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Precipitation Process for Amorphous Letermovir in Pharma Formulations

According to GlobalData’s company profile on Lupin, Cancer treatment biomarkers was a key innovation area identified from patents. Lupin‘s grant share as of September 2023 was 34%. Grant share is based on the ratio of number of grants to total number of patents.

Precipitation process for amorphous letermovir suitable for pharmaceutical formulations

Source: United States Patent and Trademark Office (USPTO). Credit: Lupin Ltd

The filed patent (Publication Number: US20230312485A1) describes a process for obtaining Letermovir, a pharmaceutical compound used for prophylaxis or treatment of diseases associated with the group of Herpesviridae, particularly human cytomegalovirus (HCMV). The patent claims various methods for obtaining Letermovir and solid pharmaceutical formulations containing the compound.

Claims 1 to 8 describe different processes for obtaining Letermovir in its amorphous state. These processes involve providing a solution of Letermovir in methyl tert-butyl ether (MTBE) and precipitating the amorphous compound by mixing the solution with heptane. The amorphous Letermovir is then isolated through filtration or centrifugation. The patent specifies that the amorphous Letermovir obtained contains residual solvents in accordance with ICH guidelines.

Claims 9 to 19 focus on solid pharmaceutical formulations containing the amorphous Letermovir. These formulations are designed to be orally administrable and can be used for prophylaxis or treatment of diseases associated with Herpesviridae, particularly HCMV. The patent emphasizes that the amorphous Letermovir used in these formulations should comply with ICH guidelines regarding residual solvents.

Overall, the patent provides a detailed description of the process for obtaining Letermovir and its use in solid pharmaceutical formulations. The methods described aim to ensure the purity and quality of the amorphous Letermovir, with specific requirements for residual solvents. These findings may have implications for the development of new treatments for diseases associated with Herpesviridae, particularly HCMV.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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




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