SI8412129A8

SI8412129A8 - Inhalator

Info

Publication number: SI8412129A8
Application number: SI8412129A
Authority: SI
Inventors: Heinrich Kladders
Original assignee: Boehringer Ingelheim Kg
Priority date: 1983-12-17
Filing date: 1984-12-14
Publication date: 1995-12-31
Also published as: HRP940699B1

Description

BOEHRINGER INGELHEIM KGBOEHRINGER INGELHEIM KG

InhalatorInhaler

Področje tehnike, v katero spada izumFIELD OF THE INVENTION

Področje tehnike, v katero spada izum so inhalatorji za inhalacije prašnatih, zlasti mikroniziranih zdravil iz običajnih kapsul.The invention relates to inhalers for the inhalation of dust, in particular micronised drugs, from conventional capsules.

Predvidena uvrstitev predmeta izuma po MKP je: A 61M 15/00.The intended classification of the object of the invention according to the IPC is: A 61M 15/00.

Izum se nanaša na inhalator za inhalacije prašnatih zlasti mikroniziranih zdravil iz običajnih kapsul, pri katerem so med potekom inhalacije odprte kapsule s pomočjo zračnega strujanja privedene v vibracije. Kapsule obstoje običajno iz trde želatine. Razmerje med njihovo dolžino in premerom znaša v splošnem 2 : 1 do 3ί 1, vendar pa lahko zavzame tudi razmerja, ki so med 1,5 : 1 in 4 : 1.The invention relates to an inhaler for the inhalation of dusty, particularly micronised medicines from conventional capsules, in which, during the course of inhalation, the open capsules are vibrated by airflow. The capsules usually exist in hard gelatin. Their length-to-diameter ratio is generally 2: 1 to 3ί 1, but it can also take ratios between 1.5: 1 and 4: 1.

Tehnični problemA technical problem

Glede na pomanjkljivosti dosedaj znanih tovrstnih inhalatorjev ki so v tem, da je odvzemanje prašnatega mikroniziranega zdravila iz kapsule neenakomerno; nekatere kapsule se namreč praktično popolnoma izpraznijo, druge pa po inhaliranju vsebujejo še znatne deleže zdravila - se pred izumitelja postavlja tehnični problem s kakšnimi konstrukcijskimi ukrepi odpraviti neenakomerno odvzemanje prašnatega mikroniziranega zdravila in zagotoviti odvzemanje zdravila iz kapsule z manjšim standardnim odstopanjem in hkrati preprečiti sprijemanje prašnatih mikroniziranih zdravil.Given the drawbacks of such known inhalers, which are that the extraction of powdered micronized drug from the capsule is uneven; some capsules are practically completely emptied, while others contain significant portions of the drug after inhalation - the inventor faces a technical problem with some structural measures to eliminate uneven withdrawal of powdered micronized drug and to ensure withdrawal of the drug from the capsule with a smaller standard deviation while preventing the adhesion of dusty micronized medicines.

Stanje tehnikeThe state of the art

Znani so že inhalatorji za inhaliranje zdravil vsebovanih v kapsulah, pri katerih so med inhalacijo te kapsule privedene do gibanja. Inhalator take vrste je že znan iz DE-A-1566604.Inhalers are known in the art for inhaling medicaments contained in capsules, in which these capsules are brought into motion during inhalation. Such an inhaler is already known from DE-A-1566604.

V navedenem spisu opisani inhalator ima pripravo s propelerskimi lopaticami, ki je nameščena koaksialno z vzdolžno osjo inhalatorja in je predvidena za sprejem kapsule. Pri inhaliranju s takim inhalatorji, bo priprava s kapsulo privedena v rotacijo.In the foregoing, the inhaler described herein has a propeller blade device coaxially arranged with the longitudinal axis of the inhaler and intended to receive the capsule. When inhaled with such inhalers, the capsule preparation will be rotated.

Medtem ko je pri predhodno opisanem inhalatorju kapsula z zdravilom pritrjena v gibljivem delu priprave in se z njim giba, opisuje FR-A-2146202 inhalacijsko pripravo s plosko cilindrično komoro_?ν kateri se giba samo kapsula. Na konceh odprta kapsula pri poteku inhaliranja rotira okoli njene prečne osi, zaradi pogona, ki ga kapsuli podeli tangencialno potekajoči zrak.While in the previously described inhaler, the drug capsule is attached to and movable in the moving portion of the device, describes FR-A-2146202 inhalation device with a flat cylindrical chamber _? ν only the capsule moves. At the ends, the open capsule rotates about its transverse axis during the course of inhalation, due to the drive provided by the capsule through tangentially flowing air.

