CA1178152A - Dosage inhalator i - Google Patents
Dosage inhalator iInfo
- Publication number
- CA1178152A CA1178152A CA000405889A CA405889A CA1178152A CA 1178152 A CA1178152 A CA 1178152A CA 000405889 A CA000405889 A CA 000405889A CA 405889 A CA405889 A CA 405889A CA 1178152 A CA1178152 A CA 1178152A
- Authority
- CA
- Canada
- Prior art keywords
- membrane
- active compound
- propellant
- dosing
- dosing unit
- 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.)
- Expired
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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
- A61M15/0065—Inhalators with dosage or measuring devices
-
- 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
- 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
-
- 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
- A61M2205/82—Internal energy supply devices
- A61M2205/8218—Gas operated
- A61M2205/8225—Gas operated using incorporated gas cartridges for the driving gas
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
Abstract A dosage inhalator intended for inhalation of pharma-cologically active compound in solid, micronized form or in solution, comprising a) a propellant container and a propellant dispensing unit; and b) a dosing unit for dosing the pharmacologically active compound, characterized in that the dosing unit for dosing the pharmacologically active compound comprises a storage chamber for the active compound directly connected to a dosing unit, said dosing unit comprising a perforated membrane, a holder for the said perforated membrane, and means for displacing the membrane, whereby the membrane is displaceably arranged between a first position where active compound is introduced into the perforations in the membrane and second position where the membrane is inserted in the propellant passage.
Description
1 ~78152 `
DOSAGE INHALATOR I
Field of the invention ' The present inventiori relates to a new dosage inhalator intended to be used at inhalation of pharmacologically active compounds. The invention also relates tD a new dosage unit for measuring dosages of the active compound in solid, micronized form or in solution.
-Back~round of the invention Special requirements are made with regard to dosage inhalators intended for local administration of drugs to the respiratory tract and to the lungs. Since mostly very pntent drugs are to be administered, the dose accuracy must be great. The dosage of active c:ompound that is to be administered may be as small as 0.1 mg. It is also necessary that the particles that leave the dosage in-halator have a suitable size di~itribution, since too bigparticles tend -to be deposited ln the mouth.
Several systems are available fnr local administra~ion o~
drugs tn the respiratory tract and to the lungs. Among these systems may be mentioned nebulizing devices, powder inhalators which are activated by the air flow generated at inhalation, pressurized aerosols and pump inhalators.
The available systems work but are not without disadvan-tages.
The nebulizing devices, which are driven by a compressor, by compressed gases or by ultrasound, are relatively big and bulky and are mainly intended for stationary use. They are complicated to use. The drug administration must con-~k - ~
1~781~2 tinue during a fairly long period of time, 5 to 10 minutes.
The use of powder~inhalators has been increasing during the last few years. They are activated by the air flow S generated at inhalation. When the patient inhales through the inhalator the active compound in solid, micronized form, usually kept in a capsule, is mixed with the in-haled air and administered to the respiratory tract and to the lungs of the patient. These inhalators require, of technical reasons connected with the dispensing of the active compound, a fairly great amount of active compound, 20 mg or more, in order to give an acceptable dosage accuracy. They are, therefore, only useful for low-active compounds, or for high-active compounds in combination with diluting agents, usually lactose. They are cumbersome to load and to clean, and as a rule several inhalations are necessary in order to empty a capsule. Furthermore, they are difficult to handle for certain categories of patients, and the diluting agent, lactose, is irritating at inhalation ano may.cause in`creased frequence o-F caries.
, The pressuri~ed aerosols are today most widely used at ambulatory treatment. Normally, they comprise a pressure unit that contains the propellant, most often different types of halogenated hydrocarbons, e.g. Freon~, together with the active compound which either is dissolved in the propellant or suspended in the propellant in solid, mic-ronized form. Dosage aerosols where a unit dosage of the active compound is kept separated from the propellant have also been described. Usually surface active compounds and lubricating agents are added in order to obtain a suspen-sion which can be stored and in order to make the dosage mechanism work. The propellants, most widely used, may, furthermore, have undesirable toxicological and environ-mental effects.
The so called pump inhalators, finally, make use ofcompressed air as propellant. The active compound is normally in the form of a solution. The compression of the air is obtained by a piston system, but it is difficult in a simple manner to generate a pressure which is sufficiently high to permit an adequate particle size distribution. Furthermore, it is difficult to obtain an exact measuring of dosages of the active compound.
Summary of the invention The invention provides a dosing unit for dosing in a dosage inhalator of pharmacologically active compound, characterized in that it comprises a storage ehamber for -the active compound in connection with a dosing unit which comprises a perforated membrane arranged to be loaded with active compound, and means for displacing the said membrane, whereby the perforated membrane is displaceably arranyed in relation to the storage ehamber between a first position where active compound is introduced into perforations in part of the area of the membrane and a second position where the said membrane area is introduced in the propellant passage of the dosage inhalator.
In one aspeet, the present invention provides a dosage inhalator intended for inhalation of pharmaeologically aetive compound in solid, mieronized form eomprising a propellant container adapted to be connected to a propellant dispensing unit; a dosing unit for dosing the pharmacologically active compound, and means for delivering propellant from said dispensing unit through a propellant passage in said dosing unit; characterized in that the dosing unit for dosing the pharmacologically active compound comprises a storage chamber for the active compound directly connected to a dosing unit, .~ .
~78~X
said dosing unit comprising a perforated membrane, a holder for the said perforated membrane, and means for displacing the membrane, whereby the membrane is displaceably arranged between a first position where active compound is introduced into the perforations in part of the area of the membrane and a second position where the said part area of the membrane is inserted in the propellant passage.
