WO2007033316A3 - Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces - Google Patents

Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces Download PDF

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Publication number
WO2007033316A3
WO2007033316A3 PCT/US2006/035822 US2006035822W WO2007033316A3 WO 2007033316 A3 WO2007033316 A3 WO 2007033316A3 US 2006035822 W US2006035822 W US 2006035822W WO 2007033316 A3 WO2007033316 A3 WO 2007033316A3
Authority
WO
WIPO (PCT)
Prior art keywords
affinity
increasing
active agents
drug formulation
formulation based
Prior art date
Application number
PCT/US2006/035822
Other languages
French (fr)
Other versions
WO2007033316A2 (en
Inventor
Mark Hokenson
Keith A Oberg
Original Assignee
Mannkind Corp
Mark Hokenson
Keith A Oberg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to IN9128DEN2014 priority Critical patent/IN2014DN09128A/en
Priority to KR1020147002141A priority patent/KR101486829B1/en
Priority to AU2006290870A priority patent/AU2006290870B2/en
Priority to EP06803583.1A priority patent/EP1928423B1/en
Priority to CA2620758A priority patent/CA2620758C/en
Priority to JP2008531320A priority patent/JP5167133B2/en
Application filed by Mannkind Corp, Mark Hokenson, Keith A Oberg filed Critical Mannkind Corp
Priority to ES06803583.1T priority patent/ES2559677T3/en
Priority to DK06803583.1T priority patent/DK1928423T3/en
Priority to BRPI0615819A priority patent/BRPI0615819B8/en
Publication of WO2007033316A2 publication Critical patent/WO2007033316A2/en
Publication of WO2007033316A3 publication Critical patent/WO2007033316A3/en
Priority to HK08110376.5A priority patent/HK1116088A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/25—Growth hormone-releasing factor [GH-RF] (Somatoliberin)
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH] (Somatotropin)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone (parathormone); Parathyroid hormone-related peptides
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5052—Proteins, e.g. albumin
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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    • A61P5/00—Drugs for disorders of the endocrine system
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    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

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.
PCT/US2006/035822 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces WO2007033316A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
KR1020147002141A KR101486829B1 (en) 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of active agents for crystalline micropaticle surfaces
AU2006290870A AU2006290870B2 (en) 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces
EP06803583.1A EP1928423B1 (en) 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces
CA2620758A CA2620758C (en) 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces
JP2008531320A JP5167133B2 (en) 2005-09-14 2006-09-14 Method of drug formulation based on increased affinity of active agents for crystalline microparticle surfaces
IN9128DEN2014 IN2014DN09128A (en) 2005-09-14 2006-09-14
ES06803583.1T ES2559677T3 (en) 2005-09-14 2006-09-14 Drug formulation method based on increasing the affinity of the active ingredients for microcrystalline particle surfaces
DK06803583.1T DK1928423T3 (en) 2005-09-14 2006-09-14 A method for drug formulation based on increasing the affinity of the active substances to the crystalline microparticle surfaces
BRPI0615819A BRPI0615819B8 (en) 2005-09-14 2006-09-14 process for preparing a drug delivery composition comprising an active agent and a crystalline fumaryl diketopiperazine microparticle.
HK08110376.5A HK1116088A1 (en) 2005-09-14 2008-09-19 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US71752405P 2005-09-14 2005-09-14
US60/717,524 2005-09-14
US74488206P 2006-04-14 2006-04-14
US60/744,882 2006-04-14

Publications (2)

Publication Number Publication Date
WO2007033316A2 WO2007033316A2 (en) 2007-03-22
WO2007033316A3 true WO2007033316A3 (en) 2007-05-31

Family

ID=37726824

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2006/036034 WO2007033372A2 (en) 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
PCT/US2006/035822 WO2007033316A2 (en) 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2006/036034 WO2007033372A2 (en) 2005-09-14 2006-09-14 Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents

Country Status (16)

Country Link
US (15) US7803404B2 (en)
EP (3) EP1937219B1 (en)
JP (4) JP5465878B2 (en)
KR (7) KR101557502B1 (en)
CN (3) CN104324366B (en)
AU (2) AU2006290227B2 (en)
BR (2) BRPI0616071B8 (en)
CA (2) CA2621806C (en)
DK (3) DK1928423T3 (en)
ES (3) ES2559677T3 (en)
HK (2) HK1116088A1 (en)
HU (2) HUE028623T2 (en)
IN (1) IN2014DN09128A (en)
MX (2) MX358592B (en)
RU (3) RU2394550C2 (en)
WO (2) WO2007033372A2 (en)

