Chiesi Farmaceutici has filed a patent for stable formulations of tissue-type plasminogen activator (tPA). The patent claims a liquid composition containing specific amounts of tPA, tranexamic acid, sucrose, and optional additives. The formulation has a pH of 6.0 to 8.0. GlobalData’s report on Chiesi Farmaceutici 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 Chiesi Farmaceutici, Inhalation devices was a key innovation area identified from patents. Chiesi Farmaceutici's grant share as of September 2023 was 50%. Grant share is based on the ratio of number of grants to total number of patents.
A recently filed patent (Publication Number: US20230310717A1) describes a liquid composition for the treatment of impaired functionality of a catheter. The composition includes tissue plasminogen activator (tPa), tranexamic acid, sucrose, and optionally a nonionic surfactant and pH buffering agent. The formulation has a pH of 6.0 to 8.0 and can be stable at room temperature for at least 3 months. The composition can be provided in a single-use vial and is suitable for restoring the functionality of a central venous access device (CVAD).
The liquid composition includes specific concentrations of tPa, tranexamic acid, and sucrose. The tPa is preferably reteplase and is present at an amount of 0.15 to 0.25 units (U)/mL. Tranexamic acid is present at about 1 mM to 10 mM. The sucrose content is about 2.5 to 5.0% (w/w), with a preferred concentration of 3.0% (w/w). The composition may also contain a nonionic surfactant, specifically polysorbate 80 (PS80), at an amount of 0.001% (w/w) to 0.1% (w/w). The pH buffering agent used is a potassium phosphate buffering system, preferably containing 20-30 mM potassium phosphate.
The liquid composition is designed to be administered into an occluded catheter of a patient suffering from impaired functionality. The method of treatment involves instilling the liquid formulation into the catheter, which can be a central venous access device (CVAD). This method is suitable for restoring the functionality of the patient's CVAD. The instillation can be a single administration or repeated once after an interval of about 60 to 120 minutes.
The patent also describes a kit comprising the unit dosage composition in the form of a powder, obtained by removing water from the liquid composition, and water for reconstitution. Additionally, there is a method provided for reconstituting the composition by admixing water to the lyophilized powder.
Overall, this patent presents a liquid composition and method for treating impaired functionality of a catheter, specifically a CVAD. The composition includes specific concentrations of tPa, tranexamic acid, and sucrose, and may contain a nonionic surfactant and pH buffering agent. The method involves instilling the liquid formulation into the occluded catheter, either as a single administration or repeated after a specific interval. The patent also includes a kit and method for reconstituting the composition.
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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
