Pharmaceutical P.I.N. Points: Patent Innovation News

Neelam Sharma, MS; LakshmiLavanya Kundurthy, BE; and Hemant N. Joshi, Ph.D., MBA* - Tara Innovations, LLC; www.tarainnovations.com and www.tara-marketing.com; *[email protected]

The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in September-October, 2022.

Device and Methods for Endoscopic Patch Delivery;

A. Smith, A. Pic, and H. Rebar; Boston Scientific  Scimed, Maple Grove, MN; U.S. Patent # 11,439,374; September 13, 2022.

Endoscopic procedures are performed for various reasons including – collection of tissue samples, mucosal resection and submucosal dissection. Such procedures can lead to wounds in need of repair. This patent claims a method of delivering a patch to the target site. It involves a patch in folded or crimped configuration, releasing the patch from the endoscope to the target site. The patch is at the distal end of the endoscope on a cap secured by a flexible band. Releasing the patch from the cap includes actuating a wire to cut the flexible band from the cap. The patch may comprise of a biomaterial such as chitosan or extracellular matrix and may be biocompatible and/or bioresorbable.

Ultrasonic Urinary Bladder Drug Delivery;

A. Geva and L. Kushkuley; Vensica Medical Ltd, Tel Aviv, Israel; U.S. Patent # 11478618; October 25, 2022.

The present invention relates to the fi eld of intravesical therapy. Intravesical treatment is a method that allows direct transfer of drugs into the urinary bladder. It may involve several challenges and limitations such as non-effective penetration of therapeutic drug delivery to the bladder. The current invention is a kit comprising a urinary catheter with a first and a second longitudinal lumen. The first longitudinal lumen is disposed inside a balloon and configured to inflate the balloon. The second longitudinal lumen is disposed outside the balloon and configured to deliver a therapeutic fluid into the urinary bladder. Activation of one ultrasonic transducer in the urinary bladder causes cavitation bubbles to form in the therapeutic fluid adjacent to an internal surface of the urinary bladder, and little or no cavitation bubbles are formed in acoustic coupling medium.

Adjustable Dosing Delivery and Multi-Sectioned Drug Compartment;

D. Shahaf and I. Shichor; Sipnose Ltd., Israel; U.S. Patent # 11,471,618; October 18, 2022.

The present invention pertains to a system for delivering aerosolized substance to a natural orifice of the body. In the pharmaceutical and therapeutic areas, although nasal delivery is an acceptable delivery route, providing an adjustable dose to a specific need is always an obstacle. It is therefore needed to provide a system which can be optimized for efficient delivery of a substance to a target site. This device is for delivering a predetermined volume of at least one substance within a body cavity of a subject. The device contains a) a capsule for containing the predetermined volume of substances; b) a delivery end, having at least one orifice of diameter D, c) a valve mechanically connectable to the capsule- an active configuration and an inactive configuration; d) a fluid tight chamber. The capsule further contains at least one mixing mechanism that mixes the substances and the pressurized gas after the valve is reconfigured to the active configuration.

Drug Delivery Composition Comprising a Self-Assembled Gelator;

J.M. Karp, P.K. Vemula, G. John, and G. Cruikshank; Th e Research Foundation of the City University of New York, NY and Th e Brigham and Women’s Hospital, Inc., Boston, MA; U.S. Patent # 11,471,515; October 4, 2022.

This invention relates to low-molecular-weight amphiphilic gelators. These gelators self-assemble into various nano- and micro-structures in a wide range of organic and aqueous solvents. The gelators also have the capability to deliver drugs. This patent discloses drug-delivery compositions, methods of making prodrugs, and methods of drug delivery using a self-assembled gelator. The backbone of the gelator can contain a drug or prodrug, such as acetaminophen or salicin. Additional drugs or agents can be encapsulated in the gelator. Enzymatic or hydrolytic cleavage can be used to release the drugs.

Oral Liquid Compositions Comprising Amlodipine Besylate and Methods of Using the Same;

N. R. Bhatt and A. Kapadia; ECI Pharma, Fort Lauderdale, FL; U.S. Patent # 11,452,690; September 27, 2022.

Amlodipine is mostly available as tablets. Just recently, amlodipine suspension and solutions were approved. So far, liquid dosage forms were prepared by compounding tablets into a suspension and such formulations result in a variety of issues. The current patent claims an oral liquid composition comprising: 0.1 to about 1.9 mg/mL amlodipine besylate, about 5 mg/mL to about 90 mg/mL cyclodextrin, about 0.5 mg/mL to about 4 mg/ mL paraben and water. The composition may further include a sweetener, a flavoring agent, a stabilizer, a coloring agent and a thickener. It claims that the volume of this oral liquid composition retains at least 90% of initial concentration of amlodipine after the formulation has been stored in a sealed container for six months at various storage conditions

Restoration of Tumor Suppression Using MRNA-Based Delivery System;

J. Shi, M.A. Islam, Y. Xu, O.C. Farokhzad, and B. Zetter; Th e Brigham and Women’s Hospital and Children’s Medical Center Corp., Boston, MA; U.S. Patent # 11,458,153; October 18, 2022.

Loss and/or mutation of tumor-suppressor genes is a dominant force in tumor development and clinical resistance to a variety of therapies. Restoring tumor-suppressor activity in cancer cells is highly challenging and requires the design of a functionally improved tumor suppressor with unique therapeutic modality. Recently, chemically modified mRNA has emerged as an intriguing alternative to DNA-based gene therapy. The delivery of mRNA presents several potential challenges. The object of the present invention is to provide nanotechnologies, which can be used to deliver a therapeutic tumor suppressor mRNA or combinations of different tumor suppressor mRNAs for cancer treatment. Patent discloses compositions and methods for treating cancer that include administering a therapeutically effective amount of a tumor suppressor mRNA complexed with a delivery vehicle.

Aqueous Wound Healing Formulation;

H. Spanjer, K.J. Rivera, S. Maida, J. Librizzi, and A. D’Ovidio; Advantice Health, NJ; U.S. Patent # 11,446,256; September 20, 2022.

Typical wound covers (textile or adhesive bandages) aim to stop bleeding, promote healing and prevent contamination to reduce risk of infection. These have many disadvantages, such as dust collection, contamination, difficult application to certain areas etc. Liquid bandages can eliminate some of these issues, but have issues of their own such as the presence of organic solvents, and toxic polymers, stinging sensation and harsh scent. This patent claims an aqueous formulation comprising a water-soluble polymeric material capable of adhering to skin and acting as a barrier to moisture but not to oxygen, and allowing water within the formulation to evaporate leaving a film covering the injured area.

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