MXPA97002799A - Drug carrier for dry powder inhaler and process to form my - Google Patents
Drug carrier for dry powder inhaler and process to form myInfo
- Publication number
- MXPA97002799A MXPA97002799A MXPA/A/1997/002799A MX9702799A MXPA97002799A MX PA97002799 A MXPA97002799 A MX PA97002799A MX 9702799 A MX9702799 A MX 9702799A MX PA97002799 A MXPA97002799 A MX PA97002799A
- Authority
- MX
- Mexico
- Prior art keywords
- carrier
- medicament
- screen
- sprayed
- interstices
- Prior art date
Links
- 229940112141 Dry Powder Inhaler Drugs 0.000 title claims abstract description 23
- 238000000034 method Methods 0.000 title claims description 15
- 239000003937 drug carrier Substances 0.000 title description 6
- 239000003814 drug Substances 0.000 claims abstract description 173
- 239000000969 carrier Substances 0.000 claims abstract description 134
- 239000000725 suspension Substances 0.000 claims description 25
- 239000000758 substrate Substances 0.000 claims description 15
- 239000000463 material Substances 0.000 claims description 11
- 239000000375 suspending agent Substances 0.000 claims description 10
- 238000001704 evaporation Methods 0.000 claims description 7
- -1 meotaranol Chemical compound 0.000 claims description 7
- 239000010935 stainless steel Substances 0.000 claims description 7
- 229910001220 stainless steel Inorganic materials 0.000 claims description 7
- 150000002430 hydrocarbons Chemical class 0.000 claims description 6
- JWZZKOKVBUJMES-UHFFFAOYSA-N 4-{1-hydroxy-2-[(propan-2-yl)amino]ethyl}benzene-1,2-diol Chemical compound CC(C)NCC(O)C1=CC=C(O)C(O)=C1 JWZZKOKVBUJMES-UHFFFAOYSA-N 0.000 claims description 5
- XWTYSIMOBUGWOL-UHFFFAOYSA-N Bricaril Chemical compound CC(C)(C)NCC(O)C1=CC(O)=CC(O)=C1 XWTYSIMOBUGWOL-UHFFFAOYSA-N 0.000 claims description 5
- WMWTYOKRWGGJOA-CENSZEJFSA-N Fluticasone propionate Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(OC(=O)CC)[C@@]2(C)C[C@@H]1O WMWTYOKRWGGJOA-CENSZEJFSA-N 0.000 claims description 5
- 229940039009 Isoproterenol Drugs 0.000 claims description 5
- VQDBNKDJNJQRDG-UHFFFAOYSA-N Pirbuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=N1 VQDBNKDJNJQRDG-UHFFFAOYSA-N 0.000 claims description 5
- NDAUXUAQIAJITI-UHFFFAOYSA-N Salbutamol Chemical group CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims description 5
- GIIZNNXWQWCKIB-UHFFFAOYSA-N Serevent Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 GIIZNNXWQWCKIB-UHFFFAOYSA-N 0.000 claims description 5
- 229960000195 Terbutaline Drugs 0.000 claims description 5
- 229960000289 fluticasone propionate Drugs 0.000 claims description 5
- 229960001317 isoprenaline Drugs 0.000 claims description 5
- 229960004692 perflenapent Drugs 0.000 claims description 5
- NJCBUSHGCBERSK-UHFFFAOYSA-N perfluoropentane Chemical compound FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F NJCBUSHGCBERSK-UHFFFAOYSA-N 0.000 claims description 5
- 229960005414 pirbuterol Drugs 0.000 claims description 5
- 229960002052 salbutamol Drugs 0.000 claims description 5
- 229960004017 salmeterol Drugs 0.000 claims description 5
- KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone dipropionate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 claims description 4
- 229940092703 Beclomethasone Dipropionate Drugs 0.000 claims description 4
- FAYMLNNRGCYLSR-UHFFFAOYSA-M Triphenylsulfonium triflate Chemical compound [O-]S(=O)(=O)C(F)(F)F.C1=CC=CC=C1[S+](C=1C=CC=CC=1)C1=CC=CC=C1 FAYMLNNRGCYLSR-UHFFFAOYSA-M 0.000 claims description 4
- 229950000210 beclometasone dipropionate Drugs 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 4
- 229910052751 metal Inorganic materials 0.000 claims description 4
- RKIMETXDACNTIE-UHFFFAOYSA-N 1,1,2,2,3,3,4,4,5,5,6,6-dodecafluorocyclohexane Chemical compound FC1(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C1(F)F RKIMETXDACNTIE-UHFFFAOYSA-N 0.000 claims description 3
- XTZNCVSCVHTPAI-UHFFFAOYSA-N 2-carboxynaphthalen-1-olate;[2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethyl]-[6-(4-phenylbutoxy)hexyl]azanium Chemical compound C1=CC=CC2=C(O)C(C(=O)O)=CC=C21.C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 XTZNCVSCVHTPAI-UHFFFAOYSA-N 0.000 claims description 3
- ZJIJAJXFLBMLCK-UHFFFAOYSA-N Perfluorohexane Chemical compound FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F ZJIJAJXFLBMLCK-UHFFFAOYSA-N 0.000 claims description 3
- DLHYHXMSPLUHRA-UHFFFAOYSA-N Perfluoromethylcyclohexane Chemical compound FC1C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C1(F)C(F)(F)F DLHYHXMSPLUHRA-UHFFFAOYSA-N 0.000 claims description 3
- 229960004624 perflexane Drugs 0.000 claims description 3
- 239000000919 ceramic Substances 0.000 claims description 2
- VOVIALXJUBGFJZ-VXKMTNQYSA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3O[C@@H](CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-VXKMTNQYSA-N 0.000 claims 4
- MGNNYOODZCAHBA-GQKYHHCASA-N Fluticasone Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(O)[C@@]2(C)C[C@@H]1O MGNNYOODZCAHBA-GQKYHHCASA-N 0.000 claims 1
