US20040178218A1

US20040178218A1 - Dosing stick containing rod-shaped tablets

Info

Publication number: US20040178218A1
Application number: US10/480,609
Authority: US
Inventors: Jurgen Schomakers; Andreas Grummel
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-06-15
Filing date: 2002-06-13
Publication date: 2004-09-16
Also published as: WO2002102296A1; DE10128956A1; EP1395225A1

Abstract

The invention relates to a novel form of medicament or of administration, embodied as a dosing stick containing at least one rod-shaped tablet for the individual dosage of active ingredients, said dosage being adapted to the treatment.

Description

The present invention relates to a new form of medicine or way of administering it, namely a dosing pen containing at least one tablet bar and the use thereof in therapy and a method for the controlled individual dosing of active ingredients for therapeutic purposes.

The invention can be extensively used in the pharmaceutical industry and with patients undergoing therapy. The form of medicine according to the invention, as well as the method of administering it, is advantageous with respect to other forms of administering medicines because of its use and dosing characteristics.

In prior art dispensing, peroral medication for administering solids (tablets, dragees, capsules) does not take into account the fact that every patient has an individual physiological status (body weight, metabolism, chronic ailments which influence the reabsorption and elimination of active ingredients, etc.), and also shows a circadian fluctuation in the reabsorption of medicines (chronopharmacology). In the therapy of chronic illnesses involving the administering of solids, dosages of commercially available preparations usually differ, whether by reason of the creeping dosages that are necessary, of problems with the adjustment of dosages or because of the development of metabolic tolerance, etc.

Because of the shortage of individually dosable preparations, particularly in the field of cytostatic/chemotherapeutic agents, it frequently happens that additional amounts of active ingredients which are not necessary for disease therapy are given disadvantageously, resulting in an inevitable and inappropriate accumulation of these physiologically questionable pharmaceutical products in the human organism.

Other known forms of administering medicines are tablets that can be divided by hand into an appropriately smaller dose with the aid of notches that enable them to be broken into fragments. Tablets conforming to prior art often have problems following tablet division with regard to the uniformity of the compound (as set out in Test 2.9.5 of the European Pharmacopoeia; 3rd addendum, 2001). During the course of the licensing procedure, this frequently leads to failure of the preparation or to deletion of the reference as to the divisibility of the tablets, in information contained in instructions for use and in specialist advice. Everyday practice shows that there are problems both with the mechanical division of the tablets by patients as well as with the storage of residual fragments in suitable containers.

The dosing pen containing at least one tablet bar according to the invention takes these circumstances into account by providing the doctor and patients with a form of medicine or medicine administration which facilitates therapeutic dosing that meets the requirements of patients.

A further advantage lies in the fact that national institutes for pharmaceutical products no longer need to make several applications for the licensing of identical products which have different dose strengths, as the tablet bar according to the invention covers all dosage ranges by virtue of its metrical dosing capability.

Accordingly, it is the object of the invention to provide a form of medicine or form of medicine administration which is simple to use, adapted to a therapy, and which facilitates the safe division or partitioning thereof into individual pieces of the required length, whereby the separate cuttings/fragments may constitute individual doses.

