored for 3 months at 40° C. and 75% relative humidity. An antioxidant, such as ascorbic acid, may be included in the composition.
The patent also includes a method for treating schizophrenia using the described composition. The method involves administering the composition to a patient in need, with different dosage strengths used during different periods of treatment. Specifically, a first oral pharmaceutical composition with a dosage strength of 50 mg xanomeline free base and 20 mg trospium chloride is administered for a first period, followed by a second oral pharmaceutical composition with a dosage strength of 100 mg xanomeline free base and 20 mg trospium chloride for a second period, and finally a third oral pharmaceutical composition with a dosage strength of 125 mg xanomeline free base and 30 mg trospium chloride for a third period.
In summary, the patent describes an oral pharmaceutical composition for the treatment of schizophrenia, consisting of xanomeline and trospium chloride beads. The composition has specific dosage strengths, dissolution rates, and impurity limits, and can be administered in a step-wise manner for effective treatment.
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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
