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 2024.
Hydroxypropyl Beta Cyclodextrin Compositions and Methods;
B.N. Machielse, and A. Darling; Mandos LLC, US; U.S. Patent # 11,938,144; March 26, 2024.
Niemann-Pick disease is a rare group of conditions that affects the body’s ability to break down and use fats. It is caused by autosomal recessive mutations in either the NPC1 or NPC2 gene. 2-Hydroxypropyl-beta-cyclodextrins (HPBCD) have been shown to alleviate excess cholesterol storage in NPC cells. All existing parenteral grade compositions of HPBCDs contain complex mixtures of HPBCD species having different degrees of hydroxypropyl substitution and also contain impurities. The present patent discloses methods of manufacturing pharmaceutical compositions of HPBCD suitable for chronic intra-thecal or intra-cerebroventricular administration, having low levels of impurities, and having specific and structurally defined composition.
Oral Administration Formulation of Blueberry Extract as a Co-Adjuvant for Preserving the Health of Human Precorneal Film;
A.S Garcia, J. C. A. Vallejo, J. A. Garcia, A. G. De La Rosa; Centro De Retina Medica Y Quirurgica, S.C., Mexico; U.S. Patent # 11,937,625; March 26, 2024.
The present invention relates to the field of ophthalmology. The patent discloses a nutraceutical formulation, which has been developed as a co-adjuvant for preserving the health of the precorneal film and of the eye surface. The formulation contains an extract of natural origin (Vaccinium myrtillus L), fish oil (omega-3 and omega-6), recombinant human lactoferrin, vitamin A, and vitamin E, for human oral consumption. The formulation helps to improve tear quality as the compounds used have anti-microbial and anti-inflammatory effects.
All-in-One Fixed-Dose Combination for Treating Helicobacter Pylori Infection;
R. Fathi, G. Raday, G. Goldberg, P. Gosselin; RedHill Biopharma Ltd, Israel; U.S. Patent # 11,931,463; March 19, 2024.
H. Pylori is one of the causes for suffering from gastric acidity. It is difficult to eradicate these bacteria. The oral dosage form invented contains two antibiotics and a delayed release of a proton pump inhibitor. Less than 10% of the proton pump inhibitor gets released in the stomach and more than 75% is released in 45 minutes at pH 6.8. The two antibiotics could be amoxicillin and ansamycin or rifabutin.
Iron Chelators in Tumor Therapy;
F.Hoppe-Seyler, J. A. Braun, and K. Hoppe-Seyler; Deutsches Krebsforschungszentrum Stiftung des offentlichen Rechts, Heidelberg, DE; U.S. Patent # 11,931,349; March 19, 2024.
Cancer cells tend to exhibit higher levels of iron compared to normal cells. Iron is assumed to initiate tumor cell formation and support growth. Intracellular iron induces the production of reactive oxygen and in turn, facilitates the initiation of tumors. Ciclopirox is a topical antifungal agent. It has been shown to chelate intracellular iron, which could be the mechanism of its antitumor activity. This method is useful mainly in hypoxic cancer cells where the oxygen saturation level is less than 5% or at most about 1%.
Pharmaceutical Compositions for Prevention and/or Treatment of Infections and Antibacterial Induced Dysfunctions;
A. Typas, A. R. G. Brochado, and S. Gottig; European Molecular Biology Lab, Heidelberg, DE; U.S. Patent # 11,926,862; March 12, 2024.
While treating bacterial infections, the antibacterial agent must possess high species-specificity to inhibit the growth of a small number of bacterial species, and also, to be effective against multi-drug-resistant bacterial species. In this invention, a non-antibiotic drug, vanillin, seemed to have a synergistic effect with an antibiotic, spectinomycin against Gram-negative bacteria. The formulations were shown to have less adverse effects on the gut microbiome.
Methods for Treating Alzheimer’s Disease;
S. H. Hrynkow, J. L. Tate, and N. S. Fine, Cyclo Therapeutics, Inc., US; U.S. Patent # 11,925,659; March 12, 2024.
There is a need to develop new treatments for Alzheimer’s Disease (AD) that target the underlying mechanisms and lead to a halt or reverse the progression of the disease process. The invention provides methods for the prevention or treatment of AD in humans by administering an effective amount of HPBCD composition. The HPBCD composition in a dose amount of 500 mg/kg to 3000 mg/ kg by parenteral or 100 mg to 750 mg by the central nervous system is administered at intervals selected to ensure patient safety. The effective amount of HPBCD is administered to AD patients weekly, twice a month, or once a month intravenously, subcutaneously, by intrathecal or intra-cerebroventricular administration.
Orally Ingestible Delivery System;
D. S. Soane, A. H. Greene, and A. V. Soane, Soane Pharma LLC, US; U.S. Patent # 11,918,694; March 5, 2024.
The bioavailability advantages of parenteral administration are important in intensive care and emergencies. This invention relates to orally ingestible delivery systems for drugs, biologics, and other therapeutic agents within the intestine of a mammal. The invention is a method of delivering an effective amount of a therapeutic agent to a patient through an orally ingestible delivery system. The orally ingestible delivery system is exposed to stomach acid that interacts with it to form the dispersible acid barrier, and the orally ingestible delivery system then passes into the intestine of the patient. The dispersible acid barrier is dispersed by interaction with intestinal fluids, and intestinal fluids penetrate the acid-resistant shell following the dispersal of the dispersible acid barrier to release the therapeutic agent from the therapeutic agent compartment, thereby delivering the effective amount of the therapeutic agent to the patient.
Author Details
Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE; and Hemant N. Joshi, Ph.D., MBA* - Tara Innovations, LLC www.tarainnovations.com *hemantjoshi@tarainnovations.com
Publication Details
This article appeared in American Pharmaceutical Review: Vol. 27, No. 4 May/June 2024Pages: 94-95
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