CA2248050A1 - Components for inhalation devices - Google Patents
Components for inhalation devices Download PDFInfo
- Publication number
- CA2248050A1 CA2248050A1 CA002248050A CA2248050A CA2248050A1 CA 2248050 A1 CA2248050 A1 CA 2248050A1 CA 002248050 A CA002248050 A CA 002248050A CA 2248050 A CA2248050 A CA 2248050A CA 2248050 A1 CA2248050 A1 CA 2248050A1
- Authority
- CA
- Canada
- Prior art keywords
- carbon black
- component
- polymeric material
- spacer
- loaded
- 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.)
- Abandoned
Links
Classifications
-
- 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
-
- 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
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01C—RESISTORS
- H01C7/00—Non-adjustable resistors formed as one or more layers or coatings; Non-adjustable resistors made from powdered conducting material or powdered semi-conducting material with or without insulating material
- H01C7/02—Non-adjustable resistors formed as one or more layers or coatings; Non-adjustable resistors made from powdered conducting material or powdered semi-conducting material with or without insulating material having positive temperature coefficient
- H01C7/027—Non-adjustable resistors formed as one or more layers or coatings; Non-adjustable resistors made from powdered conducting material or powdered semi-conducting material with or without insulating material having positive temperature coefficient consisting of conducting or semi-conducting material dispersed in a non-conductive organic material
-
- 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
-
- 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- 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
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0233—Conductive materials, e.g. antistatic coatings for spark prevention
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
Abstract
A component for use in an inhalation apparatus is described, said component being made of or coated with a polymeric material loaded with carbon black in an amount sufficient to impart to the polymeric material a specific volume resistivity of less than 109 Ohmcm.
Description
~ CA 022480~0 1998-09-01 D1518-lWO PCT/ SE 9 7 / O 0 4 7 0 'O 3 ~ 1998 I
COMPONENTS FOR INHALATION DEVICES
The present invention relates to components for inhalation devices for inhaling medicament, especially those components which can affect airborne particles or come into contact with medicament.
Inhalation devices include dry powder inhalers, intended to dispense medicament which is in the form of a dry powder, and pressurised metered dose inhalers, which generally contain a medicament dissolved or suspended in a liquefied propellant gas, optionally o together with surfactants and other excipients. The mechanism for dispensing the medicament varies between inhalers, but in general the medicament must exit the body of the inhaler and pass through a channel to a mouthpiece. The mouthpiece may connect with a spacer, that is, a dispersion chamber designed to facilitate inhalation.
Pressurised metered dose inhalers release a metered dose of medicament upon eachactuation, and for maximum benefit with direct inhalation a degree of co-ordination between actuation and inhalation is required. Powder inhalers are actuated by the air flow generated at inhalation and for maximum benefit a certain air flow is required. With a spacer, the medicament is dispensed into the spacer chamber from where it can be inhaled ~o simply by breathing normally. The residence time of the medicament in the spacer can be from a few seconds to several minutes, for example.
An example of a dry powder inhaler is the Turbuhaler(~) inhaler. Examples of spacers include the Nebuhaler(~) and Nebuchamber~) spacers.
'5 In the course of inhalation, medicament will come into contact with various parts of an inhalation device, including for example the body, channel and mouthpiece of an inhaler, and a spacer. Such components are generally (but not essentially) made of a polymeric material, for example, a polypropylene or a polyethylene, which is moulded into the required shape.
A~E~ SHE~
' CA 022480~0 1998-09-01 Dls4s-lwo PCT/SE97 /a0470 ~ 3 -n6- 1998 Not all of a nominal dose of medicament from an inhaler will reach its intended target, which may be, for example, the lungs. The medicament which does not reach the target is lost, for example, in the inhaler, mouth and respiratory tract. Clearly, the amount of wastage should be as low as possible.
WO-A-91/19524 describes an inhaler for inhaling pulverulent medicament from within a capsule, including a capsule chamber which may be formed of components made of apolymeric material with low surface resistivity in order to rninimice the extent to which o released powdered medicament can agglomerate on the surface of the air passage through the inhaler. The surface resistivity desired is preferably less than 101- Ohms and more preferably less than 108 Ohms. The polymeric material may incorporate carbon or steel filler, for example, in the form of fibres or non-fibrous chemical additives. As examples of the polymeric material are mentioned a polyether block amide product with chemical additives and a range of polypropylenes with chemical additives. The inhaler also includes a mouthpiece, which may be integral with the chamber, preferably having at least its inner wall formed from such a polymeric material of low surface resistivity.
WO-A-95/20414 describes a spacer for children, primarily intended to be used in conjunction with a pressurised metered dose inhaler. The spacer is made from stainless steel, which has a surface resistivity such that electrostatic attraction between the respirable particles and spacer walls is minimised. The surface resistivity is less than 109 Ohm, preferably less than 106 Ohm and most preferably less than 1 Ohm.
