Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE; and Hemant N. Joshi, Ph.D.- MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in June and July 2025.
Nasal Powder Formulation for Treatment of Hypoglycemia
S. Mantripragada, C.A. Piche, and J.J. F. Van Betsbrugge; Amphastar Pharmaceuticals, USA; U.S. Patent # 12,370,241; July 29, 2025.
People with diabetes who use insulin are at risk of severe hypoglycemia. This can lead to confusion, unconsciousness, seizures, or even death if not treated quickly. Traditionally, glucagon injections are required, but they require reconstitution and are hard to administer during emergencies. The present patent provides a dry powder formulation for intranasal administration. The powder formulation comprises three components:lucagon (Glucagon analog), phospholipid surfactant, and cyclodextrin. These are combined such that at least a portion of the powder exists in a structural “mesophase” detectable by X-ray powder diffraction (XRPD) as a mesopeak at low diffraction angles. The patent also covers the devices and methods for using the powder formulation.
Deformable Nano-Scale Vehicles (DNVs) for Trans-Blood Brain Barrier, Transmucosal, and Transdermal Drug Delivery;
V. John, I. Nishimura, N. Subbiah, J. Campagna, P.R. Spilman, and M.R. Alam; The Regents of the University of California, USA; U.S. Patent # 12,364,661; July 22, 2025.
Deformable nanoscale vehicles (DNVs) have been shown to cross the skin and blood-brain barrier to deliver drugs to the brain. The basic dosage form is liposomes consisting of one of two phospholipids, N-(2,3-Dioleoyloxy-1-propyl) trimethyl ammonium (DOTAP), cholesterol, a non-ionic detergent, and a therapeutic agent. The system can deform to allow passage through the pores of the blood-brain barrier. The drug delivery vehicle is neutrally charged. These are deformable and elastic particles. The organic components are dissolved in isopropyl alcohol and mixed with the aqueous phase in a microfluidic reactor. The inventors studied the effect of the percentage of various components on the stability of DNVs
Pharmaceutical Composition for Reducing Local Fat and Uses Thereof;
F. Ling; Caliway Biopharmaceuticals, Taiwan; U.S. Patent # 12,357,588; July 15, 2025.
The invention provides a pharmaceutical composition for reducing localized fat without surgery. It uses curcumin encapsulated in micelles, which are nano-sized structures formed by surfactants. This innovative formulation promotes apoptosis of adipocytes at targeted sites such as the waist, arms, chin, and thighs, providing a safer alternative to liposuction. The composition may also include additional lipophilic or hydrophilic bioactive agents, antioxidants, local anesthetics, cosolvents, or oil-phase excipients to enhance efficacy, stability, and patient comfort. Administered via subcutaneous injection, intravenous infusion, or transdermal systems (e.g., creams, patches). It offers high bioavailability, sustained release, and minimal side effects. This meets the growing need for a safe and effective way to reduce fat in specific areas. It also offers faster recovery and fewer side effects.
Bivalent Dengue/Hepatitis B Vaccines
D. H. Libraty; University of Massachusetts, USA; U.S. Patent # 12,350,331; July 8, 2025.
Dengue is a widespread arthropod-borne viral disease that threatens nearly half of the global population. The four dengue virus serotypes (DENV 1–4), members of the Flaviviridae family, complicate vaccine development. The present invention addresses this challenge by providing a novel bivalent peptide vaccine. It is designed to induce high, long-lasting levels of broadly neutralizing antibodies against DENV 1–4, while minimizing enhancing antibody activity. The vaccine consists of two dengue virus epitopes separated by a glycine-rich spacer. It may include hepatitis B virus (HBV) epitopes for additional immunogenicity. These epitopes are chemically linked using heterobifunctional crosslinkers, and the resulting construct is suitable for neonatal, adolescent, or adult immunization. This approach offers a broad-spectrum, low-risk immunization strategy against dengue, with potential cross-protection against HBV.
Method and Apparatus for the Fail-Safe Termination of In Vivo Drug Delivery from an Implantable Drug Delivery System;
M. Farina, R.L. Hood, and A. Grattoni; The Methodist Hospital, USA; U.S. Patent # 12,337,141; June 24, 2025.
Implantable drug delivery systems are advantageous but suffer from a drawback. In the event the drug delivery has to be terminated due to several reasons, surgical explantation is the only reliable option. The invention provides an implantable system, which can be activated from outside, be fail-safe, and allow termination of drug delivery in the case of an emergency. The device contains a barrier element positioned across the fluid pathway. The material is hydrophobic in nature, having a solid state at physiological conditions. When the fluid flow has to be terminated, the temperature of the barrier element is increased, allowing it to flow, which closes the opening of the fluid flow.
Antimicrobial Tailored Chitosan;
O. Jordan, V. Patrulea, G. Borchard, B.H. Gan, and J. L. Reymond; Université deGenèvee; Switzerland; U.S. Patent # 12,329,822; June 17, 2025.
The invention describes coupling an antimicrobial peptide (AMP) with a chitosan derivative for use in the treatment of microbial infections, such as wound healing. The invention used this concept to develop nanoparticle, gel, or lyophilized formulations. The following chitosan derivatives were used: O-carboxymethyl chitosan, O-carboxymethyl-N, N, N-trimethyl chitosan, N-(4-N, N-dimethylamino cinnamyl) chitosan, and methylated N-(4-pyridylmethyl) chitosan chloride. There is a spacer consisting of a C1-C12 aliphatic carbon chain terminated with an amino group at both ends. It also contains a sulfo-crosslinker and a cysteine. The bioconjugate preserves its antimicrobial activity for at least one week after administration.
Combination of Antibody-Drug Conjugate and Immune Checkpoint Inhibitor;
T. Iwata, C. Ishii, T. Wada, S. Ishida, and Y. Kamai; Daiichi Sankyo Company, Japan; U. S. Patent # 12,319,736; June 3, 2025.
This patent relates to therapeutic combinations and compositions involving an antibody drug conjugate (ADC) used together with an immune checkpoint inhibitor (ICI), where the ADC is designed not only to kill tumor cells but also to activate antitumor immunity. Some cancers can protect themselves from attack by stimulating immune checkpoint targets. The ADC is defi ned as one in which a specific drug linker moiety is conjugated to the antibody via a thioether bond. Immune checkpoint inhibitors are agents that inhibit the immune suppression system and activate antitumor immunity. The immune checkpoint inhibitors mentioned include anti-PD1, aanti-PD-L1anti-CTLA-4 antibodies. The current patent demonstrates a synergy effect combining an ADC that is designed not just for tumor cell killing but also immune activation, together with immune checkpoint inhibitors, to achieve enhanced antitumor efficacy over what either agent alone can do.
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