This dosage inhalatorhas the following advantages-3a-1 ~ ~81`~2 1. No lubricating agents need to be used.
DOSAGE INHALATOR I
Field of the invention ' The present inventiori relates to a new dosage inhalator intended to be used at inhalation of pharmacologically active compounds. The invention also relates tD a new dosage unit for measuring dosages of the active compound in solid, micronized form or in solution.
-Back~round of the invention Special requirements are made with regard to dosage inhalators intended for local administration of drugs to the respiratory tract and to the lungs. Since mostly very pntent drugs are to be administered, the dose accuracy must be great. The dosage of active c:ompound that is to be administered may be as small as 0.1 mg. It is also necessary that the particles that leave the dosage in-halator have a suitable size di~itribution, since too bigparticles tend -to be deposited ln the mouth.
Several systems are available fnr local administra~ion o~
drugs tn the respiratory tract and to the lungs. Among these systems may be mentioned nebulizing devices, powder inhalators which are activated by the air flow generated at inhalation, pressurized aerosols and pump inhalators.
The available systems work but are not without disadvan-tages.
The nebulizing devices, which are driven by a compressor, by compressed gases or by ultrasound, are relatively big and bulky and are mainly intended for stationary use. They are complicated to use. The drug administration must con-~k - ~
1~781~2 tinue during a fairly long period of time, 5 to 10 minutes.
The use of powder~inhalators has been increasing during the last few years. They are activated by the air flow S generated at inhalation. When the patient inhales through the inhalator the active compound in solid, micronized form, usually kept in a capsule, is mixed with the in-haled air and administered to the respiratory tract and to the lungs of the patient. These inhalators require, of technical reasons connected with the dispensing of the active compound, a fairly great amount of active compound, 20 mg or more, in order to give an acceptable dosage accuracy. They are, therefore, only useful for low-active compounds, or for high-active compounds in combination with diluting agents, usually lactose. They are cumbersome to load and to clean, and as a rule several inhalations are necessary in order to empty a capsule. Furthermore, they are difficult to handle for certain categories of patients, and the diluting agent, lactose, is irritating at inhalation ano may.cause in`creased frequence o-F caries.
, The pressuri~ed aerosols are today most widely used at ambulatory treatment. Normally, they comprise a pressure unit that contains the propellant, most often different types of halogenated hydrocarbons, e.g. Freon~, together with the active compound which either is dissolved in the propellant or suspended in the propellant in solid, mic-ronized form. Dosage aerosols where a unit dosage of the active compound is kept separated from the propellant have also been described. Usually surface active compounds and lubricating agents are added in order to obtain a suspen-sion which can be stored and in order to make the dosage mechanism work. The propellants, most widely used, may, furthermore, have undesirable toxicological and environ-mental effects.
The so called pump inhalators, finally, make use ofcompressed air as propellant. The active compound is normally in the form of a solution. The compression of the air is obtained by a piston system, but it is difficult in a simple manner to generate a pressure which is sufficiently high to permit an adequate particle size distribution. Furthermore, it is difficult to obtain an exact measuring of dosages of the active compound.
Summary of the invention The invention provides a dosing unit for dosing in a dosage inhalator of pharmacologically active compound, characterized in that it comprises a storage ehamber for -the active compound in connection with a dosing unit which comprises a perforated membrane arranged to be loaded with active compound, and means for displacing the said membrane, whereby the perforated membrane is displaceably arranyed in relation to the storage ehamber between a first position where active compound is introduced into perforations in part of the area of the membrane and a second position where the said membrane area is introduced in the propellant passage of the dosage inhalator.
In one aspeet, the present invention provides a dosage inhalator intended for inhalation of pharmaeologically aetive compound in solid, mieronized form eomprising a propellant container adapted to be connected to a propellant dispensing unit; a dosing unit for dosing the pharmacologically active compound, and means for delivering propellant from said dispensing unit through a propellant passage in said dosing unit; characterized in that the dosing unit for dosing the pharmacologically active compound comprises a storage chamber for the active compound directly connected to a dosing unit, .~ .
~78~X
said dosing unit comprising a perforated membrane, a holder for the said perforated membrane, and means for displacing the membrane, whereby the membrane is displaceably arranged between a first position where active compound is introduced into the perforations in part of the area of the membrane and a second position where the said part area of the membrane is inserted in the propellant passage.
This dosage inhalatorhas the following advantages-3a-1 ~ ~81`~2 1. No lubricating agents need to be used.
2. Active compound in an amount from 0.1 mg, in solid micronized form or in solution, can be dispensed with sufficient accuracy and without need for use of diluting agents for active compound in solid micronized form.
3. The quality of the generated aerosol is independent of the breathing capacity of the patient.
4. Propellants under high pressure, for example liquid carbon dioxide, can be used. Thereby a particle size distribution at administration of active`compound in solution can be obtained which is better than the par-ticle size distribution which i5 obtained with a pumpinhalator.
5. An atoxic propellant can be used, for example carbon dioxide in liquid form or in solution.
2~
In a further aspect, the invbntion rela-tes to a new dosing unit for dosing in a dosage inhalator of pharma cologically active compound in solid micronized form or in solution. The said dosing unit is characterized in that it comprises a storage chamber for the active compound in connection with a dosing unit which comprises a perfo-rated membrane, a holder for said perforated membrane, and means for displacing the said membrane, whereby the dosing unit and the perforated membrane are displaceably arranged in relation to each other between a first position where active compound is introduced into the perforations in part of the area of the membrane and a second position where the said part area of membrane is introduced in the propellant passage of the dosage inhalator.
