SI8910189A

SI8910189A - Device for Increasing of Dosage Reliability of Suspension-based Aerosol Apparatus

Info

Publication number: SI8910189A
Application number: SI8910189A
Authority: SI
Inventors: Adolf Knecht; Ottfried Daab; Hans-Hermann Weil
Original assignee: Boehringer Ingelheim Kg
Priority date: 1988-01-28
Filing date: 1989-01-26
Publication date: 1997-08-31
Also published as: HRP940722A2; HRP940722B1; SI8910189B

Abstract

Z vgradnjo lijakastega elementa (5) in/ali pokrivne plošče (6) in/ali elementa (8), ki zmanjšuje prostornino, se znatno poveča zanesljivost doziranja v napravah, pri katerih se uporabljajo aerosoli na osnovi suspenzije, ki vsebujejo učinkovine, ki so nagnjene k sedimentacijiBy installing a funnel element (5) and / or cover plate (6) and / or reducing element (8) volume, the dosage reliability in devices using aerosols based on suspensions containing active substances that are prone to sedimentation

Description

Boehringer Ingelheim KG, Ingelheim am RheinBoehringer Ingelheim KG, Ingelheim am Rhein

Priprava za povečanje zanesljivosti doziranja pri aerosolnih aparatih na osnovi suspenzijePreparation for increasing the dosage reliability of suspension-based aerosol dispensers

Izum se nanaša na pripravo za povečanje zanesljivosti doziranja aerosolnih aparatov na osnovi suspenzije za uporabo pri terapiji.The invention relates to a device for increasing the dosage reliability of a suspension-based aerosol apparatus for use in therapy.

Suspenzije fino zdrobljenih zdravil v fazi potisnega sredstva, ki je pod pritiskom tekoča (npr. fluorklorogljikovodiki), igrajo, med drugim pri zdravljenju astme pomembno vlogo. Suspenzije se polni v tlačno posodo z dozirnim ventilom. S pomočjo dozirnega ventila je možno vsakokrat dozirati določeno prostornino suspenzije, ki se s spontanim uparjanjem potisnega sredstva spremeni v aerosol, ki ga je možno vdihavati.Suspensions of finely divided medicines in the liquid phase of the propellant (eg hydrofluorocarbons) play an important role, among others, in the treatment of asthma. The suspensions are filled into a pressure vessel with a metering valve. With the help of a metering valve, it is possible to dose a certain volume of suspension each time, which by spontaneous evaporation of the propellant turns into an inhalable aerosol.

Iz terapevtskih razlogov je potrebno, da se količina učinkovine, ki je oddana pri vsakem sproženju dozirnega ventila, kar najmanj spreminja. S tem je možno predpostaviti enakomerno porazdelitev delcev učinkovine v tekoči fazi.For therapeutic reasons, it is necessary to minimize the amount of the substance delivered at each actuation of the dosing valve. This makes it possible to assume an even distribution of the active substance particles in the liquid phase.

Učinkovine, katerih gostota je večja od gostote utekočinjenih potisnih sredstev, se pri dolgotrajnejšem mirovanju usedejo. Če se pri tem zalogovnik aerosola nahaja v položaju uporabe (ventil navzdol), pride v bližini vstopne odprtine dozirnega ventila do povečanja koncentracije učinkovine. V odvisnosti od okoliščin primera je povečanje koncentracije, kije med drugim odvisno od razlike gostot potisnega sredstva/zdravila in trajanja faze mirovanja, lahko znatno. Homogeno suspenzijo je v splošnem možno rekonstituirati s tresenjem, udarjanjem, zvračanjem in s potresavanjem med transportom in prenašanjem s seboj. Dokler pa v skladu z navodili za uporabo takih suspenzijsko doziranih aerosolov pred uporabo slednji niso pretreseni in ni izvršeno katero od drugih omenjenih premikanj, lahko v dozirni ventil prispe močno povečana doza učinkovine. Kot posledica tega lahko v najneugodnejšem primeru znaša količina učinkovine, ki je oddana z brizgom aerosola, večkratno želeno dozo.Substances whose density is greater than the density of the liquefied propellants settle during prolonged rest. If the aerosol container is in the position of use (down valve), the concentration of the active substance will increase near the inlet opening of the metering valve. Depending on the circumstances of the case, the increase in concentration, which depends, among other things, on the difference in the densities of the propellant / drug and the duration of the resting phase can be significant. The homogeneous suspension can generally be reconstituted by shaking, knocking, knocking, and shaking during transport and transfer. However, as long as they are not shaken in accordance with the instructions for use of such suspension-metered aerosols prior to use and any of the other movements mentioned above have been performed, a substantially increased dose of the active ingredient may flow into the dosing valve. As a consequence, in the worst case scenario, the amount of the substance dispensed with the aerosol syringe may be several times the desired dose.

Naloga izuma je preprečiti nevarnost predoziranja pri suspenzijsko doziranih aerosolih z učinkovinami, ki so nagnjene k sedimentaciji, s tem, da se s pomočjo določenih naprav kar najbolj izognemo povečanju koncentracije učinkovine v bližini vstopne odprtine dozirnega ventila.It is an object of the invention to prevent the risk of overdose in suspension-metered aerosols with sediment-prone substances by avoiding, as a result of certain devices, an increase in the concentration of the active ingredient near the inlet port of the metering valve.

Ta naloga je po izumu rešena s konstrukcijskimi elementi, ki so vsakokrat zase ali v poljubni kombinaciji vgrajeni v dozirnem aerosolnem zalogovniku.This task is solved by the invention according to the invention by means of structural elements which are each incorporated into the metering aerosol container each time or in any combination.

