Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE; and Hemant N. Joshi, Ph.D., MBA*- Tara Innovations, LLC www.tarainnovations.com *hemantjoshi.tara@gmail.com
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in March 2025.
T Cell Manufacturing Compositions and Methods;
M. M. Van Buuren, D. R. Lenkala, J. Huibert, V.D. Burg, J. Kohler, M. Goldstein, E. Fritsch, R.De Boer, T. Schumacher, and N. Bakker; BioNTech US Inc, US and Stichting Het Nederlands Kanker Institut-Antoni Van Leeuwenhoek Ziekenhis, NL; US Patent # 12,258,581; March 25, 2025.
This patent focuses on advanced techniques for producing antigen-specific T cells for therapeutic applications. The controlled ex-vivo induction or expansion of antigen-specifi c T cells enables the development of highly targeted and eff ective T cell therapies. This disclosure outlines methods for manufacturing T cells. It also describes therapeutic T cell compositions that can be used to treat individuals with cancer, as well as other conditions, diseases, and disorders through personalized antigen-specific cell therapy. This expansion can be achieved by stimulating T cells with peptide-loaded antigen-presenting cells (APCs), leading to a population enriched in antigen-specific T cells.
Pharmaceutical Formulation;
R. Cavatur, K. Chen, M. Kaser, H. Qiu, E.J. Woodhouse, J. Borovicka, E. Wilkinson; RB Health, USA; U.S. Patent # 12,257,218; March 25, 2025.
This is an oral bilayer tablet formulation of guaifenesin, dextromethorphan and naproxen wherein the formulation provides a therapeutic eff ect for up to 12 hours. One layer provides an immediate release of all of the naproxen and one-sixth of the guaifenesin and one-quarter of the dextromethorphan. The formulation has expectorant, cough suppressant and analgesic eff ects. The second sustained release portion contains mainly guaifenesin and dextromethorphan, along with hydrophilicslow-dissolvingg polymers. The immediate release portion also contains sodium lauryl sulfate and sodium bicarbonate.
Liquid Concentrates of Calcium and Magnesium;
D. J. Nelson; Biolink Life Sciences, US; U.S. Patent # 12,251,400; March 18, 2025.
The invention is a liquid concentrate formulation that delivers calcium, magnesium, vitamin D₃, and vitamin K₂ in a water-soluble, palatable form. It is primarily intended to bind phosphorus in the gastrointestinal tract, making it useful for patients with hyperphosphatemia, especially those with chronic kidney disease (CKD). This is a patient-friendly alternative to solid phosphate binders, aiming to improve disease management in CKD and related conditions through better absorption, reduced side eff ects, and increased adherence. It is the first palatable and water-soluble phosphate binder using calcium and magnesium propionate. It avoids gastrointestinal issues associated with traditional calcium/magnesium salts.
Vasoconstriction Composition and Methods of Use;
Eye Therapies US; U.S. Patent # 12,246,013; March 11, 2025.
Dilation of small blood vessels in the eye can cause many clinically undesirable eff ects including surface hemorrhage. The invention claims a formulation comprising highly selective alpha-2 adrenergic receptor agonists at low concentration (below 0.05%). The composition preferably comprises imidazoline. The pH of the composition is from about 5.5 to about 6.5. The patient inserts a contact lens in a solution comprising approximately 0.005% to about 0.015% w/v brimonidine and then inserts the contact lens into the eye of the patient. The contact lens provides a reservoir to the surface of the eye allowing drugs to remain longer on the eye and increase the eff ectiveness of the drug.
Pharmaceutical Preparation Having Excellent Dissolution Properties, Containing Esomeprazole and Sodium Bicarbonate;
J.S. Choi, M.S. Kim, S.J. Park, and J. L. Lim; Chong Kun Dang Pharma. Corp., KR; U.S. Patent # 12,251,375; March 18, 2025
Omeprazole, a proton pump inhibitor used to reduce stomach acid, is chemically unstable in acidic conditions. There’s a need for a formulation that protects omeprazole from degradation at acidic pH. The invention provides a pharmaceutical preparation comprising omeprazole and sodium bicarbonate.
In this preparation, sodium bicarbonate dissolves first, raising the pH of the gastric fluid. Omeprazole dissolves in the now neutralized environment, thus avoiding acid degradation. This provides an eff ective formulation that enables immediate release of omeprazole while preserving its stability in the stomach. By controlling the release sequence, sodium bicarbonate followed by omeprazole achieves both rapid onset of action and high drug stability, addressing a key limitation of conventional omeprazole products.
Compositions and Methods for Controlling Cerumen Production;
S. L. Segebrecht; Free State Pharma Inc., US; U.S. Patent # 12,246,024; March 11, 2025.
Cerumen, or earwax, is a hydrophobic covering in the ear canal that protects the ear canal from moisture, infection, trauma, and foreign particles. Normally, jaw movements help old cerumen move out of the ear, where it flakes off naturally. However, excessive production, improper cleaning (e.g., using cotton swabs), or obstructions like hearing aids can prevent this natural process, leading to a buildup known as ceruminosis. This condition can cause discomfort, hearing loss, and infections. Current treatments for ceruminosis can result in complications such as infections, pain, dizziness, and ear damage. Therefore, there is a significant need for improved methods and formulations to manage or prevent excessive cerumen buildup. The present invention generally relates to compositions, formulations, methods, devices, and kits for modulating the production of cerumen, for the treatment and prevention of excessive or impacted cerumen.
Controlled-Release CNP Agonists with Low Initial NPR-B Activity;
K. Sprogee, H. Rau, F. Cleemann and U. Hersel; Ascendis Pharma, Denmark; U.S. Patent # 12,239,689; March 4, 2025.
Endothelial C-type natriuretic peptide (CNP) participates in the local regulation of vascular tone. Natriuretic peptide is a hormone molecule that plays a role in the regulation of the cardiovascular system. C-type natriuretic peptide (CNP) primarily interacts with NPR-B, which triggers an increase in the concentration of CNP in the cell. This process can lead to several physiological eff ects, such as tissue remodeling, reduction of pulmonary hypertension and fi brosis, and stimulation of long bone growth. In this patent, the inventors subcutaneously administered a controlled-release CNP agonist. In one embodiment, the CNP agonist was covalently and reversibly conjugated to a water-insoluble polymer.
Author Details
Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE; and Hemant N. Joshi, Ph.D., MBA*- Tara Innovations, LLC www.tarainnovations.com *hemantjoshi.tara@gmail.com
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 28, No. 4
May/June 2025Pages: 62-63
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