CA2507766A1 - Novel dry powder inhalation system for transpulmonary administration - Google Patents
Novel dry powder inhalation system for transpulmonary administration Download PDFInfo
- Publication number
- CA2507766A1 CA2507766A1 CA002507766A CA2507766A CA2507766A1 CA 2507766 A1 CA2507766 A1 CA 2507766A1 CA 002507766 A CA002507766 A CA 002507766A CA 2507766 A CA2507766 A CA 2507766A CA 2507766 A1 CA2507766 A1 CA 2507766A1
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- Prior art keywords
- freeze
- air
- dried composition
- vessel
- fine particles
- Prior art date
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- 239000000843 powder Substances 0.000 title claims abstract 24
- 239000000203 mixture Substances 0.000 claims abstract 65
- 239000010419 fine particle Substances 0.000 claims abstract 61
- 239000002245 particle Substances 0.000 claims abstract 15
- 239000007788 liquid Substances 0.000 claims abstract 10
- 238000007599 discharging Methods 0.000 claims abstract 9
- 238000004108 freeze drying Methods 0.000 claims abstract 7
- 239000004615 ingredient Substances 0.000 claims 9
- 229940112141 dry powder inhaler Drugs 0.000 claims 8
- 238000004519 manufacturing process Methods 0.000 claims 8
- 239000004480 active ingredient Substances 0.000 claims 7
- 229940079593 drug Drugs 0.000 claims 7
- 239000003814 drug Substances 0.000 claims 7
- 238000002360 preparation method Methods 0.000 claims 7
- 238000000034 method Methods 0.000 claims 4
- 238000010298 pulverizing process Methods 0.000 claims 4
- 238000007789 sealing Methods 0.000 claims 3
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
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- 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
-
- A—HUMAN NECESSITIES
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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
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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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
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- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
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- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
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- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
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- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
- A61M15/0033—Details of the piercing or cutting means
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- 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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- 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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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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- A—HUMAN NECESSITIES
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- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
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- A—HUMAN NECESSITIES
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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61M2205/075—Bulb type
Abstract
It is intended to provide a novel dry powder inhalation system for transpulmonary administration which is suitable for transpulmonary administration. This novel dry powder inhalation system for transpulmonary administration comprises : (1) a container having a freeze-dried composition for transpulmonary administration which is prepared by freeze-drying a liquid composition containing a component in an undissolved state and has the following properties (i) to (iii): (i) being in the form of a non-powdery cake; (ii) having a disintegration index of 0.05 or more; and (iii) upon an air impact of an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec, being disintegrated into fine particles having an average particle diameter (an aerodynamic particle diameter) of 10 µm or less or an effective particle rate of 10% or more; combined with (2) a means of applying the above-described air impact to the freeze-dried composition in the above-described container, and a means of discharging the powdery freeze-dried composition having been disintegrated into fine particles.
Claims (22)
1. ~A freeze-dried composition for transpulmonary administration prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form which has the following properties (i) to (iii):
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1m/sec and an air flow rate of at least 17ml/sec.
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1m/sec and an air flow rate of at least 17ml/sec.
2. ~The freeze-dried composition according to Claim 1, wherein a high-molecular-weight drug is contained as an active ingredient.
3. A method of manufacturing a dry powdered preparation for transpulmonary administration, comprising:
introducing air into a vessel to apply to a freeze-dried composition an air impact having an air speed of at least 1m/sec and an air flow rate of at least 17ml/sec using a device capable of applying said air impact to the freeze-dried composition in the vessel, thereby making said freeze-dried composition into fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more;
the freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form and having the following properties:
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of the air impact.
introducing air into a vessel to apply to a freeze-dried composition an air impact having an air speed of at least 1m/sec and an air flow rate of at least 17ml/sec using a device capable of applying said air impact to the freeze-dried composition in the vessel, thereby making said freeze-dried composition into fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more;
the freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form and having the following properties:
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of the air impact.
4. The method of manufacturing a dry powdered preparation for transpulmonary administration according to Claim 3, wherein the freeze-dried composition contains a high-molecular-weight drug as an active ingredient.