- XBDQKXXYIPTUBI-UHFFFAOYSA-M propionate Chemical compound CCC([O-])=O XBDQKXXYIPTUBI-UHFFFAOYSA-M 0.000 claims 1
- 229940079593 drugs Drugs 0.000 description 35
- 239000002245 particle Substances 0.000 description 17
- 239000000843 powder Substances 0.000 description 13
- 239000002775 capsule Substances 0.000 description 8
- 238000011068 load Methods 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- 239000003981 vehicle Substances 0.000 description 5
- 208000006673 Asthma Diseases 0.000 description 3
- 206010038683 Respiratory disease Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- 239000007921 spray Substances 0.000 description 3
- GUBGYTABKSRVRQ-UUNJERMWSA-N Lactose Natural products O([C@@H]1[C@H](O)[C@H](O)[C@H](O)O[C@@H]1CO)[C@H]1[C@@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1 GUBGYTABKSRVRQ-UUNJERMWSA-N 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 2
- 239000000443 aerosol Substances 0.000 description 2
- 239000003708 ampul Substances 0.000 description 2
- 238000009835 boiling Methods 0.000 description 2
- VOVIALXJUBGFJZ-KWVAZRHASA-N budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 description 2
- KYKAJFCTULSVSH-UHFFFAOYSA-N chloro(fluoro)methane Chemical compound F[C]Cl KYKAJFCTULSVSH-UHFFFAOYSA-N 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 210000002345 respiratory system Anatomy 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 229920002994 synthetic fiber Polymers 0.000 description 2
- 239000012209 synthetic fiber Substances 0.000 description 2
- UPHOPMSGKZNELG-UHFFFAOYSA-M 1-carboxynaphthalen-2-olate Chemical compound C1=CC=CC2=C(C([O-])=O)C(O)=CC=C21 UPHOPMSGKZNELG-UHFFFAOYSA-M 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N D-Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 241000509579 Draco Species 0.000 description 1
- 229920000840 ETFE Polymers 0.000 description 1
- 239000001828 Gelatine Substances 0.000 description 1
- 210000004072 Lung Anatomy 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 210000002700 Urine Anatomy 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000003213 activating Effects 0.000 description 1
- 239000011149 active material Substances 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000000240 adjuvant Effects 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000001088 anti-asthma Effects 0.000 description 1
- 239000000924 antiasthmatic agent Substances 0.000 description 1
- 229910010293 ceramic material Inorganic materials 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
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- 239000000428 dust Substances 0.000 description 1
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- 238000000605 extraction Methods 0.000 description 1
- 230000002349 favourable Effects 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 150000004676 glycans Polymers 0.000 description 1
- 230000002209 hydrophobic Effects 0.000 description 1
- 238000005470 impregnation Methods 0.000 description 1
- 238000002664 inhalation therapy Methods 0.000 description 1
- 229910010272 inorganic material Inorganic materials 0.000 description 1
- 239000011147 inorganic material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
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- 230000004048 modification Effects 0.000 description 1
- 238000006011 modification reaction Methods 0.000 description 1
- 230000003000 nontoxic Effects 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 231100000956 nontoxicity Toxicity 0.000 description 1
- 239000011368 organic material Substances 0.000 description 1
- CBENFWSGALASAD-UHFFFAOYSA-N ozone Chemical compound [O-][O+]=O CBENFWSGALASAD-UHFFFAOYSA-N 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 150000004804 polysaccharides Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000003380 propellant Substances 0.000 description 1
- 230000035485 pulse pressure Effects 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 230000000241 respiratory Effects 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N β-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
Abstract
The present invention relates to a medicament carrier for use in a dry powder inhaler device, comprising a carrier having at least one portion of carrier mesh, defining a plurality of interstices therein, and charging with at least one dose of a powdered medicament, characterized in the carrier because the powdered medicament is loaded onto the surface of the carrier mesh portion, such that the interstices are at least partially open and free of the medicament in pol
Description
CARRIER OF DRUG INHALER DRYER AND PROCESS TO FORM THE SAME C am p o d a l n e v e n c i n
The present invention relates to a carrier or vehicle for medicament, and more particularly to a carrier or vehicle containing a dry powder medicament thereon and which is adapted to be placed inside a dry powder inhaler.
