FI83032C - DOSERINGSANORDNING. - Google Patents

Description

1 83032

The metering device

The present invention relates to a novel dosing device for use in dispensing micronized or granulated substances or microcapsules (hereinafter collectively referred to as particulate matter) containing pharmacologically active substances.

Today, several drugs are administered in the form of micronized or granulated or microcapsules. These substances are filled into capsules made of hard gelatin, which are intended for oral administration and are swallowed whole by the patient. Children and adults who have difficulty swallowing the whole capsule are advised to open the capsule and spread the contents on a suitable piece of food to be swallowed. However, opening the capsule and pouring the contents without wasting the substance is difficult. Capsules made of hard gelatin are an expensive but effective way to administer pharmacologically active substances to patients who can swallow the capsules whole. However, it does not make sense to use this expensive method of administration for capsules made of hard gelatin * if the patient later opens the capsule with some difficulty and pours out the contents.

‘In the past, the use of dosing devices has been proposed to allow:: accurate dosing of particulate matter. For example, DE-A-2 052 051 discloses a dosing device comprising a drive unit and a storage chamber. The drive unit is relatively loosely fitted to the housing of the device. Substances containing small particles thus easily fall on the sliding surfaces of two units moving relative to each other, so that the substance to be fed gets stuck.

1 “With such a dosing device without forced force supply *. . it is difficult to dispense small amounts of micronized or · /. granulated substances with a precision sufficient for the distribution of medicinal products.

2,83032

More particularly, the invention relates to a dosing device for highly accurate dosing of a particulate substance containing a pharmacologically active substance, the device comprising a storage chamber, a rotatable dosing unit adjacent to the storage chamber, an upwardly extending dispensing channel and a drive unit at least one of which opens into a storage chamber for receiving particulate matter, the device being characterized in that the scrapers are arranged to seal and level the particulate matter in the recesses and level it according to the upper surface of the dosing unit as the dosing unit rotates in the position of the dosage unit is connected to said recesses so that said recess can be emptied by turning the device upside down.

With the structure according to the present invention, the substance is prevented from coming into contact with the sliding surfaces of the two mutually moving parts of the dosing device, and in this way each dose can be fed without problems. According to the invention, in the dosing device, the scrapers enable the recesses of the dosing unit to be filled in an accurately reproducible manner. Thus, high dosing accuracy can be achieved by rotating the dosing unit.

In order that the invention may be more readily understood, the following description is given by way of example only, with reference to the accompanying drawing, in which Figure 1 is an axial cross-section of one embodiment of a dosing device according to the invention and Figure 2 is a cross-section taken along line II-II.

The dosing device of the present invention is preferably made of plastic and can be considered to comprise four separate 3,83032 units as follows: a drive unit 1 at the bottom of the dosing device, a spring-loaded dosing unit 2, a scraper unit 3, and a storage chamber 4 with a distribution channel 5 for dispensing.

A separate add-on is shown in the drawings and is preferred but not essential. This part consists of a plastic or metal figure 6 which can be held in place by a circumferential spool (not shown) at the top of the drive unit 1. Thanks to this rib, the hood can be detachably held in place. Alternatively, the device can be sealed using a plug at the top of the distribution channel 5.

In the lower central part of the storage chamber 4, the scraping unit 3 is fixed to the inner wall of the storage chamber so that it cannot rotate relative to it. The scraping unit actually comprises a lower part of the distribution channel 5, which is made in one piece with the storage chamber 4. It can be seen more clearly from Figure 2 that the scraping unit 3 '/ [comprises radial arms, each of which supports a flexible scraper 8 in sliding contact with the upper surface of the dosing unit 2, the dosing unit in turn being provided with six ... · circumferentially spaced, slightly truncated cone:. with a recess 7 located immediately in the cabinet. mien 8 alle. For controlling the rotation of the dosing unit, the scraper head has an outer circumferential flange which contacts the outer surface of the dosing unit 2 and a short inner ring which contacts the upper surface of the dosing unit inside the recesses 7 to prevent clogging during feeding. The dosing unit 2 is loaded by a spring 9 to compress the dosing unit towards the scraping unit. Between the dosing unit with the toothed ring 13 and the spring is a disc 14 which is wedged into the storage chamber. The drive unit 1, ____ on one end of which the spring 9 rests, supports a flexible arm. . 12, which can engage the toothed ring 13. The disc thus actually controls the angular movement of the drive unit 1 and the dosing unit 2, so that one recess 7 always stops in the correct position immediately below the distribution channel 5, as shown in Fig. 1 «83032. In addition, the disc 14 dienes friction between the spring and the dosing unit.

The drive unit 1 has a space 10, which is shown closed by a porous pad, in which a desiccant such as silica gel can be placed to protect the contents of the device from air humidity.