Oba znana inhalatorja kažeta pomanjkljivosti predvsem v tem, da je odvzemanje zdravila iz kapsule neenakomerno. Nekatere kapsule se praktično popolnoma izpraznijo, druge pa po inhaliranju vsebujejo še znatne deleže zdravila. To se pojavlja zlasti pri zdravilih s finimi prašnatimi (mikroniziranimi) delci.Both known inhalers show disadvantages in that the withdrawal of the drug from the capsule is uneven. Some capsules are practically completely emptied, while others contain significant portions of the drug after inhalation. This is especially true for medicines with fine dust (micronized) particles.

Opis rešitve tehničnega problema s primeri izvedbe ter seznamom slikA description of the solution to a technical problem with examples of execution and a list of images

Glede na predhodno obravnavani tehnični problem, bo ta rešen z inhalatorjem po izumu za inhalacijo prašnatih, zlasti mikroniziranih zdravil iz običajnih kapsul z zanesljivim odvzemanjem zdravila iz kapsule z manjšim standardnim odstopanjem in s sposobnostjo preprečenja sprijemanja mikroniziranega zdravila v kapsuli.In view of the technical problem discussed above, this will be solved by the inhaler of the invention for the inhalation of powdery, especially micronised, medicines from conventional capsules by reliably withdrawing the drug from the capsule with a small standard deviation and by the ability to prevent the adhesion of the micronized drug in the capsule.

- 3 Mikronizirana zdravila v kapsulah namreč težijo k tvorbi sprijemkov (aglomeratov). Ti sprijemki oz. aglomerati so v terapevtskem pogledu nezaželeni, kajti zaželena je kar se da mogoča fina porazdelitev zdravila. Medtem ko je pri znanih inhalatorjih dosežena nezadostna dezaglomerizacija, se pri uporabi inhaltorja po izumu aglomerati oz. sprijemki v kar največji meri porušijo.- 3 Micronized drugs in capsules tend to form agglomerates. These clips respectively. agglomerates are undesirable in therapeutic terms, since a fine distribution of the drug is desirable as much as possible. While insufficient disagglomeration is achieved in the known inhalers, agglomerates and / or agglomerates are used when using the inhaler according to the invention. the clutches break to the maximum extent.

Inhalator v smislu izuma ima komoro za sprejem kapsule katere svetla širina je približno 1,1 do 2,5 prednostno pa 1,1 do 2,2-krat zlasti pa 1,2 do 1,6-krat večja od premera kapsule, dolžina komore pa je 0,02 do 1- prednostno pa 0,04 do 0,8, zlasti pa 0,1 do 0,6-krat večja kot dolžina kapsule. Pri tem mora biti svetla širina komore manjša, kot dolžina kapsule. Vstopna odprtina za zrak je smotrno nameščena središčno v dnu komore. V kolikor vstopna odprtina za zrak ni nameščena v sredini dna komore, mora biti nameščena tako, da jo kapa kapsule lahko zapre, kar bo razvidno iz opisa delovanja, ki bo podan v naslednjem tekstu. Odprtina je manjša kot premer kapsule, njen premer pa znaša prednostno 0,05 do 0,5 svetle širine komore. Odprtina je prednostno okrogla. Komora ima prednostno cilindrično obliko lahko ima pa tudi ovalni ali večkotni presek. Izstop za zrak mora biti nameščen na delu komore, ki je nasproti vstopne odprtine za zrak in mora biti tako izoblikovan, da se kapsula med inhaliranjem ne prisesa na izstopno odprtino. Da bi preprečili zapiranje izstopne odprtine s strani kapsule, so na razpolago različne možnosti.The inhaler of the invention has a capsule receiving chamber whose bright width is about 1.1 to 2.5, preferably 1.1 to 2.2 times, in particular, 1.2 to 1.6 times the diameter of the capsule, chamber length however, it is 0.02 to 1, preferably 0.04 to 0.8, and in particular 0.1 to 0.6 times the length of the capsule. The bright width of the chamber must be less than the length of the capsule. The air inlet is conveniently located centrally at the bottom of the chamber. If the air inlet is not located in the middle of the bottom of the chamber, it must be located so that the cap of the capsule can be closed, as will be seen in the description of the operation given in the following text. The aperture is smaller than the diameter of the capsule and its diameter is preferably 0.05 to 0.5 light chamber width. The opening is preferably round. The chamber is preferably cylindrical in shape, but may also have an oval or multi-section section. The air outlet shall be located on the part of the chamber opposite the air inlet and shall be so shaped that the capsule does not suck in the outlet during inhalation. Various options are available to prevent the capsule exit opening from closing.

