PH26664A - Dosage - Google Patents

Description

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SPECIFICATION

TO ALL WHOM IT MAY CONCERN:

BE IT KNOWN THAT I, KJELL INGVAR LEOPOLD WETTERLIN, a citizen of

Sweden, and residing at Vastervéng 19, $-240 17 S. Sandby, Sweden, : have invented an improvement in "DOSAGE DEVICE" of which the following is a specification.

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DOSAGE DEVICE

The present invention relates to a new dosage device intended to : be used for dosing of micronized or granulated substances or microcapsules (hereinafter referred to collectively as particulate material) and containing pharmacologically active substances.

Several preparations of drugs are nowadays administered in micronized or granulated form or in the form of microcapsules. These substances are filled into capsules of hard gelatine, which are intended for oral administration and are swallowed whole by the patient. Children and adults who have difficulties in swallowing a whole capsule are recommended to open the capsule and spread the contents on a suitable piece of food and to swallow. It is, however, difficult to open tha capsule and pour out the contents without any loss of the substance.

Capsules of hard gelatine are an expensive, but effective, way to administer pharmacologically active substances to patients, who are able to swallow the capsules unbroken. It is, however, not sensible to use this expensive way of dispensing into capsules of hard gelatine, when the patient later on, with some difficulty, opens the capsule and pours out the contents.

It has previously been proposed to provide dosage devices to enable the particulate material to be dispensed accurately. For example

DE-A-2 052 051 describes a dosage device comprising an operating unit and a storage chamber. The operating unit is fitted relatively

Voosely to the casing of the device. Substances having small particles thus easily fall on the sliding surfaces between the two relatively movable units, so that substance being fed jams. With such a dosage device, which does not have a feeding under force it is difficult to dose small amounts of micronized or granulated substances with an accuracy which is sufficient for the dispensing of drugs.

According to the present invention there is provided a dosage device for dosing with high accuracy a particulate material containing a pharmacologically active substance, said device comprising a storage

S CL | 2 - chamber, a rotatable dosing unit adjacent said storage chamber, an operating unit to cause relative rotation between said dosing unit and said storage chamber, a plurality of upwardly opening recesses in said dosing unit, at least one of which opens into said storage chamber, to receive particulate material therefrom, a scraping unit with scrapers positioned to pack and level the particulate material into the recesses and level it off with the upper surface of the dosing unit as the dosing unit rotates relative to the storage chamber, operating means on said operating unit for causing indexing of the : 10 dosing unit between discrete rotational positons, and a generally upwardly extending dispensing channel positioned at one of said discrete positions to communicate with one of said recesses, SO that said one recess may be emptied by turning said device upside : down.

With the construction according to the present invention, the substance is prevented from getting into contact with the sliding surfaces in the two relatively movable parts of the dosage device and in this way feeding of each dose can be achieved without any problems.

In the dosage device according to the invention, the scrapers make it possible to fill the recesses in the dosing unit in a accurately reproducable way. A high dosage accuracy can thus be obtained by the rotation of the dosing unit.

In order that the invention may more readily be understood, the following description is given, merely by way of example, reference being made to the accompanying drawing, in which:

Figure 1 is an axial cross-section of one embodiment of dosage device according to the invention; and

Figure 2 is a cross-section taken along the line II-II of Figure'l;

Figure 3 is an exploded, perspective view thereof.

The dosage device of the present invention, is preferably produced in plastic and can be considered to comprise four separate units as follows:

an operating unit 1 at the bottom of the dosage device; a spring loaded dosage dispensing dosing unit 2; : a scraping unit 3; and a storage chamber 4 provided with a dispensing channel 5 for the dose to be dispensed. : A further separate part is shown in the drawings and is preferred, but is not essential, this being in the form of a plastic or metal hood 6 which can be retained by a peripheral Fi (not shown) at the upper part of the operating unit 1. id eis enables the hood to be removably retained. An alternative way goog the Flevice is to provide a plug in the top of the:.dispen i chafinel 5g&

