CA2344816A1 - Medicinal aerosol formulation - Google Patents
Medicinal aerosol formulation Download PDFInfo
- Publication number
- CA2344816A1 CA2344816A1 CA002344816A CA2344816A CA2344816A1 CA 2344816 A1 CA2344816 A1 CA 2344816A1 CA 002344816 A CA002344816 A CA 002344816A CA 2344816 A CA2344816 A CA 2344816A CA 2344816 A1 CA2344816 A1 CA 2344816A1
- Authority
- CA
- Canada
- Prior art keywords
- formulation
- stabilizer
- metered dose
- foregoing
- mixture
- 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
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- 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
- A61P11/08—Bronchodilators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
This invention relates to a medicinal aerosol formulation and more particularly, to a medicinal aerosol formulation containing a particulate drug, a propellant, and stabilizing agent selected from an amino acid, an amino acid derivative and a mixture of the foregoing.
Claims (20)
1. A medicinal aerosol formulation, which comprises:
(a) a therapeutically effective amount of a particulate medicament;
(b) a propellant; and (c) a stabilizer selected from an amino acid, a derivative thereof, or a mixture of the foregoing.
(a) a therapeutically effective amount of a particulate medicament;
(b) a propellant; and (c) a stabilizer selected from an amino acid, a derivative thereof, or a mixture of the foregoing.
2. The formulation as defined in claim 1 wherein said stabilizer is selected from the group consisting of glycin, glycine, alanine, valine, leucine, isoleucine, methionine, threonine, isovaline, phenylalanine, tyrosine, serine, histidine, tryptophan, proline, hydroxyproline, arginine, ornithine, asparagine, citrulline, aspartic acid, cysteine, glutamic acid, glutamine, lysine, hydroxylysine, N-acetyl-L-cysteine, phenylalanine, trans-4-hydroxy-L-proline, tyrosine, L-aspartyl-L-phenylalanine methylester and a mixture of any of the foregoing.
3. The formulation as defined in claim 1 wherein the medicament is selected from the group consisting of albuterol, atropine, beclomethasone, beclomethasone monopropionate, beclomethasone dipropionate, budesonide, cromolyn, epinephrine, ephedrine, fentanyl, flunisolide, formoterol, ipratropium bromide, isoproterenol, pirbuterol, prednisone, salmeterol, amiloride, fluticasone, fluticasone esters, (-)4-amino-3,5-dichloro-a-[[[6(2-pyridinyl)ethoxy] hexyl]
amino]
methyl]benzene-methanol and pharmaceutically acceptable salts, esters, hydrates and solvates of the foregoing.
amino]
methyl]benzene-methanol and pharmaceutically acceptable salts, esters, hydrates and solvates of the foregoing.
4. The formulation as defined in claim 1, wherein said propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane or a mixture thereof.
5. The formulation as defined in claim 1 which further includes a cosolvent.
6. The formulation as defined in claim 5 wherein said cosolvent comprises ethanol.
7. The formulation as defined in claim 2 wherein said stabilizer is present in an amount effective to prevent settling, creaming or flocculation of the formulation for a time sufficient to allow reproducible dosing of the drug after agitation of the formulation.
8. The formulation as defined in claim 7 wherein said stabilizer is present in an amount ranging from about 0.000002% by weight to about 20% by weight based on the weight of the formulation.
9. A method of preparing a medicinal aerosol formulation according to claim 1, which comprises:
(a) combining (i) said medicament in an amount sufficient to provide a plurality of therapeutically effective doses, (ii) said propellant in an amount sufficient to propel a plurality of said therapeutically effective doses from an aerosol canister; and (iii) said stabilizer in an amount effective to stabilize the formulation; and (b) dispersing components (i), (ii) and (iii).
(a) combining (i) said medicament in an amount sufficient to provide a plurality of therapeutically effective doses, (ii) said propellant in an amount sufficient to propel a plurality of said therapeutically effective doses from an aerosol canister; and (iii) said stabilizer in an amount effective to stabilize the formulation; and (b) dispersing components (i), (ii) and (iii).
10. The method as defined in claim 9 wherein the medicinal aerosol formulation further comprises combining in step (a) a cosolvent and in step (b) dispersing components (i), (ii), (iii) with said cosolvent.
11. A method of treating in an animal a condition capable of treatment by oral or nasal inhalation, which comprises, administering a formulation according to claim 1 to said animal by oral or nasal inhalation.
12. A formulation according to claim 1 in an aerosol canister equipped with a metered dose valve.
13. A method of stabilizing a suspension aerosol formulation comprising a propellant and a particulate drug which comprises, incorporating into the formulation a stabilizer selected from the group consisting of a suitable amino acid, a derivative thereof, or any mixture of the foregoing, in an amount which is effective to prevent settling, creaming, or flocculation of the formulation for a time sufficient to allow reproducible dosing of the drug after agitation of the formulation.