Tako se npr. stena komore za sprejem kapsule, ki je nasproti vstopne odprtine za zrak lahko izvede kot sitasta plošča, ali pa so predvideni navzven štrleči konstrukcijski elementi, ki se drug drugemu toliko približajo, da je njihov razmak manjši kot premer kapsule. Nadalje je lahko na zgornjem koncu stranskih sten predvidena ena ali več odprtin. Presek, ki je na razpolago za iztekanje zraka iz komore, za kapsulo je prednostno vedno večji kot vstopna odprtina za zrak, zato da zrak , ki sojemno nosi zdravilo lahko čimbolj nemoteno izteka.Thus, e.g. the wall of the capsule receiving chamber opposite the air inlet may be provided as a sieve plate, or projecting outwardly projecting structural members which are so close to each other that their distance is less than the diameter of the capsule. Further, one or more openings may be provided at the upper end of the side walls. The cross section available for expelling the air from the chamber to the capsule is preferably always larger than the air inlet, so that the air co-carrying the drug can flow as smoothly as possible.

Zrak, ki se v komori pomeša s snovjo zdravila se s pomočjo ustnika privede v usta uporabnika., Ustnik, ki-je qbi čajno cevast ali v danem primeru nekoliko sploščen je lahko nameščen aksialno ali pod kotom napram osi komore, ali pa je lahko tudi bočno prestavljen napram osi komore.The air mixed in the chamber with the substance of the drug is introduced into the mouth of the user by means of a mouthpiece. The mouthpiece, which is qbi tea tubular or, if appropriate, slightly flattened, may be positioned axially or at an angle to the axis of the chamber, or may also be laterally moved to the axis of the chamber.

Inhalator v smislu izuma obstoji prednostno iz najmanj dveh delov, ki sta med seboj držana s pomočjo vijačne ali vtične povezave. Pri tem so ti deli tako izvedeni, da je pri njihovi ločitvi komora odprta, in da se v tako odprto komoro kapsula lahko vloži ali odvzame. V kolikor je komora nameščena bočno, se lahko predvidi aksialno pomično prekritje, ki glede na njen položaj navedeno komoro odpre ali zapre in ki v zaprtem položaju oblikuje del stranskih sten komore. V kolikor je v komori vsebovani del inhalatorja izoblikovan cilindrično, se lahko prekritje komore doseže tudi z okoli osi inhalatorja zasučno tulko, ki v enem položaju dovoljuje vlaganje oz. odvzemanje kapsule iz komore.The inhaler of the invention preferably consists of at least two parts that are held together by a screw or plug connection. In doing so, these parts are so designed that the chamber is open when separated, and that the capsule can be inserted or removed in such an open chamber. If the chamber is positioned laterally, an axial sliding cover may be provided which, depending on its position, the said chamber opens or closes and which forms part of the side walls of the chamber in the closed position. Insofar as the chamber portion of the inhaler is cylindrical in shape, the chamber overlap can also be achieved by rotating the sleeve around the axis of the inhaler, allowing in one position the insertion or insertion of the inhaler. removal of the capsule from the chamber.

