JPH0559744B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention relates to a new dosing device adapted to be used for the administration of finely divided or granular substances or microcapsules containing pharmacologically active substances (hereinafter collectively referred to as particulate substances). Several drugs are currently administered in finely divided or granular form or in the form of microcapsules.
These substances are filled into hard gelatin capsules and are intended for oral administration;
The entire capsule is swallowed by the patient. For children and adults who have difficulty swallowing the entire capsule, it is recommended that the capsule be opened and its contents spread over a suitable food and swallowed with the food. However, it is difficult to open a capsule and pour out its contents without any loss of such drug substance. Although hard gelatin capsules are expensive, they are an effective method for administering pharmacologically active substances to patients who are able to swallow unbroken capsules. However, it is prudent to use expensive methods such as dispensing the drug in hard gelatin when the patient subsequently opens the capsule and pours out the contents with some difficulty. It's not a big deal. In the past, it has been proposed to provide dosing devices to enable accurate dispensing of particulate materials.
For example, German Patent Publication No. 2052051 (DE
A-A-2052051) describes a dosing device with an operating unit and a storage chamber. This operating unit is relatively loosely attached to the housing of the dosing device. Therefore, the particulate matter easily falls onto the sliding surface between the two relatively movable units, so that the particulate matter becomes clogged and the device becomes immovable. With such dosing devices that do not force-feed particulate material, it is difficult to administer small amounts of particulate or granular material with sufficient precision for drug dispensing. The present invention is an administration device for administering particulate material containing a pharmacologically active substance with high precision,
a storage chamber, a rotatable dosing unit adjacent to said storage chamber, an operating unit for producing relative rotation between said unit and said storage chamber, and a plurality of upwardly directed openings formed in said dosing unit. a recess, at least one of the recesses opening into the storage chamber to receive particulate material from the storage chamber, and further comprising: filling the particulate material into the recess and flattening the particulate material; a leveling device comprising a leveling member arranged to flatten the particulate material by a top surface of the dosing unit as the dosing unit rotates relative to the storage chamber; and a leveling device between separate rotational positions. an operating unit on said operating unit for indexing the dispensing unit with said separate dispensing unit in communication with one of said recesses so that one of said recesses can be emptied by overturning said dispensing device; and a generally upwardly extending dispensing channel disposed in one of the positions. The structure according to the invention prevents the particulate material from coming into contact with the sliding surfaces of the two relatively movable parts of the dosing device and in this way delivers each dose without any problems. be able to. In the dosing device according to the invention, the leveling element makes it possible to fill the recesses of the dosing unit with particulate material in a precisely reproducible manner. In this way, rotation of the dosing unit provides high precision dosing. In order to make the invention more easily understood, one embodiment of the invention will be described below with reference to the accompanying drawings. The dosing device of the present invention is preferably constructed of plastic and is contemplated to be comprised of four separate units as follows: An operating unit 1 at the bottom of the dosing device, a spring-loaded dosing unit 2, a storage chamber 4 with a leveling device 3 and a dispensing channel 5 for the dose to be dispensed, as well as a hood 6 made of plastic or metal.
Although separate components in the form of are shown in the drawings,
Although this is preferred, it is not absolutely necessary. The hood 6 can be held on top of the operating unit 1 by means of surrounding ribs (not shown). This rib can removably hold the hood 6. Another way to seal the dosing device is to provide a plug at the top of the dispensing channel 5. A leveling device 3 is fixed to the inner wall of the storage chamber 4 at the lower central portion of the storage chamber 4 so as not to rotate with respect to the storage chamber 4 . The leveling device 3 actually comprises a lower part of a dispensing channel 5 which is formed in one piece with the storage chamber 4 . From FIG. 2 it can be seen that the leveling device 3 comprises five radially extending arms,
Each arm carries a resilient leveling member 8 in sliding contact with the upper surface of the dosing unit 2, and the dosing unit 2 has six circumferentially spaced slightly It will be more clearly understood that it is provided with a frusto-conical recess 7. In order to guide the rotation of the dosing unit, the leveling device 3 has a circumferential skirt that engages with the outer cylindrical surface of the dosing unit 2 to prevent it from moving when dispensing the particulate material, and on the inside of the recess 7. It has a short inner annular portion which engages the upper surface of the dosing unit 2. The dosing unit 2 is loaded by a spring 9 in order to press the dosing film against the leveling device 3. Dosing unit 2 with toothed ring 13
A disk 14 is arranged between the spring 9 and the spring 9. The disk 14 is keyed to the storage chamber 4. The operating unit 1, which abuts the other end of the spring 9, carries an elastic arm 12. The arm 12 is engageable with a toothed ring 13. The disc 14 adjusts the relative angular position of the operating unit 1 and the dispensing unit by engaging and disengaging the arm 12 with a toothed projection that is configured to engage in a rotational position corresponding to the spacing between the arm 12 and the circumferential recess 7. Controllably, one of the recesses 7 is always locked in the correct position beneath the dispensing channel as shown in FIG. Moreover, the disc 14 reduces the friction between the spring 9 and the dosing unit 2. The operating unit 1 is provided with a space 10 which is closed off by a porous pad as illustrated. A desiccant agent, such as silica gel, can be inserted into the space 10 to protect the contents of the dosing device from atmospheric moisture. Moisture ingress is also reduced by providing a hood 6. The particulate pharmacologically active substance is stored in the storage chamber 4 and the actual dosing operation is carried out by first rotating the operating unit 1 in a clockwise direction with the dosing device held in the upright position shown in FIG. This is done by rotating in the direction and then in the counterclockwise direction.
Toothed ring 13 and elastic arms 12
A ratchet mechanism constituted by indexes the dosing unit 1 so that a first recess 7 is located directly below the dispensing channel 5 and then another recess 7.
is located directly below the dispensing channel 5. All the recesses 7 pass through the storage chamber 4 in succession and the recesses 7 can be filled with particulate material. In this way, by correctly selecting the size of the recess 7, a predetermined amount of granular pharmacological substance can be administered. The operation of the scraper 8 of the leveling device 3 is first to force and fill the granular material into the recess 7 and then to precisely level the granular material at the top of the recess 7. This means that the particulate material is completely and precisely filled into the recess 7 when it reaches just below the dispensing channel 5. The dosing device then only needs to be tipped over to flush the particulate material into the dispensing channel 5. By selecting the size of the recess 7 into which the particulate material is to be dispensed, the size of the dose can be selected. The dosage ranges widely, e.g. 1 mg to 5 mg.
Or it can be changed within the range of 5mg to 200mg. The number of recesses 7 in the dosing unit 2 can vary depending on different factors, such as the amount of active substance to be administered in each dose, the physical properties of the active substance, etc. In a preferred embodiment, the dosing unit 2 has six recesses 7, which are preferably cylindrical or, as shown, frustoconical, and which preferably contain the active substance. One dose should be stored and retained. The size of the reservoir 4 can be selected to suit the anticipated requirements for the particular active substance. In this dosing device, the reservoir 4 can contain enough active substance for approximately 100 doses, for example. This dosing device is located in storage compartment 4.
It has an opening for filling or refilling with active substance. Preferably, this opening is sealed by a plastic plug 11. In another embodiment, the dispensing device has a resilient key. This elastic key can be operated with one hand to supply the active substance to the dosing device. By pressing this key once, the dosing device is indexed and the recess 7 filled with active substance is brought into communication with the dispensing channel 5. This dosing device can be used as a container and can contain a number of active substances, for example enprohyrin,
Can assist in dispensing theophylline and turbyutalin. The best currently known method for carrying out the invention is illustrated in FIG. EXAMPLE In order to demonstrate the dosing accuracy of the dosing device according to the invention, the following tests were carried out using different dosing units and recesses A-G of different sizes. The container was filled with Theo-dur Sprinkle material (a slow-release microencapsulated formulation of theophylline) mixed with 1% and 2% talc.
3.5% when dosing accuracy of 500 doses is obtained
The maximum deviation was obtained. Please refer to the following table for comparison. Testing of 7 different dosing units containing Theo-Dure Sprinkle material mixed with talc The following values are the average values obtained from 500 dosings in each dosing device.