Background of Related Art
Asthma and other respiratory diseases are typically treated by inhaling a medically appropriate lung deposition to make breathing easier for the patient and increase their air capacity. The most widely used treatments for respiratory diseases have been (1) inhalation of a drug from a solution or suspension of the drug in a pressurized inhaler, aerosol, metered dose, and (2) inhalation of a powdered drug ( usually mixed with an excipient) from a dry powder inhaler. However, in light of recent evidence of the relationship between chlorofluorocarbon emissions and the deterioration of the earth's atmospheric ozone layer Rf.24557, the use of drugs in pressurized inhalers is less desirable and interest in dry powder inhalation systems they have increased substantially. The applicant is currently informed of several different basic methods in the use of providing fine particle powders to the respiratory tract without the use of undesirable chlorofluorocarbon propellants. The first method uses hard gelatine capsules which contain both a dose of the active material and, in addition, potential adjuvants. The inhaler used by the asthmatic patient for this method comprises a device for piercing or opening the capsule which is then inserted into the inhaler when necessary. A current of air generated by the patient on a mouthpiece of the inhaler serves to remove the dust contained within the open capsule. The empty capsule is then ejected from the inhaler, which is then ready to receive the next capsule. The air stream which passes through the capsule during inhalation acts to remove the sprayed medication from the broken capsule, but it has been found that the air stream created by the patient using this type of inhaler in general does not have a enough time to remove the entire contents from the capsule. Dry powder inhalers using this technology are described in a number of prior art references, including U.S. Pat. Nos. 3,906,950; 4,013,075; 3,807,400; and 3,991, 761. Another type of inhaler device is loaded with a package having a number of ampoules or cavities, which are spaced apart from each other. Each ampoule or cavity contains a fixed amount of powdered medicament for administration to the patient. When each ampoule or cavity is moved to a predetermined position, it is broken by a suitable means to release the powder which is inhaled in turn by the patient. However, it has been found that the entry of moisture into the package of blisters or cavities can cause agglomeration of the medicine prepared therein. Accordingly, when the prepared medicament is inhaled by the user, the preferred particle size to provide greater efficacy in the treatment of respiratory disease, can not necessarily be achieved. In addition, the operation of the device requires the use of excipients (eg, lactose) to dose and administer the medication. This type of inhalation device is described in several prior art patent publications including Patent Application Publications EP0 N o s. 211595; EP0 455463; and EP0 467172A1.
Yet another type of dry powder inhaler contains a quantity of medicament therein which is sufficient for multiple doses. A representative example of this type of device is the Draco TURBUHALER which is described in U.S. Pat. Nos. 4,668,218; 4,667,668; and 4,805,811. The inhaler includes a device for extracting the sprayed medication from the container and for preparing a dose for inhalation. The extraction and dose preparation phase includes a plate having a predetermined thickness and a number of cup or cup-shaped holes therethrough. The plate can be moved by mechanical means from a position where a proportion of the orifices are filled with a powdered medicament taken from the container to another position in which the holes filled with the medicament are located within a channel. The air flows into the channel as a result of the suction provided by the patient on a nozzle in fluid communication with the channel to remove the sprayed medication from the orifices. However, it has been found that when the suction is applied to drag the medicament from one or more holes in the plate, not all of the medicament is entrained in the air flow. In addition, the TURBUHALER device is designed to administer large doses and is prone to significant variations in drug delivery. A fourth dry powder inhaler device is disclosed in German Patent No. 4020571 A1 wherein a velvet or velvet type material loaded with powder is introduced into an air jet stream. The air current acts to lift the powder from the velor-like material and to draw the powder into the air stream which is in turn inhaled by the patient. A disadvantage of this type of inhaler device is that there is a tendency for the carrier fibers to intermix with the medicament. A new type of carrier disk or vehicle for a dry powder inhaler, which has recently been proposed, is described in U.S. Serial No. 08 / 025,964 filed 3/3/93 which teaches a filter mesh disk which is impregnated in locations or portions spaced along its circumference with a dose of powdered medicament, such as hydroxynaphthoate of salmeterol, which may be useful in the treatment of asthma. Since the powdered medicament is impregnated in the interstices of the portions of the screen, the air that hits the portions of the filter or screen and the medicament sprayed during inhalation will cause the drug to fragment, to atomize or turn into a spray the same. In addition, the interstitial reservoir of the medicament over the filter portions allows turbulent air to surround each dose of the medicament and entrain it to assist in the complete distribution of the medicament dose from the portions of the filter or screen to the air stream. However, the use of the filter disc in the dry powder inhaler device also suffers from certain disadvantages including the imprecise dosing of the sprayed medicament since the interstices of the filter portion or screen are used to deliver the medicament. Other disadvantages of the interstitial deposit of the powdered medicament (or the impregnation of the medicament) in the portions of the filter or screen, are the limitations of the size of the dose with respect to the terstitial volume, and the need to crumble or disaggregate lumps or large lumps of the medicament. present in the interstitial voids. The applicant's present invention avoids many of the problems associated with dry powder inhalers of the prior art, providing a novel carrier for medicament, which allows a predetermined and accurate dose of the dry powdered medicament to be delivered through the device. inhaler when required. Furthermore, the applicant's invention provides a much greater flexibility in the range of the dose of the drug with a size of the filtering portion of the specific carrier, since the dose of the medicament does not depend on the volume of the interstitial vacuum of the filtering portion or screen by the designer