The dosing unit will admit dispensing active compound in solid, micronized form or in solution with sufficient 1 ~781S2 dosage accuracy in an amount of from 0.1 to 5 mg. Also dosages in an amount of from 5 to 50 mg can be dispensed, especially when the active compound is in solid micro-nized form. The dosing unit according to the invention can be used in dosage aerosols which are activated with propellant under pressure, as well as in inhalators in-tended to be activated by the air flow generated at in-halation.
In a further aspect, the invention relates to the use of a perforated membrane as dosing unit for active compound in solid, micronized form in dosage aerosols.
In the pre~erred embodiment of the dosage inhalator and the dosing uni-t of the invention, the active compound is used in solid, micronized form.
Specific embodiments of the invention will now be described in detail with reference to Figures 1, 2, 3J 4, 5, 6, 7 and 9.
Flgure 1 is a section through a dosage inhalator for solid, micronized active compound, activated with propellant under pressure.
Figure 2 is a section through a variant of the dosage in-halator of Figure 1 for administering the active compound in solid, micronized form.
Figure 3 is a section through a dosage inhalator for ad-ministration of active compnund in solution, activated with propellant under pressure.
Figure 4 is a section through a variant nf the dosage unit intended for dosing active compound in solution.
i 1~8152 Figure 5 and Figure 6 illustrate embodiments of the valve in the dosing unit for propellarits which is part of the dosage inhalators according to Figure 1, Figure 2 and Figure 3.
Figure 7 shows scrapers in the storage chamber, which scrapers are used to introduce solid, micronized active compound into the perforations in a horizontal perfora-ted membrane.
Figure 8 shows how solid, micronized active compound is fed from the storage unit into the perforations in the perforated membrane using the said scrapers.
A. Dosage inhalator for solid, micronized active compound (Fi~,ure 1 _n_ Figure 2) The dosage inhalator comprises three main components:
a) a dosing unit 23 for dosing the pharmacologically active cornpound.
b) a propellant container 1 intended for liquid and gaseous propellant.
c) a propellant dispensing unit 2 intended for dispensing the propellant.
The propellant container 1 is manufactured in a material, for example steel, which makes it possible to use the propellant container for liquid propellants, for example halogenated hydrocarbons, and liquid carbon diozide, and for gaseous propellants. Its construction will admit use of carbon dioxide as propellant, in liquid form and in gaseous form, in spite-of the high pressure, 49.5 bar at 15C, which is required to keep carbon dioxide in liquid form. lhe propellant container 1 is arranged to bè connec-ted to the propellant dispensing unit 2, by a threading.
11 17~152 The propellant container unit comprises a first valve 3 which is arranged in the discharge passage from the pro-pellant container 1. The valve 3 is so arranged that it automatically closes the discharge passage from the pro-5' pellant container 1 when the said container is removedfrom the propellant dispensing unit 2. The'valve 3 which is'loaded with a spring 4, comprises a displaceable con-necting arm 5 which co-operates with a tilting lever 6.
The said tilting lever is movable around an axis 7.'The valve part of the connecting arm 5 is provided with a protrusion 8 which co-operates with a depression 9 in the propellant unit 1. In the depression 9 a sealing ring 10 with rectangular section is arrangedj see figure 5;
A connecting passage 14 for'propellant is arranged from the passage in'which the connecting arm 5 is arranged to the dosin~ chamber 15 in the dosing unit 2. 0-rings 16, 17, 1~ and 19 seal where'the connec.ting arm 5 attaches to the tilting lever 6 and where the connectin~ passage 14 reaches the propellan-t dispensing unit.
The passage 14 leads to a dosin~ chamber 15. The dosing chamber 15 comprises a sprin~ loaded valve 20. constructed in the same manner as the valve 3 in the propellant con-tainer 1. The valve 20 comprises a movable connecting arm 21 which co-operates with the tilting lever 6.
From the dosing chamber 15 a passage 22 leads to the dosing unit 23. The dosing unit 23, which in Figure 1 is illustrated for dispensation of solid, micronized compound, comprises a storage chamber 24 for the active compound directly connected with a dosing unit comprising a per-forated membrane 25 in the Form of a drumJ a holder 26 for the membrane, and means for displacing the membraneJ
whereby the membrane is displaceably arranged between a first position where active compound in solidJ micronized form is introduced into the perforations in part of the area of the membraneJ and a second position where the said part of the membrane arEa containing a defined amount of - l ~78~52 -active compound is introduced in the propellant passage 22. Active compound is brought from the storage chamber 24 into the perforations in the membrane using elastic spring-loaded scrapers 27. - -5In one preferred embodiment, the perforated membrane in the dosing unit 23 can be oesigned,.as in Figure 1, as a drum-formed rotating membrane, where the active compound is pressed into the perforations using spring-loaded scrapers 27 when the drum is brought to rotate. In another preferred embodiment, the membrane 25, see Figure 2, is designed as a rotating disc connected to the storage chamber 24. The active compound is in this embodiment pressed into the perforations in the membrane using a spring-loaded plate 29. The perforated membrane ?5 is rotated using turning means 30 so that part of the mem-brane area with its perforations loaded with active corn-pound is introduced into the propellant passage 22.-The turning means 30 in Figure 2 comprise spring-loaded pins 40 which en~age in dents in the perforated membrane 25 as is shown in Figure 7.