The present invention is concerned with polymeric materials in components for inhalation devices. It has been found that the amount of medicament which is retained in a device comprising components made of a polymeric material can be significantly reduced by incorporating carbon black into the polymeric material. Components according to the present invention have anti-static properties which minimise the amount of medicament retained on component surfaces.
A!~ ED SHEr ~ CA 022480~0 1998-09-01 PCT/ SE 9 7 / 0 0 4 7 0 D1548-iWO
O ~ 199~
Carbon blacks are obtainable, for example, from Degussa AG, Frankfurt, Germany. They are chemically and physically well-defined products, which are manufactured by incomplete combustion of oils or gases, and are composed of more than 96 percent by weight of finely dispersed carbon with small amounts of oxygen, hydrogen, nitrogen and sulphur. They may be produced, for example, as dispersions, pastes, chips or pellets.
Today, the most important method for the manufacture of carbon blacks is the so-called "furnace black" process. This process can produce a large variety of carbon blacks, for example, with particular particle sizes and specific surface areas. It also permits the o control of particle aggregation, that is, the carbon black structure. Carbon blacks consist of chained-branched aggregates of approximately spherical "primary" particles. Extensive branching or interlinking produces carbon black having a "high structure", while less extensive interlinking produces a "low structure" carbon black. One method for the determination of structure is the "DBP absorption" test, which is described in ISO 4656 and ASTM D-2414. In this method, dibutylphthalate (DBP) is added dropwise to a certain amount of carbon black that has been placed in a calibrated kneading machine and the torque exerted by the kneading machine is measured. A change in the torque indicates that all of the voids between the carbon black aggregates have been filled with DBP and the surface has been wetted. The consumption of DBP thus allows determination of the degree of aggregation of the carbon black. In general, the higher the DBP absorption in ml /100 g (the "DBP number"), the higher the carbon black structure. Carbon blacks with a low structure have a DBP number of less than 70 ml/100 g of carbon black, those with a medium structure have a DBP number of between 70 and 100 ml/100 g of carbon black, and those with a high structure have a DBP number of above 110 ml/100 g of carbon black.
So-called "extra-conductive" carbon blacks typically have a DBP number in excess of 300 ml/100 g of carbon black.
The primary use of carbon blacks is in the reinforcement of rubber, for pigmentation, UV
stabilisation and as conductive blacks.
A~ND~D SllEET
CA 022480C.0 1998-09-01 Dls~s-lwo PCT/ SE 9 7 / 0 0 4 7 0 0 3 ~ 1998 Accordingly, the present invention provides a component for use in an inhalation device, said component being made of or coated with a polymeric material loaded with carbon black having a DBP number of more than 300 ml/l00 g of carbon black and in an amount of between 3 and 15 percent by weight of the polymeric material to impart to the polymeric 5 material a specific volume resistivity of less than l09 Ohmcm.
The present invention also extends to an inhalation device, in particular a spacer, incorporating the component as described above.
10 Preferably, the specific volume resistivity of the polymeric material is less than about lo6 Ohmcm, more preferably less than about 104 Ohmcm. In an especially preferred embodiment the specific volume resistivity of the polymeric material is less than about 102 Ohmcm.
15 Specific volume resistivity may be measured using commercially available apparatuses for measuring conductivity.
The use of a carbon black dispersion is particularly advantageous as good dispersion of the carbon black in the polymeric material can be achieved. Preferably, the carbon black-20 loaded polymeric material comprises a homogeneous distribution of the carbon black.
3 The very low specific volume resistivity values which may be achieved in accordance with the present invention are particularly valuable when the component is incorporated in a spacer. In a spacer, a comparatively long medicament residence time is necessary, and the longer the residence time, the more opportunity there is for the medicament to "attach" to the spacer walls.
It will be understood that the component of the present invention may be other than that incorporated in a spacer. For example, the component may comprise the body, a channel, or the mouthpiece of an inhaler.
AM~ ED SH~ET
CA 022480~0 1998-09-01 D1548-lWO PCT/ SE97 /00470 O ~ ~ 1998 Preferably, carbon black is included in an amount of between 6 and lO percent and especially between 8 and lO percent by weight of the carbon black-loaded polymeric material.
More preferably, carbon black is included in an amount of around lO percent, or around 9 percent, or around 8 percent, or around 7 percent, or around 6 percent, or around 5 percent, or around 4 percent by weight of the carbon black-loaded polymeric material.
o Suitable carbon blacks are commercially available, for example, from Degussa AG, or from Cabot Plastics, Belgium. Examples of Degussa AG carbon blacks are the range of carbon blacks known as Printex(~), for example "Printex L", "Printex L 6", and the extra-conductive "Printex XE 2".