Table: For comparison, reference is made to PHARM.NORD, which stipulates that 90% of the capsules have a weight that does not deviate by more than 10% from the indicated weight. Other items shall not deviate by more than 20%. By using the novel dosing device according to the invention, these requirements are met to a large extent.

[Brief explanation of drawings]

FIG. 1 is an axial cross-sectional view of an embodiment of the dosing device according to the invention, and FIG.
It is a cross-sectional view cut along a line. 1... Operating unit, 2... Administration unit, 3
... leveling device, 4 ... storage chamber, 5 ... distribution channel, 7 ... recess, 8 ... leveling member, 9 ... spring, 11 ... inlet, 12 ... arm, 13 ... ring , 14... disk.

Claims (1)

Claims: 1. A pharmacologically active substance comprising a storage chamber, a rotatable dosing unit adjacent to said storage chamber, and an operating unit for relative rotation of said dosing unit and said storage chamber. In the dosing device for administering with high precision a particulate material containing the dosing unit is adapted to open into said reservoir and receive particulate material from said reservoir and is further configured to fill and level particulate material into said recess; A leveling member is arranged for leveling the particulate material from the upper surface of the dosing unit when rotated relative to the storage chamber, and the operating unit is arranged so that at each predetermined rotational position at least one of the recesses is flattened. The dispensing unit can be indexed and locked in the indexed position so as to be aligned with the dispensing channel, and generally configured to allow one of the recesses to be emptied by overturning the dispensing device. A dispensing device characterized in that an upwardly extending dispensing channel is arranged at one of said predetermined rotational positions so as to communicate with one of said recesses. 2. The dispensing device according to claim 1, wherein the dispensing unit can be indexed by rotating the operating unit itself with respect to the storage chamber. 3. A ratchet mechanism is provided between the operating unit and the dosing unit, which allows the operating unit to be rotated alternately clockwise and counterclockwise about the axis of rotation of the dosing unit, and which allows the operating unit to rotate clockwise and counterclockwise. 3. A dosing device according to claim 2, characterized in that the dosing unit is indexed within a rotational range of one rotation by alternately rotating counterclockwise. 4. Claim 3, characterized in that the ratchet mechanism comprises a resilient arm on the operating unit, which resilient arm engages in locking teeth arranged at predetermined angular intervals on the dosing unit. The administration device described. 5. The administration device according to any one of claims 1 to 4, wherein the operation unit is mounted below the administration unit. 6 The disk locked in the storage room is
Dispensing device according to claim 5, characterized in that it is pressed against the dispensing unit by a spring engaged between the disc and the operating unit. 7. Dispensing device according to any of claims 1 to 6, characterized in that the dispensing channel extends through a storage chamber. 8. Claims 1 to 7, characterized in that the storage chamber has a closable inlet, by means of which it is possible to refill the storage chamber with particulate material.
The administration device according to any of paragraphs. 9. A dosing device according to any one of claims 1 to 8, characterized in that the dosing unit comprises six circumferentially spaced recesses. 10. Any one of claims 1 to 9, wherein the recess is formed in a frustoconical shape and has a wider width at an open end communicating with a storage chamber. The administration device according to the invention.