Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE and Hemant N. Joshi, Ph.D., MBA*- Tara Innovations, LLC, 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 February, 2023.
Oral Drug Dosage Forms Compromising a Fixed-Dose of an ADHD Non-Stimulant and an ADHD Stimulant; F. Deng, X. Li, S. Cheng, Y. Wang, and Q. Luo; Triastek, Inc., China; U.S. Patent # 11,571,391; February 7, 2023.
Attention deficit hyperactivity disorder (ADHD) is a common neurobiological disorder characterized by age-inappropriate levels of inattention, impulsivity, and hyperactivity. The specific cause of ADHD is unknown and there is no cure. ADHD stimulants are effective in reducing ADHD symptoms on a short-term basis. However, 15% of patients do not respond. ADHD non-stimulants, and some antidepressants, are used as a second-line therapy. They do not reduce ADHD symptoms quickly; and the therapeutic effect can last up to 24 hours. Thus, there is still a need for improved ADHD treatments. The present disclosure describes oral drug dosage forms that provide an individually controlled release of a fixed-dose of an ADHD non-stimulant and a fixed-dose of an ADHD stimulant. This patent describes an oral drug dosage form comprising: (a) an erodible non-stimulant material admixed with an ADHD non-stimulant that is released according to a desired non-stimulant release profile; and (b) an erodible stimulant material admixed with an ADHD stimulant, that is released according to an immediate release profile. The oral drug dosage forms of the present disclosure provide improved dosing accuracy, treatment efficacy, and patient compliance.
Compositions and Methods for Organ Specific Delivery of Nucleic Acids; Q. Cheng, T. Wei and D.J. Siegwart; The Board of Regents of the University of Texas System, USA; U.S. Patent # 11,590,085; February 28, 2023.
For therapeutic materials to be successfully delivered to targeted organs, several barriers need to be overcome. Viral and non-viral vectors are widely used to deliver genetic materials. Each has its respective advantages and shortcomings. CRISPR/ Cas (clustered regularly interspaced short palindromic repeat/ CRISPR-associated protein (Cas)) technologies can edit the genome in a precise, sequence dependent manner, resulting in a permanent change, but sometimes can cause rare and dangerous integration events. There remains a need to develop new lipid nanoparticles, which show preferential delivery to specific organs. The present patent provides compositions, which show preferential targeting or delivery of a nucleic acid composition to a particular organ. In some embodiments, the composition comprises a steroid or sterol, an ionizable cationic lipid, a phospholipid, a PEG lipid, and a permanently cationic lipid, which may be used to deliver a nucleic acid.
Hydrogel Systems for Skeletal Interfacial Tissue Regeneration Applied to Epiphyseal Growth Plate Repair; J.M. Taboas and J. Chen; University of Pittsburgh – of the Commonwealth System of Higher Education, USA; U.S. Patent # 11,583,613; February 21, 2023.
The epiphyseal plate is a hyaline cartilage plate in the metaphysis at each end of a long bone. It is the part of a long bone where new bone growth takes place. The patent describes a biomaterial, which is injected for the regeneration of the epiphyseal growth plate. It is a hydrogel precursor capable of carrying growth factors and mesenchymal stem cells. It contains chondrogenic and immunomodulatory cytokines and self-aggregating particles capable of prolonged and spatially controlled growth factor delivery. The hydrogel precursor comprises polyethylene glycol, gelatin and heparin. The hydrogel can be infused in an implantable scaffold.
Topical Semisolid Composition Containing an Antimicrobial Agent and Pirfenidone for the Treatment of Chronic Skin Disease; J.A.R.M Castro, and J.S.A. Borunda; Excalibur Pharmaceuticals, Inc., USA; U.S. Patent # 11,576,905; February 14, 2023.
Chronic ulceration is a loss of substance from any epithelial surface of the organism, with little or no tendency for spontaneous healing. Among the chronic ulcers, which are increasingly affecting the population, are diabetic foot ulcers, bedsores, as well as vascular, arterial and venous ulcers. The present invention describes a topical pharmaceutical gel composition for the treatment of chronic skin damage, caused by neuropathic ulcers, for the treatment of diabetic foot and vascular ulcers. The gel composition comprises a combination of Modified Diallyl Disulfide Oxide (M-DDO) and 5-methyl-1-phenyl-2(1H)-pyridone and one or more pharmaceutically acceptable excipients. This topical application is stable, biodegradable, and non-toxic, having a wide spectrum of action to treat chronic skin damage. Furthermore, the invention describes methods of treatment. The damaged area is cleaned and dried, the gel of the present invention is applied on the wound or ulcer, starting from the outer edge toward the center, gauze or bandage can be placed on the injury.
Modulation of Solubility, Stability, Absorption, Metabolism, and Pharmacokinetic Profile of Lipophilic Drugs by Sterols; O. Dhingra; Marius Pharmaceuticals, LLC, USA; U.S. Patent # 11,590,146; February 28, 2023.
The patent describes a formulation containing testosterone undecanoate (TU), sterol or sterol ester, and a non-sterol solubilizer. It contains a mixture of beta-sitosterol and stigmasterol. The non-sterol solubilizing agents could be propylene glycol monolaurate, polyoxyl 40 hydrogenated castor oil or alpha tocopherol. The new formulations showed an increase in the absorption of TU by up to threefold compared to commercial formulations. The lipid dispersion studies were used to select formulations that maximized the amount of TU in the aqueous phase.
Methods of Administering Gamma Hydroxybutyrate Formulations Aft er a High-Fat Meal; J. Grassot, D. Monteith, H. Guillard, C. Megret, and J.F. Dubuisson; Flamel Ireland Ltd., Ireland; U.S. Patent # 11,583,510; February 21, 2023.
Narcolepsy is a sleep disorder that makes people very drowsy during the day. Sometimes narcolepsy also causes a sudden loss of muscle tone, known as cataplexy. Other symptoms are hypnogogic hallucination (HH), sleep paralysis (SP), and disturbed nocturnal sleep (DNS). One of the major treatments for narcolepsy is sodium oxybate, a neuroactive agent. Sodium oxybate is also known as sodium 4-hydroxybutanoate, or gamma-hydroxybutyric acid sodium salt. Sodium oxybate is marketed commercially in the United States as Xyrem®. Xyrem is an immediate release solution. One major drawback for the product is the requirement to take the product twice each night. Several efforts have been made to provide a once[1]nightly modified release dosage form of sodium oxybate. The biggest drawback of these once-nightly formulations are the reduction in bioavailability that occurs when sodium oxybate is formulated in a modified release dosage form. The present patent provides methods of administering a once-nightly dosage of gamma-hydroxybutyrate after a high-fat meal. Patent also claims that modified release formulations of gamma-hydroxybutyrate have improved pharmacokinetic (PK) properties.
Bupropion as a Modulator of Drug Activity; H. Tabuteau; Antecip Bioventures II LLC, USA; U.S. Patent # 11,576,909; February 14, 2023.
Bupropion, sold as the branded product “Wellbutrin” is an atypical antidepressant used to treat major depressive disorder and to support smoking cessation. Dextromethorphan is a commonly used antitussive agent. It is rapidly metabolized to dextrophan affecting its bioavailability. The patent described a method of increasing dextromethorphan plasma levels by 20 to 800 times on day eight when co-administered with bupropion.
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