The polymeric material can be any which can be moulded into the desired shape. For example, the polymeric material may be a polypropylene, a polyethylene. a polyester, a polycarbonate, a polystyrene, a polyoxyethylene, a fluoropolymer, or a copolymer thereof.
Suitable polymeric materials may be obtained, for example, from Hoechst AG, Frankfurt, Germany. As specific examples of polymeric materials may be mentioned the polyethylenes Hostalen(~) and Hostalen GUR(~); the polypropylenes Hostalen PP(~) and Hostacen(~); as well as Topas(~), Hostaform(~), Kemetal@), Celanex(~3, Vandar(~), Impet g), Celstram(~), Fortron( 9, Vectra(~) and Hostaflon~), all available from Hoechst AG.
Preferably, the polymeric material is a polypropylene or a polyethylene.
The carbon black-loaded polymeric material, and the homogeneous mixture, may be manufactured by conventional methods, for example, by extrusion of the polymericmaterial together with the carbon black. The mixing parameters, flow conditions and cooling conditions may be optimised easily by methods well known to a person skilled in the art, according to the particular polymeric material and carbon black used.
A~ ND~D S~
. CA 022480S0 1998-09-01 Carbon black-loaded polymeric materials are also commercially available, for example, from Premix Oy, Rajamaki, Finland.
The components according to the present invention may be made by conventional moulding techniques, for example, by injection moulding or by blow moulding. Themoulding parameters may be optimised easily by a person skilled in the art, according to the particular materials used. The preferred method of manufacture is injection moulding.
Typical injection moulding parameters may be for example a cylinder nozzle temperature of from 200 to 250 ~C, a mould temperature of from 30 to 80 ~C, an injection pressure of o from 600 to 1800 bar and a moderate injection speed. Preferably, a low moulding speed is used initially and slowly increased during the moulding process. Preferably, the back pressure is as low as technically possible. Preferably, the material for injection moulding is pre-dried, for example, at from 75 to 80 ~C for up to 4 hours, typically from 2 to 4 hours.
The present invention also provides a method of forming the component for use in an inhalation device as described above, comprising the step of moulding the component at least in part from a carbon black-loaded polymeric material.
When the carbon black-loaded polymeric material is a coating on another polymeric material, it may be co-moulded with the other polymeric material, for example, using two extruders, to produce a moulded component in which the carbon black-loaded polymeric material is surrounded by the other material; that is, the "inner" surface of the component is of the carbon black-loaded polymeric material and the "outer" surface of the component is of the other polymeric material. The outer material may be provided with any desired pigmentation to mask the black colour of the carbon black in circumstances where this would be considered undesirable.
~ The thickness of the component or carbon black-loaded polymeric layer may vary according to the nature of the moulded component. Where the component is incorporated A~DED SHEET
CA 022480~0 1998-09-01 D1548-lWO PCT/SE97 /00470 0 3 ~ 1998 in a spacer, for example, the thickness of the carbon black-loaded polymeric material may be, for example, up to about 10 mm, preferably betw~en 1 and 5 mm thick.
The present invention will be further described with reference to the following non-limiting Examples.
Example I
A carbon black-loaded polymeric material, "PP 1381 " (formerly "Pre-Elec TP 4474"), o Premix Oy, comprising polypropylene "Hostalen PPU 1734S 1 ", Hoechst AG, and 9percent by weight of "Printex XE 2" carbon black, Degussa AG, was used to manufacture a spacer for use with a dry powder inhaler, by injection moulding using a "Ferromatic"
injection moulder, with a cylinder nozzle temperature of 240 ~C, a mould cavity temperature of 30 ~C, an injection pressure of 1700 bar, a back pressure of 1600 bar and a moderate injection speed.
The specific volume resistivity obtained was 100 Ohmcm. (Surface resistivity 1300 Ohm.) Example 2 A carbon black-loaded polymeric material, "Pre-Elec TP 4479", Premix Oy, comprising polypropylene "Hostalen PPU 1734Sl", Hoechst AG, and 22 percent by weight "Black'~ Pearls 4750" carbon black, Cabot Plastics, was used to manufacture a spacer for use with a dry powder inhaler, by injection moulding as in Example 1.
The specific volume resistivity obtained was 30 Ohmcm. (Surface resistivity 800 Ohm.) Example 3 A~D~D S~EET
_ _ . CA 022480~0 1998-09-01 D15~8-lWO PCT/ SE 9 7 t 0 0 4 7 0 0 3 ~6- 1998 A carbon bl~ck-loaded polymeric material, "Pre-Elec TP 4480", Premix Oy, comprising polypropylene "Hostalen PPU 1734S l", Hoechst AG, and 37 percent by weight "Channel Black MPC" carbon black, Cabot Plastics, was used to manufacture a spacer for use with a dry powder inhaler, by injection moulding as in Example 1.
