Neelam Sharma, MS, Lavanya Kundurthy, BE and Hemant N. Joshi, Ph.D., MBA*- Tara Innovations, LLC; www.tarainovations.com and 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 July-August, 2022.
Shape Changing Drug Delivery Devices and Methods;
P. Jarrett, MJ. McGrath, T.S. Jarrett, R. El-Hayek, A.C. Vanslette, C.A. Rosales, C.D. Blizzard, and A.S. Sawhney; Incept LLC, US; U.S. Patent # 11,413,250; August 16, 2022.
Drug delivery is the art of making and using formulations, technologies, and systems for transporting a therapeutic agent in the body as needed to safely achieve its desired therapeutic effect. There is an ongoing need to find new and better ways to deliver therapeutic agents. Placement and successful use of a drug delivery device in the eye is challenging because the interior of the eye is very sensitive to foreign bodies and has a limited volume. Depots that have a slim profile to facilitate placement and a different, compact space-saving shape after placement, are described herein for delivery of therapeutic agents. An embodiment of the vehicle component of drug depots is a highly biocompatible material shaped as a thin rod ex vivo but transforms into a curved, coiled, or even helical, hydrogel in vivo. The hydrogel matrix and the TKI or other agent can be chosen to provide conditions suitable for a controlled drug delivery, even over many months.
Carbon-Monoxide-Releasing Molecules and Therapeutic Applications Thereof;
B. Wang, X. Ji, and Z. Pan; Georgia State University Research Foundation, US; U.S. Patent # 11,420,994; August 23, 2022.
This invention is in the field of molecules that generate carbon monoxide (CO), particularly in vivo or ex vivo. CO is well-known as a lethal, toxic gas. CO has been found to play a key beneficial role in various inflammatory and cardiovascular diseases, Inflammatory Bowel Disease (IBD), psoriasis, mid-ear infection-induced inflammation, rheumatoid arthritis and osteoarthritis of inflammatory disorders and many more. Besides anti inflammatory effects, evidence suggests that CO plays a beneficial role in treating cardiovascular disease. A key issue in the use of CO as a therapeutic agent is the safe delivery of low doses to the desired site of action. Currently available CO delivery systems are metal-containing CORMs that can release CO, especially upon exposure to light and/or water. For medicinal applications, for systemic administration, overcoming the toxicity of residual metal ions is a key issue. In this invention the molecules can be synthesized prior to administration or formed in vivo. In those embodiments where the molecules are formed in vivo, reactants are administered under physiological conditions and undergo a cycloaddition reaction to form a product which releases carbon monoxide. For example, in some embodiments, the cycloaddition reaction and/or release of carbon monoxide occur at a temperature of about 37°C and pH of about 7.4.
Antiviral Compositions and Methods;
M.D. Powell, and E.V.A. Gbodossou; Morehouse School of Medicine, US; U.S. Patent # 11,413,320; August 16, 2022.
The present application relates to a method for preventing or reducing symptoms of HIV infection. The conventional approach to HIV treatment involves the use of combinations of anti-retrovirals known as Highly Active Anti-Retroviral Therapy (HAART). Withdrawal of HAART results in rebound of viral loads and disease progression. HAART is expensive to maintain and is beyond the means of many individuals in third-world countries. There is a need for a treatment that can be administered short-term and induce a long suppression of viral loads. Present patent discloses the antiviral compositions comprising a plant MOMO30 protein for treatment and prevention of viral infections. The MOMO30 protein is derived from a plant species of the Momordica genus, preferred species is Momordica balsamina. The MOMO30 protein has a size of about 30 kDa, and is capable of binding to HIV gp120. The protein is stable to both heat and protease treatment. It is also non-toxic to cells at therapeutic levels. MOM030 can block the interaction of viral glycoproteins to cellular receptors resulting in inactivation of an enveloped virus, such as HIV-1.
