Acadia Pharmaceuticals has filed a patent for stable aqueous compositions of carbetocin for the treatment of neurodevelopmental disorders like Prader-Willi syndrome. The compositions have improved stability and do not require interfacial stabilizers, surfactants, or chelating agents. The intranasal pharmaceutical preparation has a concentration of carbetocin ranging from 10 mg/ml to 70 mg/ml and includes a hydrotrope and a viscoelastic polymer. The preparation shows 75-125% bioavailability compared to a saline solution of the same carbetocin concentration. GlobalData’s report on Acadia Pharmaceuticals 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 Acadia Pharmaceuticals, human telomerase RT biomarker was a key innovation area identified from patents. Acadia Pharmaceuticals's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
Stable intranasal pharmaceutical preparation for carbetocin treatment
A recently filed patent (Publication Number: US20230201300A1) describes a stable intranasal pharmaceutical preparation containing carbetocin or a pharmaceutically acceptable salt thereof. The preparation consists of an aqueous solution of carbetocin with a concentration ranging from about 10 mg/ml to about 70 mg/ml. It also includes a hydrotrope and a viscoelastic polymer. Importantly, the solution does not contain an interfacial stabilizer, a surfactant, or a chelating agent. The pharmaceutical preparation is designed to have little to no visible solids and has been shown to have a bioavailability of 75-125% compared to an aqueous solution of carbetocin in saline.
In one embodiment of the invention, the hydrotrope used is nicotinamide, and the viscoelastic polymer is hydroxypropyl methylcellulose (HPMC). The pharmaceutical preparation may also include additional excipients. The concentration of carbetocin in this embodiment ranges from about 10 mg/ml to about 40 mg/ml.
The patent also describes specific concentrations of carbetocin, such as about 34.3 mg/ml and about 11.4 mg/ml. The viscoelastic polymer HPMC can be of medium viscosity or high viscosity grade and is present in an amount ranging from 0.005% w/v to 0.05% w/v. The hydrotrope nicotinamide is present in a concentration ranging from 50 mM to 500 mM. Additionally, sorbitol can be included in the pharmaceutical preparation in a concentration ranging from about 100 mM to about 287 mM.
The solution of the pharmaceutical preparation remains stable with little to no visible solids even after shaking for 1, 2, or 3 days at 5° C. and/or 25° C. The unit volume of the pharmaceutical preparation is 140 µL.
Overall, this patent describes a stable intranasal pharmaceutical preparation of carbetocin that does not require interfacial stabilizers, surfactants, or chelating agents. The preparation includes specific concentrations of carbetocin, hydrotrope, and viscoelastic polymer, and may also contain additional excipients. The solution remains visually clear even after extended periods of shaking and has demonstrated good bioavailability compared to a saline solution of carbetocin.
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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
