CA2274758A1 - Stable glassy state powder formulations - Google Patents
Stable glassy state powder formulations Download PDFInfo
- Publication number
- CA2274758A1 CA2274758A1 CA002274758A CA2274758A CA2274758A1 CA 2274758 A1 CA2274758 A1 CA 2274758A1 CA 002274758 A CA002274758 A CA 002274758A CA 2274758 A CA2274758 A CA 2274758A CA 2274758 A1 CA2274758 A1 CA 2274758A1
- Authority
- CA
- Canada
- Prior art keywords
- powdered
- active material
- pharmacologically active
- composition
- matrix
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
Classifications
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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
- A61K9/0012—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
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- 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
- A61K38/22—Hormones
- A61K38/28—Insulins
-
- 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
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1658—Proteins, e.g. albumin, gelatin
-
- 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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
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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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- 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
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
- A61P5/12—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH for decreasing, blocking or antagonising the activity of the posterior pituitary hormones
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0086—Inhalation chambers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/07—General characteristics of the apparatus having air pumping means
- A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
- A61M2205/073—Syringe, piston type
Abstract
A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (T g) and a recommended storage temperature (T
s), wherein the difference between T g and T s is at least about °C (i.e. T g-T s is greater than 10 °C). The composition comprises a mixture of a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix. It may be further mixed with a powdered, pharmaceutically-acceptable carrier. It is particularly valuable in unit dosage form having a moisture barrier, in combination with appropriate labelling instructions. A
process for producing a powdered dispersible composition is also provided, wherein the process comprises removing the solvent from a solution comprising a solvent, a glass former and a pharmacologically active material under conditions sufficient to form a glassy matrix having the pharmacologically active material within the matrix.
s), wherein the difference between T g and T s is at least about °C (i.e. T g-T s is greater than 10 °C). The composition comprises a mixture of a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix. It may be further mixed with a powdered, pharmaceutically-acceptable carrier. It is particularly valuable in unit dosage form having a moisture barrier, in combination with appropriate labelling instructions. A
process for producing a powdered dispersible composition is also provided, wherein the process comprises removing the solvent from a solution comprising a solvent, a glass former and a pharmacologically active material under conditions sufficient to form a glassy matrix having the pharmacologically active material within the matrix.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/733,225 | 1996-10-17 | ||
US08/733,225 US6258341B1 (en) | 1995-04-14 | 1996-10-17 | Stable glassy state powder formulations |
PCT/US1997/018901 WO1998016205A2 (en) | 1996-10-17 | 1997-10-14 | Stable glassy state powder formulations |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2274758A1 true CA2274758A1 (en) | 1998-04-23 |
CA2274758C CA2274758C (en) | 2009-09-29 |
Family
ID=24946736
