The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office during March-April 2019.
Topical Corticosteroids for the Treatment of Inflammatory Diseases of the Gastrointestinal Tract;
R. Dohil, J. Bastian, S. Aceves, E. Phillips and M. Hill; The Regents of the University of California, US; U.S. Patent # 10,272,037; April 30, 2019.
The present invention discloses the use of topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract. It focuses on a method of treating esophageal inflammatory disease by Budesonide. Budesonide is an anti-inflamatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. It is used in the management of asthma and in the treatment of skin disorders and allergic rhinitis. The present invention uses a solution of budesonide and polyvinyl pyrrolidone in the treatment of esophageal inflammatory disease. A rapid dissolving tablet of Budesonide and polyvinyl pyrrolidone is made and then administered orally in the form of a solution.
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Shape Memory Polymer
Intraocular Lenses; M.Y. Kahook, N. Mandava, R. Shandas, and B. Rech, Th e Regents of the University of Colorado, US; U.S. Patent # 10,272,176; April 30, 2019.
Shape memory polymers are shape changing polymers (SMP). These materials have dual-shape capability. When exposed to certain stimulus, they can come back to original shape and vice-versa. The present invention discloses a method of manufacturing an intra-ocular device with a shape memory polymer. Due to the unique nature of SMPs, they can be tailored to have significant mechanical property changes. The ability to precisely control the mechanical properties of polymer and its transparent nature may help in the design of variety of intra-ocular lenses. Lenses made from SMPs can have an accurate and uniform shape.
Drug Device Configured for Wireless Communication;
R.L. Altschul, N.D. Theise, R.A. Ene, M. Rapkin, and R. O’Brien, Pop Test Abuse Deterrent Technology, US; U.S. Patent # 10,245,323; April 2, 2019.
Smart pills have already revolutionized the health care system. But death from drug overdoses is still a major public health burden in the US. The answer to this need is the present invention. This invention relates to an ingestible drug delivery device configured for wireless communication with other ingestible drug delivery devices. The present invention provides the Smart Pill System. The smart pill is a miniature electronic device molded in a pharmaceutical capsule. It has a micro controller, memory, wireless communication capabilities, onboard sensors, and a Micro-Electro-Mechanical System (MEMS) drug delivery system. The Smart Pills can detect other API’s, drugs of abuse; alcohol; pregnancy, and can prevent release of teratogenic APIs when the patient is determined to be pregnant. The detection can be made via RF signal, pH, acidity level, detection of drug or metabolites presence, etc.
Absorption Enhancers for Drug Administration;
E.T. Maggio; Aegis Therapeutics, US; U.S. Patent # 10,265,402; April 23, 2019.
The present invention provides for a solid oral dosage form containing a pharmaceutically active ingredient and an alkyl-saccharide, which enhances the oral bioavailability for the absorption of the active ingredient. It focuses on development of a therapeutic composition containing a drug enhancing agent for increasing the absorption and bioavailability of the drug at the same time avoiding various adverse toxic effects of the drug. The drug enhancing agents contain a non-toxic surfactant consisting of an alkyl glycoside or saccharide alkyl ester. These compositions permit administration and delivery of the therapeutic agents with high bioavailabilities at concentrations of enhancing agents that are dramatically below their so-called “no observable adverse effect levels” ( NOAEL’s).
Delayed Release Drug Formulation;
R.C. Bravo Gonzalez, T. Buser, F.J.C. Goutte, A.W. Basit, F.J.O. Varum and A.C. Freire; Tillotts Pharma AG, Switzerland; U.S. Patent # 10,226,430; March 12, 2019.
The present invention relates to a delayed release formulation for delivering a drug to the colon. Patent describes a formulation comprising: a core and a coating for the core. The core has the drug and the coating comprises an inner and outer layer. Both the layers are made up of polymeric materials. The outer layer comprises of a mixture of a polymeric material. The first material is susceptible to attack by colonic bacteria and a second polymeric material has a pH threshold at about pH 6 or above. The inner layer comprises a third polymeric material, which is soluble in intestinal fluid or gastrointestinal fluid. Partially neutralized polycarboxylic acid polymer is the sole fi lm-forming polymer in the inner layer. The inventors believe that, once intestinal fluid or gastrointestinal fluid penetrates the outer layer, the inner layer begins to dissolve before the outer layer to form a fluid region between the core and the outer layer. The fluid region not only facilitates dissolution and/or disintegration of the outer layer from the inside, but also softens and begins to break up the core so that, when the outer layer degrades, the drug is released from the core more quickly.
Optical Capsule and Spectroscopic Method for Treating and Diagnosing the Intestinal Tract;
M.A. Imaran; Entrack Inc., US; U.S. Patent # 10,226,608, March 12, 2019.
This patent invention provides a device and method for mapping, diagnosing and treating the intestinal tract using a capsule passing through the intestinal tract. It also provides an improved tracking system for determining the coordinates of the capsule in three-dimensional space where an acoustic signal is transmitted between the capsule as it is passing through the intestinal tract, and a location external a patient’s body. The velocity of an acoustic signal through tissue is about 1,540 m/sec. Using the amount of time the signal takes to travel to the receiver and the signal velocity, the relative capsule distance to the location external to the patient’s body is determined. As the capsule traverses through the tract, it senses diagnostic information. From this information, a location along the length traveled is identified for treatment and therapeutic functions.
Natural Polymer Nanoparticles from Ionic Liquid Emulsions;
J. Alston, J. Mabry, and A. Guenthner; The United States of America, the Secretary of the Air Force, U.S. Patent # 10,233,261; March 19, 2019.
Many natural polymers, such as cellulose, collagen etc. are water insoluble and it is hard to work with them to produce nano-scale products. The authors invented an ionic liquid, which can dissolve the natural polymers without degradation and derivatization. The solution is mixed with a non-polar phase along with a surfactant to form a microemulsion. An antisolvent is added to the system to precipitate the polymer as nanoparticles. The natural polymer nanoparticles made according to the claimed method have numerous applications. Several factors were discussed, which control the particle size of the nano-particles.