The hood 6 also reduces the ingress of moisture.

The particulate pharmaceutically active substance is stored inside the storage chamber 4, and the actual dosing step is performed with the dosing device in the vertical position shown in Fig. 1 by first turning the drive unit clockwise and then counterclockwise. The latch mechanism formed by the flexible arm 12 and the toothed ring 13 thus controls the dosing unit so that first one and then the second recess immediately hits the lower hole of the distribution channel. All the recesses pass successively past the storage chamber and can be filled with particulate matter therein. Thus, a predetermined amount of particulate pharmaceutically active agent can be administered by proper selection of the size of the well 7. The purpose of the scrapers 8 of the scraping unit 3 is first to force and seal the particulate matter into the recesses and secondly to precisely level the particulate matter in the upper part of the recesses. This means that when the recess 7 is immediately below distribution channel 5, it is completely and ... accurately filled.

All that is needed is to turn the dosing device upside down and the particulate material drains down into the distribution channel 5. Thus, by selecting the size of the well for any material to be dispensed, a dose size can be selected which can be varied within wide limits, e.g. from 1 mg to 5 mg or 5 mg to 200 mg. The number of wells in a dosage unit may vary depending on various factors such as the amount of active ingredient to be administered in each dose, the physical properties of the active ingredients * ... and so on. In a preferred embodiment, the dosage unit has six wells, and these wells are preferably cylindrical or preferably frustoconical, as shown, and should contain 1 dose of active ingredient.

5,83032

The size of the storage chamber can be selected to suit the requirements of a particular active substance. In the dosing device, for example, the chamber may contain sufficient active substance for about 100 doses. The dosing device has an opening for filling or refilling the active substance at the top of the storage chamber. The opening is preferably closed with a plastic plug 11.

In an alternative embodiment, the dosing device has a flexible key that allows the device to be fed with one hand. Each push on the key provides control of the dosing device so that a well filled with active substance is placed in contact with the dispensing channel.

The dosing device can be used as a container and aid for dispensing large amounts of active substances such as enprophylline, theophylline and terbutaline.

The best known embodiment of the invention today is shown in Figure 1.

Example

In order to demonstrate the dosing accuracy of the dosing device according to the present invention, the following experiments have been performed with different dosing units with recesses A-G of different sizes.

The container was filled with Theo-Dur Sprinkle (a slow-release microencapsulated theophylline preparation) mixed with 1 and 2 μg of talc, respectively. When a dosing accuracy of 500 doses was found, a maximum deviation of 3.5% was obtained. See. the table below.

Experiments with seven different dosage units containing Theo-Dur Sprinkle mixed with talc

The figures below are the average of 500 doses for each dosing device.

6 83032

Dosage _Talkki___ unit ^ ^ 2% _ mg / dose rel. % mg / dose rel. % A 104.1 2.15 2.1 104.2 2.45 2.4 B 94.0 2.36 2.5 94.0 2.66 2.8 C 85.4 2.29 2.7 84 .8 2.30 2.7 D 73.2 2.45 3.3 75.1 1.73 2.3 E 64.7 1.68 2.6 64.5 2.02 3.1 F 54.3 1.33 2.5 53.4 1.87 3.5 G 45.8 1.34 2.9 45.9 1.30 2.8

For comparison, reference is made to Pharm. Nord, which states that 90% of the capsules must have a weight that does not deviate by more than 10% from the prescribed weight. The remainder must not deviate by more than 20%. With the sticky new dosing device of the invention, these requirements are thus met by a fair margin.

7 83032

Dosage formulation The formulation of the dosage form is based on the dosage form of the micronized or microcapsular substance (which is defined as a subset of the particulate formulation) and the pharmacologically active substance.

It is possible to administer microcapsules or microcapsules. These substances are filled into oral administration capsules, which are used for oral administration and do not affect the patient. For barrels and vats which have been exposed to a capsule, the capsule is recommended to be encapsulated in one or more portions. The emellants are exposed to the capsule and the heat to be removed. Härdgelatinkapslar är ett dyrt men effektivt sätt att administrera läkemedelssubstanser account patienter som har förmäga att svälja kapslarna hela.

The docking device is provided with a dispensing device in the form of a capsule for the patient under the skin of the capsule and the skin.

For example, the size of the dosage form can be adjusted to give a particulate form of the material. Exemption of the test device DE-A-2052 051 is a dosage system for maneuvers and substances. Maneuverability is not relatively inflatad i apparathuset. Finkorniga substanser hamnar dä lätt pä glidytorna mellan de bäda mot varandra rörliga delarna, vilket medför att frammatningen kärvar. However, the dosage form of the dosage form does not depend on the size of the micron series or the substance on the basis of the particulate matter to be dispersed.