Kapsula mora biti za zagotovitev poteka inhalacije v bližini svojega konca na dveh mestih preluknjana. Pri tem polkroglasti kapici kapsule ne smeta biti poškodovani. To je važno zaradi tega, ker izvaja kapsula oz. kapica kapsule nekeThe capsule must be punctured in two places to ensure inhalation near its end. In this case, the hemispherical caps of the capsule must not be damaged. This is important because it is a capsule or a capsule. capsule cap some

- 5 vrste funkcije ventila. Na osnovi razmer tlaka, bo kapsula potisnjena proti vtekajočemu zraku ob vstopno odprtino, katero bo zaprla. Ker uporabnik še naprej sesa na ustniku, nastane v komori za kapsulo podtlak, zaradi katerega bo kapsula z utekajočim zrakom potegnjena v smeri iztoka zraka.- 5 types of valve function. Based on the pressure conditions, the capsule will be pushed against the intake air at the inlet opening, which will close it. As the user continues to suck on the nozzle, a vacuum is created in the capsule chamber, which causes the capsule with the leaky air to be drawn in the direction of air outflow.

Tako nastali podtlak na vstopu zraka povzroči, da je kapsula ponovno potegnjena na vstopno odprtino. Celotni potek se ponovi v hitrem zaporedju, v kolikor inhaliramo skozi ustnik, in na ta način privede kapsulo do močnega vibriranja.The resulting pressure at the air inlet causes the capsule to be pulled back into the inlet. The whole course is repeated in rapid succession, as long as it is inhaled through the mouthpiece, thus causing the capsule to vibrate vigorously.

Odpiranje kapsule se lahko izvrši izven inhalatorja. Vendar pa je bolj smotrno, da se na samem inhalatorju namestijo po sebi znana rezalna orodja, ki omogočijo, da se odpre že v komori vložena kapsula.Opening of the capsule can be performed outside the inhaler. However, it is more advantageous to install known cutting tools on the inhaler itself, which allow the capsule inserted into the chamber to be opened.

Izum bomo podrobno obrazložili na osnovi izvedbenega primera in priloženih načrtov, v katerih kaže sl. 1 vzdolžni prerez skozi inhalator, sl. 2 prečni prerez po črti A-A iz sl. 1 in sl. 3 prečni prerez skozi variantno izvedbo inhalatorja po izumu pri katerem je komora nameščena bočno in pri kateri se komora lahko zapre oz. odpre s pomočjo premične ploščeThe invention will be explained in detail on the basis of an embodiment and the accompanying drawings in which FIG. 1 is a longitudinal section through an inhaler; FIG. 2 is a cross-sectional view taken along line A-A of FIG. 1 and FIG. 3 is a cross-sectional view through a variant embodiment of an inhaler according to the invention in which the chamber is positioned laterally and in which the chamber can be closed or closed. opens with the help of a movable panel

Kot je razvidno iz sl. 1 obsega izvedbeni primer inhalator po izumu spodnji del 1, v katerega je drsno vtaknjen ustnik 2, na obodu katerega je nameščen vzmetni element 9, ki se z enim koncem opira ob spodnji del, z nasprotnim koncem pa ob ustnik 2. Votlina ustnika 2 drsno objema iz dna 1’ spodnjega dela 1 štrleči tulec 3· V vodilnih odprtinah 11’ spodnjeg a dela 1 in v odgovarjajočih odprtinah 12 ustnika 2 - kadar sta ustnik 2 in spodnji del 1 potisnjena drug k drugemu,tako da zgornji rob spodnjega dela 1 napram ustniku 2 zavzame položaj 10, ki je v sl. 1 vrisan v črtkano črto - sta drsno nameščeni konici 11 rezalne priprave 4.As can be seen from FIG. 1 comprises an embodiment of the inhaler according to the invention, the lower part 1, into which the mouthpiece 2 is slidably inserted, on the circumference of which is mounted a spring element 9, which rests on one end with the bottom part and with the opposite end on the mouthpiece 2. The mouthpiece cavity 2 slides · From the bottom 1 'of the lower part 1, the projecting sleeve 3 · In the leading openings 11' of the lower a part 1 and in the corresponding openings 12 of the mouthpiece 2 - when the mouthpiece 2 and the lower part 1 are pushed together so that the upper edge of the lower part 1 is facing the mouthpiece 2 is positioned 10 in FIG. 1 drawn in dashed line - the tips 11 of the cutting device 4 are slidably mounted.