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002274758A Expired - Fee Related CA2274758C (en) | 1996-10-17 | 1997-10-14 | Stable glassy state powder formulations |
Country Status (21)
Country | Link |
---|---|
US (1) | US6258341B1 (en) |
EP (2) | EP0941067B1 (en) |
CN (1) | CN1124843C (en) |
AR (1) | AR013854A1 (en) |
AT (1) | ATE245969T1 (en) |
AU (1) | AU734891B2 (en) |
CA (1) | CA2274758C (en) |
CO (1) | CO5011099A1 (en) |
DE (1) | DE69723854T2 (en) |
DK (1) | DK0941067T3 (en) |
EA (1) | EA002055B1 (en) |
ES (1) | ES2203792T3 (en) |
GE (1) | GEP20032985B (en) |
HK (1) | HK1024618A1 (en) |
HU (1) | HUP0001108A3 (en) |
IL (1) | IL130476A (en) |
NZ (1) | NZ336171A (en) |
PT (1) | PT941067E (en) |
TW (1) | TW504389B (en) |
WO (1) | WO1998016205A2 (en) |
ZA (1) | ZA979145B (en) |
Cited By (2)
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---|---|---|---|---|
CN112512534A (en) * | 2018-05-14 | 2021-03-16 | 艾伊拉米治疗有限公司 | Insulin preparations for reconstitution into highly concentrated liquid solutions |
CN112956693A (en) * | 2021-02-26 | 2021-06-15 | 深圳大学 | Emergency food and preparation method thereof |
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- 1997-10-14 GE GEAP19974861A patent/GEP20032985B/en unknown
- 1997-10-14 EP EP97913707A patent/EP0941067B1/en not_active Revoked
- 1997-10-14 AT AT97913707T patent/ATE245969T1/en not_active IP Right Cessation
- 1997-10-14 PT PT97913707T patent/PT941067E/en unknown
- 1997-10-14 DE DE69723854T patent/DE69723854T2/en not_active Revoked
- 1997-10-14 DK DK97913707T patent/DK0941067T3/en active
- 1997-10-14 HU HU0001108A patent/HUP0001108A3/en unknown
- 1997-10-14 IL IL13047697A patent/IL130476A/en not_active IP Right Cessation
- 1997-10-14 EP EP03013343A patent/EP1342469A3/en not_active Withdrawn
- 1997-10-14 CA CA002274758A patent/CA2274758C/en not_active Expired - Fee Related
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- 1997-10-14 CN CN97180736A patent/CN1124843C/en not_active Expired - Fee Related
- 1997-10-14 NZ NZ336171A patent/NZ336171A/en unknown
- 1997-10-14 AU AU50834/98A patent/AU734891B2/en not_active Ceased
- 1997-10-14 ES ES97913707T patent/ES2203792T3/en not_active Expired - Lifetime
- 1997-10-14 WO PCT/US1997/018901 patent/WO1998016205A2/en not_active Application Discontinuation
- 1997-10-15 TW TW086115145A patent/TW504389B/en not_active IP Right Cessation
- 1997-10-17 AR ARP970104834A patent/AR013854A1/en not_active Application Discontinuation
- 1997-10-17 CO CO97061158A patent/CO5011099A1/en unknown
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CN112512534A (en) * | 2018-05-14 | 2021-03-16 | 艾伊拉米治疗有限公司 | Insulin preparations for reconstitution into highly concentrated liquid solutions |
EP3793568A4 (en) * | 2018-05-14 | 2022-01-19 | Aerami Therapeutics, Inc. | Insulin formulations for reconstitution into high concentration liquid solutions |
CN112956693A (en) * | 2021-02-26 | 2021-06-15 | 深圳大学 | Emergency food and preparation method thereof |
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EP1342469A3 (en) | 2004-01-21 |
DK0941067T3 (en) | 2003-11-17 |
EA002055B1 (en) | 2001-12-24 |
CN1240349A (en) | 2000-01-05 |
WO1998016205A3 (en) | 1998-09-03 |
AR013854A1 (en) | 2001-01-31 |
NZ336171A (en) | 2001-06-29 |
HK1024618A1 (en) | 2000-10-20 |
PT941067E (en) | 2003-12-31 |
AU734891B2 (en) | 2001-06-28 |
WO1998016205A2 (en) | 1998-04-23 |
AU5083498A (en) | 1998-05-11 |
ZA979145B (en) | 1998-05-11 |
TW504389B (en) | 2002-10-01 |
EP0941067A2 (en) | 1999-09-15 |
CO5011099A1 (en) | 2001-02-28 |
CA2274758C (en) | 2009-09-29 |
DE69723854D1 (en) | 2003-09-04 |
HUP0001108A2 (en) | 2000-08-28 |
CN1124843C (en) | 2003-10-22 |
ES2203792T3 (en) | 2004-04-16 |
IL130476A (en) | 2005-05-17 |
GEP20032985B (en) | 2003-06-25 |
HUP0001108A3 (en) | 2000-11-28 |
EP1342469A2 (en) | 2003-09-10 |
EA199900454A1 (en) | 1999-12-29 |
DE69723854T2 (en) | 2004-04-22 |
EP0941067B1 (en) | 2003-07-30 |
US6258341B1 (en) | 2001-07-10 |
IL130476A0 (en) | 2000-06-01 |
ATE245969T1 (en) | 2003-08-15 |
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