Novartis has been granted a patent for a solid phase pharmaceutical composition that includes a specific active pharmaceutical ingredient and non-basic excipients, notably glyceryl behenate, while excluding magnesium stearate. The formulation aims to prevent exposure of the active ingredient to basic compounds. GlobalData’s report on Novartis 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 Novartis, Cancer treatment biomarkers was a key innovation area identified from patents. Novartis's grant share as of July 2024 was 51%. Grant share is based on the ratio of number of grants to total number of patents.

Solid phase pharmaceutical composition with specific non-basic excipients

Source: United States Patent and Trademark Office (USPTO). Credit: Novartis AG

The granted patent US12071402B2 outlines a solid phase pharmaceutical composition that includes a specific compound, 1-{4-[1-(4-cyclohexyl-3-trifluoromethyl-benzyloxyimino)-ethyl]-2-ethyl-benzyl}-azetidine-3-carboxylic acid, or its pharmacologically acceptable salt. The composition is characterized by the inclusion of one or more non-basic excipients, with glyceryl behenate being a required component, while explicitly excluding magnesium stearate. The claims further detail that the composition may also contain fumaric acid and can be formulated into particles with a specified X90 diameter range, ensuring precise dosage and uniformity in pharmaceutical applications.

Additionally, the patent describes a tablet formulation that comprises a compressed mixture of the aforementioned compound and non-basic excipients, including the potential use of colloidal silica. The claims specify that the tablet must comply with established pharmacopeial standards for content uniformity. The formulations are designed to enhance the stability and bioavailability of the active ingredient, with particular attention to the particle size of the components, which is critical for achieving the desired therapeutic effect. Overall, the patent presents a novel approach to solid phase pharmaceutical compositions, focusing on specific excipient choices and formulation parameters.

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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