The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the U.S. Patent Office in September-October 2020.
Palatal Drug Delivery;
J.P. Allen; Oregon, USA, U.S. Patent # 10,806,675; October 20, 2020.
There are different methods of delivering drugs to patients. Each method has its own limitations. Oral drug delivery is by far the most preferred route of drug administration. For certain classes of drugs oral administration is impossible or less than ideal. The oral mucosa, due to its unique structural and physiological properties, makes it a very attractive and feasible site for systemic drug delivery. The present patent discloses devices, systems and methods for delivering a precise, controlled drug delivery to a user via the user’s palatal mucosa. The drug delivery devices include a body shaped to conform to a user’s palate, and cavities in a palate facing surface of the body that are configured to receive a drug in liquid form. The drug delivery devices can be easily used by a patient or other user and reduce the likelihood of (or in some cases eliminate) dilution of the drug by saliva and fluids and inadvertent swallowing or unplanned uptake of the drug by the patient.
Shape Changing Drug Delivery Devices and Methods;
P. Jarrett, M.J. McGrath, T.S. Jarrett, R. El-Hayek, A.C. Vanslette, C.A. Rosales, C.D. Blizzard, and A.S. Sawhney; Incept LLC, Lexington, MA; U.S. Patent # 10,786,462, September 29, 2020.
Drug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. The present patent is related to drug delivery using bio-affecting drugs particularly with shape changing drug delivery devices. Materials and methods of drug delivery described in the patent are not only useful in the eye but also in the body. Patent describes the use of hydrogel depots for delivery of a therapeutic agent that change from an elongated state ex vivo to a coil in vivo where the agent is released.
Controllably Degradable Compositions and Methods;
N. Artzi, E.R. Edelman, R. Kelmansky, M.M. Cervantes, and Y. Zhang; MIT, Cambridge, MA; U.S. Patent # 10,780,195; September 22, 2020.
The patent discloses materials, methods, and kits for making and using the materials and drug delivery devices for treating, adhering, or sealing biological tissues. Biological tissues can be natural or artificially generated. The materials and adhesives described are capable of reversible polymerization, reversible dimerization or combination. Materials are not limited to biocompatible materials and adhesives only. Method includes combining a first solution that includes an oligomer/polymer component and a second solution that includes a dendrimer component, and at least one of the two components includes at least one substituent that is capable of photo-reversible dimerization. The substituent that is capable of photo-reversible dimerization can be bonded to each other by the application of light, such as UV light. Upon the application of different wavelength of light, the dimer can be cleaved, and polymerization can be reversed. The ability to remove the adhesives or materials rapidly can reduce additional injury associated with the removal of the adhesives or materials for additional medical treatment.
Measurement of Glucose in an Insulin Delivery Catheter by Minimizing the Adverse Effects of Insulin Preservatives;
W.K. Ward, R.S. Cargill, G. Heinrich, S. Benware, M. Vreeke, J.D. Kowalski, and T. Seidl; Pacifi c Diabetes Technologies, Inc.; U.S. Patent # 10, 780,222; September 22, 2020.
Many diabetic patients use insulin pumps and continuous glucose monitoring (CGM). These people need to carry many devices resulting in a “device burden”. For this reason, there is an unmet need to integrate a CGM and insulin pump cannula into a single device. Phenol or m-cresol are used in insulin formulations as preservatives. These preservatives in the vicinity of glucose sensing electrode create a false current, generating erroneous glucose levels. The patent proposes electrodes with osmium-based redox mediators that operate at a low bias potential, electrons can be transferred from glucose to an indicating electrode without interference from the insulin preservatives.
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Pharmaceutical Compositions and Methods for Countering Chemotherapy Induced Cardiotoxicity;
C.G. Armstrong, K.J. Kim, L.M.L, Pham, E. Park, Z. Zhong, G. Huang, J.C. Wu, S.P. Elmer, V. Visuthikraisee, E.M.G. Cadag, T. B. Freeman and P.Y. Lum; Auransa, Inc., Palo Alto, CA and SCT II LLC, Naperville, IL; U.S. Patent #10, 806,716; October 20, 2020.
Cancer has been one of the leading causes of death and many people undergo chemotherapy. Cardiotoxicity is one of the major side-effects of chemotherapies, especially after anthracycline treatment. The patent discloses pharmaceutical compositions for anticancer agents and protective agents. Various protective agents disclosed are - myricetin, tricetin, robinetin, ficetin, vitexin, quercetin, dihydrorobinetin, kaempferol, 7,3’,4’,5’-tetrahydroxyflavone, and myricitrin. These are members of the flavonoid class of polyphenolic compounds, with antioxidant properties. The protective agent and cancer treatment may also be combined with a different cardioprotective agent (e.g., dexrazoxane). Dexrazoxane chelates iron and thus reduces the number of metal ions complexed with anthracycline and consequently, decrease the formation of superoxide radicals.
Microparticles and Nanoparticles Having Negative Surface Charges;
B. Wu; Phosphorex Inc.; U.S. Patent #10,780,053; September 22, 2020.
Certain carboxylated particles (assumed to possess a negative charge), such as carboxylated polystyrene, PLGA, etc. may ameliorate certain conditions such as pathological inflammatory immune responses. The patent teaches to make polymer particles with high negative surface charge. The negative charges can be conferred by chemical groups such as carboxyl, sulfonate, nitrate, fluorate, chloride, iodide, persulfate, and many others, with carboxyl group being preferred. The method includes emulsion formation. Polyacrylic acid and polyvinyl alcohol are dissolved in water maintaining a basic pH. PLGA is dissolved in an organic solvent. The two solvents are emulsified using a microfluidizer and the microparticles are produced by the evaporation method.
Combinatorial Therapies of Neurological Disorders;
D. Cohen, S. Nabirotchkin, and R. Hajj; Pharnext, France; U.S. Patent # 10,799,499; October 13, 2020.
This patent describes a combination of compounds comprising (i) 3-phenylsulfonyl-8-(piperazin-1-yl) quinoline or a salt derivative or prodrug thereof and (ii) baclofen and acamprosate, or salt derivatives or prodrugs thereof for the treatment of neurological disorders, such as Alzheimer’s Disease (AD). Baclofen or Lioresal among others, is a medication used to treat muscle spasticity such as from a spinal cord injury or multiple sclerosis. Acamprosate, or Campral, is a medication used to treat alcohol dependence. The combination can also be used to treat the neurological disorders such as - Parkinson’s disease, Lewy body dementia, multiple system atrophy and other related synucleinopathies.