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US8623817B2 (en) 2008-08-11 2014-01-07 Mannkind Corporation Method of treating diabetes type 2 by administering ultrarapid acting insulin
CN101969928B (en) * 2007-10-24 2014-05-07 曼金德公司 Delivery of active agents
US8785396B2 (en) 2007-10-24 2014-07-22 Mannkind Corporation Method and composition for treating migraines
US8889099B2 (en) 1999-06-29 2014-11-18 Mannkind Corporation Methods and compositions for delivering peptides
US8912193B2 (en) 2008-06-13 2014-12-16 Mannkind Corporation Dry powder inhaler and system for drug delivery
US9006175B2 (en) 1999-06-29 2015-04-14 Mannkind Corporation Potentiation of glucose elimination
US9220687B2 (en) 2008-12-29 2015-12-29 Mannkind Corporation Substituted diketopiperazine analogs for use as drug delivery agents
US9233159B2 (en) 2011-10-24 2016-01-12 Mannkind Corporation Methods and compositions for treating pain
US9241903B2 (en) 2006-02-22 2016-01-26 Mannkind Corporation Method for improving the pharmaceutic properties of microparticles comprising diketopiperazine and an active agent
US9283193B2 (en) 2005-09-14 2016-03-15 Mannkind Corporation Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
US9358352B2 (en) 2008-06-13 2016-06-07 Mannkind Corporation Dry powder drug delivery system and methods
US9364436B2 (en) 2011-06-17 2016-06-14 Mannkind Corporation High capacity diketopiperazine microparticles and methods
US9364619B2 (en) 2008-06-20 2016-06-14 Mannkind Corporation Interactive apparatus and method for real-time profiling of inhalation efforts
US9393372B2 (en) 2008-06-13 2016-07-19 Mannkind Corporation Dry powder drug delivery system
US9675674B2 (en) 2004-08-23 2017-06-13 Mannkind Corporation Diketopiperazine salts for drug delivery and related methods

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ES2300568T3 (en) 2002-03-20 2008-06-16 Mannkind Corporation INHALATION APPARATUS
US20080260838A1 (en) * 2003-08-01 2008-10-23 Mannkind Corporation Glucagon-like peptide 1 (glp-1) pharmaceutical formulations
US9078866B2 (en) 2003-08-01 2015-07-14 Mannkind Corporation Method for treating hyperglycemia with GLP-1
US8921311B2 (en) 2003-08-01 2014-12-30 Mannkind Corporation Method for treating hyperglycemia
MX2007001903A (en) 2004-08-20 2007-08-02 Mannkind Corp Catalysis of diketopiperazine synthesis.
MX2008013216A (en) * 2006-04-14 2008-10-27 Mannkind Corp Glucagon-like peptide 1(glp-1) pharmaceutical formulations.
MX2010004510A (en) * 2007-10-24 2010-07-02 Mannkind Corp Method of preventing adverse effects by glp-1.
RU2508093C2 (en) * 2008-07-01 2014-02-27 Нитто Денко Корпорейшн Pharmaceutical composition containing coated microparticles
JP6087504B2 (en) 2008-11-07 2017-03-01 マサチューセッツ インスティテュート オブ テクノロジー Amino alcohol lipidoids and uses thereof
CA2748490C (en) 2008-12-29 2016-10-04 Mannkind Corporation Substituted diketopiperazine analogs for use as drug delivery agents
PL2405963T3 (en) 2009-03-11 2014-04-30 Mannkind Corp Apparatus, system and method for measuring resistance of an inhaler
EP2440184B1 (en) * 2009-06-12 2023-04-05 MannKind Corporation Diketopiperazine microparticles with defined specific surface areas
MY172858A (en) 2009-06-12 2019-12-12 Mannkind Corp Diketopiperazine microparticles with defined isomer contents
WO2011017554A2 (en) 2009-08-07 2011-02-10 Mannkind Corporation Val (8) glp-1 composition and method for treating functional dyspepsia and/or irritable bowel syndrome
CN102596238B (en) 2009-11-02 2014-06-18 曼康公司 Apparatus and method for cryogranulating a pharmaceutical composition
WO2011053963A1 (en) 2009-11-02 2011-05-05 Mannkind Corporation Reactor for producing pharmaceutical particles in a precipitation process
WO2011056889A1 (en) 2009-11-03 2011-05-12 Mannkind Corporation An apparatus and method for simulating inhalation efforts
EP2567219B1 (en) 2010-05-07 2019-09-18 MannKind Corporation Method and apparatus for determining weight percent of microparticles of diketopiperazine in suspension using raman spectroscopy
US10140619B2 (en) * 2010-06-22 2018-11-27 Sizmek Technologies, Inc. Dynamic creative creation and delivery
EP2637657B1 (en) 2010-11-09 2019-05-22 MannKind Corporation Composition comprising a serotonin receptor agonist and a diketopiperazine for treating migraines
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