Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE and Hemant N. Joshi, PhD, MBA* - Tara Innovations, LLC. www.tarainovations.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 November-December, 2022.
Dose Control System for Injectable-Drug Delivery Devices and Associated Methods of Use; Marcoz, A. et al., Biocorp Production S.A., Issoire, FR; U.S. Patent # 11,524,120; December 13, 2022.
Autoinjectors or self-injecting drug delivery systems have become common in recent years. However, these devices can be subject to abuse, misuse or a user error. Also, in the current devices, one can change the injected amount by mechanical alterations. In the present patent, there is a dose control system, a displacement detection feature and an integrated control unit. The dose control system contains a three-dimensional magnetic field. A magnetic detection device detects changes in the magnetic field. The displacement detection measures a relative displacement or relative movement of the drug delivery device. The integrated control unit is connected to the magnetic detection feature and to the displacement detection device.
Dry Powder Composition Comprising Long-Chain RNA; Eber F. J. et al., CureVac AG, Tubingen, DE; U.S. Patent # 11,534,405; December 27, 2022.
Use of nucleic acids for therapeutics and diagnostics have increased in the last decade. Other than DNA, application of RNA also represents a favored tool in modern molecular medicine. RNA exhibits some superior properties over DNA cell transfection. However, the main disadvantage of the use of RNA is its instability. RNA is susceptible to hydrolysis. The only method for stabilization of long chain RNA, comprises lyophilization or freeze drying of the RNA. A cake-like product is obtained by lyophilization which cannot be divided into distinct aliquots. Therefore, if a powder-like product is needed, an additional step of granulation is needed, which is costly and time consuming. The present invention describes a method to prepare dry powder composition comprising a long chain RNA molecule by spray freeze drying. The patent also proposes the use of such a composition in the preparation of pharmaceutical compositions and vaccines.
Methods and Compositions for Treating Diabetes and Diabetic Complications; Gruber, L.S.; Siwa Corporation, Chicago, IL; U.S. Patent # 11,518,801; December 6, 2022.
Diabetes is a significant public health problem. Diabetic complications comprise many diseases or disorders such as stroke, glaucoma, kidney disease, high blood pressure, and high blood LDL cholesterol. The present invention uses enhanced clearance of cells expressing AGE-modified cells to treat the onset of diabetes and diabetic complications by removing or killing senescent cells. This may be accomplished by administering anti-AGE antibodies to a subject. A composition for treating the diabetic complications comprise a first anti-AGE antibody, a second anti-AGE antibody and a pharmaceutically acceptable carrier. The first anti-AGE antibody is different from the second anti-AGE antibody. A method of treating or preventing the onset of diabetes or diabetic complications comprises immunizing a subject in need thereof against AGE-modified proteins or peptides of a cell.
Method for Making Reduction Sensitive Nano Micelles; Zhang, L., Ni, C., Sang, X. and Shi, G.; Jiangnan University, Wuxi, China; U.S. Patent # 11,510,874; November 29, 2022.
Reduction-sensitive materials, such as polymers, proteins, liposomes, microcapsules, nanoparticles, and nano micelles, have emerged as a fascinating class of biomedical materials. The current patent describes a method to make reductionsensitive nano micelles. It uses taurine, and essential amino acids, lipoic acid and glutathione. Taurine has a strong ionizable sulfonic acid group. Previously reported nano micelles physically adsorb drugs resulting in low drug loading, drug leak and low bioavailability. The current patent overcomes these drawbacks. It describes loading of doxorubicin to the reduction-sensitive nano micelles and the solution is then freeze dried.
Trigger Mechanism for an Inhaler; Howgill, S.J.; Kindeva Drug Delivery L.P.; St. Paul, MN; U.S. Patent # 11,497,866; November 15, 2022.
Existing devices like pressurized metered dose inhalers (pMDI) are used for asthma and chronic obstructive pulmonary disease. These devices have one or more disadvantages, for example complexity, performance issues or excessive size. The present application relates to a breath-responsive metered dose inhaler. It has a trigger mechanism for triggering delivery of a medicament and a trigger mechanism chassis for locating the trigger mechanism within the inhaler. The trigger mechanism includes a breath-responsive member moveable upon inhalation of the user from a primed position to a triggered position in which the medicament is delivered to the user. A spiral spring is used which is flexible along its longitudinal axis, wherein the spring is configured to bias the breath-responsive member from its triggered position to its primed position by flexure along its longitudinal axis.
Oral Sweetener Compositions and Methods; Chen. Y. et al.; The Coca-Cola Company, Atlanta, GA; U.S. Patent # 11,49,106; November 8, 2022.
Sugar has traditionally been used to sweeten edible products. But sugar is caloric. Both synthetic and natural high-intensity sweeteners are known and commonly used to sweeten edible products marketed as no or low-calorie oral dosage forms. The present invention permits a reduction in total carbohydrate intake while providing equivalent or superior sweetness intensity. The invention relates generally to single-use, oral dosage forms (e.g., fast dissolving strips), as well as methods of using such oral dosage forms to sweeten edible compositions. The invention also describes the methods for manufacturing such oral dosage forms. The dosage form is comprised of miraculin and dihydrochalcone derivative, wherein the oral dosage form fully dissolves within 60 seconds. The monomer form of miraculin is flavorless at all pH as well as at high concentration. The dimer form only elicits its taste modifying activity at acidic pH. Miraculin has an effect of modifying the perceived quality and intensity of tastes. Dihydrochalcone compound is an artificial sweetener derived from citrus.
Drug-Coated Balloon Catheters for Body Lumens; Wang, L., Barnett, P., and Hendrickson, D.; Urotronic, Inc., Plymouth, MN; U.S. Patent # 11,504,450; November 22, 2022.
Anastomotic stricture (stenosis) happens when scar tissue causes a passageway to narrow. It can occur in intestine, urethra etc. The current patent claims a method of treatment of an anastomotic stricture including – 1. Flushing with a media, 2. Inserting a balloon catheter into the required site (balloon has a coating layer comprising an initial drug load), 3. Exposing the balloon to the flushing media to soak the coating layer, 4. Inflating the balloon at the target site to contact the coating layer with the walls of the body lumen and keep in contact for a predetermined inflation period. Various kinds of drugs can be delivered exactly at the site of action.
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