In use the dosage inhalator a,ccording to Figure l and Figure 2 will operate as follows. The valve 3 in the propellant container 1 is opened by depressing the por-tion of the tilting lever 6 which is situated in connec-tion with the valve 3, using a trigger 31. When the valve 3 is open the propellant, which can be in li~uid or gaseous form, passes from the propellant unit 1 along the sides of the connecting arm 5 and via the passage 14 to the dosing chamber 15. The dosing chamber 15 is filled with propellant. When the pressure on the tilting lever above the valve 3 ceases, the valve 3 is closed by action of the combined pressure from the propellant in the propellant container 1 and the spring 4 in the valve 3. Now the valve 20 is opened by depressing, using the trigger 32, that part o-F the tilting lever 6 which is situated in connection with the valve 20, whereupon the `
11781~2 propellant in the dosing chamber 15 and the propellant in the passage 14 passes along the sides of the connecting arm to the valve 20 and via the passage 22 to the dosing unit 23. The propellant will here pass that part area of the perforated membrane 25 in Figure 1 respectively Figure 2 which has been introduced into the propellant passage and will remove the active compound which had been loaded into the perforations in the membrane. The active compound will be driven out through the nozzle 28.
By the co-operation between the tilting lever 6 and the valves 3 and 20, the connection between the propellant container 1 and the dosing chamber 15 will be broken before the valve 20 of the dosing chamber 15 can be acted upon and the metered amount of propellant discharged. Thus, the construction of the tilting lever will admit only one o~ the valves 3 and 20 in the propellant container ~nd in the dosing chamber, respectively. to be open at a given time. Both valves cannot be open simultaneously. The 2n construction of the valve 3 in the propellant container is such that it will always be closed when the propellant container ls released from the propellant dispensing unit.
In an alternative embodiment of the valves 3 and 20, see Figure 6, the propellant unit can be provided with a protrusion 11 which co-operates with an opposite depression 12 in the valve part of the connecting arm 5. In the depression 12 a sealing ring 13 with rectangular section is arranged.
The valve construction utilized in the valves 3 and 2n, see Figures 5 and 6, is an important part of the dosage inhalator, because this valve construction makes it possible to use propellant under high pressure, for example liquid carbon dioxide, without risk for leaking.
~178~2 . 1 o B. Dosage inhalator for active substance in solution (Figure 3 and Figure 4) .
The dosage inhalator according to Figure 3 ~iffers from S the dosage inhalator according to Figure 1 only with respect to the dosing unit for the active compound, which in Figure 3 is designed for dispensing active compound in solution. The dosing unit is arranged with a perforated membrane 33 which is arranged to be able to be displaced from a first position, where the membrane is immersed in the storage chamber 34 for active compound in solution, to a second position where the membrane is placed in the propellant passage 22. The membrane is operated with a spring-loaded trigger 35. 0-rings 36 and 37 seal the connections between the membrane 33 and the propellant passage 22.
Figure 4 illustrates an alternat:ive embodiment of the dosing u-nit for active compound in solution. The storage chamber 34 for active cornpound in solution is here connec-ted with a second storage chamber 33 where a greater volume of the solution of the active compound can be kept, The rnembrane 33 can in the same way as in Figure 3 using the trigger 35 be brought into the storage chamber 34 and then be brought into the propellant passage 22.
The size of the dosing chamber 15 may vary. Its size will depend upon whether liquid or gaseous propellant is to be dispensed. A suitable size for liquid propellant, for example liquid carbon dioxide, may be 25-300 yl. For gaseous propellants, for example gaseous carbon dioxide, a suitable size may be 50-1000 ,ul.
The perforated membrane can be manufactured in any suitable material, for example metal or plastic. The size of the dosage of active compound which is to be administered is determined by the size of the perfora-tions in the membrane, the -thickness of the membrane, and 1 178~2 1~.
the number of perforations that is brought into the pro-pellant passage, and by the area of the propellant passage.
The accuracy of~'the dosage will mainly depend on the accuracy in the manufacturing of the membrane. Examples of perforated membrane's that can be used are the metal nets which are manufactured by Veco Beheer B.V., Eerbeek, The Netherlands. These nets can be obtained with various sizes of the perforations.'They can be formed in desired manner, for example in drum form or they can be used in the form of horizontal, plane membranes. Also woven nets o-F metal, fiber or of other materials can be used, espe-cially at administration of active compound in solution.
The important factor is the dosage accuracy that can be obtained. ' '' At dispensing of active compound in solid, micrnnized form, it is preferred that the perforations in the per-forated membrane are in the form of truncated cones withtheir larger area directed towards the nozzle. Such a construction will partly facilitate the loading of the membrane with active compound, partly facilitàte the emptying oF the perforations when the active compound is administerE~d. See Figure ~.
The perforated membrane, when it is in the form of a drum, can be arranged for loading from the outside as well as from the inside of the drum.
The perforations in the perforated membranes can be of arbitrary design. They can be circular, square, elliptic, rectangular or have other geometrical form. The area of the perforations in the membrane can be a large or a small part of the membrane area, for exarnple from 1 to 95 %, whereby the term "membrane area" refers to that area of the membrane which is inserted into the propellant passage.
The number of perforations in the membrane area can vary depending on factors such as the amount of active cnmpound al7sls2 that is to be administered per dosage, the physical pro-perties of the active compound, etc. In a preferred embodiment, the perforations have conical shape, as said above, at dosing of solid, micronized compDund.
; 5 At ad~inistration of active compound in solution the con-struction of the perforated membrane inciuding the form of the perforations is less critical. Also membranes in the form of nets, for example woven nets in metal or in fiber can be used, as mentioned above.
.
The size of the dosages of bronchospasmolytically active compounds, or steroids for inhalation, that normally are administered at each administration is as folIows.
Terbutaline: standard dosage 0.5 mg Salbutamol : standard dosage n ~ 2 mg Budesonide : standard dosage 0.1 mg a The active compound can be administered in micronized form without additional ingredients ror in pharmaceutically modified micronized form in order to obtain improved flow properties. The micronized particles may be covered with a film functioning for example by masking bitter taste of the active compound, or by providing slow release of the active compound in the respiratory tract.