The object of this invention takes the form of a dosing pen containing at least one tablet bar (also a tablet bar that can provide metric doses), the active ingredients of which are homogeneously distributed, preferably over its length and diameter. This homogeneous distribution of the active ingredients is ensured by the method of mixing or granulation of the substances and by the subsequent further processing of the mixture of pharmaceutical agents into tablet bars, as the average specialist will properly know. Further processing of the tablet bar mixture into a bar is effected by well-established extruding, compacting or casting methods. According to the invention, the tablet bar may also contain auxiliary substances and additives such as fillers, binding agents, bursting agents (disintegration substances), wetting agents, fluxing agents and lubricants, in addition to at least one active ingredient or mixture of active ingredients and combinations of active ingredients. The fillers may comprise auxiliary materials, for example cellulose, modified cellulose, admixtures of cellulose and other auxiliary substances, starch, modified starch, lactose monohydrate, sorbitol, mannitol, calcium phosphate and other substances. [0009]
Binding agents such as gelatin, starch paste, cellulose ether, cellulose paste, polyvinyl pyrrolidone, vinyl pyrrolidone/mixed vinyl acetate polymer and collidone, as well as other binding agents, may be used. [0010]
Bursting agents (disintegration aids) promote the disintegration of the bar of active ingredients after coming into contact with water. Some disintegration aids that may be used are, for example, starch, cross-linked sodium-carboxymethyl starch, micro-crystalline cellulose, sodium alginate, potassium alginate, cross-linked polyvinyl pyrrolidone, sodium hydrogen carbonate, and other compounds. Humectants are substances that can retain small quantities of water while keeping the solid form in which they are administered. Consequently, they prevent the bar of active ingredients from drying out. Glycerol, starch, highly dispersed silicon dioxide, polyethyelene glycol (low molecular) and sorbitol solutions can be employed as humectants. [0011]
Flow-regulating agents improve the slippage and flow characteristics of the tablet bar mass. Highly dispersed silicon dioxide is largely used here. [0012]
Lubricants facilitate improved separation of the tablet bar from a shaped product on the one hand, but may influence the strength of the pharmaceutical bar on the other. Some suitable lubricants are salts of stearic acid, stearic acid and polyethylene glycol (medium and low-molecular), among others. [0013]
An active ingredient within the meaning of this invention is any substance that may likewise be contained in other forms of medicine or pharmaceutical preparations to be administered, hence those which fulfill a therapeutic or diagnostic purpose or which exhibit a curative or palliative effect in human and veterinary medicine. [0014]
Therefore, the invention relates to the therapeutic use of the dosing pen containing a tablet bar according to this invention. [0015]
Moreover, the invention relates to a method for controlling dose strength, whereby the tablet bar according to the invention is advanced within a dosing pen by means of an adjusting mechanism (e.g. FIG. 1, FIG. 3-5) and is divided into individual cut sections of the required length by a cutting means (e.g. FIG. 2[0016] a, b, c). The required length can be ascertained by means of a dosing indicator.
The homogeneous distribution of active ingredients in the tablet bar enables exact dosing to be effected by means of the feed mechanism for the tablet bar in the dosing pen (FIG. 1) ([0017] 1). The dosing pen feed is actuated by an adjusting mechanism.
The advanced dose amount is indicated in every position by a dose indicator ([0018] 1) (2); at the same time, a counter-current dose indicator shows the amount of active ingredients remaining in the dosing pen. A screw mechanism (a) is an example of a suitable adjusting means. The screw thread (FIG. 1) (3) is connected to rotate freely within the casing and is moved at the head of the dosing pen by means of a turning wheel (FIG. 1) (4). The guide pocket (FIG. 1) (5), into which the tablet bar is inserted, is advanced or retracted by the screw thread. The screw mechanism enables a tablet bar to be wound back if it has been mistakenly advanced too far. Dose adjustment is possible at all times. A continuous inspection window is affixed to one side so that the patient is also visually informed about the availability of his remaining medicine, in addition to the dose reading, and can easily follow the medical instructions. In the case of photosensitive materials, the inspection window can be made preferably of a material that filters out UV radiation.
The metrically dosable tablet bar according to the invention can be sealed off within the dosing pen by a watertight and airtight rubber cap just in front of the discharge opening (FIGS. 1, 8). [0019]
Additional suitable adjusting mechanisms: [0020]
b) Pressure Mechanism (FIG. 3) [0021]
A metal or plastic pin ([0022] 1), which leads at one end to a pyramidal snap fastener, serves as a feed member for the guide pocket of the tablet bar. Along the dosing pen there is preferably a 1-3 mm wide opening up to the level of the cutting blade. The guide pocket can be pushed along this opening by pressing the push-button against the interior of the casing. The guide pocket can stop in an infinitely variable manner, depending on the material tension of the metal or plastic clip. The amount of active ingredients corresponding to the forward feed can be read off the inspection window, as previously described in a).
c) Pumping Mechanism (FIG. 4) [0023]
The pumping-in of air and thus the forward feed of the tablet bar guide pocket is brought about by compression effected by a pumping attachment ([0024] 1) of a material such as rubber. Air inlet gaps (2) caused by the flow of air into the cavity between the guide pocket and the head of the casing are closed by thin rubber flaps on the outer wall of the casing. These facilitate the inflow of air from outside by another expansion of the rubber attachment. The forward feed reading is given in the manner described in a).
d) Pulley Mechanism (FIG. 5) [0025]
The guide pocket of the tablet bar is pushed downwards by actuating a rotary thread that can be stopped by means of a locking button ([0026] 1). A filament of flexible plastic material or rubber is tensioned with the aid of a rotary bobbin (2).
In the event that the tablet bar is mistakenly advanced too far, this tension makes it possible for the guide pocket to be returned without stopping after releasing the guide pocket stop. [0027]
At its opposite end the rotary thread is fitted with a dose indicator at which the user can read off the dose amount corresponding to the length of the forward advance. This dose indicator is connected with the guide pocket by means of a filament. The filament is in turn firmly connected to a cogwheel in the interior of the dose indicator. [0028]
All of the dosing pens described in a)-d) contain a tablet bar and have the following in common: depending on the cost aspect, the casing walls may be of either plastic material (primarily for one-way use), or of light metals. Moreover, the dose indicator or residual quantity reading may also be given digitally. [0029]
Forward feed of the guide pocket within the casing can be realized for the mechanisms described in a) and d) by fitting an electrically powered motor, preferably a battery-driven one. With this mode of operation, the respective manually operated rotary thread is replaced by a toggle switch on the outer wall of the casing which makes it possible to advance and return the guide pocket by activating the motor housed in the head of the casing. [0030]
The cutting means (FIG. 1) ([0031] 6) at the discharge shaft (FIG. 1) (7) are preferably made of a material that facilitates the clean and precise separation of a fragment from the tablet bar. The cut/break is made directly at the discharge shaft by means of a cutting blade (e.g. 6, FIG. 1). The discharge shaft is suitably tapered in any desired manner. The required cut or broken fragment is separated from the tablet bar. The one or more cutting blade(s) at the discharge shaft are preferably made of stainless steel or ceramic material. The required cut or broken fragment is separated from the tablet bar. The one or more cutting blade(s) can be stopped after making the cut and can seal the tablet bar in the dosing pen.
The cutting blades may be diagonal (FIG. 2[0032] a), parallel (FIG. 2b) or take the form of an aperture closure (FIG. 2c) which interacts. The cross-section of the cutting blades must be suitably adapted to the respective consistency of the tablet bars with respect to their concavity/angle.
Furthermore, a sealable cap with a rubber coating is provided at the end of the dosing pen. This gives protection against dirt, moisture and light (FIG. 1, 8). [0033]
In a further preferred embodiment of the invention, the entire lower part of the dosing pen (cutting blades, sealable rubber-coated cap) can be removed by means of a screw thread/plug connection so as to facilitate the easy exchange or cleaning of the cutting blades. At the same time, this makes it possible to insert the tablet bar into the dosing pen and to remove it. [0034]
The tablet bars can be manufactured so as to be of any required length, diameter and hardness. An individual scaling is possible by means of the appropriate distribution/compression of the active ingredients, depending on the category of active ingredient and the indication range. [0035]
A broad range of choice is available with respect to the hardness of the tablet bar owing to the manufacturing process and the different variables regarding cutting blade material and the type of cut or break. [0036]
The concept of the tablet bar and that of the dosing pen facilitate the easy exchange of tablet bars within different categories of active ingredients while retaining the dosing pen in use. The dosing pen may be considered to be a durable container: it is lightweight, resistant to breakage, easy to handle and sealed off against external physical, chemical and atmospheric influences. Because of the form of administering medicines according to this invention, the expensive encapsulation of individual tablets in aluminium-sealed PVC, PP or PE blisters can be dispensed with. [0037]
The metrically dosable tablet bars according to the invention may be packed individually, however the bulk packaging of several tablet bars in one primary container is conceivable. This would do away with the cost-intensive individual encapsulation of tablets. Depending on the active ingredient, wax-coated paper could conceivably be used as primary packing. [0038]
Within the scope of this invention, the dosing pen is meant to be any dosing container which is already designed advantageously and ergonomically as a pen for the purpose of easy handling and which contains a suitable dose indicator (scaling, inspection window, digital reading, among others), depending on the design. [0039]
The following examples and illustrations are intended to explain the nature of the invention and its design, but without in any way limiting the extent of its applicability. [0040]
FIG. 1 Dosing pen containing a tablet bar with a screw-type adjusting mechanism [0041]
FIG. 2 Cutting means [0042]
FIG. 3 Pressure mechanism [0043]
FIG. 4 Pumping mechanism [0044]
FIG. 5 Pulley mechanism [0045]

