Abstract: Methods are provided for promoting the adsorption of an active agent to microparticles by modifying the structural properties of the active agent in order to facilitate favorable association to the microparticle.
Abstract: Cryogranulation systems with improved dispenser assemblies are provided for use in manufacturing frozen pellets of pharmaceutical substances in a fluid medium. Methods of cryogranulating the pharmaceutical substance in the fluid medium are also provided. In particular embodiments, the dispenser assembly is used with suspensions or slurries of pharmaceutical compositions including biodegradable substances, such as proteins, peptides, and nucleic acids. In certain embodiments, the pharmaceutical substance can be adsorbed to any pharmaceutically acceptable carrier particles suitable for making pharmaceutical powders. In one embodiment, the pharmaceutical carrier can be, for example, diketopiperazine-based microparticles. The dispenser assembly improves the physical characteristics of the cryopellets formed and minimizes product loss during processing.
Type:
Application
Filed:
June 30, 2021
Publication date:
October 21, 2021
Applicant:
MannKind Corporation
Inventors:
Edwin Amoro, Karel Vanackere, Michael A. White
Abstract: An ultra-rapid acting insulin composition and method for treating hyperglycemia in patients with diabetes are disclose. The composition is an inhalable dry powder composition comprising fumaryl diketopiperazine and insulin for pulmonary delivery, which significantly reduces the rates of hypoglycemic events in patients in patients on mealtime insulin therapy.
Type:
Grant
Filed:
June 21, 2019
Date of Patent:
September 7, 2021
Assignee:
MannKind Corporation
Inventors:
Marshall Grant, Simon R. Bruce, Robert A. Baughman
Abstract: Methods are provided for promoting the adsorption of an active agent to microparticles by modifying the structural properties of the active agent in order to facilitate favorable association to the microparticle.
Abstract: Reactors, reactor systems and methods for producing particles in a precipitation process are provided. The reactor includes a housing defining a reaction chamber, a stator assembly including two or more stators, a rotor assembly including two or more rotors, the rotor assembly configured for rotation about an axis of rotation relative to the stator assembly, a first inlet to supply a first reactant material to the reaction chamber at a first radial location, a second inlet to supply a second reactant material to the reaction chamber at a second radial location different from the first radial location, wherein the first and second reactant materials react to produce precipitation of particles in the reaction chamber, and an outlet to supply the particles formed in the reaction chamber.
Type:
Grant
Filed:
March 7, 2018
Date of Patent:
August 31, 2021
Assignee:
MannKind Corporation
Inventors:
Sanket Gandhi, Karen Moraleda, Jadwiga Jachowicz, Michael Zupon
Abstract: A method for treating obesity associated to Prader Willi Syndrome and/or binge eating is disclosed. The method utilizes a rapid drug delivery system which delivers small molecules and peptides to the lungs by oral inhalation.
Type:
Application
Filed:
April 25, 2019
Publication date:
August 26, 2021
Applicant:
MannKind Corporation
Inventors:
Michael CASTAGNA, David KENDALL, Kelly KRAFT, Chad C. SMUTNEY, Marshall GRANT
Abstract: Cryogranulation systems with improved dispenser assemblies are provided for use in manufacturing frozen pellets of pharmaceutical substances in a fluid medium. Methods of cryogranulating the pharmaceutical substance in the fluid medium are also provided. In particular embodiments, the dispenser assembly is used with suspensions or slurries of pharmaceutical compositions including biodegradable substances, such as proteins, peptides, and nucleic acids. In certain embodiments, the pharmaceutical substance can be adsorbed to any pharmaceutically acceptable carrier particles suitable for making pharmaceutical powders. In one embodiment, the pharmaceutical carrier can be, for example, diketopiperazine-based microparticles. The dispenser assembly improves the physical characteristics of the cryopellets formed and minimizes product loss during processing.
Type:
Grant
Filed:
November 6, 2019
Date of Patent:
August 3, 2021
Assignee:
MannKind Corporation
Inventors:
Edwin Amoro, Karel Vanackere, Michael A. White
Abstract: Disclosed herein are heat-stable dry powders which include peptides or protein such as oxytocin for use as a pharmaceutical composition. The composition is highly stable at increased temperatures and relatively high humid environments, and are intended for storage at room temperature with an improved shelf-life. In particular, the dry powders are intended for inhalation, however, other routes of administration can be used when reconstituted in solution.
Type:
Grant
Filed:
August 1, 2019
Date of Patent:
May 25, 2021
Assignee:
MannKind Corporation
Inventors:
Karine Fabio, Joseph J. Guarneri, Kieran Curley, Marshall L. Grant, Andrea Leone-Bay
Abstract: Methods are provided for coating crystalline microparticles with an active agent by altering the surface properties of the microparticles in order to facilitate favorable association on the microparticle by the active agent. Types of surface properties that are altered by the disclosed methods include electrostatic properties, hydrophobic properties, and hydrogen bonding properties.