Brief Description of the Invention
In accordance with the present invention, a medicament carrier is provided, for use in a dry powder inhaler device, comprising a carrier having at least one filter or screen portion of the carrier defining a plurality of interstices therein. and loaded with at least one dose of a powdered medicament, wherein the sprayed medicament is loaded onto the surface of the filtering portion or screen of the carrier, such that the interstices therein are at least partially open and free of charge. powdered medication. Also, according to an alternative embodiment of the present invention, a medicament carrier, for use in a dry powder inhaler device, is provided, which comprises at least one carrier or vehicle portion comprising two screens or spaced apart filters, wherein each screen or filter defines a plurality of interstices therein, and a plurality of substantially spherical substrate elements, placed between the screens or filters and charged with at least one dose of a medicament sprayed wherein the medicament The sprayed material is removed from the spherical substrate elements and entrained in an air flow introduced through the two screens or filters spaced apart. The present invention also provides a process for forming a carrier for medicament, for use in a dry powder inhaler device, comprising the steps of: (a) providing a carrier having a plurality of carrier or vehicle surfaces defining a plurality of interstices between them; (b) applying a predetermined amount of a suspension comprising at least one dose of a sprayed medicament to the carrier surfaces of the carrier so that the interstices are at least partially open and free of the suspension; and (c) evaporating the suspending agent from the carrier surfaces to leave the sprayed medicament deposited mainly on the carrier surfaces of the carrier and not within the interstices thereof. The present invention further provides a process for forming a medicament carrier for use in a dry powder inhaler device comprising the steps of: (a) providing a carrier having at least one portion of the carrier screen or filter defining a carrier plurality of interstices between them; (b) applying a predetermined amount of a suspension comprising at least one dose of a sprayed medicament to the surface of the portion of the screen or filter of the carrier, so that the interstices are at least partially open and free of the suspension; and (c) evaporating the suspension agent from the portion of the screen or filter of the carrier, to leave the sprayed medicament deposited mainly on the surfaces of the carrier and not within the interstices thereof. Therefore, the object of the present invention is to provide a medicament carrier for use in a dry powder inhaler, which is provided for the administration of a precise, determined dosage of the powdered medicament. It is another object of the present invention to provide a medicament carrier, for use in a dry powder inhaler device, which is provided so that the particle size ingested from the dose of the sprayed medicament is formed for maximum beneficial efficiency. Some of the objects of the invention have already been established, other objects will become apparent when the description proceeds, when taken in relation to the accompanying drawings described hereinafter.
Brief Description of the Drawings
Figure 1 is a perspective view of a first representative medicament carrying cassette, for use in a dry powder inhaler device according to the present invention; Figure 2 is a perspective view of a second representative medicament carrying cassette, for use in a dry powder inhaler device according to the present invention; Figure 3 is a perspective view of a third representative medicament carrying cassette, for use in a dry powder inhaler device according to the present invention; Figure 4 is a perspective view of an individual medicament carrier such as that used in the representative cassettes shown in Figures 1-3; Figure 5 is an exploded perspective view of the medicament carrier shown in Figure 4; Figure 6 is an exploded vertical cross-sectional view of the medicament carrier shown in Figure 4; Figure 7 is a schematic view illustrating the application of a suspension solution of a sprayed medication that is applied to the portion of the filter or screen of the medicament carrier shown in Figures 5 and 6; Figure 8 is an enlarged, perspective view showing the loading of the sprayed medicament on the surface of the portion of the screen or filter of the medicament carrier after evaporation of the suspending agent, such that the interstices of the portion of the screen or filter of the medicament carrier are at least partially open and free of the sprayed medicament; Figure 9 illustrates the carrier of the medicament of the present invention and the effect thereon when subjected to a pulse of inhalation air; Figures 10A and 10B show a plan view and an enlargement of a selected portion thereof, respectively, of a screen portion or filter of the medicament carrier with a sprayed powdered medicament loaded thereon; and Figure 11 illustrates a second embodiment of the medicament carrier of the present invention wherein the carrier comprises two screens or filters spaced apart having a plurality of substantially spherical substrate elements, placed therebetween, which are loaded with a medicament. pulverized And the effect on it when subjected to a pulse of inhalation air.
Best Way to Carry Out the Invention
Referring now to Figures 1-11 of the drawings in which the identical reference numerals indicate similar elements in all the various views, three (3) embodiments of the drug carrying cassettes are illustrated in Figures 1-3 which include each a number of drug carriers 10, spaced apart, therein, which form the subject of the present invention. The powdered medicaments which can be used with the medicament carrier of the present invention for inhalation therapy of the systematic absorption through the respiratory tract include, but are not limited to, salbutamol, terbu-talin, isoproterenol, metaprotaranol , pirbuterol, salmeterol hydroxy naphthoate, fluticasone propionate, budese-nida, beclomethasone dipropionate, and triacetonide. In addition, it is understood that the powdered medicaments can optionally be mixed with excipients such as lactose and glucose. Referring more specifically to the drawings, the medicament carriers 10 are shown in Figures 4-6. The medicament carriers 10, a plurality of which are included in each of the representative medicament-carrying cases of Figures 1-3, are formed from the portions 12 of the carrier screen or filter, which more preferably they are secured or sandwiched between the