Konstrukcijski elementi so:The structural elements are:

1. Lijakast element, ki oklepa ventil in je (v položaju uporabe zalogovnika) navzgor odprt ter v pusti bližini ostenja zalogovnika pusti odprt prehod, npr. krožno špranjo;1. A funnel element that encloses the valve and is open (upstream of the storage tank) upstream and leaves a passage open in the vicinity of the tank wall, e.g. circular slit;

2. pokrivna plošča pod lijakom, ki obročasto obdaja ohišje ventila in kar najbolj zapolni svetlo dolžino zalogovnika;2. a cover plate under the hopper that encircles the valve body annularly and fills the light tank length as far as possible;

3. obročast element pod pokrivno ploščo, ki kar najbolj zmanjša prostornino v območju vstopne odprtine ventila.3. an annular element under the cover plate that minimizes volume in the area of the inlet opening of the valve.

S1.1 kaze prednostno izvedbeno obliko izuma, ki naj bi služila kot primer. Razume se, da je konstrukcijske elemente, po potrebi v prilagojeni obliki, možno uporabiti tudi pri drugih običajnih dozirnih ventilih.S1.1 shows a preferred embodiment of the invention which is intended to serve as an example. It is understood that structural elements, if necessary in a customized form, can also be used with other conventional metering valves.

Na sl.l je z 1 označen zalogovnik aerosola, z 2 pa nataknjena in zarobljena zapiralna kapa, na kateri je pritrjen ventil 3. Ventil 3 obsega vstopno odprtino 4 za suspenzijo.In FIG. 1, an aerosol reservoir is indicated with 2 and a closing cap is inserted and sealed with a valve 3. The valve 3 comprises an inlet opening 4 for suspension.

Konstrukcijski elementi po izumu so lijakast del 5, pod katerim je nameščena pokrivna plošča 6 s povišanim robom 7, medtem ko je prostornina v zoženem delu zapiralne kape 2 deloma zapolnjena z elementom 8.The structural members of the invention are a funnel-shaped part 5 under which a cover plate 6 with an elevated edge 7 is mounted, while the volume in the tapered portion of the closure cap 2 is partially filled with the element 8.

Med elementi 5, 6 in 8 ter ostenjem zalogovnika oz. zapiralno kapo obstaja toliko vmesnega prostora, da delovanje ventila ni moteno in lahko zadostna količina suspenzije mimo teh elementov dospe do vstopne odprtine 4.Between the elements 5, 6 and 8 and the storage tank or. the closure cap has so much intermediate space that the operation of the valve is not disturbed and a sufficient amount of suspension past these elements can reach the inlet 4.

Pri vrsti ventila, ki je prikazana na sLl, je predzalogovnik (zunanji del ventila) pritrjen na jedro ventila in se torej premika z njim. V primeru ventilov, pri katerih se telo ventila ne premika, so konstrukcijski elementi lahko tako zasnovani, da nalegajo na ostenju zalogovnika in kot prehod v bližini ostenja obsegajo majhne odprtine (npr. kanale, žlebiče).For the type of valve shown in sLl, the pre-tank (outer portion of the valve) is attached to the valve core and therefore moves with it. In the case of valves where the valve body does not move, the structural members may be so designed that they rest on the reservoir wall and include small openings (eg channels, grooves) as a passage near the reservoir.

Taka izvedbena oblika je prikazana na sl.2. Na slednji sta lijakast del 5 in odpravljeni del 8 za zmanjšanje prostornine kombinirana na pokrivni plošči 6. Kot prehod za suspenzijo so predvideni žlebiči 9, ker del 5 v zgornjem območju nalega na ostenju zalogovnika aerosola in v spodnjem območju na ostenju zapiralne kape ter tesno oklepa ohišje ventila.Such an embodiment is shown in FIG. On the latter, the funnel part 5 and the eliminated volume reduction part 8 are combined on the cover plate 6. The grooves 9 are provided as a suspension passage, because the part 5 in the upper area rests on the wall of the aerosol container and in the lower area on the wall of the closure cap and tightly encloses valve body.

Nadaljnja izvedbena oblika izuma je prikazana na sl.3, kjer je odstranjen lijakast element 5, vendar pa je rob 7 pokrivne plošče 6 močno povišan.A further embodiment of the invention is shown in FIG. 3, where the funnel element 5 is removed, but the edge 7 of the cover plate 6 is substantially elevated.

Elementi 5, 6 in 8 so lahko izdelani iz gradiv, ki so obstojni proti suspenziji, kot so npr. umetne snovi, nerjavno jeklo ali aluminij. Elementi so npr. tako zasnovani, da jih je na primeren način možno pritrditi na ohišje ventila ali tudi tvorijo sestavni del le-tega.Elements 5, 6 and 8 may be made of materials that are resistant to suspension, such as e.g. plastics, stainless steel or aluminum. The elements are e.g. so designed that they can be conveniently attached to the valve body or form an integral part thereof.

Claims

PATENT APPLICATIONS

1. Preparation for improved dosage of a sediment-based suspension of aerosol products from conventional aerosol dispensers with a metering valve, characterized in that they are arranged around the valve body

a) a funnel-shaped structural member (5) that surrounds as closely as possible the space between the inner wall of the aerosol container and the valve body, and / or

b) a cover plate (6) with an elevated edge (7) below the element (5) that maximizes the bright length of the aerosol container, and / or

c) a annular, volume-reducing element (8) which minimizes the volume in the area of the inlet opening (4).

Device according to claim 1, characterized in that the elements (5), (6) and (8), or combinations thereof, consist of one piece.

Device according to claim 1 or 2, characterized in that the elements (5) and / or (6) and / or (8) form one unit with the outer parts of the valve extending into the reservoir.

Device according to claim 1, 2 or 3, characterized in that the funnel element (5) and the eliminated, volume reducing element (8) on the cover plate (7) are covered by a single element.