Claims

1. Dosing pen containing at least one tablet bar (1, FIG. 1), characterised in that the tablet bar is associated with a guide pocket (5, FIG. 1) and is conveyed to a discharge shaft (7, FIG. 1) with the aid of an adjusting means and can be divided into individually cut pieces of required length by a cutting means (6, FIG. 1).

2. Dosing pen according to claim 1, characterised in that the adjusting means is a screw mechanism (3 and 4, FIG. 1), a pressure mechanism (FIG. 3), a pumping mechanism (FIG. 4), a pulley mechanism (FIG. 5) or an electric feed mechanism.

3. Dosing pen according to claim 1 or 2, characterised in that the dosing pen contains a dose indicator (2, FIG. 1).

4. Dosing pen according to any one of claims 1 to 3, characterised in that the cutting means (6, FIG. 1) consists of one or several cutting blades and is arranged diagonally (FIG. 2a), in parallel (FIG. 2b) or in the form of an aperture closure (FIG. 2c) at the discharge shaft (7).

5. Dosing pen according to any one of claims 1-4, characterised in that the tablet bar contains at least one active ingredient or combination of active ingredients and may preferably also contain further ancillary substances and additives.

6. Dosing pen according to claims 1-5, characterised in that the tablet bar exhibits a homogeneous distribution of active ingredients and may feature breakage notches.

7. Method of controlling the dosage strength of active ingredients, whereby a tablet bar according to claim 5 or 6 is advanced in a dosing pen by means of an adjusting mechanism according to claim 2 and is separated by a cutting means into individual pieces of the required length in accordance with claim 4.

8. Method according to claim 7, whereby the required length of individual pieces is recorded by a dose indicator.

9. The use of a dosing pen in therapy, according to claims 1-6.