closure screens or filters 14 and 16, although the screens or filters 14 and 16 may not be required in other embodiments of the medicament carriers 10 in accordance with the present invention. It should be appreciated that the medicament carrying cassettes of Figures 1-3 are configured to be insertable into any suitable respiratory inhaled dry powder inhaler (not shown) such as those well known in the art and that carriers of the novel drug of the present invention, could be incorporated into many other types of sheets, plates, discs and the like in addition to the three representative illustrated cassettes. The portion 12 of the screen of the carrier can be a woven or non-woven filter or screen, formed of natural or synthetic fibers, or stamped from a blank piece of metal or etched with a photo acid from stainless steel or ceramic, or formed in any other suitable manner, to provide a plurality of interstices 12A (see Figure 8) therein. The applicant's invention is provided for the deposition of a prescribed dose of a dry powdered medicament substantially on the surface of the portion 12 of the carrier screen (see Figure 8) and not primarily within the interstices 12A thereof. The size of the dose depends on the drug used. For example, a common drug used for antiasthmatics is salmeterol hydroxynatodate which is normally distributed in single doses of approximately 50 micrograms (_g). Accordingly, each drug dose of such drug could be deposited on the surface of a portion 12 of the screen of the selected carrier, which is more adequately formed to be approximately 0.15 - 0.635 cm (0.06-0.25 inches) in diameter in its size and to have interstices in it that measure approximately 0.00127 cm (0.0005 inch) or more in width. As noted hereinbefore, the portion 12 of the carrier screen can be formed in many ways including a woven or nonwoven screen formed of natural or synthetic fibers or stamped from a blank piece of metal or engraved with a Photoacid from a stainless steel or ceramic material. The portion 12 of the carrier screen is formed with interstices 12A of about 0.00127 cm (0.0005 inches) or more in width and (optionally) secured or sandwiched between the closure screens 14 and 16 to form the carrier 10 of the medicament. It is to be understood that the carrier 10 of the medicament could be formed exclusively from the portion 12 of the carrier screen as a matter of design selection to form the carrier 10 of the medicament. A plurality of the drug carriers 10 are placed on the perimeter of a cassette of the medicament carrier such as the rings shown in Figures 1 and 2respectively, or along the length of a cassette tape of the medicament carrier such as that shown in Figure 3. Optional closure screens 14 and 16, each permit access of an external air flow or pulses of air through the exposed area of the carrier 10 of the medicament when the carrier is placed inside a suitable dry powder inhaler device (not shown) so that the sprayed medicament can be entrained in the air (see Figure 9) which is then inhaled by the patient through the mouthpiece of the inhaler (not shown) which communicates with the air flow. By suitable mechanical or electromechanical means, the drug carriers 10 within the drug-carrying cassettes such as those shown in Figures 1-3, are selectively indexed to present a new dose of a sprayed medicament to the air flow or pulse of air from the inhaler device. Since the sprayed medicament is deposited primarily on the surface of port portion 12 of the porthole and extends over a significant number of interstices in portion 12 of the carrier screen (see Figure 8), the number of particles in the carrier screen (see FIG. physical contact with each other is significantly reduced and therefore the amount of energy required to disaggregate the particles in the range of the respirable particle size is minimized (as opposed, for example, to the interstitial deposit strictly of the sprayed medicament). The thickness of the sprayed drug layer on the surface of the elements forming the portion 12 of the carrier screen can be selected to minimize the degree of particle-particle contact and / or the particle micro-particle size. The pulse of directed air in the dry powdered medicament will serve to clean the dose of powdered medicament out of portion 12 of the carrier screen, to suck the dose out of portion 12 of the carrier screen by virtue of the Bernoulli effect and / o to quickly separate the dose that joins the interstices with a bridge. The Applicant has discovered that the high shear forces and turbulence experienced by the deposited sprayed medication will lead to the removal and / or disaggregation of the particles or microgrips of the particles. Accordingly, each gap 12A of portion 12 of the carrier screen will act as a nozzle or spout if any particles are not adhered directly to the surface of the elements defining the portion 12 of the carrier screen but are not accreted to the same (see, for example, Figures 10A and 10B). The screen 14 (which, as noted previously, is optional and not a required element of the medicament carrier of the invention) is used to further assist in the disaggregation of the drug particles due to the impact and forces of the drug. high shear resulting from the contact of the sprayed medicament (removed by the air flow of portion 12 of the carrier screen and entrained in the through-air flow) with the screen 14. Also, the upstream 16 screen serves to modify the air flow to maximize turbulence and shear, to facilitate the disaggregation of the sprayed medication. An alternative embodiment of the applicant's invention contemplates providing the carrier 20 of the medicament (see Figure 11), which does not require the deposition of the dry powder medicament directly on the surface of the elements defining the portions 12 of the screen of the carrier The medicament carrier 20 of the alternative embodiment comprises substantially spherical substratum elements 22, formed from materials such as organic or inorganic materials such as metals, polymers or polysaccharides and on the surfaces from which the dried powdered medicament is deposited. The spherical substrate elements 22 are carried between two screen elements 24 and 26 to place the spherical substrate elements 22 in the air flow or the air pulse through the exposed area of the medicament carrier 20 within the channel for the flow of air from an inhaler so that the dry powdered medication can be entrained in the air or converted into an aerosol for inhalation by a patient. The carrier 20 of the medicament is placed with an inhaler device (not shown) so that the interstices of the screen elements 24 and 26 functionally serve as air jets to facilitate the disaggregation and removal of the dried spray from the surfaces of the spherical substrate elements 22.