Type:
Grant
Filed:
June 12, 2019
Date of Patent:
May 25, 2021
Assignee:
MannKind Corporation
Inventors:
Keith A. Oberg, Joseph Sulner, Marshall L. Grant
Abstract: Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Abstract: Drug delivery systems have been developed based on the formation of diketopiperazine carboxylate salts and microparticles containing the same. The systems may further comprise a bioactive agent. Related methods for making and using the biologically active agent delivery compositions are also provided. In certain embodiments, the pharmaceutically acceptable salts described can be formed by removal of solvent by methods including distillation, evaporation, spray drying or lyophilization.
Type:
Grant
Filed:
January 27, 2020
Date of Patent:
February 9, 2021
Assignee:
MannKind Corporation
Inventors:
Andrea Leone-Bay, Destardi Moye-Sherman, Bryan R. Wilson
Abstract: Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Type:
Grant
Filed:
March 2, 2018
Date of Patent:
December 8, 2020
Assignee:
MannKind Corporation
Inventors:
Peter Richardson, Robert A. Baughman, Elizabeth Potocka, Anders Hasager Boss, Richard Petrucci
Abstract: Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Type:
Grant
Filed:
June 29, 2018
Date of Patent:
September 15, 2020
Assignee:
MannKind Corporation
Inventors:
Anders Hasager Boss, Richard Petrucci, Campbell Howard, Alfred Mann
Abstract: Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m2/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.
Type:
Grant
Filed:
March 17, 2017
Date of Patent:
September 15, 2020
Assignee:
MannKind Corporation
Inventors:
Marshall L. Grant, Grayson W. Stowell, Paul Menkin, John J. Freeman, Jr.
Abstract: A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided. The dry powder inhaler can be provided with or without a unit dose cartridge for using with the inhaler. The inhaler and/or cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of diabetes and/or obesity. The dry powder inhaler is compact; can be provided in various shapes and sizes, colors, and comprises a housing, a mouthpiece, a cartridge placement area, and a mechanism for opening and closing the medicament cartridge. The device is easy to manufacture, provides a pre-metered single unit dose, it is relatively easy to use, and can be reusable or disposable.
Type:
Grant
Filed:
April 13, 2016
Date of Patent:
August 25, 2020
Assignee:
MannKind Corporation
Inventors:
Chad C. Smutney, P. Spencer Kinsey, Carl R. Sahi, Benoit Adamo, John M. Polidoro
Abstract: A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, with or without a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, small organic molecules, peptides and proteins, including, hormones such as insulin and glucagon-like peptide 1 for the treatment of disease and disorders, for example, diseases and disorders, including endocrine disease such as diabetes and/or obesity.
Type:
Grant
Filed:
September 15, 2017
Date of Patent:
August 18, 2020
Assignee:
MannKind Corporation
Inventors:
Chad C. Smutney, Benoit Adamo, Brendan F. Laurenzi, P. Spencer Kinsey
Abstract: Disclosed herein are DKP microcrystals made by an improved method where they do not irreversibly self-assemble into microparticles. The microcrystals can be dispersed by atomization and re-formed by spray drying into particles having spherical shell morphology. Active agents and excipients can be incorporated into the particles by spray drying a solution containing the components to be incorporated into microcrystalline diketopiperazine particles. In particular, the microcrystalline particle compositions are suitable for pulmonary drug delivery of one or more peptides, proteins, nucleic acids and/or small organic molecules.
Type:
Grant
Filed:
August 6, 2019
Date of Patent:
August 18, 2020
Assignee:
MannKind Corporation
Inventors:
Bryan R. Wilson, Joseph J. Guarneri, Marshall L. Grant
Abstract: Described herein are interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The devices can be used in a wired or wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system, to evaluate the performance of the inhalation system and/or to detect the characteristics profile of a dry powder formulation emitted from the inhalation system in use.
Type:
Application
Filed:
April 21, 2020
Publication date:
August 6, 2020
Applicant:
MANNKIND CORPORATION
Inventors:
Dennis Overfield, Carl R. Sahi, Benoit Adamo, P. Kinsey, Scott Mclean, John M. Polidoro, Chad C. Smutney
Abstract: Described herein are interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The devices can be used in a wired or wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system, to evaluate the performance of the inhalation system and/or to detect the characteristics profile of a dry powder formulation emitted from the inhalation system in use.
Type:
Grant
Filed:
May 12, 2016
Date of Patent:
June 9, 2020
Assignee:
MannKind Corporation
Inventors:
Dennis Overfield, Carl R. Sahi, Benoit Adamo, P. Spencer Kinsey, Scott McLean, John M. Polidoro, Chad C. Smutney
Abstract: Disclosed herein are diketopiperazine microparticles having high capacity for adsorbing a drug or active agent. In particular, the diketopiperazine microparticle are formed using fumaryl diketopiperazine and can comprise a drug in large doses for the treatment of disease or disorders by pulmonary delivery via oral inhalation.
Type:
Application
Filed:
January 10, 2020
Publication date:
May 14, 2020
Applicant:
MannKind Corporation
Inventors:
Marshall Grant, Paul Menkin, Grayson W. Stowell