The specific volume resistivity obtained was 10000 Ohmcm. (Surface resistivity 100000 Ohm.) Example 4 Doses of budesonide from a dry powder inhaler (Pulmicort Turbuhalertg)) containing 200 unit doses each comprising 400 ~g of budesonide were expelled by means of a suction flow into a spacer according to Example I above After a 2 second delay, suction flow means were employed to expel the dose from the spacer onto a filter.
The experiment was repeated using a spacer constructed of polypropylene only. The means of manufacture of the polypropylene-only spacer was as in Example 1, but with aninjection pressure of 900 bar and a back pressure of 600 bar.
~o The amount of budesonide on the filter after expulsion from the carbon black-loaded polypropylene spacer of Example 1 was 2.4 times greater than the amount resulting from expulsion from the conventional polypropylene spacer. This was taken as an indication of ~ the greatly reduced amount of medicament which had been retained in the spacer according to the present invention as compared with a conventional spacer.
~5 Example 5 Doses of budesonide from a dry powder inhaler (Pulmicort Turbuhalertg)) containing 200 unit doses each comprising 400 llg of budesonide were expelled by means of a suction flow ~E0 SHEET
CA 022480~0 1998-09-01 D15~8-lwO PCT/ SE97 / OC470 0 3 ~ 1998 into a spacer according to Example 1 above. After a 30 second delay, suction flow means were employed to expel the dose from the spacer ont~ a filter.
The experiment was repeated using a spacer constructed of polypropylene only. The means of manufacture of the polypropylene-only spacer was as in Example 1, but with aninjection pressure of 900 bar and a back pressure of 600 bar.
The amount of budesonide on the filter after expulsion from the carbon black-loaded polypropylene spacer of Example 1 was 2.8 times greater than the amount resulting from o expulsion from the conventional polypropylene spacer. This was taken as an indication of the greatly reduced amount of medicament which had been retained in the spacer according to the present invention as compared with a conventional spacer.
D S~
COMPONENTS FOR INHALATION DEVICES
The present invention relates to components for inhalation devices for inhaling medicament, especially those components which can affect airborne particles or come into contact with medicament.
Inhalation devices include dry powder inhalers, intended to dispense medicament which is in the form of a dry powder, and pressurised metered dose inhalers, which generally contain a medicament dissolved or suspended in a liquefied propellant gas, optionally o together with surfactants and other excipients. The mechanism for dispensing the medicament varies between inhalers, but in general the medicament must exit the body of the inhaler and pass through a channel to a mouthpiece. The mouthpiece may connect with a spacer, that is, a dispersion chamber designed to facilitate inhalation.
Pressurised metered dose inhalers release a metered dose of medicament upon eachactuation, and for maximum benefit with direct inhalation a degree of co-ordination between actuation and inhalation is required. Powder inhalers are actuated by the air flow generated at inhalation and for maximum benefit a certain air flow is required. With a spacer, the medicament is dispensed into the spacer chamber from where it can be inhaled ~o simply by breathing normally. The residence time of the medicament in the spacer can be from a few seconds to several minutes, for example.
An example of a dry powder inhaler is the Turbuhaler(~) inhaler. Examples of spacers include the Nebuhaler(~) and Nebuchamber~) spacers.
'5 In the course of inhalation, medicament will come into contact with various parts of an inhalation device, including for example the body, channel and mouthpiece of an inhaler, and a spacer. Such components are generally (but not essentially) made of a polymeric material, for example, a polypropylene or a polyethylene, which is moulded into the required shape.
A~E~ SHE~
' CA 022480~0 1998-09-01 Dls4s-lwo PCT/SE97 /a0470 ~ 3 -n6- 1998 Not all of a nominal dose of medicament from an inhaler will reach its intended target, which may be, for example, the lungs. The medicament which does not reach the target is lost, for example, in the inhaler, mouth and respiratory tract. Clearly, the amount of wastage should be as low as possible.
WO-A-91/19524 describes an inhaler for inhaling pulverulent medicament from within a capsule, including a capsule chamber which may be formed of components made of apolymeric material with low surface resistivity in order to rninimice the extent to which o released powdered medicament can agglomerate on the surface of the air passage through the inhaler. The surface resistivity desired is preferably less than 101- Ohms and more preferably less than 108 Ohms. The polymeric material may incorporate carbon or steel filler, for example, in the form of fibres or non-fibrous chemical additives. As examples of the polymeric material are mentioned a polyether block amide product with chemical additives and a range of polypropylenes with chemical additives. The inhaler also includes a mouthpiece, which may be integral with the chamber, preferably having at least its inner wall formed from such a polymeric material of low surface resistivity.
