Amphastar Pharmaceuticals. has filed a patent for a powder formulation containing glucagon or a glucagon analog for nasal administration, specifically for the treatment of severe hypoglycemia. The patent also includes a method of making the powder formulation and devices and methods for using it. The powder composition includes glucagon, phospholipid surfactant, and cyclodextrin, and is prepared through a specific process. GlobalData’s report on Amphastar 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 Amphastar Pharmaceuticals, Hormone-based therapies for metabolic disorders was a key innovation area identified from patents. Amphastar Pharmaceuticals's grant share as of September 2023 was 47%. Grant share is based on the ratio of number of grants to total number of patents.

Powder formulation for nasal administration of glucagon for hypoglycemia treatment

Source: United States Patent and Trademark Office (USPTO). Credit: Amphastar Pharmaceuticals Inc

A recently filed patent (Publication Number: US20230302093A1) describes a powder composition for the treatment of hypoglycemia. The composition includes glucagon, a phospholipid surfactant, and cyclodextrin. The powder composition is prepared by forming a solution of glucagon and the phospholipid in an aqueous carrier, adding cyclodextrin to the mixture, drying the mixture to form a solid formulation, and processing the solid formulation to produce a uniform powder. The powder composition is characterized by an XRPD mesopeak, indicating its unique phase.

The powder composition consists of 5 to 15 wt% glucagon, 5 to 51 wt% phospholipid surfactant, and 44 to 90 wt% cyclodextrin. The phospholipid surfactant can be selected from various options, including dodecylphosphocholine, didecylphosphatidylcholine, lysolauroylphosphatidylcholine, dioctanoylphosphatidylcholine, and dilauroylphosphatidylglycerol. Similarly, the cyclodextrin can be an a-cyclodextrin, ß-cyclodextrin, or ?-cyclodextrin. The composition may also contain up to 10 wt% of sodium citrate or citric acid.

The drying of the mixture can be achieved through freeze drying or spray drying methods. The patent also describes a nasal applicator that includes a powder formulation reservoir containing the powder composition. This nasal applicator can be used to administer the powder composition to the nasal mucosa of an individual suffering from hypoglycemia.

In summary, the patent presents a powder composition for the treatment of hypoglycemia. The composition includes glucagon, a phospholipid surfactant, and cyclodextrin. It is prepared through a specific method involving the formation of a solution, addition of cyclodextrin, drying, and processing. The composition has specific weight percentages of its components and can also contain sodium citrate or citric acid. The patent also introduces a nasal applicator for administering the powder composition to the nasal mucosa of individuals with hypoglycemia.

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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