At the lower mid part of the storage chamber , he sdyaping anit 3 ig fixed to the inner wall of the storage clamber sq, that pit cannot rotate relative thereto. The scraping jupit in¥act Bit ludes the lower part of the dispensing channel 5 which is f&tmed Bh tegrally with the storage chamber 4. From Figure 2, it will be seen more clearly that the scraping unit 3 includes 5 radially : 20 extending arms 3A and outlet openings 3B, each arm of which carries a resilient scraper 8 in sliding contact with the upper surface of the dispensing unit 2 which, in turn, is provided with six circumferentially spaced slightly frusto- conical recesses 7 positioned immediately under the scrapers 8.

In order to guide for rotation of the dispensing unit 2, the scraping unit has an outer peripheral skirt engaging the cylin- drical outer surface of the dispensing unit 2 and a short inner annulus engaging the upper surface of the dosing unit inwardly of the recesses 7 in order to prevent jamming at feeding. The dispensing unit 2 is loaded by a spring 9 in order to press the dosing unit against the scraping unit.

Between the dosing unit, which has a toothed ring 13, and the spring there is situated a disc 14 which is keyed to the storage chamber. The operating unit 1, against which the other end of the spring 9 abuts, carries a resilient arm 12 ~ which is engageable with the toothed ring 13. Thus, the disc 14, in effect, controls the angular movement of the operating unit 1 and the dispensing unit 2 so that one of the recesses 7 will always stop in the correct position that is 40 immediately below the dispensing channel 5 as shown in

Figure 1. Furthermore, the disc 14 reduces the friction betweeli the spring and the dosing unit.

EE | ©" BAD ORIGINAL 9

In the operating unit 1 there is provided a space 10, as illustrated closed by a porous pad and into the space 10 can be inserted a drying agent such as silica gel in order to protect the contents of the device from the humidity of the air. The ingress of humidity will also be reduced by the provision of the hood 6. ]

The particulate pharmaceutically active substance is stored inside the storage chamber 4 and the actual dosing operation is carried out with the dosing device in the upright position shown in Figure 1, by rotating the operating unit at first clockwise and then counter- clockwise. The ratchet mechanism formed by the toothed ring 13 and the resilient arm 12 will thus index the dosing unit so that first one and then another recess appear immediately under the dispensing channel. All of the recesses passes successively the storage chamber and can be filled with the particulate material therein. Thus, a predetermined amount of particulate pharmaceutically active substance can be dosed by the correct choice of the size of the recess 7.

The effect of the scrapers 8 on the scraping unit 3 is firstly to force and pack the particulate material into the recesses and secondly accurately to level off the particulate material at the top of the recesses. This means that when a recess 7 arrives immediately below the dispensing channel 5 it will be completely and accurately filled.

All that is then necessary is to turn the dosage device upside down and the particulate material will flow down the dispensing channel © 25 . 5, By choosing the size of the recess for which ever substance is to be dispensed, one can thus choose the size of a dose which may : for example be varied within wide limits, say from 1 to 5 mg or "5 to 200 mg. The number of recesses in the dispensing unit may vary depending on different factors, such as the amount of active substance which should be administered in each dose, the physical properties of the active substances and so on. In a preferred embodiment, the dosing unit has six recesses and these recesses are preferably cylindrical or preferably frustoconical as shown and should preferably hold 1 dose of -ctive substance. . ‘

The size of the storage chamber may be chosen to suit the requirements expected for a particular active substance. In the dosage device the chamber may, for example, contain sufficient active substance for about 100 doses. The dosage device has an opening for filling or refilling of active substance in the upper part of the storage chamber. The opening is preferably sealed by a plastic plug 11.

In an alternative embodiment the dosage device has a resilient key which makes it possible to feed the device with one hand. Each push on the key causes indexing of the dosing device so that a recess filled with the active substance is placed in communication with the dispensing channel.

The dosage device may be used as container and aid in dispensing of a great number of active substances such as enprophylline, theophylline and terbutaline.