WO-A-95/20414 describes a spacer for children, primarily intended to be used in conjunction with a pressurised metered dose inhaler. The spacer is made from stainless steel, which has a surface resistivity such that electrostatic attraction between the respirable particles and spacer walls is minimised. The surface resistivity is less than 109 Ohm, preferably less than 106 Ohm and most preferably less than 1 Ohm.
The present invention is concerned with polymeric materials in components for inhalation devices. It has been found that the amount of medicament which is retained in a device comprising components made of a polymeric material can be significantly reduced by incorporating carbon black into the polymeric material. Components according to the present invention have anti-static properties which minimise the amount of medicament retained on component surfaces.
A!~ ED SHEr ~ CA 022480~0 1998-09-01 PCT/ SE 9 7 / 0 0 4 7 0 D1548-iWO
O ~ 199~
Carbon blacks are obtainable, for example, from Degussa AG, Frankfurt, Germany. They are chemically and physically well-defined products, which are manufactured by incomplete combustion of oils or gases, and are composed of more than 96 percent by weight of finely dispersed carbon with small amounts of oxygen, hydrogen, nitrogen and sulphur. They may be produced, for example, as dispersions, pastes, chips or pellets.
Today, the most important method for the manufacture of carbon blacks is the so-called "furnace black" process. This process can produce a large variety of carbon blacks, for example, with particular particle sizes and specific surface areas. It also permits the o control of particle aggregation, that is, the carbon black structure. Carbon blacks consist of chained-branched aggregates of approximately spherical "primary" particles. Extensive branching or interlinking produces carbon black having a "high structure", while less extensive interlinking produces a "low structure" carbon black. One method for the determination of structure is the "DBP absorption" test, which is described in ISO 4656 and ASTM D-2414. In this method, dibutylphthalate (DBP) is added dropwise to a certain amount of carbon black that has been placed in a calibrated kneading machine and the torque exerted by the kneading machine is measured. A change in the torque indicates that all of the voids between the carbon black aggregates have been filled with DBP and the surface has been wetted. The consumption of DBP thus allows determination of the degree of aggregation of the carbon black. In general, the higher the DBP absorption in ml /100 g (the "DBP number"), the higher the carbon black structure. Carbon blacks with a low structure have a DBP number of less than 70 ml/100 g of carbon black, those with a medium structure have a DBP number of between 70 and 100 ml/100 g of carbon black, and those with a high structure have a DBP number of above 110 ml/100 g of carbon black.
So-called "extra-conductive" carbon blacks typically have a DBP number in excess of 300 ml/100 g of carbon black.
The primary use of carbon blacks is in the reinforcement of rubber, for pigmentation, UV
stabilisation and as conductive blacks.
A~ND~D SllEET
CA 022480C.0 1998-09-01 Dls~s-lwo PCT/ SE 9 7 / 0 0 4 7 0 0 3 ~ 1998 Accordingly, the present invention provides a component for use in an inhalation device, said component being made of or coated with a polymeric material loaded with carbon black having a DBP number of more than 300 ml/l00 g of carbon black and in an amount of between 3 and 15 percent by weight of the polymeric material to impart to the polymeric 5 material a specific volume resistivity of less than l09 Ohmcm.
The present invention also extends to an inhalation device, in particular a spacer, incorporating the component as described above.
10 Preferably, the specific volume resistivity of the polymeric material is less than about lo6 Ohmcm, more preferably less than about 104 Ohmcm. In an especially preferred embodiment the specific volume resistivity of the polymeric material is less than about 102 Ohmcm.
15 Specific volume resistivity may be measured using commercially available apparatuses for measuring conductivity.
The use of a carbon black dispersion is particularly advantageous as good dispersion of the carbon black in the polymeric material can be achieved. Preferably, the carbon black-20 loaded polymeric material comprises a homogeneous distribution of the carbon black.
3 The very low specific volume resistivity values which may be achieved in accordance with the present invention are particularly valuable when the component is incorporated in a spacer. In a spacer, a comparatively long medicament residence time is necessary, and the longer the residence time, the more opportunity there is for the medicament to "attach" to the spacer walls.
It will be understood that the component of the present invention may be other than that incorporated in a spacer. For example, the component may comprise the body, a channel, or the mouthpiece of an inhaler.
AM~ ED SH~ET
CA 022480~0 1998-09-01 D1548-lWO PCT/ SE97 /00470 O ~ ~ 1998 Preferably, carbon black is included in an amount of between 6 and lO percent and especially between 8 and lO percent by weight of the carbon black-loaded polymeric material.