14. A metered dose inhaler containing a medicinal aerosol formulation, the formulation comprising:
(a) a drug in particulate form in a therapeutically effective amount;
(b) a propellant; and (c) a suitable stabilizer selected from an amino acid, an amino acid derivative, or a mixture of the foregoing, present in an amount sufficient to stabilize the formulation to prevent settling, creaming or flocculation for a time sufficient to allow reproducible dosing of the drug after agitation of the formulation.
(a) a drug in particulate form in a therapeutically effective amount;
(b) a propellant; and (c) a suitable stabilizer selected from an amino acid, an amino acid derivative, or a mixture of the foregoing, present in an amount sufficient to stabilize the formulation to prevent settling, creaming or flocculation for a time sufficient to allow reproducible dosing of the drug after agitation of the formulation.
15. The metered dose inhaler as defined in claim 14 wherein the stabilizer is selected from the group consisting of glycin, glycine, alanine, valine, leucine, isoleucine, methionine, threonine, isovaline, serine, histidine, tryptophan, proline, hydroxyproline, arginine, ornithine, asparagine, citrulline, aspartic acid, cysteine, glutamic acid, glutamine, lysine, hydroxylysine, N-acetyl-L-cysteine, phenylalanine, trans-4-hydroxy-L-proline, tyrosine, L-aspartyl-L-phenylalanine methylester and a mixture of any of the foregoing.
16. The metered dose inhaler as defined in claim 15 wherein said stabilizer is present in an amount of 0.000002% by weight to about 20% by weight based on the weight of the medicinal aerosol formulation.
17. The metered dose inhaler as defined in claim 14 wherein the drug is selected from the group consisting of albuterol, atropine, beclomethasone, beclomethasone monopropionate, beclomethasone dipropionate, budesonide, cromolyn, epinephrine, ephedrine, fentanyl, flunisolide, formoterol, ipratropium bromide, isoproterenol, pirbuterol, prednisone, salmeterol, amiloride, fluticasone, an ester of fluticasone,(-)4-amino-3,5-dichloro-.alpha.-[[[6(2-pyridinyl)ethoxy]
hexyl] amino]
methyl]benzene-methanol and pharmaceutically acceptable hydrates, salts and solvates of the foregoing.
hexyl] amino]
methyl]benzene-methanol and pharmaceutically acceptable hydrates, salts and solvates of the foregoing.
18. The metered dose inhaler as defined in claim 14 wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane or a mixture thereof.
19. The metered dose inhaler as defined in claim 14 wherein the medicinal aerosol formulation further comprises a cosolvent.
20. The metered dose inhaler as defined in claim 19 wherein said cosolvent comprises ethanol.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09158369 US6136294C1 (en) | 1998-09-22 | 1998-09-22 | Amino acid stabilized medical aerosol formulation |
US09/158,369 | 1998-09-22 | ||
PCT/US1999/021510 WO2000016814A1 (en) | 1998-09-22 | 1999-09-17 | Medicinal aerosol formulation |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2344816A1 true CA2344816A1 (en) | 2000-03-30 |
CA2344816C CA2344816C (en) | 2011-05-24 |
Family
ID=22567809
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2344816A Expired - Fee Related CA2344816C (en) | 1998-09-22 | 1999-09-17 | Medicinal aerosol formulation |
Country Status (15)
Country | Link |
---|---|
US (1) | US6136294C1 (en) |
EP (2) | EP1731140B1 (en) |
JP (1) | JP2002526459A (en) |
CN (1) | CN100337614C (en) |
AT (2) | ATE336268T1 (en) |
AU (1) | AU745554B2 (en) |
CA (1) | CA2344816C (en) |
CY (1) | CY1105538T1 (en) |
DE (2) | DE69932835T2 (en) |
DK (1) | DK1123120T3 (en) |
ES (1) | ES2267288T3 (en) |
HK (2) | HK1041835A1 (en) |
MX (1) | MXPA01002894A (en) |
PT (1) | PT1123120E (en) |
WO (1) | WO2000016814A1 (en) |