Enhanced Expansion of Tumor-Infiltrating Lymphocytes for Adoptive Cell Therapy;
A.A. Sarnaik, J.S. Weber, S. Pilon-Th omas, L.G. Radvanyi, J.A. Chacon, J.J. Mule, and M.S. Hall; H. Lee Moffi tt Cancer Center and Research Institute, US; U.S. Patent # 11,401,506; August 2, 2022.
The present patent discloses a method for ex vivo expanding tumor infiltrating lymphocytes for use in Adoptive Cell Therapy (ACT). ACT, also known as cellular immunotherapy, is a form of treatment that uses the cells of our immune system, such as T cells to eliminate cancer. The immune cells are usually isolated from a patient, expanded and, in some cases, engineered to enhance their natural abilities to eliminate cancer. Tumor-Infiltrating Lymphocytes (TILs) are an experimental cell therapy being developed for treating solid tumors. As cancers grow, lymphocytes recognize these cells as abnormal and penetrate into the tumor. TILs come directly from the tumor; they already recognize many targets on the cancer cells. This makes them a very attractive therapy. The method involves culturing tumor fragments from the subject in a culture medium containing interleukin -2 (IL-2) and a 41BB agonist in an amount effective to expand tumor-infiltrating lymphocytes with enriched tumor-reactivity and specificity. The patient also gets some immune-modulating therapies, such as IL-2, to stimulate the TIL activity.
Therapeutic Combination for Treatment of Cerebellar Ataxia;
V. Shakkottai, and D. Bushart; Th e Regents of the University of Michigan, US; U.S. Patent # 11,382,897; July 12, 2022.
Degenerative cerebellar ataxias are a group of disorders with progressive changes in balance, speech, and gait. This is caused by neuronal loss, and abnormal neurons. The patent proposed a combination of effective amounts of baclofen and chlorzoxazone. Baclofen is used to treat muscle spasticity. Chlorzoxazone is a muscle relaxant used to treat muscle spasm. The cerebellum is the region of the brain responsible for controlling stance, gait and balance. Ataxia describes a lack of muscle control or coordination of voluntary movements, such as walking or picking up objects. The optimal dose of each drug in this combination therapy is very difficult to obtain. The treatment involves close monitoring of effectiveness and side effects, and the drugs might be given sequentially.
Pharmaceutical and Food Compositions for Inducing Satiation and Prolonging Satiety in Subjects in Need Thereof;
S. Fetissov, P. Dechelotte, J. Breton, G. Lambert, N. Tennoune and R. Legrand; INSERM, France; U.S. Patent # 11,389,489; July 19, 2022.
Satiety means reaching a homeostatic phase wherein the cravings for food are satisfied or minimized. As a result, further eating is inhibited. The effect of food on satiation can be determined by scoring the time point of meal termination. ClpB is also known as heat shock protein F84.1, which is a member of the Hsp100/ClpB family of hexameric AAA+-ATPases. ClpB has been described as an essential factor for acquired thermos tolerance and for the virulence and infectivity of several Gram[1]negative and Gram-positive pathogenic bacteria. In the patent, the ClpB protein is administered as a gastro-resistant and sustained-release pharmaceutical composition along with food. The administered food contains dietary fibers, prebiotics etc.
Magnesium-Containing Oxytocin Formulations and Methods of Use;
D.C. Yeomans, D. Carson, and R. Thirucote; Tonix Pharma Holding Corp, US; U.S. Patent # 11,389,473; July 19, 2022.
Oxytocin is a peptide hormone and neuropeptide normally produced in the hypothalamus and released by the posterior pituitary. It plays a role in social bonding, reproduction, childbirth, and the period after childbirth. Oxytocin has been shown to reduce pain, in particular chronic pain, associated with the trigeminal nerve, such as trigeminal neuralgia and migraine headache. The latency to analgesia caused by nasal oxytocin is around two hours, with the maximal analgesic effect not occurring until about four hours after dosing. Magnesium containing oxytocin peptide formulations described herein provide faster, stronger and longer lasting analgesic effect compared to oxytocin alone. Magnesium has been reported to act as a blocker of the N-methyl-D-aspartate receptor and can play a role in reducing pain hypersensitivity. Magnesium chloride or citrate salts were used in the formulations.
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