More preferably, carbon black is included in an amount of around lO percent, or around 9 percent, or around 8 percent, or around 7 percent, or around 6 percent, or around 5 percent, or around 4 percent by weight of the carbon black-loaded polymeric material.
o Suitable carbon blacks are commercially available, for example, from Degussa AG, or from Cabot Plastics, Belgium. Examples of Degussa AG carbon blacks are the range of carbon blacks known as Printex(~), for example "Printex L", "Printex L 6", and the extra-conductive "Printex XE 2".
The polymeric material can be any which can be moulded into the desired shape. For example, the polymeric material may be a polypropylene, a polyethylene. a polyester, a polycarbonate, a polystyrene, a polyoxyethylene, a fluoropolymer, or a copolymer thereof.
Suitable polymeric materials may be obtained, for example, from Hoechst AG, Frankfurt, Germany. As specific examples of polymeric materials may be mentioned the polyethylenes Hostalen(~) and Hostalen GUR(~); the polypropylenes Hostalen PP(~) and Hostacen(~); as well as Topas(~), Hostaform(~), Kemetal@), Celanex(~3, Vandar(~), Impet g), Celstram(~), Fortron( 9, Vectra(~) and Hostaflon~), all available from Hoechst AG.
Preferably, the polymeric material is a polypropylene or a polyethylene.
The carbon black-loaded polymeric material, and the homogeneous mixture, may be manufactured by conventional methods, for example, by extrusion of the polymericmaterial together with the carbon black. The mixing parameters, flow conditions and cooling conditions may be optimised easily by methods well known to a person skilled in the art, according to the particular polymeric material and carbon black used.
A~ ND~D S~
. CA 022480S0 1998-09-01 Carbon black-loaded polymeric materials are also commercially available, for example, from Premix Oy, Rajamaki, Finland.
The components according to the present invention may be made by conventional moulding techniques, for example, by injection moulding or by blow moulding. Themoulding parameters may be optimised easily by a person skilled in the art, according to the particular materials used. The preferred method of manufacture is injection moulding.
Typical injection moulding parameters may be for example a cylinder nozzle temperature of from 200 to 250 ~C, a mould temperature of from 30 to 80 ~C, an injection pressure of o from 600 to 1800 bar and a moderate injection speed. Preferably, a low moulding speed is used initially and slowly increased during the moulding process. Preferably, the back pressure is as low as technically possible. Preferably, the material for injection moulding is pre-dried, for example, at from 75 to 80 ~C for up to 4 hours, typically from 2 to 4 hours.
The present invention also provides a method of forming the component for use in an inhalation device as described above, comprising the step of moulding the component at least in part from a carbon black-loaded polymeric material.
When the carbon black-loaded polymeric material is a coating on another polymeric material, it may be co-moulded with the other polymeric material, for example, using two extruders, to produce a moulded component in which the carbon black-loaded polymeric material is surrounded by the other material; that is, the "inner" surface of the component is of the carbon black-loaded polymeric material and the "outer" surface of the component is of the other polymeric material. The outer material may be provided with any desired pigmentation to mask the black colour of the carbon black in circumstances where this would be considered undesirable.
~ The thickness of the component or carbon black-loaded polymeric layer may vary according to the nature of the moulded component. Where the component is incorporated A~DED SHEET
CA 022480~0 1998-09-01 D1548-lWO PCT/SE97 /00470 0 3 ~ 1998 in a spacer, for example, the thickness of the carbon black-loaded polymeric material may be, for example, up to about 10 mm, preferably betw~en 1 and 5 mm thick.
The present invention will be further described with reference to the following non-limiting Examples.
Example I
A carbon black-loaded polymeric material, "PP 1381 " (formerly "Pre-Elec TP 4474"), o Premix Oy, comprising polypropylene "Hostalen PPU 1734S 1 ", Hoechst AG, and 9percent by weight of "Printex XE 2" carbon black, Degussa AG, was used to manufacture a spacer for use with a dry powder inhaler, by injection moulding using a "Ferromatic"
injection moulder, with a cylinder nozzle temperature of 240 ~C, a mould cavity temperature of 30 ~C, an injection pressure of 1700 bar, a back pressure of 1600 bar and a moderate injection speed.
The specific volume resistivity obtained was 100 Ohmcm. (Surface resistivity 1300 Ohm.) Example 2 A carbon black-loaded polymeric material, "Pre-Elec TP 4479", Premix Oy, comprising polypropylene "Hostalen PPU 1734Sl", Hoechst AG, and 22 percent by weight "Black'~ Pearls 4750" carbon black, Cabot Plastics, was used to manufacture a spacer for use with a dry powder inhaler, by injection moulding as in Example 1.
