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 March and April 2023.
Treatment of Inflammatory Skin Disorders;
C. J. Jackson and M. Xue, ZZ Biotech, Australia; U.S. Patent # 11,617,785; April 4, 2023.
Keratinocytes, endothelial cells, and fibroblasts are the major cell types in the skin and activated protein C (APC) acts on these major cellular components to ensure their appropriate functions. Keratinocytes represent the major cellular component of the epidermis and are responsible for maintaining structure and homeostasis of the epidermal barrier. The invention relates to skin disorders characterized by hyper-proliferation of keratinocytes, including but not limited to psoriasis and to treatment of same. The keratinocyte is the key driver of pathogenic inflammation in psoriasis. There is no cure for psoriasis. Topical medications, phototherapy, traditional systemic agents, and biologics only off er symptom management. There is a need for new approaches and therapies for treatment of, or for minimizing progression or symptoms of, disease or disorders characterized by keratinocyte hyperproliferation, such as psoriasis The invention relates to methods of using an effective amount of APC to treat an individual for a skin disorder characterized by the presence of hyperproliferative keratinocytes.
Non-Aqueous Liquid and Semi-Solid Formulations of Amorphous Calcium Carbonate;
Y. Blum, Y. Ben, and S. Hershkovitz; Amorphical Ltd., USA; U.S. Patent # 11,602,542; March 14, 2023.
Calcium is one of the most important minerals in our body. Calcium carbonate is used in many commercial formulations. Calcium carbonate has six polymorphs – three are anhydrous crystalline, two hydrated crystalline and one hydrated amorphous (ACC or amorphous calcium carbonate). ACC is the least stable polymorph. The patent describes a method of treating topical inflammation such as psoriasis, erythema, and scaling by applying liquid or semisolid non-aqueous compositions comprising stabilized synthetic ACC and a non-aqueous liquid carrier. ACC is stabilized in an amorphous form. The viscosity of the composition is above 40 centipoise at 25°C.
Hypotonic Microbicidal Formulations and Methods of Use;
K. Maisel, C.W. Hendrix, L. Ensign, E. Fuchs, R. Cone, and J. Hanes; Th e Johns Hopkins University, USA; U.S. Patent # 11,633,350; April 25, 2023.
There is an ongoing need for the prevention of HIV infection. Men who have sex with men (MSM) are at highest risk of HIV acquisition through unprotected receptive anal intercourse (URAI). Strong strategies are needed to prevent HIV infection associated with URAI. An object of the present invention is to provide formulations for rectally delivery of an effective amount of an antimicrobial, especially antiviral, agent to reduce the likelihood of HIV infection. These formulations need to be safe, comfortable, easy to store and use. Hypotonic microbicidal compositions include an antimicrobial, such as an antiviral compound, and a pharmaceutically acceptable carrier in a solution formulation. To prevent or decrease HIV infection, the microbiocidal is tenofovir, or a prodrug or derivative thereof. The formulations may include additional agents such as surfactants to enhance cleansing, buffers, or preservatives. Polymers may be included for osmolarity as well as for comfort. The formulations are preferably stored at room temperature and administered rectally at least one hour before intercourse.
Liquid Formulations Containing Picosulfate and Magnesium Citrate;
A. C.Y. Liang, N. G. Patel, and J. X. Li; Ferring B.V., Netherlands; U.S. Patent # 11,612,592; March 28, 2023.
Sodium picosulfate is a stimulant laxative. Magnesium citrate is an osmotic laxative. The patient needs to dissolve both in water before administration. However, they do not dissolve easily. There is a need to supply this composition in liquid form. However, the product produces precipitate during storage. This patent includes a precipitation inhibitor in the formulation. The formulation contains a carboxylic acid such as malonic acid, citric acid etc. In some embodiments, the formulation includes a soluble anionic polymer such as sodium carboxymethyl cellulose. In some, formulations they include an ammonium salt such as ammonium acetate. The pH of the formulation is kept between 4.0 and 6.5.
Compositions and Methods for Deep Dermal Drug Delivery;
D.W. Osborne, and B.N. Tofig; Arcutis Biotherapeutics, Inc., USA; U.S. Patent # 11,628,177; April 18, 2023.
Transdermal and topical delivery can be used to deliver drugs continuously into the systemic circulation. Transdermal and topical delivery also have advantages over intravenous administration. Transdermal delivery can be non-sterile, non-invasive and self-administered. The skin consists of four layers: (a) the stratum corneum, (b) viable epidermis, (c) dermis, and (d) subcutaneous tissues. The skin also contains appendages in the form of terminal hairs, the hair follicle, hair shaft, and sebaceous gland, which secretes a lubricating oil matter into the hair follicles, which comprise what is known as a pilosebaceous unit. The present invention relates to pharmaceutical compositions for the topical administration of a drug to the pilosebaceous unit and methods for administering the same. The inventors have made the discovery that a pharmaceutical composition comprising small particles of an active pharmaceutical ingredient can be delivered to the pilosebaceous unit resulting in deeper penetration into the dermis and improved efficacy. In preferred embodiments, the pharmaceutical composition comprises SHR0302 or spironolactone as an active pharmaceutical ingredient.
Use of Cannabinoids in the Treatment of Epilepsy;
G. Guy, S. Wright, and O. Devinsky; GW Research Ltd., Great Britain; U.S. Patent # 11,633,369; April 25, 2023.
Epilepsy occurs in approximately 1% of the population worldwide. Individuals who develop epilepsy during the first few years of life are often termed treatment-resistant. Childhood epilepsy is a relatively common neurological disorder in children and young adults. The main symptom of epilepsy is repeated seizures. Epileptic syndromes often present with many different types of seizure. One such childhood epilepsy syndrome is Lennox-Gastaut syndrome. It is a severe form of epilepsy. The present disclosure relates to the use of cannabidiol (CBD) as more effective in reducing atonic seizures in patients suffering with etiologies that include Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The first aspect of the present invention is - cannabidiol (CBD) for use in the treatment of atonic seizures. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs). The second aspect is a method of treating atonic seizures comprising administering cannabidiol (CBD) to a subject and the third aspect is the composition for use in the treatment of atonic seizures characterized by atonic seizures comprising cannabidiol (CBD), a solvent, a co-solvent, a sweetener, and a flavoring agent.
Smallpox Vaccine for Cancer Treatment;
A. Szalay and B. Minev; Calidi Biotherapeutics, Inc., USA; U.S. Patent # 11,607,450; March 21, 2023.
The patent describes a method of treating a solid tumor or a hematologic malignancy with a composition comprising a small-pox vaccine and a carrier cell (autologous stem cell), wherein the smallpox vaccine and the carrier cell were cultured together in-vitro. Cancer cells contain tumor-associated antigens, which are not present in normal cells. Vaccine treatment helps the immune system to learn to recognize and react to these antigens. Stem cells from various parts of body can be used in this patent. The smallpox vaccine is selected from Dryvax, Lister, EM63, Tian Tan, etc. strains. Other smallpox immunogenic compositions can also be used.
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