5. The method of manufacturing a dry powdered preparation for transpulmonary administration according to Claim 3 comprising pulverizing a freeze-dried composition into fine particles using a dry powder inhaler described under item (A) or (B) as a device:
(A) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having an air jet flow path, a needle part having a discharge flow path, air pressure-feeding member for feeding air into the air jet flow path of said needle part, and an inhalation port that communicates with the discharge flow path of said needle part, and characterized by being constituted such that a stopper that seals up said vessel is pierced by said needle parts, thus 131~
communicating the air jet flow path and the discharge flow path with the inside of said vessel, and air is jetted into said vessel through said air bet flow path using said air pressure-feeding member, thus pulverizing said freeze-dried composition into fine particles by the impact of the jetted air, and discharging the fine particles obtained from the inhalation port via said discharge flow path, or (B) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having a suction flow path, a needle part having an air introduction flow path, and an inhalation port that communicates with said suction flow path, and characterized by being constituted such that, in a state in which a stopper sealing up said vessel has been pierced by said needle parts, through the inhalation pressure of the user, air in said vessel is inhaled from said inhalation port, and at the same time outside air flows into said vessel, at a negative pressure, through said air introduction flow path, and as a result said freeze-dried composition is pulverized into fine particles by the impact of the air flowing in, and the fine particles obtained are discharged from the inhalation port through said suction flow path.
(A) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having an air jet flow path, a needle part having a discharge flow path, air pressure-feeding member for feeding air into the air jet flow path of said needle part, and an inhalation port that communicates with the discharge flow path of said needle part, and characterized by being constituted such that a stopper that seals up said vessel is pierced by said needle parts, thus 131~
communicating the air jet flow path and the discharge flow path with the inside of said vessel, and air is jetted into said vessel through said air bet flow path using said air pressure-feeding member, thus pulverizing said freeze-dried composition into fine particles by the impact of the jetted air, and discharging the fine particles obtained from the inhalation port via said discharge flow path, or (B) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having a suction flow path, a needle part having an air introduction flow path, and an inhalation port that communicates with said suction flow path, and characterized by being constituted such that, in a state in which a stopper sealing up said vessel has been pierced by said needle parts, through the inhalation pressure of the user, air in said vessel is inhaled from said inhalation port, and at the same time outside air flows into said vessel, at a negative pressure, through said air introduction flow path, and as a result said freeze-dried composition is pulverized into fine particles by the impact of the air flowing in, and the fine particles obtained are discharged from the inhalation port through said suction flow path.
6. A dry powder inhalation system for transpulmonary administration, using a combination of:
(1) a vessel housing a freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form, and has:
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) a property of becoming fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more upon receiving an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) a device comprising a member capable of applying said air impact to the freeze-dried composition in said vessel, and a member for discharging the powder-form freeze-dried composition that has been made into fine particles.
(1) a vessel housing a freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form, and has:
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) a property of becoming fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more upon receiving an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) a device comprising a member capable of applying said air impact to the freeze-dried composition in said vessel, and a member for discharging the powder-form freeze-dried composition that has been made into fine particles.
7. The dry powder inhalation system for transpulmonary administration according to Claim 6, wherein the vessel and the device are used in combination at the time of inhalation.
8. The dry powder inhalation system for transpulmonary administration according to Claim 6, wherein the freeze-dried composition contains a high-molecular-weight drug as an active ingredient.
9. The dry powder inhalation system for transpulmonary administration according to Claim 6, wherein the device is:
A) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having an air jet flow path, a needle part having a discharge flow path, air pressure-feeding member for feeding air into the air jet flow path of said needle part, and an inhalation port that communicates with the discharge flow path of said needle part, and characterized by being constituted such that a stopper that seals up said vessel is pierced by said needle parts, thus communicating the air jet flow path and the discharge flow path with the inside of said vessel, and air is jetted into said vessel through said air jet flow path using said air pressure-feeding member, thus pulverizing said freeze-dried composition into fine particles by the impact of the jetted air, and discharging the fine particles obtained from the inhalation port via said discharge flow path, or B) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having a suction flow path, a needle part having an air introduction flow path, and an inhalation port that communicates with said suction flow path, and characterized by being constituted such that, in a state in which a stopper sealing up said vessel has been pierced by said needle parts, through the inhalation pressure of the user, air in said vessel is inhaled from said inhalation port, and at the same time outside air flows into said vessel, at a negative pressure, through said air introduction flow path, and as a result said freeze-dried composition is pulverized into fine particles by the impact of the air flowing in, and the fine particles obtained are discharged from the inhalation port through said suction flow path.
A) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having an air jet flow path, a needle part having a discharge flow path, air pressure-feeding member for feeding air into the air jet flow path of said needle part, and an inhalation port that communicates with the discharge flow path of said needle part, and characterized by being constituted such that a stopper that seals up said vessel is pierced by said needle parts, thus communicating the air jet flow path and the discharge flow path with the inside of said vessel, and air is jetted into said vessel through said air jet flow path using said air pressure-feeding member, thus pulverizing said freeze-dried composition into fine particles by the impact of the jetted air, and discharging the fine particles obtained from the inhalation port via said discharge flow path, or B) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having a suction flow path, a needle part having an air introduction flow path, and an inhalation port that communicates with said suction flow path, and characterized by being constituted such that, in a state in which a stopper sealing up said vessel has been pierced by said needle parts, through the inhalation pressure of the user, air in said vessel is inhaled from said inhalation port, and at the same time outside air flows into said vessel, at a negative pressure, through said air introduction flow path, and as a result said freeze-dried composition is pulverized into fine particles by the impact of the air flowing in, and the fine particles obtained are discharged from the inhalation port through said suction flow path.
10. A transpulmonary administration method comprising:
making a freeze-dried composition into fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more by applying an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec to the freeze-dried composition at the time of use, and administering the resulting fine particle powder to a user by inhalation;
the freeze-dried composition being prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form and having the following properties:
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of the air impact.
making a freeze-dried composition into fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more by applying an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec to the freeze-dried composition at the time of use, and administering the resulting fine particle powder to a user by inhalation;
the freeze-dried composition being prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form and having the following properties:
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of the air impact.
11. The transpulmonary administration method according to Claim 10, wherein the freeze-dried composition is housed in a vessel, and the fine particle powder are prepared using a device comprising a member capable of applying the air impact to the freeze-dried composition in the vessel and a member for discharging the resulting fine particle powder-form freeze-dried composition out of the vessel.
12. The transpulmonary administration method according to Claim 10, wherein the freeze-dried composition contains a high-molecular-weight drug as an active ingredient.
13. The transpulmonary administration method according to Claim 11, using a dry powder inhaler described under item (A) or (B) as the device:
(A) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having an air jet flow path, a needle part having a discharge flow path, air pressure-feeding member for feeding air into the air jet flow path of said needle part, and an inhalation port that communicates with the discharge flow path of said needle part, and characterized by being constituted such that a stopper that seals up said vessel is pierced by said needle parts , thus communicating the air jet flow path and the discharge flow path with the inside of said vessel, and air is jetted into said vessel through said air jet flow path using said air pressure-feeding member, thus pulverizing said freeze-dried composition into fine particles by the impact of the jetted air, and discharging the fine particles obtained from the inhalation port via said discharge flow path, or (B) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having a suction flow path, a needle part having an air introduction flow path, and an inhalation port that communicates with said suction flow path, and characterized by being constituted such that, in a state in which a stopper sealing up said vessel has been pierced by said needle parts, through the inhalation pressure of the user, air in said vessel is inhaled from said inhalation port, and at the same time outside air flows into said vessel, at a negative pressure, through said air introduction flow path, and as a result said freeze-dried composition is pulverized into fine particles by the impact of the air flowing in, and the fine particles obtained are discharged from the inhalation port through said suction flow path.