The dosing unit in the dosage inhalator according to the present invention admits dispensing of an amount of active compound of mainly from 0.1 to 1 mg, but also dosages from 1 to 5 mg and from 5 to 50 mg, especially when solid, micronized active compound is used, can be dispensed by suitable design of perforations and size of that part of the area of the perforated membrane which is intended to be introduced into the propellant passage.
, :
1 1`~8:l~2 The storage chamber 24 for active compound in solid, micronized form, respectively the storage chamber 34 for active compound in solution can be intended to contain active compound for about 100 to 200 dosages, which is sufficient for about a month's normal use for local administration of active compound to the respiratory tract.
The storage chamber 24 for solid, micronized compourid can be placed above as well as below the perforated membrane.
In a preferred embodiment the storage chamber is placed above the membrane. The storage chamber 24 can be arranged to be refilled via a seaIable opening 39.
1~ The storage chamber 34 for active compound in solution is in one preferred embodiment connected with a larger seal-able storage charnber 38.
In a preferred embodirnent of the dosage inhalator according to the invention the perforated membrane 25 is displaceably arranged in relation to the storage charnber 24.
2~
In a further aspect, the invbntion rela-tes to a new dosing unit for dosing in a dosage inhalator of pharma cologically active compound in solid micronized form or in solution. The said dosing unit is characterized in that it comprises a storage chamber for the active compound in connection with a dosing unit which comprises a perfo-rated membrane, a holder for said perforated membrane, and means for displacing the said membrane, whereby the dosing unit and the perforated membrane are displaceably arranged in relation to each other between a first position where active compound is introduced into the perforations in part of the area of the membrane and a second position where the said part area of membrane is introduced in the propellant passage of the dosage inhalator.
The dosing unit will admit dispensing active compound in solid, micronized form or in solution with sufficient 1 ~781S2 dosage accuracy in an amount of from 0.1 to 5 mg. Also dosages in an amount of from 5 to 50 mg can be dispensed, especially when the active compound is in solid micro-nized form. The dosing unit according to the invention can be used in dosage aerosols which are activated with propellant under pressure, as well as in inhalators in-tended to be activated by the air flow generated at in-halation.
In a further aspect, the invention relates to the use of a perforated membrane as dosing unit for active compound in solid, micronized form in dosage aerosols.
In the pre~erred embodiment of the dosage inhalator and the dosing uni-t of the invention, the active compound is used in solid, micronized form.
Specific embodiments of the invention will now be described in detail with reference to Figures 1, 2, 3J 4, 5, 6, 7 and 9.
Flgure 1 is a section through a dosage inhalator for solid, micronized active compound, activated with propellant under pressure.
Figure 2 is a section through a variant of the dosage in-halator of Figure 1 for administering the active compound in solid, micronized form.
Figure 3 is a section through a dosage inhalator for ad-ministration of active compnund in solution, activated with propellant under pressure.
Figure 4 is a section through a variant nf the dosage unit intended for dosing active compound in solution.
i 1~8152 Figure 5 and Figure 6 illustrate embodiments of the valve in the dosing unit for propellarits which is part of the dosage inhalators according to Figure 1, Figure 2 and Figure 3.
Figure 7 shows scrapers in the storage chamber, which scrapers are used to introduce solid, micronized active compound into the perforations in a horizontal perfora-ted membrane.
Figure 8 shows how solid, micronized active compound is fed from the storage unit into the perforations in the perforated membrane using the said scrapers.
A. Dosage inhalator for solid, micronized active compound (Fi~,ure 1 _n_ Figure 2) The dosage inhalator comprises three main components:
a) a dosing unit 23 for dosing the pharmacologically active cornpound.
b) a propellant container 1 intended for liquid and gaseous propellant.
c) a propellant dispensing unit 2 intended for dispensing the propellant.
The propellant container 1 is manufactured in a material, for example steel, which makes it possible to use the propellant container for liquid propellants, for example halogenated hydrocarbons, and liquid carbon diozide, and for gaseous propellants. Its construction will admit use of carbon dioxide as propellant, in liquid form and in gaseous form, in spite-of the high pressure, 49.5 bar at 15C, which is required to keep carbon dioxide in liquid form. lhe propellant container 1 is arranged to bè connec-ted to the propellant dispensing unit 2, by a threading.
11 17~152 The propellant container unit comprises a first valve 3 which is arranged in the discharge passage from the pro-pellant container 1. The valve 3 is so arranged that it automatically closes the discharge passage from the pro-5' pellant container 1 when the said container is removedfrom the propellant dispensing unit 2. The'valve 3 which is'loaded with a spring 4, comprises a displaceable con-necting arm 5 which co-operates with a tilting lever 6.
The said tilting lever is movable around an axis 7.'The valve part of the connecting arm 5 is provided with a protrusion 8 which co-operates with a depression 9 in the propellant unit 1. In the depression 9 a sealing ring 10 with rectangular section is arrangedj see figure 5;
A connecting passage 14 for'propellant is arranged from the passage in'which the connecting arm 5 is arranged to the dosin~ chamber 15 in the dosing unit 2. 0-rings 16, 17, 1~ and 19 seal where'the connec.ting arm 5 attaches to the tilting lever 6 and where the connectin~ passage 14 reaches the propellan-t dispensing unit.
The passage 14 leads to a dosin~ chamber 15. The dosing chamber 15 comprises a sprin~ loaded valve 20. constructed in the same manner as the valve 3 in the propellant con-tainer 1. The valve 20 comprises a movable connecting arm 21 which co-operates with the tilting lever 6.
