Pharmaceutical P.I.N. Points Patent Innovation News July/August 2021

By: Neelam Sharma, M.S. and Hemant N. Joshi, Ph.D., MBA*  Tara Innovations, LLC and *[email protected]

Herbo-Mineral Formulation for Prevention, Treatment and Management of Renal Disorders and Method of Preparation Th ereof; M.V. Shetty; Muniyal Ayurvedic Research Centre, India; US Patent # 10,973,851; April 13, 2021.

Ayurvedic medicines attain/maintain harmony in the system and work on improving the health of the body rather than treating symptoms. The patent covers compositions to treat renal disorders and mainly nephrons. The patent describes processes to prepare bhasmas, gugglu and shilajit. The compositions contain various herbs and several minerals (iron, iron rust, copper pyrite, gold) as actives and the disclosed formulation may act as at least one of anti-lipid, free radical scavenging, hypolipidemic and nephro-protective agent. The inventor conducted animal tox studies followed by a clinical trial.

Drug Delivery System with Electromagnetic Field Generator; S. Toy, M.K.L. Lee, D. Busby, M.D. Norton and J. Chen; Amgen, Inc., US; US Patent # 10,994,112; May 4, 2021.

Many drugs administered orally or parenterally, can also be administered through transdermal patches. This advanced patch includes arrays of micro-needles that slightly penetrate the patient’s skin to increase skin permeability and facilitate drug delivery. Present patent discloses a drug-delivery system with electromagnetic field generator. The drug delivery device includes a base having a first region with a drug delivery assembly associated therewith. The drug delivery device also includes an antenna disposed in the first region to radiate an electromagnetic field. The base defining a plane and the antenna disposed in the plane of the base, and an electromagnetic field generator selectively coupled to the antenna. The electromagnetic field causes migration of cells within the patient relative to the delivery device, and delivering a drug to the patient via the drug delivery assembly.

Use of a Statin Compound as Local Drug for Treating Obesity, Diabetes, Hypertension and Hyperlipemia; C. Song, N. Yang, Y. Cui, and Y. Yu; Peking University Th ird Hospital, China; US Patent # 10, 632,115; April 28, 2021.

Statins, also known as HMG-CoA reductase inhibitors, are a class of lipid-lowering medications that reduce illness and mortality in those who are at high risk of cardiovascular disease. They are the most commonly used cholesterol-lowering drugs. The invention discloses a use of a statin compound in the preparation of a local drug delivery system for improving lipid metabolism and treating obesity, hypertension, hyperlipidemia, fatty liver and hyperglycemia.

It was shown that a local single application of a statin compound can maintain a long time to promote the secretion of insulin, to increase insulin sensitivity of peripheral tissue, to lower blood glucose, and can be used in the treatment of diabetes. The drug is a non-storage form of local administration, preferably the drug is an injectable dosage form administered skeletally, preferably intraosseously. The dose can be as low as 2 to 10 mg.

Toxic Aldehyde Related Diseases and Treatment; T. Brady, S. Young, W.A. Kinney, an K.J. Mandell; Aldeyra Th erapeutics, Inc., US; US Patent # 11,007,157; May 18, 2021.

Metabolic and inflammatory processes in cells generate toxic aldehydes, such as malondialdehyde (MDA), 4-hydroxyl- 2-nonenal (4HNE), and 8-hydroxy-2-deoxyguanosine (8- OHdg). These aldehydes are highly reactive to proteins, carbohydrates, lipids and DNA, leading to chemically modified biological molecules, activation of inflammatory mediators. The inventors propose to treat various conditions associated with toxic aldehydes by the administration of small molecule therapeutics acting as a scavenger for aldehydes. The patent discloses administering to an eye of a subject who has undergone photorefractive keratectomy a therapeutically effective amount of a compound or its suitable salt along with a type of cyclodextrin.

Treatment of Dermatological Conditions; K. L. Rice, Jr., and J. Bunce-Stone; Hygia Bioscience, US; US Patent # 10,980,855; April 20, 2021.

The present patent discloses an oxygen-permeable topically-applied composition (OPTC) and methods of its use for the treatment of skin conditions and injuries. The invention relates to treatment of injured skin after laser ablation and/or scarring. Ablating the skin disrupts the skin barrier, exposing the skin to infectious agents from the outside world. The current treatment guideline to minimize this risk is the application of topical petroleum-based products to act as a barrier until the true skin barrier reforms. But lack of oxygen permeability, the thick consistency, and presence of potential irritants in many petrolatum products can lead to unwanted side effects. Side effects might include unpleasant healing time, contact dermatitis and can result in longer healing times. Oxygen-permeable topical formulations can comprise of petrolatum, avocado oil, and hydrogenated polyisobutene (Panalane). OPTC compositions can take the place of lost natural sebum and can replicate its barrier and moisture retention functions.

Compositions for Relieving Pain with Malkangni Oil and Cypriol Oil as Active Ingredients and Method of Topical Administration of the Same; Y.S. Kim; YSBio Co. Ltd, Seoul, Korea; US Patent # 11,007,241; May 18, 2021.

The patent reports the compositions for relieving pain with malkangni oil and cypriol oil as active ingredients and method of topical administration of the same. Malkangani or Jyotishmati (Celastrus Paniculatus) is oil extracted from seeds with cold press technology, to retain all nutrients and chemicals intact. Malkangani oil is considered to be one of the best aids in memory loss, dementia, alzheimer’s, neurological mental disorders. Cyperus scariosus or cypriol oil is also known as Nagarmotha in Hindi, belongs to the family of Cyperaceae. Cypriol oil is obtained by the steam distillation of dried roots. Synergistic pain-relieving eff ect was observed when using the combination of these active compared to individual active. Various formulations such as gel, cream, ointment or patch were prepared with these two actives.

Pulmonary Delivery of Progestogen; C. Lee and T.T. Du; Shenzhen Evergreen Therapeutics Co. Ltd.; Shenzhen, China; US Patent # 10,993,879; May 4, 2021.

The invention describes an inhalation formulation comprising a progesterone as a glucocorticoid sensitizer to restore corti-costeroid sensitivity. The method of preparation comprises of preparing a bulk powder formulation containing progesterone by milling in water to produce fine particulates, recovering the fine particulate by spray-drying; and blending the fine particulate with lactose monohydrate to generate the composition. Inventors claimed DV50 particle size of 278 μm after cycle 25 and 2.521 μm after cycle 40 and a span distribution value of 1.636 μm and 1.505 μm after 25 and 40 cycles, respectively. The milling is performed in the absence of a surfactant.

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