Biotronik SE has filed a patent for a method of manufacturing a microsphere composition for drug delivery. The method involves dissolving the drug in a solvent, depositing the mixture onto a substrate, and evaporating it to create the microspheres. The patent focuses on materials and manufacturing methods for drug coating formulations. GlobalData’s report on Biotronik SE 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 Biotronik SE, Neuromodulation implants was a key innovation area identified from patents. Biotronik SE's grant share as of September 2023 was 48%. Grant share is based on the ratio of number of grants to total number of patents.

Method of manufacturing microsphere composition for drug delivery

Source: United States Patent and Trademark Office (USPTO). Credit: Biotronik SE & Co KG

A recently filed patent (Publication Number: US20230293780A1) describes a method for manufacturing a microsphere composition that includes at least one drug. The method involves dissolving the drug in a solvent to create a hydrophobic mixture, depositing the mixture onto a substrate, and then evaporating it to produce the microsphere composition. The solvent used in the process is specified to be dry, containing less than 7% water.

The patent also includes additional steps that can be incorporated into the manufacturing process. One such step involves cleaning the substrate with an organic solvent before depositing the hydrophobic mixture. Another step involves applying a water-soluble material to the substrate and drying it prior to the deposition step. Additionally, the method may include a cleansing step using plasma treatment before applying the water-soluble material or depositing the hydrophobic mixture.

The patent also describes a medical device that incorporates a coating layer made up of multiple drug microspheres. Specifically, the medical device is identified as a balloon catheter with a balloon. The microspheres in the coating layer have an average diameter ranging from 1 to 20 µm. The coating layer can consist solely of drug microspheres, and the microspheres themselves can be composed of various drugs, including rapamycin (sirolimus), everolimus, zotarolimus, biolimus, novolimus, myolimus, temsirolimus, and rapamycin derivatives. The structure of the drug microspheres is also specified in the patent, with R representing a specific chemical group.

The medical device may also include a primer layer made of a water-soluble material, which can be a protein with a molecular weight between 50 to 200 kD. The balloon of the balloon catheter is mentioned to be made of a polyamide material. In some embodiments, the coating layer consisting of drug microspheres is the only layer on the balloon, while in others, the primer layer is applied first, followed by the coating layer.

Overall, this patent presents a method for manufacturing a microsphere composition containing drugs and describes the incorporation of this composition into a medical device, specifically a balloon catheter. The patent provides specific details regarding the manufacturing process, the composition of the microspheres, and the structure of the medical device.

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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