Fabrication process
The novel drug carriers 10 and 20 of the Applicant are more adequately formed by supplying small amounts of selected medicaments in the urine of a suspension on the portions 12 of the carrier screen or on the elements of the carrier's spherical substrate 22 and then removing by Evaporation of the suspension medium The suspension medium must be relatively non-toxic, non-flammable or non-flammable, and must have a boiling point close to or slightly above ambient temperature, so that it is suitable for an adjustment of production. Applicant has found that perfluoropentane, perfluorohexane, perfluoro-methylcyclohexane and perfluorocyclohexane serve as a good suspending medium although other means of suspension are contemplated to be within the scope of the present invention (including hydrocarbons and / or fluorinated hydrocarbons). disc, ring or ribbon or similar, which will arrive n to be the drug cassette (such as those shown in Figures 1-3) will be passed to a drug filling zone in the manufacturing process. The manufacture of the drug filling zone will consist of an array of spray nozzles or needles N (see Figure 7) that will dose a predetermined amount of a drug as a suspension or solution S of the drug onto the portions 12 of the screen of the drug. carrier or on the spherical substrate elements 22. Since it is desirable to remove the suspension medium described hereinbefore, a sufficient time interval will be allowed to allow the suspension medium to evaporate. Optionally, heat and / or a small positive or negative air pressure can be applied to the portions 12 of the carrier screen or to the substantially spherical substrate elements 22 to facilitate evaporation. Accordingly, the essence of the applicant's manufacturing process is the application of the drug on the surface elements of the portions 12 of the carrier screen, and the spherical substrate elements 22 to leave the interstices therebetween substantially open and free of all drug
Experimental Test
The Applicant used an extensive study to select an appropriate suspension medium for the dry powder medicament to be applied to the portions of the carrier screen of the drug carriers of a cassette of the medicament carrier (e.g., a sheet, plate disc, tape or the like having a plurality of screen portions of the medicament carrier therein). Selection criteria may include non-flammability, non-toxicity, a boiling point close to room temperature (for high vapor pressure and low energy input, to remove liquid), and a low environmental impact. The Applicant found that perfluoropentane is going to be a good suspension medium which has significant advantages over many other liquids, although other suspension medium can be used in the practice of the present invention. The dry powder drug of micronized salmeterol can be easily suspended in perfluoropentane, and at refrigeration temperatures the suspensions of perfluoropentane-salmeterol appear to be stable for several days.
The applicant studied several of the screen materials for use as the screen portions of the cassette holder of the medicament carrier, etc. The physico-chemical properties of the screen material, which are important, include the moisture content, the abrasion / heat / chemical resistance, the dimensional stability, the physical properties of the screen (such as the area percentage open, air permeability), the diameter of the fiber or filament and the type of drawing. The screen samples for use as portions of the carrier screen were studied, including nylon, polyester, polypropylene and stainless steel, and the applicant currently believes that stainless steel and non-hygroscopic polymers are preferred screen materials since moisture is a problem with many dry powder medicament formulations. Therefore, the screen material must be relatively non-hygroscopic and hydrophobic, and this fact decreases the likelihood that nylon and polyester are suitable screen materials. Polypropylene, ethylene tetrafluoroethylene (ETFE) and E-CTFE are non-hygroscopic and have excellent hydrophobicities and therefore should be suitable screen materials to form the screen portions of the carrier of the medicament carriers of the invention. Although other types of screens can be used as described in some detail here above, screens of the stainless steel type were used in the test which will be described in greater detail here below.
Test Results
The applicant's statistically designed, preliminary experiments used stainless steel carrier screens and the following factors were investigated: mesh count (180, 230, 325, the same wire diameter, an open area of different percentage), a drug load (50_g and 250_g), a spot size (0.254 cm (0.1 inches), 0.381 cm (0.15 inches), 0.508 cm (0.2 inches)), an air pulse pressure (2.0, 3.5 and 5.0 atmospheres), a volume of the air pulse (0.1, 0.2 and 0.3 milliliters) and a configuration of the screen (the air pulse has influence on the first drug -DF, the first screen -SF, and twin screens -TS) . The point size is understood to be the diameter of the wearer's screen. A 2.5% suspension of fluticasone propionate in per f luoropentane was prepared, and the drug was distributed or filled on the screens using an EPPENDORF electronic pipette. The sizing of the particle was carried out by placing the appropriate screen in the dispersion apparatus of the inhalation, testing, and activating the dose in an analyzer of the particle size of the flight time API brand AEROSIZER. In summary, the test results reveal that the best results were obtained by applying the dry powdered medicament to the carrier of the medicament of the invention using a single screen (none of the closure screens 14 and 16) with the high volume of air, the pressure of high air, low drug loading and a small dot size. However, on average the highest particle counts were obtained with a double screen, high drug loading and small dot configuration. When the three screen configurations were analyzed separately, the applicant discovered that a portion of the carrier screen, coarse or coarse mesh, worked best for the single-screen configurations (none of the closure screens 14 and 16), while that a fine mesh worked better for the double screen configuration (including the closing screen 14). The Applicant's analysis, carried out only on the measurements of a high air volume / high air pressure, confirms the fact that a single screen configuration, a low drug load and a small dot size, provided the distributions of the more favorable particle size, while a double screen with a high drug load produced the highest particle counts. Additionally, the fine screen mesh tended to provide higher than average particle counts. The Applicant's test results from which the observations mentioned above were obtained are described in Table 1 and Table 2 given below.
TABLE 1
TEST RESULTS
DRUG CHARGE - -40 _g AIR PRESSURE - 4.92 kg / cmJ (70 psig) AIR VOLUME = 0.3 mi
NOTE: The results were averaged over the screen mesh and the dot size
TABLE 2
TEST RESULTS
DRUG CHARGE = -175_g AIR PRESSURE - 4.92 kg / cm2 (70 psig) AIR VOLUME - 0.3 mi
NOTE: The results were averaged over the size of the dot and screen mesh. It will be understood that various details of the invention can be changed without departing from the scope of the invention. In addition, the foregoing description is for the purpose of illustration only; and the invention extends to modifications, variations and improvements thereto.
