Pharmaceutical P.I.N. Points - Patent Innovation News - in May/June 2022

Neelam Sharma, MS, Lavanya Kundurthy, BE and Hemant N. Joshi, PhD, MBA - Tara Innovations, LLC - www.tarainovations.com and www.tara-marketing.com; [email protected]

Detecting Diverted Drugs

S. Curtiss, B. Smith, and M. Benoit; Bottomline Technologies, Inc., US; US Patent # 11,367,515; June 21, 2022.

In the US, billions of prescriptions are filled every year. One of the medicines frequently prescribed is the opioid hydrocodone. In the out-patient setting, there are checks and balances to prevent diversion of drugs. However, in the healthcare facility environment, vulnerability to diversion of drugs exists. This patent describes a system by which such diversions of drugs might be prevented. A method comprising receiving an application layer network packet for a pharmacy application on a network; reviewing said application layer network packet for contents related to controlled substances; identifying a network location of an origin of the application layer network packet; determining a physical location of the origin of the application layer network packet based on the network location; executing a rules engine on the contents of the application layer network packet and the physical location to determine, if the application layer network packet contains evidence of a possible controlled substance diversion has been claimed.

Oral Combination Drug Formulation Comprising a Non-Steroidal Anti-Inflammatory Drug and a Complementary Low Dose of Tranexamic Acid for the Treatment of Menstrual Pain Accompanied with Excessive Menstrual Blood Loss

A. Rubin; Arstat, Inc., US: US Patent # 11,351,132; June 7, 2022.

Painful menstrual periods (dysmenorrhea) associated with heavy menstrual bleeding, (menorrhagia) affect the lives of millions of women. Non-steroidal anti-inflammatory drugs (NSAIDs) are currently considered the most appropriate initial therapy for dysmenorrhea. Oral NSAIDs are also effective in reducing Menstrual Blood Loss (MBL). To ensure greater reduction of MBL, maximal doses need to be administered, which leads to undesirable side effects. Also, NSAIDS have shown inferior efficacy in reducing MBL as compared to oral tranexamic acid (TXA). Oral TXA also has potentially disturbing side effects. The present invention provides a method for effectively relieving menstrual pain and reducing excessive MBL without the undesirable side effects. The present patent discloses an oral combination drug formulation comprising a NSAID and TXA for the treatment of menstrual pain accompanied with excessive MBL. The critical aspect of the method of the present invention is the use of a complementary low dose of TXA ranging from 50 mg to 425 mg per oral combination drug formulation.

Hydrogen Sulfide Releasing olymer Compounds

M. Prinz, and M. Hoff er; Croma-Pharma Gesellschaft M.B.H., Austria; US Patent # 11,331,338; May 17, 2022.

Hydrogen sulfide is believed to be involved in angiogenesis and inflammation. As it is a gas, it is difficult to deliver hydrogen sulfide. Thus, compounds releasing hydrogen sulfide could be used as medicinal agents. The patent claims a hydrogen sulfide releasing polymer compound comprising of a polysaccharide backbone and at least two substructures. The substructures release hydrogen sulfide by thiol activation. The polysaccharide backbone could be sodium hyaluronate, alginic acid, or chitosan. The inventive system can be used to treat or prevent skin conditions, ocular diseases, or osteoarthritis. The substructures release essentially no hydrogen sulfide by hydrolysis, but release hydrogen sulfide only by thiol activation.

Methods and Compositions for the Treatment of Hair Loss

J.E. Wurst; Aneira Pharma, Inc., US; US Patent # 11,369,610; June 28, 2022.

Hair loss is a psychologically devastating condition causing significant psychological stress in both men and women. Negative effects on quality of life due to hair loss have been reported in both men and women. Hair growth is generally divided into four phases. The anagen phase is the phase of active hair growth. The catagen phase is a short transitional phase. The telogen phase is where hair growth ceases before the hair is eventually shed. A fourth stage is the exogen phase where the old hair is shed. The anagen phase begins with new hair growth where the new hair ejects the old hair. The present invention is directed to the use of certain prostaglandin analogues alone and in combination with other compounds such as cyclosporine, to prevent hair loss and/or grow hair on the scalp and other areas of the body. This invention is also directed to formulations and methods for treating certain hair loss disorders such as androgenetic alopecia and alopecia areata.

Periodontal Gel Composition and Method of Use

K. Mevorat Kaplan, D. Segal, D. Rosenbaum, I. Liapis, I. Makarovsky, and M. Stern; Prudentix Ltd., Israel; US Patent # 11,324,772; May 10, 2022.

Periodontal diseases are common ailment in the population especially at advanced age. Gingivitis is the mildest form of a periodontal disease that causes the gums to become red, swollen, and bleed easily. Oral systemic administration of antibiotics has been shown to be a useful method of controlling the subgingival flora. However, it has the potential dangers associated with the development of resistant strains and super-imposed infections, and discontinuation of therapy, is often associated with the return of the potential pathogens to the pockets. In fact, due to side effects such as to the digestive system, oral administration has had only limited short term use, and variable success in treating periodontal disease. The present invention relates to a periodontal liquid gel composition, a low viscosity at ambient temperature, which upon warming to body temperature solidifies into a viscous gel and then releases a therapeutic agent, e.g., an antibacterial agent, in a sustained release manner.

Method for Preventing and Treating Angiocardiopathy

J. Li; Talengen Int. Ltd., China; US Patent # 11,338,022; May 24, 2022.

A close link exists between Diabetes Mellitus (DM) and cardiovascular disease (CVD). At present, methods for treating cardiovascular complications of diabetes mellitus mainly include controlling blood glucose, lowering blood lipids, controlling blood pressure and the like. The present invention relates to the effect of plasminogen in the treatment and/or elimination of angiocardiopathy, especially angiocardiopathy caused by diabetes mellitus, Angiocardiopathy is the disease affecting both the heart and the blood vessels. Diabetic angiocardiopathy refers to a disease with the histological and functional changes of the cardiovascular system caused by diabetes mellitus. Plasminogen is the inactive precursor of the enzyme plasmin, present in blood. Plasmin degrades many blood plasma proteins, including fi brin clots. The dissolution of fi brin is the key to prevent pathological thrombosis. Plasminogen can significantly repair injury to the heart and blood vessel walls, promote the dissolution of microthrombus, and recover the response function of injured nerves, thereby opening a new therapeutic approach for diabetic complications such as diabetic angiocardiopathy.

Methods and Compositions for Modulating Gene Expression Using Oligo-Nucleotide Based Drugs Administered in vivo or in vitro

L.J. Smith; Larry J. Smith, NE, US; US Patent # 11,359,201; June 14, 2022.

Oligo-nucleotides are short DNA or RNA molecules. An Antisense Oligonucleotide (ASO) is a short strand of deoxyribonucleotide analogue that hybridizes with the complementary mRNA. ASO targets a specific gene to inhibit the expression of the target gene. Success in animal models face the following problems: poor choice of target gene, use of inappropriate animal models for predicting clinical response, use of oligo with suboptimum mechanisms for inhibiting the selected gene target, selection of suboptimum oligo sequences and use of interfering concomitant medications. The in-vitro two-step administration method includes administration of first oligo strand to said cell, incubation followed by an administration of a second oligo strand. The first and second oligo strands form an intracellular duplex, which is effective to catalyze degradation of target gene mRNA. In the in vivo condition, both oligo strands are targeted to the same cells.

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