The specific volume resistivity obtained was 30 Ohmcm. (Surface resistivity 800 Ohm.) Example 3 A~D~D S~EET
_ _ . CA 022480~0 1998-09-01 D15~8-lWO PCT/ SE 9 7 t 0 0 4 7 0 0 3 ~6- 1998 A carbon bl~ck-loaded polymeric material, "Pre-Elec TP 4480", Premix Oy, comprising polypropylene "Hostalen PPU 1734S l", Hoechst AG, and 37 percent by weight "Channel Black MPC" carbon black, Cabot Plastics, was used to manufacture a spacer for use with a dry powder inhaler, by injection moulding as in Example 1.
The specific volume resistivity obtained was 10000 Ohmcm. (Surface resistivity 100000 Ohm.) Example 4 Doses of budesonide from a dry powder inhaler (Pulmicort Turbuhalertg)) containing 200 unit doses each comprising 400 ~g of budesonide were expelled by means of a suction flow into a spacer according to Example I above After a 2 second delay, suction flow means were employed to expel the dose from the spacer onto a filter.
The experiment was repeated using a spacer constructed of polypropylene only. The means of manufacture of the polypropylene-only spacer was as in Example 1, but with aninjection pressure of 900 bar and a back pressure of 600 bar.
~o The amount of budesonide on the filter after expulsion from the carbon black-loaded polypropylene spacer of Example 1 was 2.4 times greater than the amount resulting from expulsion from the conventional polypropylene spacer. This was taken as an indication of ~ the greatly reduced amount of medicament which had been retained in the spacer according to the present invention as compared with a conventional spacer.
~5 Example 5 Doses of budesonide from a dry powder inhaler (Pulmicort Turbuhalertg)) containing 200 unit doses each comprising 400 llg of budesonide were expelled by means of a suction flow ~E0 SHEET
CA 022480~0 1998-09-01 D15~8-lwO PCT/ SE97 / OC470 0 3 ~ 1998 into a spacer according to Example 1 above. After a 30 second delay, suction flow means were employed to expel the dose from the spacer ont~ a filter.
The experiment was repeated using a spacer constructed of polypropylene only. The means of manufacture of the polypropylene-only spacer was as in Example 1, but with aninjection pressure of 900 bar and a back pressure of 600 bar.
The amount of budesonide on the filter after expulsion from the carbon black-loaded polypropylene spacer of Example 1 was 2.8 times greater than the amount resulting from o expulsion from the conventional polypropylene spacer. This was taken as an indication of the greatly reduced amount of medicament which had been retained in the spacer according to the present invention as compared with a conventional spacer.
D S~
Claims (12)
1. A component for use in an inhalation device, said component being made of or coated with a polymeric material loaded with carbon black having a DBP number of more than 300 ml/100 g of carbon black and in an amount of between 3 and 15 percent by weight of the polymeric material to impart to the polymeric material a specific volume resistivity of less than 10 9 Ohmcm.
2. The component of claim 1, wherein the specific volume resistivity is less than 10 6 Ohmcm.
3. The component of claim 2, wherein the specific volume resistivity is less than 10 2 Ohmcm.
4. The component of any of claims 1 to 3, wherein the carbon black is a carbon black dispersion.
5. The component of any of claims 1 to 4, wherein the carbon black-loaded polymeric material comprises a homogeneous mixture of carbon black and polymeric material.
6. The component of any of claims 1 to 5, wherein the carbon black-loaded polymeric material comprises carbon black in an amount of between 8 and 10 percent by weight of the polymeric material.
7. The component of any of claims 1 to 6, wherein the polymeric material is a polypropylene, a polyethylene, a polyester, a polycarbonate, a polystyrene, or acopolymer thereof.
8. The component of any of claims 1 to 6, wherein the polymeric material is a polypropylene or a polyethylene.
9. The component of any of claims 1 to 8, wherein the component is one of the body of an inhaler, the mouthpiece of an inhaler or a channel of an inhaler.