It is noted that in relation to this date the best method known by the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.
Having described the invention as above, property is claimed as contained in the following
Claims (21)
1. A carrier for medicament, for use in a dry powder inhaler device, characterized in that it comprises a carrier having at least one screen portion of the carrier defining a plurality of interstices therein, and loaded with at least one dose of a sprayed medicament, wherein the sprayed medicament is loaded onto the surface of the portion of the carrier screen so that the interstices thereof are at least partially open and free of the sprayed medicament.
2. The medicament carrier according to claim 1, characterized in that the portion of the screen is formed from a material selected from the group consisting of woven or non-woven screens, blanks of stamped metal, stainless steel etched with a photo-acid and ceramic engraved with a photoacid.
3. The medicament carrier according to claim 1, characterized in that the carrier comprises a plurality of carrier screen portions each loaded with a dose of a powdered medicament.
4. The medicament carrier according to claim 1, characterized in that the interstices in the mesh portion of the carrier screen are at least 0.00127 cm (0.0005 inches) wide.
5. The medicament carrier according to claim 1, characterized in that the powdered medicament loaded on the carrier portion of the carrier is selected from the group consisting of salbuta-mol, terbutaline, isoproterenol, meotaranol, pirbute-rol, salmeterol hydroxynatodate. , fluticasone propionate, budesenide, beclomethasone dipropionate, and triaceto-nuro.
6. The medicament carrier according to claim 1, characterized in that at least one screen is placed adjacent but spaced away from the carrier to facilitate the disaggregation of the sprayed medicament.
7. The medicament carrier according to claim 6, characterized in that a screen is placed adjacent but spaced away from each side of the carrier to facilitate the disaggregation of the sprayed medicament.
8. The medicament carrier according to claim 1, characterized in that the sprayed medicament is loaded onto the surface of the portion of the carrier screen in a suspension and the suspending agent is evaporated.
9. A medicament carrier for use in a dry powder inhaler device, characterized in that it comprises a carrier having at least a portion of the carrier comprising two screens spaced apart where each screen defines a plurality of interstices therein, and a plurality of substantially spherical substrate elements placed between the screens and loaded with at least one dose of a sprayed medicament, wherein the sprayed medicament is removed from the spherical substrate elements and entrained in a flow of air introduced through the two screens spaced away.
10. The medicament carrier according to claim 9, characterized in that the surface of the plurality of spherical substrate elements is loaded with a dose of sprayed medicament.
11. The medicament carrier according to claim 9, characterized in that the powdered medicament loaded onto the spherical substrate elements, is selected from the group consisting of salbuta-mol, terbutaline, isoproterenol, meotaranol, pirbute-rol, salmeterol hydroxy naphthoate, propionate of flutica-sona, budesenide, beclomethasone dipropionate, and triace-tonuro.
12. A process for forming a medicament carrier for use in a dry powder inhaler device, characterized in that it comprises the steps of: (d) providing a carrier having a plurality of carrier surfaces defining a plurality of interstices therebetween; (b) applying a predetermined amount of a suspension comprising at least one dose of a sprayed medicament to the carrier surfaces of the carrier, such that the interstices are at least partially open and free of the suspension; and (c) evaporating the suspending agent from the carrier surfaces to leave the sprayed medicament deposited mainly on the carrier surfaces of the carrier and not within the interstices therein.
13. The process according to claim 12, characterized in that the carrier surfaces comprise a carrier screen portion.
14. A process according to claim 12, characterized in that the carrier surfaces comprise a plurality of spherical substrate elements.
15. The process according to claim 12, characterized in that the suspension comprises a powdered medicament selected from the group consisting of salbutamol, terbutaline, isoproterenol, meta-protaranol, pirbuterol, salmeterol hydroxy naphthoate, fluticasone propionate, budesenide, beclomethasone dipropionate, and triacetonide.
16. The process according to claim 12, characterized in that the suspending agent is selected from the group consisting of perfluoropentane, perfluorohexane, perfluoromethylcyclohexane and perfluorocyclohexane.
17. The process according to claim 12, characterized in that the suspending agent comprises hydrocarbons and / or fluorinated hydrocarbons.
18. A process for forming a medicament carrier for use in a dry powder inhaler device, characterized in that it comprises the steps of: (a) providing a carrier having at least one portion of the carrier screen defining a plurality of interstices between the carriers same; (b) applying a predetermined amount of a suspension comprising at least one dose of a sprayed medicament to the surface of the portion of the carrier screen so that the interstices are at least partially open and free of the suspension; and (c) evaporating the suspending agent from the portion of the carrier screen to leave the sprayed medicament deposited mainly on the surfaces of the carrier and not within the interstices thereof.
19. The process according to claim 18, characterized in that the suspension comprises a powdered medicament selected from the group consisting of salbutamol, terbutaline, isoproterenol, meta-protaranol, pirbuterol, salmeterol hydroxynatolate, fluticasone pro-pionate, budesenide, becl dipropionate -metasone, and triacetonide.
20. The process according to claim 18, characterized in that the suspending agent is selected from the group consisting of perfluoropentane, perfluorohexane, perfluoromethylcyclohexane and perfluorocyclohexane.
