Cara Therapeutics has been granted a patent for a formulation that allows for the oral delivery of a therapeutic agent. The formulation includes a kappa opioid receptor agonist and an absorption enhancer, which includes a medium chain fatty acid or a salt of a medium chain fatty acid, as well as a medium chain fatty acid glyceride. The invention also includes capsules containing the oral formulations and methods for using these formulations to treat various kappa opioid receptor-associated diseases and conditions. The patent claim specifies the specific percentages of the components in the formulation and the desired bioavailability of the therapeutic agent. GlobalData’s report on Cara Therapeutics 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 Cara Therapeutics, tetrapeptide derivatives was a key innovation area identified from patents. Cara Therapeutics'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.

The patent is granted for a formulation of a therapeutic agent

Source: United States Patent and Trademark Office (USPTO). Credit: Cara Therapeutics Inc

A recently granted patent (Publication Number: US11684674B2) discloses a formulation for oral delivery of a kappa opioid receptor agonist called CR845.HCl. The formulation consists of CR845.HCl, trehalose, and a glyceride of one or more medium chain fatty acids. The CR845.HCl is present in the formulation at a concentration ranging from about 18% to about 23% (w/w), while trehalose makes up about 60% to about 77% (w/w) of the formulation. The glyceride of the medium chain fatty acids, which can be caproic acid, caprylic acid, or capric acid, is present in the formulation as a mono/di/triglyceride.

In addition to the main components, the formulation may also include capric acid or a salt of capric acid, such as sodium caprate. A chelating agent, specifically EDTA, may be added to the formulation as well. The concentration of the caprylic/capric fatty acid di/triglyceride in the formulation can range from about 25% to about 92% (w/w), while the concentration of capric acid can range from about 5% to about 50% (w/w). If capric acid is included, it can be present at a concentration of about 5% to about 20% (w/w), along with a salt of capric acid in the same concentration range.

The patent also mentions that the CR845.HCl can be spray-dried or crystallized. The stability of the formulation is highlighted, with the CR845.HCl exhibiting a stability of greater than about 96% when stored for 3 months at 40°C and 75% relative humidity.

Furthermore, the patent describes a pharmaceutical composition that includes the formulation along with a pharmaceutically acceptable excipient, diluent, or binder. This composition can be encapsulated in an enterically coated capsule or a capsule with intrinsically enteric properties.

Another aspect of the patent is a formulation specifically designed for oral delivery of the kappa opioid receptor agonist. This formulation includes CR845.HCl embedded in trehalose and a glyceride of one or more medium chain fatty acids. Similar to the previous formulation, the glyceride can be a mono/di/triglyceride of caprylic acid and/or capric acid. The stability of this formulation is emphasized, with the CR845.HCl exhibiting a stability of greater than about 96% when stored for at least a year at 25°C.

Overall, this patent provides a detailed description of formulations for oral delivery of a kappa opioid receptor agonist, highlighting the specific components and their concentrations, as well as the stability of the formulations under different storage conditions.

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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