Amgen. has been granted a patent for a method to prevent lamellar silica formation in borosilicate glass containers used for pharmaceutical formulations. The method involves washing, drying under specific conditions, pre-heating, and depyrogenizing the containers to enhance their resistance to silica formation. GlobalData’s report on Amgen 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 Amgen, NSAID cancer drugs was a key innovation area identified from patents. Amgen's grant share as of June 2024 was 43%. Grant share is based on the ratio of number of grants to total number of patents.
Method to prevent lamellar silica in borosilicate glass containers
The granted patent US12042830B2 outlines a method for treating borosilicate glass containers to enhance their resistance to the formation of lamellar silica during the storage of pharmaceutical formulations. The method involves several key steps: initially, the interior of the glass container is washed using a pressurized water jet, followed by drying the container with compressed air or inert gas for a minimum of 3000 milliseconds to eliminate residual hydroxyl groups. The container is then pre-heated in an oven at approximately 90°C for 60 minutes before undergoing a depyrogenization process, where the temperature is increased to at least 250°C and maintained for a specified duration. Variations of the method include specific temperature ranges for depyrogenization and the use of multiple drying cycles.
Further claims detail additional parameters and conditions for the treatment process. For instance, the pressurized water jet must be at least 72°C and exert a pressure of at least 7.25 psi. The patent also specifies that the pharmaceutical formulation can include various acids, polyols, and anionic surfactants, with a pH range of 6 to 8. Notably, the treated glass containers are designed to remain free of lamellar silica for at least 30 days when storing the pharmaceutical formulation at 40°C. The patent emphasizes the importance of maintaining the glass container stationary during the heating process and provides specific washing durations based on the container's volume, ensuring a comprehensive approach to preventing silica formation in pharmaceutical storage.
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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
