JCR Pharmaceuticals has been granted a patent for an aqueous preparation that contains a stable protein as an active ingredient, reducing injection pain. The preparation includes a phosphate buffer, human growth hormone, poloxamer as a non-ionic surfactant, and phenol as an isotonic agent. The pH is 6.2, osmotic pressure ratio is 0.9 to 1.1, and it does not include NaCl. GlobalData’s report on JCR 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 JCR Pharmaceuticals, Nanoparticle drug conjugates was a key innovation area identified from patents. JCR Pharmaceuticals's grant share as of September 2023 was 54%. Grant share is based on the ratio of number of grants to total number of patents.

Aqueous preparation for stable storage of protein injection

Source: United States Patent and Trademark Office (USPTO). Credit: JCR Pharmaceuticals Co Ltd

A recently granted patent (Publication Number: US11738068B2) discloses an aqueous preparation for the delivery of growth hormone. The preparation consists of specific concentrations of various components.

Claim 1 describes an aqueous preparation that includes 8 to 12 mM of a phosphate buffer, 4 to 8 mg/mL of growth hormone, 2 mg/mL of poloxamer 188, 3.3 mg/mL of phenol, and D-mannitol. The pH of the preparation is 6.2, and the osmotic pressure ratio is between 0.9 and 1.1. Notably, this preparation does not contain sodium chloride (NaCl).

Claim 2 outlines an aqueous preparation that is similar to claim 1 but specifies a concentration of 10 mM for the phosphate buffer and 40 mg/mL for D-mannitol. The pH and osmotic pressure ratio remain the same as in claim 1.

Claim 3 and claim 4 are dependent on claim 2 and specify different concentrations of growth hormone in the aqueous preparation. Claim 3 states that the preparation includes 4 mg/mL of growth hormone, while claim 4 specifies a concentration of 8 mg/mL.

These claims highlight the specific composition of the aqueous preparation for the delivery of growth hormone. The inclusion of phosphate buffer, poloxamer 188, phenol, and D-mannitol, along with the absence of sodium chloride, suggests that these components play a crucial role in the stability and effectiveness of the preparation.

The disclosed pH of 6.2 and osmotic pressure ratio of 0.9 to 1.1 indicate that the aqueous preparation is designed to maintain physiological conditions for optimal delivery and absorption of the growth hormone.

Overall, this granted patent provides valuable information for the development of aqueous preparations for growth hormone delivery, offering specific concentrations of components that can enhance stability and efficacy.

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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