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-April 2018.
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Vanadium Compounds as Therapeutic Adjuncts for Cartilage Injury and Repair; Rutgers, The State University of New Jersey; S.S. Lin, D.N. Paglia, J.P. O’Connor, A. Wey, J. Benevenia and V. Tan; U.S. Patent # 9,931,348; April 3, 2018.
Articular cartilage has little capacity to repair itself or regenerate intrinsically. Therefore, cartilage defects repair by forming scar tissue (or fibrocartilage) from the subchondral bone. This scar tissue is deficient in type II collagen and has “abnormal” proteoglycans which lowers load bearing capacity, and its formation will often result in short term recovery only. This later surface deterioration may progress to give chronic pain and poor function and may in some cases lead to early onset osteoarthritis. The patent describes a novel method for accelerating cartilage healing or repair using organovanadium agents. The patent claims that the method can be used in conjunction with an allograft, autograft or orthopedic biocomposite.
Gastric Retentive Pharmaceutical Compositions for Treatment and Prevention of CNS Disorders; Depomed, Inc., US; S.Y.E Hou; U.S. Patent # 9,937,142; April 10, 2018.
This patent highlights methods and compositions for ameliorating, preventing and treating central nervous system (CNS) disorders. The gastric retentive pharmaceutical compositions comprise of orally administering an extended release dosage form comprising of a polymer matrix, having at least one hydrophilic polymer in the range of 20 wt percent to 60 wt percent. The polymer matrix swells upon imbibition of fluid to a size sufficient for gastric retention in a gastrointestinal tract of the subject. It aims at treating patients suffering from those disorders which are associated with neurotransmitter system dysfunction such as neurodegenerative diseases including presenile dementia, senile dementia of the Alzheimer’s type, Parkinsonism including Parkinson’s disease, and other CNS disorders including attention deficit disorder, schizophrenia and Tourette’s syndrome. One of the hydrophilic polymers used is polyethylene oxide having a molecular weight of about 900,000 Daltons to 2,000,000 Daltons.
Liposome Loading; Comfort Care for Animals LLC, US, T.D. Heath, L.A. Krugner-Higby, and A. Lautenbach; U.S. Patent #9,931,298; April 3, 2018.
Liposomes are one of most well-known drug delivery systems. The percent of drug-loading in liposomes and the desired release rate from the liposomes are key factors. In particular, one desires a slow early release rate from liposomes. The patent used gradient loading technology. Normally ammonium sulfate is used, but in this case they used a weaker base such as pyridine or nicotiamide than the drug. The pH and buffer used in the extraliposomal compartment are crucial to percent drug loading. Using a weaker base for loading also reduces the initial rapid release rate of the drug that is observed when ammonium sulfate is used for loading. The temperature of the system during the liposome preparation is also a critical factor. Liposomes are produced by dissolving lipids in a solvent (C3 or C4 alcohol) to produce a lipid solution, dissolving the active moiety in the aqueous solution and adding the aqueous solution to the lipid solution.
Injection Devices with a Twist-Lock Safety Mechanism; OcuJect, LLC; L.E. Lerner; U.S.; U.S. Patent #9,913,750; March 13, 2018.
Currently the commercially available intravitreal injection devices lack features that are useful in exposing the site of injection, stabilizing the device against the sclera, and/or controlling the angle and depth of injection. Ergonomic devices that simplify the intravitreal injection procedure and reduce the risk of complications would be useful. This patent describes an injection device for delivering pharmaceutical compositions into the eye. The device includes a resistance component for controllably deploying an injection needle through the eye wall. The resistance component may be disposed on the injector device, or on a portion of the injection device housing, or on a drug reservoir. These device accurately and atraumatically inject drugs, e.g., liquid, semisolid, or suspension-based drugs, into the eye.
Amniotic Fluid Formulation for Treatment of Joint Pain or Disorders; MAM Holdings of West Florida, LLC; C.R. Harrell; U.S. Patent # 9,907,821; March 6, 2018.
Acute and chronic pain, loss of structural function and range of movement can occur due to disease, injury, disorders (such as malalignment), or degeneration. The natural healing response in damaged articular cartilage is inadequate. The current methods of treatment are limited to surgical procedures, palliative (injection of steroids or anesthetics), and injection of “repair promoters” such as hyaluronic acid, none of which are totally effective. The objective of the present invention is to provide a formulation that can be used for the management of chronic joint pain, injury or disorders with reduced pain and faster healing. A human amniotic fluid formulation has been developed for treatment of the same. The formulation is a sterile de-cellularized human amniotic fluid (D-HAF), administered by injection. D-HAF contains over 300 human growth factors and is devoid of amniotic stem cells and elements of micronized membrane or chorion particles. The formulation can be diluted prior to administration, based on the severity of the disorder or injury.
Process Line for the Production of Freeze-Dried Particles; Sanofi Pasteur SA; B. Luy, M. Plitzky, M. Struschka; U.S. Patent # 9,920,989; March 20, 2018.
Freeze-drying, also known as lyophilization, is a process for drying high-quality products like pharmaceuticals, biological materials via the sublimation of ice crystals into water vapor. The above invention describes a process line for production of freeze-dried particles under closed conditions comprising of a spray chamber for generation of discrete liquid droplets and freeze congealing of the liquid droplets to form pellets and a bulk freeze-dryer for freeze drying the pellets. The freeze-dryer features a rotary drum for receiving the pellets. A transfer section is provided for particle transfer from the spray chamber to the freeze-dryer, which permanently interconnects the process devices to form an integrated process line for production of the particles under closed conditions. Also, each of the process devices and the transfer section are separately adapted for sterile operations of the particles to be freeze-dried. Sterile and contained product handling is enabled while avoiding the necessity of putting the entire process line into a separator or isolator, i.e., operation under sterile conditions can be operated in an unsterile environment. The costs and complexity related to using an isolator can therefore be avoided while still conforming to sterile and containment requirements.
hUTC as Th erapy for Alzheimer’s Disease; DePuy Synthes Products LLC, US; A.J. Kihm and A. Gosiewska; U.S. Patent # 9,943,552; April 17, 2018.
Alzheimer’s disease is a degenerative disease of the brain from which there is no recovery. The disease attacks nerve cells in all parts of the cortex of the brain, as well as some of the surrounding structures and tissues. Currently, Alzheimer’s disease treatment is based on managing disease symptomology for each individual’s disease progression. Although there are drugs for treating Alzheimer’s disease, there is no cure for the disease. The patent describes the methods for treating Alzheimer’s disease by administering a cell, population of cells or cell derivatives derived from human placental or umbilical cord tissue (“hUTC”). The patent claims that isolated human umbilical cord-derived cells are administered to cerebral spinal fluid. The patent also claims that the composition comprises diluents selected from the group consisting of: saline, aqueous buffer solutions, solvents, artificial cerebral spinal fluid, dispersion media composition and a mix thereof.