Shionogi has been granted a patent for a minimally colored solid preparation that incorporates a specific compound and is coated with light stabilizing substances like titanium oxide and talc, along with hypromellose as a polymer, to enhance its stability under light exposure. GlobalData’s report on Shionogi gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Shionogi, Cancer treatment biomarkers was a key innovation area identified from patents. Shionogi's grant share as of July 2024 was 59%. Grant share is based on the ratio of number of grants to total number of patents.
Minimally colored solid pharmaceutical preparation with light stabilizers
The granted patent US12064438B2 describes a solid preparation that includes a compound represented by a specific formula (I). The preparation features a coating layer that incorporates light-stabilizing substances, which can be selected from a variety of edible dyes and pigments, including but not limited to edible tar dyes, ferric oxides, titanium oxide, and talc. The claims detail various combinations of these substances, emphasizing the inclusion of specific food colorants such as Food Red No. 2, Food Yellow No. 5, and others, as well as polymers like hypromellose and hydroxypropyl cellulose. The patent also specifies that the solid preparation should maintain a color difference (?E) of no more than 13 under high optical illumination conditions.
Additionally, the patent outlines the formulation specifics, including the release rate of the compound represented by formula (I), which should be at least 80% after 45 minutes in a dissolution test. The solid preparation can contain varying amounts of the compound (10 mg, 20 mg, 40 mg, or 80 mg) and may include excipients such as croscarmellose sodium, lubricants, and binders in defined weight percentages. The packaging of the solid preparation is also specified, with an aluminum blister package being mentioned. Overall, the claims provide a comprehensive framework for the composition and characteristics of the solid preparation, focusing on its stability, color, and release properties.
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