(A) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having an air jet flow path, a needle part having a discharge flow path, air pressure-feeding member for feeding air into the air jet flow path of said needle part, and an inhalation port that communicates with the discharge flow path of said needle part, and characterized by being constituted such that a stopper that seals up said vessel is pierced by said needle parts , thus communicating the air jet flow path and the discharge flow path with the inside of said vessel, and air is jetted into said vessel through said air jet flow path using said air pressure-feeding member, thus pulverizing said freeze-dried composition into fine particles by the impact of the jetted air, and discharging the fine particles obtained from the inhalation port via said discharge flow path, or (B) a dry powder inhaler for transpulmonary administration, being a device used for making a freeze-dried composition that has been housed in non-powder form in a vessel into fine particles, and administering the resulting fine particles to a user by inhalation, comprising a needle part having a suction flow path, a needle part having an air introduction flow path, and an inhalation port that communicates with said suction flow path, and characterized by being constituted such that, in a state in which a stopper sealing up said vessel has been pierced by said needle parts, through the inhalation pressure of the user, air in said vessel is inhaled from said inhalation port, and at the same time outside air flows into said vessel, at a negative pressure, through said air introduction flow path, and as a result said freeze-dried composition is pulverized into fine particles by the impact of the air flowing in, and the fine particles obtained are discharged from the inhalation port through said suction flow path.
14. Use of a freeze-dried composition for transpulmonary administration by inhalation, the freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form and having the following properties:
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec, and being used by forming into fine particles having said mean particle diameter or said fine particle fraction.
(i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec, and being used by forming into fine particles having said mean particle diameter or said fine particle fraction.
15. The use of a freeze-dried composition for transpulmonary administration according to Claim 14 , wherein the freeze-dried composition is housed in a vessel, and the fine particles are prepared using a device comprising a member capable of applying the air impact to the freeze-dried composition in the vessel and a member for discharging the resulting fine particle powder-form freeze-dried composition out of the vessel.
16. The use of a freeze-dried composition for transpulmonary administration according to Claim 14, wherein the freeze-dried composition contains high-molecular-weight drug as an active ingredient.
17. Use of a freeze-dried composition for manufacture of a dry powdered preparation for transpulmonary administration by inhalation, the freeze-dried composition having the following properties:
(i) being prepared by freeze drying a composition liquid containing ingredients in the non-dissolved form, (ii) a non-powder cake-like form, (iii) a disintegration index of 0.05 or more, and (iv) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec, and being used by forming into fine particles having said mean particle diameter or said fine particle fraction at the time of use.
(i) being prepared by freeze drying a composition liquid containing ingredients in the non-dissolved form, (ii) a non-powder cake-like form, (iii) a disintegration index of 0.05 or more, and (iv) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec, and being used by forming into fine particles having said mean particle diameter or said fine particle fraction at the time of use.
18. The use of a freeze-dried composition for manufacture of a dry powdered preparation for transpulmonary administration by inhalation according to Claim 17 , wherein the freeze-dried composition contains a high-molecular-weight drug as an active ingredient.
19. The use of a freeze-dried composition for manufacture of a dry powdered preparation for transpulmonary administration according to Claim 17, wherein the freeze-dried composition is housed in a vessel, and the fine particles are prepared by using a device comprising a member for applying a prescribed air impact to the freeze-dried composition housed in the vessel and a member for discharging the resulting fine particle powder form freeze-dried composition out of the vessel.
20 . Use of a composition liquid containing ingredients in the non-dissolved form for manufacture of a freeze-dried composition having the following properties , which is used for manufacture of dry powdered preparation for transpulmonary administration:
(i) a non-powder cake-like form, (ii) a disintegration index of 4.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec, and being used by forming into fine particles having said mean particle diameter or said fine particle fraction at the time of use.
(i) a non-powder cake-like form, (ii) a disintegration index of 4.05 or more, and (iii) becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec, and being used by forming into fine particles having said mean particle diameter or said fine particle fraction at the time of use.
21. The use of a composition liquid containing ingredients in the non-dissolved form according to Claim 20, wherein the freeze-dried composition contains a high-molecular-weight drug as an active ingredient
22. The use of a composition liquid containing ingredients in the non-dissolved form according to Claim 20, wherein the freeze-dried composition is housed in a vessel, and the fine particles are prepared by using a device comprising a member for applying a prescribed air impact to the freeze-dried composition housed in the vessel and a member for discharging the resulting fine particle powder form freeze-dried composition out of the vessel.
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JP2002363158 | 2002-12-13 | ||
PCT/JP2003/015931 WO2004054555A1 (en) | 2001-06-15 | 2003-12-12 | Novel dry powder inhalation system for transpulmonary administration |
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CA2507766A Expired - Fee Related CA2507766C (en) | 2001-06-15 | 2003-12-12 | Novel dry powder inhalation system for transpulmonary administration |
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