From the dosing chamber 15 a passage 22 leads to the dosing unit 23. The dosing unit 23, which in Figure 1 is illustrated for dispensation of solid, micronized compound, comprises a storage chamber 24 for the active compound directly connected with a dosing unit comprising a per-forated membrane 25 in the Form of a drumJ a holder 26 for the membrane, and means for displacing the membraneJ
whereby the membrane is displaceably arranged between a first position where active compound in solidJ micronized form is introduced into the perforations in part of the area of the membraneJ and a second position where the said part of the membrane arEa containing a defined amount of - l ~78~52 -active compound is introduced in the propellant passage 22. Active compound is brought from the storage chamber 24 into the perforations in the membrane using elastic spring-loaded scrapers 27. - -5In one preferred embodiment, the perforated membrane in the dosing unit 23 can be oesigned,.as in Figure 1, as a drum-formed rotating membrane, where the active compound is pressed into the perforations using spring-loaded scrapers 27 when the drum is brought to rotate. In another preferred embodiment, the membrane 25, see Figure 2, is designed as a rotating disc connected to the storage chamber 24. The active compound is in this embodiment pressed into the perforations in the membrane using a spring-loaded plate 29. The perforated membrane ?5 is rotated using turning means 30 so that part of the mem-brane area with its perforations loaded with active corn-pound is introduced into the propellant passage 22.-The turning means 30 in Figure 2 comprise spring-loaded pins 40 which en~age in dents in the perforated membrane 25 as is shown in Figure 7.
In use the dosage inhalator a,ccording to Figure l and Figure 2 will operate as follows. The valve 3 in the propellant container 1 is opened by depressing the por-tion of the tilting lever 6 which is situated in connec-tion with the valve 3, using a trigger 31. When the valve 3 is open the propellant, which can be in li~uid or gaseous form, passes from the propellant unit 1 along the sides of the connecting arm 5 and via the passage 14 to the dosing chamber 15. The dosing chamber 15 is filled with propellant. When the pressure on the tilting lever above the valve 3 ceases, the valve 3 is closed by action of the combined pressure from the propellant in the propellant container 1 and the spring 4 in the valve 3. Now the valve 20 is opened by depressing, using the trigger 32, that part o-F the tilting lever 6 which is situated in connection with the valve 20, whereupon the `
11781~2 propellant in the dosing chamber 15 and the propellant in the passage 14 passes along the sides of the connecting arm to the valve 20 and via the passage 22 to the dosing unit 23. The propellant will here pass that part area of the perforated membrane 25 in Figure 1 respectively Figure 2 which has been introduced into the propellant passage and will remove the active compound which had been loaded into the perforations in the membrane. The active compound will be driven out through the nozzle 28.
By the co-operation between the tilting lever 6 and the valves 3 and 20, the connection between the propellant container 1 and the dosing chamber 15 will be broken before the valve 20 of the dosing chamber 15 can be acted upon and the metered amount of propellant discharged. Thus, the construction of the tilting lever will admit only one o~ the valves 3 and 20 in the propellant container ~nd in the dosing chamber, respectively. to be open at a given time. Both valves cannot be open simultaneously. The 2n construction of the valve 3 in the propellant container is such that it will always be closed when the propellant container ls released from the propellant dispensing unit.
In an alternative embodiment of the valves 3 and 20, see Figure 6, the propellant unit can be provided with a protrusion 11 which co-operates with an opposite depression 12 in the valve part of the connecting arm 5. In the depression 12 a sealing ring 13 with rectangular section is arranged.
The valve construction utilized in the valves 3 and 2n, see Figures 5 and 6, is an important part of the dosage inhalator, because this valve construction makes it possible to use propellant under high pressure, for example liquid carbon dioxide, without risk for leaking.
~178~2 . 1 o B. Dosage inhalator for active substance in solution (Figure 3 and Figure 4) .
The dosage inhalator according to Figure 3 ~iffers from S the dosage inhalator according to Figure 1 only with respect to the dosing unit for the active compound, which in Figure 3 is designed for dispensing active compound in solution. The dosing unit is arranged with a perforated membrane 33 which is arranged to be able to be displaced from a first position, where the membrane is immersed in the storage chamber 34 for active compound in solution, to a second position where the membrane is placed in the propellant passage 22. The membrane is operated with a spring-loaded trigger 35. 0-rings 36 and 37 seal the connections between the membrane 33 and the propellant passage 22.
Figure 4 illustrates an alternat:ive embodiment of the dosing u-nit for active compound in solution. The storage chamber 34 for active cornpound in solution is here connec-ted with a second storage chamber 33 where a greater volume of the solution of the active compound can be kept, The rnembrane 33 can in the same way as in Figure 3 using the trigger 35 be brought into the storage chamber 34 and then be brought into the propellant passage 22.
The size of the dosing chamber 15 may vary. Its size will depend upon whether liquid or gaseous propellant is to be dispensed. A suitable size for liquid propellant, for example liquid carbon dioxide, may be 25-300 yl. For gaseous propellants, for example gaseous carbon dioxide, a suitable size may be 50-1000 ,ul.
The perforated membrane can be manufactured in any suitable material, for example metal or plastic. The size of the dosage of active compound which is to be administered is determined by the size of the perfora-tions in the membrane, the -thickness of the membrane, and 1 178~2 1~.
the number of perforations that is brought into the pro-pellant passage, and by the area of the propellant passage.