8 83032 formulation of the active substance in the form of active substances and substances in the form of active substances, such as rotary batches , anordnad att ästadkomma relative rotation mellan dose-ringsenheten ocs substantantagasinet, varvid doseringsenheten är utformad med et antal uppät üppna abrume and the dosage of the dosage form and the shelf life of the particulate matter and the shelf life of the dosage form and the rotation of the dosage form have a relative rotation of the substance, and the maneuverability of the rotation era doseringsenheten account bestämda lägen, varvid dispenseringskanalen vid ett bestämt läge hos doseringsenheten communikerar med et av hälrummen sä att det kan kanmas genom att anordningen vänds upp och ner.

In the case of construction, the use of upstream feeds is essential for the use of a guide and the use of a dosing system which can be relied on in a relative manner and with the result of a problem with the shielding. In the case of dosage form, the dosage form may be reproduced in accordance with the provisions of this Regulation. In this case, the genome of the genome is selected from the rotation of the rotor.

For the purposes of the fine-tuning, the first step is to include an exemption from the fine-tuning form of Figure 1 and the axial form of the application form of the dosage form, and Figure 2 and the second part of the form. 1.

9 83032

The dosage form can be separated from the plastic and can be separated by means of a separate enhancer: the maneuverability of 1 and the dosage form can be determined by means of a dosage form of 2, a scrubber of 3, and a further one.

Ytterligare en separat del visa i ritningarna och är före-dragagen, men ej väsentlig, vilken del har formen av en plast-eller metallhuv 6, som kan hällas kvar av en räffla 1 peri-ferln (ej vlsad) vid den Övre delen av maneuvereheten 1. The period of validity of the aid shall be fixed at the same time. This alternative provision does not apply to the provisions of Article 1.

In the absence of particulate matter in the substance medium 4 and the scraping week 3, the amount of the substance in the substance is adjusted to the relative value of the substance. The scrapings of the scraper 1 may be connected to the dispensing channel 5, which is in the form of a substandard 4. As shown in Fig. 2, the scrapings of the scraping 3 are radially discharged from the arm, glid contact in the upper part of the dosage unit 2 for 1 hour in the form of a ring ring in the form of a ring, and in the case of a single ring in the peripheral ring of the peripheral ring in the peripheral ring The cylinder form can be used for a maximum of 2 weeks and the card can be used for a maximum of 7 hours for a maximum of 7 hours. Dosage measures 2 are included in Figure 9 for the purpose of scraping.

Mellan doseringsenheten, som har en tandad ring 13, och fjädern finns det en platta 14, som är fastkilad i substansmagasinet. Maneuvers 1, for which the vehicle has 10 to 8 83032 are connected to the arm 12, with the arm 12 and the ring 13. The control panel of the plate 14 is also connected to the control of the maneuvers 1 to 2, In the case of the hälrummen 7, all of them are mounted on the dispensing ring channel 5, in the case of Fig. 1. In the case of the plate plate 14, the friction of the plate 14 is continued and dosed.

In maneuver 1, it is shown in Figure 10, which is illustrated by means of a blanket and inked by means of prickly mildew, on silica gel, which can be used as a means of transport to the air. Intravenous use of wood and other genome species 6.

The particulate formulation of a pharmaceutically active substance in a substance has been shown in the composition and dosage form of the dosage form in all of Figure 1, the genomic rotation being maneuverable to the medication and sedan motors. In particular, the use of an array of 12 and three rings 13 of the same dosage form and the presence of a separate commercial air conditioner under the dispensing channel. Alla hälrummen passe-rar successivt substantialmagasinet och fylls med det particulate form material material. Säledes kan en förutbestämd mängd av en partikelformig farmaceutiskt Aktiv substans doseras genom rätt vai av storleken pä hälrummen 7. Verkan av skra-porna 8 pä scrapningsenheten 3 är första första att tvinga oc and packa det partikelformiga materet in and hälrummen och det of the particulate material in the form of a fine is provided. This means that a total of 7 commercial channels under the transmission channel 5 are fully charged and stored.

The genome may be replaced by a portion of the dosage form up to and including the particulate form of the material in the distribution channel. .ex. kan variera inom Stora interval, t.ex. from 1 to 5 mg or from 5 to 200 mg. Antalet hälrum i doseringsenheten kan variera beroende ρά skilda factorer som t.ex. den mängd Aktiv substans som skall administereras per dos, den aktiva substansens fysikaliska egenskaper etc. I have the right to use the same sex. Hälrummen i doseringsenheten är företrädesvis cylinderformiga eller företrädesvis svagt koniska säsom visas, och rymmerämmplen-gen 1 dosenhet Aktiv substans.

