Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE; and Hemant N. Joshi, PhD, MBA* - Tara Innovations, LLC, www.tarainnovations.com, *[email protected]
Self-Regulating Osmotic Gastro-Retentive Drug Delivery System
N.H. Shah, D. Desai, W. Phuapradit, J. Vaghashiya, and K. Meghpara; Amneal Complex Products Research LLC, USA; U.S. Patent # 11,793,747; October 24, 2023.
The patent describes a self-regulating, osmotic, floating gastro-retentive drug delivery system. When consumed orally and upon contact with the gastric fluid, the device floats for about 30 minutes and expands in about 60 minutes to a size that prevents passage through the pyloric sphincter. It remains in the expanded state in the stomach, releasing the therapeutic concentration of the drug for a prolonged period of time. The tablet contains 1. A pull layer comprising of an active pharmaceutical agent and a gas generating agent, 2. A push layer, 3. A functional coat. The permeable coat is an elastic membrane comprising at least one orifice.
Treatment of Circadian Rhythm Disorders
M.M. Dressman, J. J. Feeney, L. W. Licamele, and M.H. Polymeropoulos; Vanda Pharmaceuticals, USA; U.S. Patent # 11,826,339; November 28, 2023.
Non-24-hour sleep-wake Disorder is an orphan indication affecting many people. The master body clock controls the timing of many aspects of physiology, behavior, and metabolism that show daily rhythms, including the sleep-wake cycles and certain hormones that exhibit circadian variation. Individuals with Non-24 have abnormal night sleep patterns which cause difficulty in staying awake during the day that leads to significant impairment. This invention relates to the use of a melatonin agonist in the treatment of free-running circadian rhythms in patients including blind patients and to methods of measuring circadian rhythm. Tasimelteon is a circadian regulator that binds to two high-affinity melatonin receptors. These receptors are responsible for synchronizing our sleep/wake cycle. By administering an effective amount of tasimelteon, patients are able to follow a daily sleep period.
Composition and Functional Food for Preventing Myopia
Tsubota Laboratory; K. Tsubota and T. Kurihara; U.S. Patent # 11,813,299; November 14, 2023.
In recent years, myopia is rapidly progressing in ages 7 to 12 years and in adults which increases the risk of ocular diseases. The patent discloses an ophthalmic composition effective for the prevention or treatment of myopia or ocular diseases. The problem is solved by an ophthalmic composition or functional food product containing at least one component selected from the group consisting of crocetin and its pharmaceutically acceptable salts and ginkgo leaf extract. The ophthalmic composition contains an antioxidant plant extract. These components have the function of regulating the expression of genes (EGR-1) involved in axial extension that can cause axial myopia and various ocular diseases.
Stable Bacterial Extracts as Pharmaceuticals
J. Bauer and C. Pasquali; Om Pharma SA, China; U.S. Patent # 11,801,271; October 31, 2023.
Bacterial extract lysates contain antigens derived from bacteria. Such extracts are shown to increase resistance to infections by these organisms. The patent discloses novel methods of preparing bacterial extracts, pharmaceutical formulations, novel routes of administration, and delivery devices. Gram-positive and Gram-negative bacteria are lysed by alkali, which is then neutralized with a suitable acid followed by purification by filtration. It is used to treat immunological disorders caused by these bacteria. The infections in the upper and lower respiratory tract or secondary infections can be treated.
Genetic Engineering of Macrophages for Immunotherapy
C. Crane, M.C. Jensen, K.W. Moyes, and N. Lieberman; Seattle Children’s Hospital, USA; U.S. Patent # 11,826,384; November 28, 2023.
Many solid tumors and the microenvironments that they create are highly immunosuppressive and tumor-promoting. This is one of the reasons why solid tumors, including glioblastoma (GBM) tumors, have not yet responded to immunotherapy approaches. The patent discloses methods of making a genetically modified immune cell for modifying a tumor microenvironment (TME). The patent also includes methods for modifying a tumor microenvironment (TME). A method of making a genetically modified immune cell comprises delivering a first vector to an immune cell, wherein the first vector comprises a VPX protein and a nucleic acid encoding a payload protein; and differentiating the immune cell concurrently with delivering a first vector to an immune cell. Genetically engineered macrophage-based immunotherapies will neutralize the microenvironment by supporting a pro-inflammatory innate response and enhancing tumor-directed immune activity by cytotoxic T and NK cells.
Silica Nanoparticle Composition for Delivering Bioactive Material or Protein Such as a Human Proteasome
C. Won: Lemonex Inc. Seoul, Korea; U.S. Patent # 11,786,469; October 17, 2023.
Conventional mesoporous silica nanoparticles contain pores that are a few nm in diameter in which large molecules fit. In the current invention, silica particles with higher pore diameters were used (20 nm to 100 nm). Functional groups are placed on the surface to which ligands can bind. The bioactive materials from 14.7 kDa to 2,000 kDa can be fitted into the pores. The ligands can be nickel, nickel-nitrilotriacetic acid, glutathione, dextrin, biotin, or streptavidin. The expanded silica porous nanoparticle is produced by mixing the silica precursor and a surfactant for 8 hours to form silica nanoparticles with a pore diameter of less than 5 nm and treating the particles with an expanding agent to expand pore diameter.
Blood Treatment Systems and Methods
D.A. van der Merwe, K. L. Grant, and M. J. Wilt; DEKA Products, USA; U.S. Patent # 11,779,689; October 10, 2023.
The present invention generally relates to hemodialysis and similar extracorporeal blood treatment systems. The systems include a variety of systems and methods that would make hemodialysis more efficient, easier, and/or more affordable. The system can include four fluid paths: blood; inner dialysate; outer dialysate and dialysate mixing. These four paths can be combined in a single cassette or are each in a respective cassette. Some systems include two flow paths, a blood flow path, and a dialysate flow path. The blood flow path through which untreated blood is drawn from a patient and is passed through a dialyzer through which treated blood is returned to the patient. A dialysate flow path through which dialysate flows from a dialysate supply through the dialyzer. The dialyzer is a type of filter that has a semi-permeable membrane. Therapy is achieved by the passing of waste molecules (e.g., urea, creatinine, etc.) and water from the blood into the dialysate solution. At the end of treatment, the dialysate solution is discarded.
Publication Detail
This article appeared in American Pharmaceutical Review:Vol. 27, No. 1Jan/FebPages: 54-55
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