21. The process according to claim 18, characterized in that the suspending agent comprises hydrocarbons and / or fluorinated hydrocarbons.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/328,578 US5647347A (en) | 1994-10-21 | 1994-10-21 | Medicament carrier for dry powder inhalator |
| US08328578 | 1994-10-21 | ||
| US08328577 | 1994-10-21 | ||
| US08/328,577 US5503869A (en) | 1994-10-21 | 1994-10-21 | Process for forming medicament carrier for dry powder inhalator |
| PCT/US1995/013915 WO1996012515A2 (en) | 1994-10-21 | 1995-10-19 | Medicament carrier for dry powder inhalator and process for forming the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MXPA97002799A true MXPA97002799A (en) | 1997-06-01 |
| MX9702799A MX9702799A (en) | 1997-06-28 |
Family
ID=26986433
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX9702799A MX9702799A (en) | 1994-10-21 | 1995-10-19 | Medicament carrier for dry powder inhalator and process for forming the same. |
Country Status (17)
| Country | Link |
|---|---|
| EP (2) | EP0987041B1 (en) |
| JP (1) | JPH10507669A (en) |
| KR (1) | KR970706861A (en) |
| AT (2) | ATE232120T1 (en) |
| AU (1) | AU703618B2 (en) |
| BR (1) | BR9509392A (en) |
| CA (1) | CA2202919A1 (en) |
| CZ (1) | CZ287811B6 (en) |
| DE (2) | DE69529581T2 (en) |
| ES (1) | ES2148578T3 (en) |
| FI (1) | FI971676A (en) |
| HU (1) | HU219094B (en) |
| MX (1) | MX9702799A (en) |
| NO (1) | NO971817L (en) |
| NZ (1) | NZ296010A (en) |
| PL (1) | PL178716B1 (en) |
| WO (1) | WO1996012515A2 (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19533023B4 (en) | 1994-10-14 | 2007-05-16 | Basf Ag | New carboxylic acid derivatives, their preparation and use |
| GB9610821D0 (en) * | 1996-05-23 | 1996-07-31 | Glaxo Wellcome Inc | Metering apparatus |
| GB9616047D0 (en) | 1996-07-31 | 1996-09-11 | Glaxo Group Ltd | Medicament carrier with agglomerated large medicament particles and related method of manufacture thereof |
| JP2004537377A (en) * | 2001-08-09 | 2004-12-16 | グラクソ グループ リミテッド | Inhalation device with pharmaceutical composition |
| US8037880B2 (en) | 2006-04-07 | 2011-10-18 | The University Of Western Ontario | Dry powder inhaler |
| IL191190A0 (en) * | 2008-05-01 | 2009-08-03 | Dan Adler | Dry powder inhaler |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA1313805C (en) * | 1988-10-19 | 1993-02-23 | Hermann Schwartz | Article for simulation of smoking |
| GB8909891D0 (en) * | 1989-04-28 | 1989-06-14 | Riker Laboratories Inc | Device |
| CA2086123C (en) * | 1990-06-28 | 2002-01-01 | Arun Rajaram Gupte | Apparatus and process for metering powder |
| US5441060A (en) * | 1993-02-08 | 1995-08-15 | Duke University | Dry powder delivery system |
| KR960701672A (en) * | 1993-03-03 | 1996-03-28 | 윌리엄 피. 알트만 | DRY POWDER INHALATOR MEDICAMENT CARRIER |
-
1995
- 1995-10-19 NZ NZ296010A patent/NZ296010A/en unknown
- 1995-10-19 WO PCT/US1995/013915 patent/WO1996012515A2/en active IP Right Grant
- 1995-10-19 EP EP99121279A patent/EP0987041B1/en not_active Expired - Lifetime
- 1995-10-19 BR BR9509392A patent/BR9509392A/en not_active Application Discontinuation
- 1995-10-19 AT AT99121279T patent/ATE232120T1/en not_active IP Right Cessation
- 1995-10-19 HU HU9800561A patent/HU219094B/en not_active IP Right Cessation
- 1995-10-19 ES ES95937656T patent/ES2148578T3/en not_active Expired - Lifetime
- 1995-10-19 CA CA002202919A patent/CA2202919A1/en not_active Abandoned
- 1995-10-19 MX MX9702799A patent/MX9702799A/en not_active IP Right Cessation
- 1995-10-19 PL PL95319814A patent/PL178716B1/en unknown
- 1995-10-19 JP JP8514142A patent/JPH10507669A/en active Pending
- 1995-10-19 CZ CZ19971208A patent/CZ287811B6/en not_active IP Right Cessation
- 1995-10-19 AT AT95937656T patent/ATE192660T1/en not_active IP Right Cessation
- 1995-10-19 EP EP95937656A patent/EP0843566B1/en not_active Expired - Lifetime
- 1995-10-19 DE DE69529581T patent/DE69529581T2/en not_active Expired - Lifetime
- 1995-10-19 DE DE69516909T patent/DE69516909T2/en not_active Expired - Lifetime
- 1995-10-19 KR KR1019970702593A patent/KR970706861A/en active IP Right Grant
- 1995-10-19 AU AU39698/95A patent/AU703618B2/en not_active Ceased
-
1997
- 1997-04-18 NO NO971817A patent/NO971817L/en not_active Application Discontinuation
- 1997-04-18 FI FI971676A patent/FI971676A/en unknown
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