The best mode of carrying out the invention known at present is illustrated in Figure 1. :

Example ©

In order to demonstrate the dosage accuracy of the dosage device according to the present invention the following tests have been carried out with different dosing units with different sizes of the recesses A-G. The container was filled with Theo-Dur Sprinkle substance (which is a slow release microencapsulated preparation : of theophylline) mixed with 1 and 2% of talcum respectively. When the dosage accuracy of 500 doses was established a maximum deviation of 3.5% was obtained. Cf. the table below. :

RN St Cr 6 —

Test with seven different dosage units containing

Theo-Dur Sprinkle substance mixed with talcum

The figures below are the average values of 500 doses from each dosage device.

Dosage Talcum unit 1% N 2% mg/dose “rel % |mg/dose Srel %

A { 104.1 2.15 2.1 1104.2 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 |p {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

As a comparison reference is made to Pharm. Nord, which specifies that 90% of the capsules shall have a weight which does not deviate more than 10% from the stipulated weight. The rest shall not deviate more than 20%. With the new dosage device according to the invention these requirements are thus met with an ample margin.

Claims (1)

1. ’ : “ t Wi Poi aiide :

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   EK cibile amount of medication, “ * Co '8AD ORIGINAL 0 : a

   (3) maid dispense ca kb bam ratchet meas thaoveon arc anged sroonad dhe alm [SIN sobs sand apy i phon bE (4) =z ease oa vats het Cre l Earn prin Ted Fon vob ak ymin around thier SLE cre wis iy zaad dispensing veer bf porate bea mar bo pahohie tb ena ung meray tocing in mtidabhle sper beaded : } contact math malrd ratehet means, (5) =aid ratchet me ans ary ratohet ’ €1134a01090 MEAT Ap adapted to cooperate vil th saci olhher such that robs hon of maid erogasging means irr ares fob ational ire tson } } will cause =aird dispenzing onit to ‘ rotate vo the sane direction to a . . plurality of ctat ions wher ein at each station, the recesses in said . drspens ing unit are in mating rela- tion to the corresponding outlet operangs and one af the recesses

   ' . } i \ . pap ORIGINAL OF a : [; . § ’

   ee ee——————— ee ¢ a rm , Lt . -10 ie im meting relation to the dis- CEnS1ng ort let such that maid srgaging meas will relessse from } aad ratohet mea = as the raloboet . @rgaging means iz rotated in the . crposiie rotational directions, and {oY the device has stop means cman ting } betueen Lhe ratchet esroooing moos . avd bhe chtorage chamber Tor mbm ia the dizoensing wri hk al each citation : and preventing it from advancing bo : the nest station wibtil the fFatchet means las heen released, the ratchet . oo engaging means hes been rotated an =a opposite rotational direction, Zvied hes ratchet means corresponding to the newt station haz heen ernosged. a fn device according to claim Lo vherein SPIrING means + are included to maintain maid dosage dispsnoing unit in , slidable abutting relaticnshins to the oublest openings and maid dispensitg ok lal, } EJELL TRIGA LEOPOLD WETTERLINM : Inventor A ORIGINAL J

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   Le | 1 - Abstract ' 3 A dosage device for dosing with high accuracy a particulate material containing a pharmacologically active substance, including a storage chamber (4), a rotatable dosing unit (2) adjacent the storage chamber, an operating unit (1) to cause relative rotation between thé dosing unit and the storage chamber, the dosing unit (2) being provided with a plurality of upwardly opening recesses (7) opening into said storage chamber (4), to receive particulate material therefrom.

   Scrapers (8) are positioned immediately above these recesses to pack and level the particulate material into the recesses (7) and level the material off with the upper surface of the dosing unit as the dosing unit rotates relative to the storage chamber (4). The operating unit (1) causes an indexing of the dosing unit (2) between discrete rotational positions in one of which one of the recesses (7) is in direct communication with a generally upwardly extending dispensing channel (5) so that when the unit is turned upside down that recess.will discharge through the channel (5).