The accuracy of~'the dosage will mainly depend on the accuracy in the manufacturing of the membrane. Examples of perforated membrane's that can be used are the metal nets which are manufactured by Veco Beheer B.V., Eerbeek, The Netherlands. These nets can be obtained with various sizes of the perforations.'They can be formed in desired manner, for example in drum form or they can be used in the form of horizontal, plane membranes. Also woven nets o-F metal, fiber or of other materials can be used, espe-cially at administration of active compound in solution.
The important factor is the dosage accuracy that can be obtained. ' '' At dispensing of active compound in solid, micrnnized form, it is preferred that the perforations in the per-forated membrane are in the form of truncated cones withtheir larger area directed towards the nozzle. Such a construction will partly facilitate the loading of the membrane with active compound, partly facilitàte the emptying oF the perforations when the active compound is administerE~d. See Figure ~.
The perforated membrane, when it is in the form of a drum, can be arranged for loading from the outside as well as from the inside of the drum.
The perforations in the perforated membranes can be of arbitrary design. They can be circular, square, elliptic, rectangular or have other geometrical form. The area of the perforations in the membrane can be a large or a small part of the membrane area, for exarnple from 1 to 95 %, whereby the term "membrane area" refers to that area of the membrane which is inserted into the propellant passage.
The number of perforations in the membrane area can vary depending on factors such as the amount of active cnmpound al7sls2 that is to be administered per dosage, the physical pro-perties of the active compound, etc. In a preferred embodiment, the perforations have conical shape, as said above, at dosing of solid, micronized compDund.
; 5 At ad~inistration of active compound in solution the con-struction of the perforated membrane inciuding the form of the perforations is less critical. Also membranes in the form of nets, for example woven nets in metal or in fiber can be used, as mentioned above.
.
The size of the dosages of bronchospasmolytically active compounds, or steroids for inhalation, that normally are administered at each administration is as folIows.
Terbutaline: standard dosage 0.5 mg Salbutamol : standard dosage n ~ 2 mg Budesonide : standard dosage 0.1 mg a The active compound can be administered in micronized form without additional ingredients ror in pharmaceutically modified micronized form in order to obtain improved flow properties. The micronized particles may be covered with a film functioning for example by masking bitter taste of the active compound, or by providing slow release of the active compound in the respiratory tract.
The dosing unit in the dosage inhalator according to the present invention admits dispensing of an amount of active compound of mainly from 0.1 to 1 mg, but also dosages from 1 to 5 mg and from 5 to 50 mg, especially when solid, micronized active compound is used, can be dispensed by suitable design of perforations and size of that part of the area of the perforated membrane which is intended to be introduced into the propellant passage.
, :
1 1`~8:l~2 The storage chamber 24 for active compound in solid, micronized form, respectively the storage chamber 34 for active compound in solution can be intended to contain active compound for about 100 to 200 dosages, which is sufficient for about a month's normal use for local administration of active compound to the respiratory tract.
The storage chamber 24 for solid, micronized compourid can be placed above as well as below the perforated membrane.
In a preferred embodiment the storage chamber is placed above the membrane. The storage chamber 24 can be arranged to be refilled via a seaIable opening 39.
1~ The storage chamber 34 for active compound in solution is in one preferred embodiment connected with a larger seal-able storage charnber 38.
In a preferred embodirnent of the dosage inhalator according to the invention the perforated membrane 25 is displaceably arranged in relation to the storage charnber 24.
Claims (18)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A dosage inhalator intended for inhalation of pharma-cologically active compound in solid, micronized form comprising a propellant container adapted to be connected to a propellant dispensing unit; a dosing unit for dosing the pharmacologically active compound, and means for delivering propellant from said dispensing unit through a propellant passage in said dosing unit; characterized in that the dosing unit for dosing the pharmacologically active compound comprises a storage chamber for the active compound directly connected to a dosing unit, said dosing unit comprising a perforated membrane, a holder for the said perforated membrane, and means for displacing the membrane, whereby the membrane is displaceably arranged between a first position where active compound is introduced into the perforations in part of the area of the membrane and a second position where the said part area of the membrane is inserted in the propellant passage.
2. A dosage inhalator according to claim 1, characterized in that the perforated membrane is displaceably arranged in relation to the storage chamber.
3. A dosage inhalator according to claim 1, characterized in that the dosing unit comprises a perforated rotating membrane in the form of a drum, intended to be loaded from its outside with active compound in solid, micronized form.
4. A dosage inhalator according to claim 3, characterized in that the perforations in the drum-formed membrane when it is rotated are arranged to be loaded with active compound from the outside of the drum using spring-loaded scrapers in the storage chamber.
5. A dosage inhalator according to claim 3, characterized in that the perforations in the drum-formed membrane are arranged to be loaded with active compound from the inside of the drum by rotating the drum.
6. A dosage inhalator according to claim 1, characterized in that the perforations in the membrane are in the form of truncated cones with the larger surface directed towards an outlet nozzle of said propellant passage.
7. A dosage inhalator intended for inhalation of pharma-cologically active compound in solution comprising a propellant container adapted to be connected to a propellant dispensing unit; a dosing unit for dosing the pharmacologically active compound, and means for delivering propellant from said dispens-ing unit through a propellant passage in said dosing unit;
characterized in that the dosing unit comprises a perforated membrane and means for displacing the membrane, whereby the membrane is displaceable arranged between a first position where active compound is introduced into the perforations in the membrane and a second position where the membrane is inserted in the propellant passage.
characterized in that the dosing unit comprises a perforated membrane and means for displacing the membrane, whereby the membrane is displaceable arranged between a first position where active compound is introduced into the perforations in the membrane and a second position where the membrane is inserted in the propellant passage.