V predhodno opisanem položaju rezalne priprave - ko konici 11 segata skozi odprtine 12 ustnika 2 v komoro 6 - odrežeta spodnjo in zgornjo kapico kapsule. Rezalna priprava je ovzmetena z vzmetnim elementom 5, ki se z enim koncem opira ob zunanjo ploskev spodnjega dela 1 z drugim koncem pa ob rezalno pripravo 4.In the previously described position of the cutting device - when the tips 11 extend through the openings 12 of the mouthpiece 2 into the chamber 6 - they cut off the bottom and top caps of the capsule. The cutting device is suspended by a spring element 5, which with one end rests on the outer surface of the lower part 1 and the other end with the cutting device 4.

Votlina 2’ ustja 2 določa komoro 6 za kapsulo z zdravilom in je na enem koncu omejena z vstopnim ustjem 3’’ kanala 3’ za zrak na nasprotnem koncu pa z izrastki 7 ob ustnikovi izstopni odprtini 2’’ za izstop mešanice zraka in mikroniziranega zdravila. Sitasta plošča 8, ki je nameščena za izrastki 7 v izstopni odprtini 2’’ preprečuje da bi delci zdrobljenih kapic kapsule pri inhaliranju prišle v usta uporabnika .The cavity 2 'of the mouth 2 determines the chamber 6 for the drug capsule and is limited at one end by the inlet mouth 3' 'of the air duct 3 at the opposite end by the outgrowths 7 at the mouth outlet 2' 'for the air / micronized drug outlet . A sieve plate 8 mounted behind the projections 7 in the outlet 2 '' prevents particles of broken capsule caps from entering the user's mouth when inhaled.

Inhalator po izumu deluje takole:The inhaler according to the invention works as follows:

Uporabnik s pritiskom roke stisne inhalator proti sili vzmetnega elementa 9 skupaj v aksialni smeri, pri čemer zgornji rob spodnjega dela 1 pride v položaj 10,in pri čemer je zgornji rob spodnjega dela 1 v načrtu prikazan s črtopikčno črto. V tem položaju se lahko potisneta noža oz. konici 11 rezalne priprave 4 skozi odprtini 12, tako da prodreta v komoro 6 kapsule in tam fiksirano kapsulo odpreta.The user presses the inhaler against the force of the spring element 9 together in an axial direction, with the upper edge of the lower portion 1 reaching position 10, and the upper edge of the lower portion 1 being shown in the plan with a dotted line. In this position, knives or knives can be pushed. the tip 11 of the cutting device 4 through the openings 12 so that they penetrate the chamber 6 of the capsule and open the fixed capsule therein.

Sl. 2 kaže podaljšek komore za kspulo z izrastki 7, ki omejujejo prosti prostor za kapsulo na samo komoro 6 kapsule v ožjem pomenu.FIG. 2 shows an extension of the capsule chamber with outgrowths 7, which limit the free space of the capsule to only the capsule chamber 6 in the narrower sense.

V sl. 3 je prikazan prečni presek variantne izvedbe in7 halatorja po izumu pri katerem je komora 12 za kapsulo nameščena bočno, prikazan pa je tudi aksialno pomični zaporni element 14, ki rabi za odpiranje in zapiranje komore 6 za kapsulo, hkrati pa oblikuje en del stranske stene.In FIG. 3 is a cross-sectional view of a variant embodiment of the halator according to the invention in which the capsule chamber 12 is positioned laterally, and an axially movable closure member 14 is used to open and close the capsule chamber 6 while forming one part of the side wall.

Pri uporabi inhalatorja po sl. 1 se spodnji del 1 in ustnik 2 izvlečeta eden iz drugega, nakar se vloži kapsula, oba dela inha latorja pa se ponovno vtakneta skupaj. Po stisku spodnjega dela 1 in ustnika 2 v aksialni smeri proti sili vzmetnega elementa 9 se privede spodnji del 1 v položaj 10, nakar se v tem položaju pritisne na rezalno pripravo 4 in se jo takoj nato zopet spusti. Pod tlakom vzmetnega elementa 9 se inhalator samodejno >spet postavi v položaj prikazan v sl. 1. Sedaj pričnemo z vdihavanjem skozi ustnik 2.When using the inhaler of FIG. 1, the lower part 1 and the mouthpiece 2 are pulled out of each other, after which the capsule is inserted and the two parts of the inhaler are re-inserted together. After compressing the lower part 1 and the mouthpiece 2 in the axial direction against the force of the spring element 9, the lower part 1 is brought to position 10, and then the cutting device 4 is pressed in this position and then lowered again. Under the pressure of spring element 9, the inhaler is automatically> restored to the position shown in FIG. 1. We now start inhaling through the mouthpiece 2.