Storleken pä substansmagasinet kan pois sä att detar de krav som kan väntas finnas för en viss partikelformig Aktiv substans. I doseringsanordningen kan augstinet t.ex. innehälla tillräcklig mängd Aktiv substans för omkring 100 doser. Doseringsanordningen har en öppning i den Övre delen av claiminet, där man kan fylla eller dterfylla Aktiv substans. the aid is granted in accordance with Article 11.

In the alternative formulation, the dosage form can be used as a tangent to the frame size of the handpiece. For this purpose, the tangent rot is used to disperse the active substance from the dispensing channel.

Doseringsanordningen kan avvändas som behällare och dispenser ingshjälpmedel för et stort antal active substance, säsom exempelvis enprofyllin, teopyllin och terbutalin.

This provision is based on the illustration, which is illustrated in Figure 1.

Exemption For all exacerbations of the dosage form is determined by means of a single dose-ring medium with a maximum of one hour (A-G). Behäl-Laren is filled with Theo-Dur Sprinkle Substance (i.e., i2 83032 microencapsules slow release of theophylline) with 1 or 2% talc. The total value of the subsidy grants of 500 is limited to a maximum of ρά 3,5%. Jfr nedanstäende tabell.

Försök med sju olika doserlngsenheter innehällande Theo-Dur Sprinkle-substans med inblandnlng av talk.

NedanstAende siffror är medelvärden av 500 doser fr An varje doseringsanordning.

Doseringsenhet Talk _1 _% _ 2 _% _ _mg / dos srel% _mg / dos srel% A 104.1 2.15 2.1 104.2 2.45 2.4 B 94.0 2.36 2.5 94.0 2 .66 2.8 C 85.4 2.29 2.7 84.8 2.30 2.7 D 73.2 2.45 3.3 75.1 1.73 2.3 E 64.7 1.68 2.6 64.5 2.02 3.1 F 54.3 1.33 2.5 53.4 1.87 3.5 G 45.8 1.34 2.9 45.9 1.30 2.8

Som en jämförelse hänvisas till Pharm. Nord., Where the capsule weight is 90% of the capsule size, the total value of which is 10% of the total weight. Aterstoden fAr awika högst 20%. In the case of dossiersanordningen enligt uppfinning uppfylls sAledes dessa krav mer An väl.

Claims (10)

A dosing device for high accuracy dosing of a particulate material containing a pharmacologically active substance, the device comprising a substance tray (4), a rotatable dosing unit (2) next to said substance tray, a spaced up dispensing channel (5) and an operating unit (1) arranged to provide relative rotation between the metering unit (2) and the substance reservoir (4), the metering unit being formed with a number of open open cavities (7), of which at least one is open to the substance reservoir (4) for receiving particulate material therefrom, characterized in that scrapers (8) are arranged to abut against the metering unit (2) for packing and scraping the particulate material in the hollow spaces and for smoothing it evenly with the upper planar surface of the the metering unit (2) when the metering unit (2) rotates relative to the substance reservoir (4) and the operating unit (1) is arranged to rotate the metering unit The dispenser (5) communicates with one of the heel compartments (7) at a fixed position of the dispensing unit so that it can be emptied by turning the device upside down. Device according to Claim 1, characterized in that the operating unit (1) is in itself rotatable relative to the substance tray (4) for effecting the feeding of the dosing unit. Device according to claim 2, characterized in that the control unit (1) can be rotated alternately clockwise and counterclockwise around the axis of rotation of the dosing unit (2) and that a locking device (12, 13) is placed between the control unit (1) and the dosing unit (2), the alternate rotation clockwise and counterclockwise of the control unit means that the metering unit (2) is only measured before eating a pour at the rotation. ie 83032 Device according to claim 3, characterized in that the locking device with which the dosing is promoted consists of a resilient arm (12) on the operating unit (1), which fits into a toothed ring (13) on the dosing unit (2). Device according to any of the preceding claims, characterized in that the operating unit (1) is located below said dosing unit. Apparatus according to claim 5, characterized in that a plate (14), which is wedged in the substance magazine, is pressed against said dosing unit (2) with a spring (9) arranged between the plate (14) and the operating unit (1). Device according to any of the preceding claims, characterized in that the dispensing channel (5) passes through the substance magazine (4). Apparatus according to any of the preceding claims, characterized in that the substance magazine (4) has a closable opening (11) through which the substance magazine can be filled. Device according to any of the preceding claims, characterized in that the metering unit has six circumferentially distributed heel cavities. Device according to any of the preceding claims, characterized in that said hollow space (7) is in the form of truncated cones, which are further at their open end, which communicates with the substance tray (4).