8. A dosage inhalator according to claim 1, characterized in that the propellant container comprises a first valve connecting the propellant container with a passage leading to a dosing chamber containing a second valve, said valve connecting the dosing chamber with said propellant passage leading to an outlet nozzle, whereby the said first and second valves are arranged to be opened and closed using connecting arms and, respectively attached to a tilting lever, the said tilting lever being arranged to close one of the valves at the opening of the other valve and whereby the said first and the second valves comprise a protrusion co-operating with an opposite depression in the propellant container and in the propellant dispensing unit, respectively.
9. A dosage inhalator according to claim 8, characterized in that the said first valve and the said second valve comprise a protrusion arranged on the connecting arm which protrusion cooperates with an opposite depression in the propellant container and in -the propellant dispensing unit, respectively, whereby the said depression is provided with a sealing ring with rectangular section.
10. A dosing unit for dosing in a dosage inhalator of pharmacologically active compound in solid micronized form characterized in that it comprises a storage chamber for the active compound in connection with a dosing unit which comprises a perforated membrane, a holder for said perforated membrane, and means for displacing the said membrane, whereby the dosing unit and the perforated membrane are displaceably arranged in relation to each other between a first position where active compound is introduced into the perforations in part of the area of the membrane and a second position where the said membrane area is introduced in the propellant passage of the dosage inhalator.
11. A dosing unit according to claim 10, characterized in that the perforated membrane is displaceably arranged in relation to the storage chamber.
12. A dosing unit according to claim 10, characterized in that the dosing unit comprises a perforated drum-formed membrane which can be rotated and which is arranged to be loaded from its outside with active compound in solid, micronized form.
13. A dosing unit according to claim 12, characterized in that the perforations in the drum-formed membrane when the said membrane is rotated are arranged to be loaded with active compound from the outside of the drum using spring-loaded scrapers in the storage chamber.
14. A dosing unit according to claim 12, characterized in that the perforations in the drum-formed membrane are arranged to be loaded with active compound from the inside of the drum when the drum is rotated.
15. A dosing unit according to claim 13, characterized in that the perforations in the drum-formed membrane are in the form of truncated cones with the larger area directed towards the outside of the membrane.
16. A dosing unit for dosing in a dosage inhalator of pharmacologically active compound in solution, characterized in that it comprises a storage chamber for the solution of the active compound in connection with a dosing unit which comprises a perforated membrane arranged to be loaded with active compound in solution, and means for displacing the said membrane, whereby the perforated membrane is displaceably arranged in relation to the storage chamber between a first position where active compound in solution is introduced into perforations in part of the area of the membrane and a second position where the said membrane area is introduced in the propellant passage of the dosage inhalator.
17. A dosing unit according to claim 16, characterized in that the perforated membrane is displaceably arranged between a first position where the membrane is immersed in a storage chamber for active compound in solution, and a second position where the membrane is introduced into the propellant passage.
18. A dosing unit for dosing in a dosage inhalator of pharmacologically active compound, characterized in that it comprises a storage chamber for the active compound in connection with a dosing unit which comprises a perforated membrane arranged to be loaded with active compound, and means for displacing the said membrane, whereby the perforated membrane is displaceably arranged in relation to the storage chamber between a first position where active compound is introduced into perforations in part of the area of the membrane and a second position where the said membrane area is introduced in the propellant passage of the dosage inhalator.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE8104240A SE438261B (en) | 1981-07-08 | 1981-07-08 | USE IN A DOSHALATOR OF A PERFORED MEMBRANE |
| SE8104240-0 | 1981-07-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1178152A true CA1178152A (en) | 1984-11-20 |
Family
ID=20344221
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000405889A Expired CA1178152A (en) | 1981-07-08 | 1982-06-24 | Dosage inhalator i |
Country Status (17)
| Country | Link |
|---|---|
| US (2) | US4534345A (en) |
| JP (1) | JPS5819268A (en) |
| AT (1) | AT386524B (en) |
| AU (2) | AU560654B2 (en) |
| BE (1) | BE893795A (en) |
| CA (1) | CA1178152A (en) |
| CH (1) | CH657054A5 (en) |
| DE (1) | DE3224562A1 (en) |
| DK (1) | DK304582A (en) |
| FR (1) | FR2509181B1 (en) |
| GB (2) | GB2102295B (en) |
| IT (1) | IT1148984B (en) |
| LU (1) | LU84256A1 (en) |
| NL (1) | NL8202676A (en) |
| NO (1) | NO154906C (en) |
| NZ (1) | NZ201153A (en) |
| SE (4) | SE438261B (en) |
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- 1982-06-30 US US06/393,720 patent/US4534345A/en not_active Expired - Lifetime
- 1982-07-01 DE DE19823224562 patent/DE3224562A1/en not_active Withdrawn
- 1982-07-01 IT IT48730/82A patent/IT1148984B/en active
- 1982-07-02 NL NL8202676A patent/NL8202676A/en not_active Application Discontinuation
- 1982-07-05 NZ NZ201153A patent/NZ201153A/en unknown
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- 1982-07-05 LU LU84256A patent/LU84256A1/en unknown
- 1982-07-05 AU AU85609/82A patent/AU560654B2/en not_active Ceased
- 1982-07-06 CH CH4127/82A patent/CH657054A5/en not_active IP Right Cessation
- 1982-07-06 GB GB08219474A patent/GB2102295B/en not_active Expired
- 1982-07-07 JP JP57117051A patent/JPS5819268A/en active Pending
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- 1982-07-07 DK DK304582A patent/DK304582A/en not_active Application Discontinuation
- 1982-07-07 FR FR8211929A patent/FR2509181B1/en not_active Expired
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- 1985-04-23 US US06/726,064 patent/US4667668A/en not_active Expired - Fee Related
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