~Ίότ Ί - - Ί ' ' - ' · Navedba ο najboljšem, prijavitelju znanem načinu za gospodarsko izkoriščanje izuma~ Ίότ Ί - - Ί '' - '· Indication of the best applicant-known way of economically exploiting the invention

Pri realizaciji inhalatorja za inhalacijo prašnatih zlasti mikroniziranih zdravil iz kapsul po izumu je potrebno upoštevati naslednje izkušnje:In the realization of the inhaler for the inhalation of particulate matter in particular micronised capsules according to the invention, the following experience should be considered:

Inhalator je izveden iz polistirola ali polipropilena. Dimenzije inhalatorja so izbrane glede na velikost uporabljene kapsule za zdravilo.The inhaler is made of polystyrene or polypropylene. The dimensions of the inhaler are selected based on the size of the drug capsule used.

Dimenzije kapsul za zdravila so naslednje:The dimensions of the capsules for medicinal products are as follows:

Dolžina kapsule je od 15 do 20 mm, njen premer pa je med 5 in mm.The length of the capsule is from 15 to 20 mm and its diameter is between 5 and mm.

Običajno uporabljene kapsule imajo dolžino 18 mm in premerCommonly used capsules have a length of 18 mm and a diameter

6,5 mm.6.5 mm.

Razmerje med premerom kapsule in premerom komore 6 inhalatorja znašajo:The ratio of the capsule diameter to the diameter of the inhaler chamber 6 is:

Svetli premer komore 6 = 1,1 do 2,5 premera kapsule za zdravilo .Light chamber diameter 6 = 1.1 to 2.5 diameters of the drug capsule.

Dolžina komore 6 = 0,02 do 1-krat večja kot dolžina kapsule za zdravilo.Chamber length 6 = 0.02 to 1 times the length of the drug capsule.

Možna pa je tudi naslednja izvedbaThe following implementation is also possible

Svetli premer komore 6 = 1,2 do 1,6-krat večji kot premer kapsule za zdravilo.The bright chamber diameter is 6 = 1.2 to 1.6 times the diameter of the drug capsule.

Dolžina komore 6 = 0,1 do 0,6-krat večja od dolžine kapsule za zdravilo.The chamber length is 6 = 0.1 to 0.6 times the length of the drug capsule.

ZaFor

BOEHRINGER INGELHEIM KG:BOEHRINGER INGELHEIM KG:

Claims

PATENT APPLICATIONS

Dust inhaler, in particular micronised capsule medication, having an elongated capsule receiving chamber, an air inlet at one end and an air outlet at the other end of the chamber, characterized in that it is in the lower part (1) a slidingly inserted mouthpiece (2) on the circumference of which a spring element (9) is mounted, which abuts one end at the bottom (1) with the opposite end at the mouthpiece (2) and that the cavity (2 ') of the mouthpiece (2) slides the projecting sleeve (3) protruding from the bottom (1 ') of the lower part (1), and the tips (11) of the cutting device are slidably mounted in the guide openings (11') of the lower part (1) and the corresponding openings (12) of the mouthpiece (2) (4) on which the spring element (5) rests with one end, the opposite end of which rests against the outer surface of the lower part (1), so that the cavity (2 ') defines the chamber (6) for the drug capsule and is at one end limited by the inlet mouth (3 '') of the air duct (3 ') at the opposite end, with the outgrowths (7) positioned in the cavity (2 ) at the mouth outlet (2 '') for a mixture of air and micronized drug, wherein the bright width of the chamber (6) is about 1.1 to 2.5 times greater than the diameter of the drug capsule, the length of the chamber (6) is 0 , 02 to 1 times the length of the capsule, and the mouth (3 '') of the inlet duct (3 ') is smaller than the diameter of the capsule.

An inhaler according to claim 1, characterized in that a substantially cylindrical chamber (6) is provided coaxially arranged with an inlet duct (3 ') for the air and an outlet port (2' ').

Inhaler according to claims 1 or 2, characterized in that the diameter of the chamber (6) is 1.2 to 1.6 times greater than the diameter of the drug capsule and that the length of the chamber (6) is 0.1 to 0.6 times the length of the capsule.