10. An inhalation device incorporating the component of any of claims 1 to 8.
11. A spacer incorporating the component of any of claims 1 to 8.
12. A method of forming the component of any of claims 1 to 8, comprising the step of moulding the component at least in part from a carbon black-loaded polymeric material.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9601126A SE9601126D0 (en) | 1996-03-22 | 1996-03-22 | Components for inhalation devices |
| SE9601126-7 | 1996-03-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2248050A1 true CA2248050A1 (en) | 1997-09-25 |
Family
ID=20401923
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002248050A Abandoned CA2248050A1 (en) | 1996-03-22 | 1997-03-20 | Components for inhalation devices |
Country Status (22)
| Country | Link |
|---|---|
| EP (1) | EP0910422A1 (en) |
| JP (1) | JP2000507132A (en) |
| KR (1) | KR20000064736A (en) |
| CN (1) | CN1213975A (en) |
| AR (1) | AR006359A1 (en) |
| AU (1) | AU709989B2 (en) |
| BR (1) | BR9708135A (en) |
| CA (1) | CA2248050A1 (en) |
| CZ (1) | CZ300798A3 (en) |
| EE (1) | EE9800462A (en) |
| ID (1) | ID16289A (en) |
| IL (1) | IL126069A0 (en) |
| IS (1) | IS4842A (en) |
| MY (1) | MY132493A (en) |
| NO (1) | NO984313L (en) |
| NZ (1) | NZ331615A (en) |
| PL (1) | PL328950A1 (en) |
| SE (1) | SE9601126D0 (en) |
| SK (1) | SK129298A3 (en) |
| TR (1) | TR199801869T2 (en) |
| WO (1) | WO1997034653A1 (en) |
| ZA (1) | ZA972059B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FI20020909A0 (en) * | 2002-05-14 | 2002-05-14 | Perlos Oyj | Inhaler, component of an inhaler and method of manufacturing the same |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ238489A (en) * | 1990-06-14 | 1995-09-26 | Rhone Poulenc Rorer Ltd | Inhaler with capsule in swirling chamber: capsule pierced in chamber |
| SE9400257D0 (en) * | 1994-01-27 | 1994-01-27 | Astra Ab | spacer |
| ATE280995T1 (en) * | 1995-03-22 | 2004-11-15 | Tyco Electronics Corp | CONDUCTIVE POLYMER COMPOSITION AND DEVICE |
-
1996
- 1996-03-22 SE SE9601126A patent/SE9601126D0/en unknown
-
1997
- 1997-03-10 ZA ZA9702059A patent/ZA972059B/en unknown
- 1997-03-20 ID IDP970906A patent/ID16289A/en unknown
- 1997-03-20 JP JP9533411A patent/JP2000507132A/en active Pending
- 1997-03-20 NZ NZ331615A patent/NZ331615A/en unknown
- 1997-03-20 MY MYPI97001188A patent/MY132493A/en unknown
- 1997-03-20 IL IL12606997A patent/IL126069A0/en unknown
- 1997-03-20 PL PL97328950A patent/PL328950A1/en unknown
- 1997-03-20 KR KR1019980707472A patent/KR20000064736A/en not_active Application Discontinuation
- 1997-03-20 SK SK1292-98A patent/SK129298A3/en unknown
- 1997-03-20 BR BR9708135A patent/BR9708135A/en not_active Application Discontinuation
- 1997-03-20 CN CN97193243A patent/CN1213975A/en active Pending
- 1997-03-20 EE EE9800462A patent/EE9800462A/en unknown
- 1997-03-20 WO PCT/SE1997/000470 patent/WO1997034653A1/en not_active Application Discontinuation
- 1997-03-20 AU AU21866/97A patent/AU709989B2/en not_active Ceased
- 1997-03-20 CA CA002248050A patent/CA2248050A1/en not_active Abandoned
- 1997-03-20 CZ CZ983007A patent/CZ300798A3/en unknown
- 1997-03-20 EP EP97914728A patent/EP0910422A1/en not_active Withdrawn
- 1997-03-20 TR TR1998/01869T patent/TR199801869T2/en unknown
- 1997-03-21 AR ARP970101162A patent/AR006359A1/en unknown
-
1998
- 1998-09-03 IS IS4842A patent/IS4842A/en unknown
- 1998-09-17 NO NO984313A patent/NO984313L/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| WO1997034653A1 (en) | 1997-09-25 |
| AR006359A1 (en) | 1999-08-25 |
| AU709989B2 (en) | 1999-09-09 |
| KR20000064736A (en) | 2000-11-06 |
| BR9708135A (en) | 1999-07-27 |
| NZ331615A (en) | 2000-02-28 |
| EE9800462A (en) | 1999-06-15 |
| SK129298A3 (en) | 1999-02-11 |
| CN1213975A (en) | 1999-04-14 |
| EP0910422A1 (en) | 1999-04-28 |
| SE9601126D0 (en) | 1996-03-22 |
| PL328950A1 (en) | 1999-03-01 |
| IS4842A (en) | 1998-09-03 |
| MY132493A (en) | 2007-10-31 |
| ZA972059B (en) | 1997-09-22 |
| NO984313D0 (en) | 1998-09-17 |
| NO984313L (en) | 1998-09-17 |
| IL126069A0 (en) | 1999-05-09 |
| CZ300798A3 (en) | 1999-01-13 |
| JP2000507132A (en) | 2000-06-13 |
| ID16289A (en) | 1997-09-18 |
| TR199801869T2 (en) | 1998-12-21 |
| AU2186697A (en) | 1997-10-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |