Abstract: Powder dispensing and sensing apparatus and methods are provided. The powder dispensing and sensing apparatus includes a tray support structure to receive a cartridge tray holding cartridges, a powder dispenser assembly including powder dispenser modules to dispense powder into respective cartridges of a batch of cartridges in the cartridge tray, a powder transport system to deliver powder to the powder dispenser modules, a sensor module including sensor cells to sense respective fill states, such as the weights, of each of the cartridges in the batch of cartridges, and a control system to control the powder dispenser modules in response to the respective sensed fill states of each of the cartridges of the batch of cartridges.
Type:
Grant
Filed:
September 13, 2017
Date of Patent:
April 14, 2020
Assignee:
MannKind Corporation
Inventors:
Trent A. Poole, David F. Bonneau, Per B. Fog
Abstract: Provided is a method for the synthesis of N-protected 3,6-bis-[4-aminobutyl]-2,5-diketopiperazine including the step of heating a solution of ?-amino protected lysine in the presence of a catalyst selected from the group consisting of sulfuric acid, phosphoric acid, and phosphorus pentoxide.
Type:
Grant
Filed:
October 4, 2018
Date of Patent:
March 31, 2020
Assignee:
Mannkind corporation
Inventors:
John J. Stevenson, Destardi Moye-Sherman
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:
Grant
Filed:
June 26, 2019
Date of Patent:
March 31, 2020
Assignee:
MannKind Corporation
Inventors:
Marshall Grant, Paul Menkin, Grayson W. Stowell
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:
October 4, 2018
Date of Patent:
March 10, 2020
Assignee:
Mannkind corporation
Inventors:
Andrea Leone-Bay, Destardi Moye-Sherman, Bryan R. Wilson
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:
November 6, 2019
Publication date:
March 5, 2020
Applicant:
MannKind Corporation
Inventors:
Edwin Amoro, Karel Vanackere, Michael A. White
Abstract: A mouthpiece cover for an inhaler is described. The mouthpiece cover is designed for use with a dry powder inhaler and is provided with structural features to prevent a patient from inhaling the cover.
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:
August 1, 2018
Date of Patent:
December 10, 2019
Assignee:
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:
Application
Filed:
June 21, 2019
Publication date:
December 5, 2019
Applicant:
MannKind Corporation
Inventors:
Marshall Grant, Simon R. Bruce, Robert A. Baughman
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:
June 26, 2019
Publication date:
November 7, 2019
Applicant:
MannKind Corporation
Inventors:
Marshall Grant, Paul Menkin, Grayson W. Stowell
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:
March 14, 2014
Date of Patent:
September 24, 2019
Assignee:
MannKind Corporation
Inventors:
Bryan R. Wilson, Joseph J. Guarneri, Marshall L. Grant
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:
January 31, 2018
Date of Patent:
September 17, 2019
Assignee:
Mannkind Corporation
Inventors:
Karine Fabio, Joseph J. Guarneri, Kieran Curley, Marshall L. Grant, Andrea Leone-Bay
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:
Grant
Filed:
October 4, 2018
Date of Patent:
August 13, 2019
Assignee:
MannKind Corporation
Inventors:
Marshall Grant, Paul Menkin, Grayson W. Stowell
Abstract: Methods are provided for drying a particle. Specifically, there is provided a spray-dried diketopiperazine-insulin particle formulation having improved aerodynamic performance and in which the active agent is more stabile and efficiently delivered as compared to that of the lyophilized diketopiperazine-insulin formulation. The dry powders have utility as pharmaceutical formulations for pulmonary delivery.
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 21, 2017
Date of Patent:
July 23, 2019
Assignee:
MannKind Corporation
Inventors:
Keith A. Oberg, Joseph Sulner, Marshall L. Grant
Abstract: A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, and 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, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of endocrine disease, for example, diabetes and/or obesity.
Type:
Grant
Filed:
June 14, 2016
Date of Patent:
July 9, 2019
Assignee:
MannKind Corporation
Inventors:
Chad C. Smutney, Benoit Adamo, John M. Polidoro, P. Spencer Kinsey, Dennis Overfield, Carl R. Sahi, Christine Billings, Mark T. Marino
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: Methods and compositions for treating pain are disclosed. The compositions are based on dry powders comprising microparticles of diketopiperazines and an analgesic active agent. The analgesic in the compositions comprises one or more peptide analgesics or derivatives thereof, which are administered to a subject using a pulmonary inhalation drug delivery system comprising a dry powder inhaler and the analgesic composition. The present compositions produce fewer side effects associated with current opioid therapy.
Type:
Grant
Filed:
February 22, 2017
Date of Patent:
April 16, 2019
Assignee:
MannKind Corporation
Inventors:
Andrea Leone-Bay, Richard A. Houghten, Joseph J. Guarneri, Grayson W. Stowell