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IL104068A (en) * | 1991-12-12 | 1998-10-30 | Glaxo Group Ltd | Surfactant-free pharmaceutical aerosol formulation comprising 1,1,1,2-tetrafluoroethane or 1,1,1,2,3,3,3-heptafluoro-n- propane as propellant |
US5653962A (en) * | 1991-12-12 | 1997-08-05 | Glaxo Group Limited | Aerosol formulations containing P134a and particulate medicaments |
US5744123A (en) * | 1991-12-12 | 1998-04-28 | Glaxo Group Limited | Aerosol formulations containing P134a and particulate medicaments |
GB9202522D0 (en) * | 1992-02-06 | 1992-03-25 | Glaxo Group Ltd | Medicaments |
US5736124A (en) * | 1991-12-12 | 1998-04-07 | Glaxo Group Limited | Aerosol formulations containing P134a and particulate medicament |
GB9202519D0 (en) * | 1992-02-06 | 1992-03-25 | Glaxo Group Ltd | Medicaments |
NZ263686A (en) * | 1993-03-17 | 1997-09-22 | Minnesota Mining & Mfg | Medicinal aerosol with dispersing aid derived from a hydroxy acid, an amino acid and/or a mercapto acid |
PT731688E (en) * | 1993-12-02 | 2003-07-31 | Abbott Lab | FORMULATIONS OF AEROSOL DRUGS FOR USE WITH CFC-FREE PROPULSORS |
CN1069192C (en) * | 1994-04-21 | 2001-08-08 | 王世立 | Aerosol preparation and preparation method thereof |
MX9704550A (en) * | 1994-12-22 | 1997-10-31 | Astra Ab | Aerosol drug formulations. |
US6136346A (en) * | 1995-04-14 | 2000-10-24 | Inhale Therapeutic Systems | Powdered pharmaceutical formulations having improved dispersibility |
-
1998
- 1998-09-22 US US09158369 patent/US6136294C1/en not_active Expired - Lifetime
-
1999
- 1999-09-17 AU AU59267/99A patent/AU745554B2/en not_active Ceased
- 1999-09-17 JP JP2000573775A patent/JP2002526459A/en active Pending
- 1999-09-17 MX MXPA01002894A patent/MXPA01002894A/en active IP Right Grant
- 1999-09-17 AT AT99946974T patent/ATE336268T1/en active
- 1999-09-17 ES ES99946974T patent/ES2267288T3/en not_active Expired - Lifetime
- 1999-09-17 AT AT06016853T patent/ATE505184T1/en not_active IP Right Cessation
- 1999-09-17 EP EP06016853A patent/EP1731140B1/en not_active Expired - Lifetime
- 1999-09-17 DE DE69932835T patent/DE69932835T2/en not_active Expired - Lifetime
- 1999-09-17 WO PCT/US1999/021510 patent/WO2000016814A1/en active IP Right Grant
- 1999-09-17 CA CA2344816A patent/CA2344816C/en not_active Expired - Fee Related
- 1999-09-17 DK DK99946974T patent/DK1123120T3/en active
- 1999-09-17 PT PT99946974T patent/PT1123120E/en unknown
- 1999-09-17 EP EP99946974A patent/EP1123120B1/en not_active Expired - Lifetime
- 1999-09-17 DE DE69943360T patent/DE69943360D1/en not_active Expired - Lifetime
- 1999-09-17 CN CNB998135674A patent/CN100337614C/en not_active Expired - Fee Related
-
2002
- 2002-05-08 HK HK02103508A patent/HK1041835A1/en not_active IP Right Cessation
-
2006
- 2006-09-12 CY CY20061101291T patent/CY1105538T1/en unknown
-
2007
- 2007-05-23 HK HK07105448.0A patent/HK1097777A1/en unknown
Also Published As
Publication number | Publication date |
---|---|
MXPA01002894A (en) | 2002-06-04 |
DE69932835T2 (en) | 2007-02-01 |
EP1123120B1 (en) | 2006-08-16 |
EP1731140A2 (en) | 2006-12-13 |
AU745554B2 (en) | 2002-03-21 |
ATE336268T1 (en) | 2006-09-15 |
WO2000016814A1 (en) | 2000-03-30 |
US6136294A (en) | 2000-10-24 |
CA2344816C (en) | 2011-05-24 |
ATE505184T1 (en) | 2011-04-15 |
HK1097777A1 (en) | 2007-07-06 |
CN100337614C (en) | 2007-09-19 |
EP1731140B1 (en) | 2011-04-13 |
DK1123120T3 (en) | 2006-10-02 |
EP1123120A4 (en) | 2003-07-23 |
HK1041835A1 (en) | 2002-07-26 |
ES2267288T3 (en) | 2007-03-01 |
EP1123120A1 (en) | 2001-08-16 |
DE69943360D1 (en) | 2011-05-26 |
AU5926799A (en) | 2000-04-10 |
US6136294C1 (en) | 2002-09-24 |
JP2002526459A (en) | 2002-08-20 |
DE69932835D1 (en) | 2006-09-28 |
CN1328473A (en) | 2001-12-26 |
EP1731140A3 (en) | 2007-06-27 |
PT1123120E (en) | 2006-10-31 |
CY1105538T1 (en) | 2010-07-28 |
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