U.S. patent application number 10/480609 was filed with the patent office on 2004-09-16 for dosing stick containing rod-shaped tablets.
Invention is credited to Grummel, Andreas, Schomakers, Jurgen.
Application Number | 20040178218 10/480609 |
Document ID | / |
Family ID | 7688330 |
Filed Date | 2004-09-16 |
United States Patent
Application |
20040178218 |
Kind Code |
A1 |
Schomakers, Jurgen ; et
al. |
September 16, 2004 |
Dosing stick containing rod-shaped tablets
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.
Inventors: |
Schomakers, Jurgen; (Alfter,
DE) ; Grummel, Andreas; (Alfter, DE) |
Correspondence
Address: |
JULIA CHURCH DIERKER
DIERKER & ASSOCIATES, P.C.
3331 W. BIG BEAVER RD. SUITE 109
TROY
MI
48084-2813
US
|
Family ID: |
7688330 |
Appl. No.: |
10/480609 |
Filed: |
April 22, 2004 |
PCT Filed: |
June 13, 2002 |
PCT NO: |
PCT/EP02/06513 |
Current U.S.
Class: |
221/289 |
Current CPC
Class: |
A61J 3/06 20130101; A45D
40/08 20130101; A45D 40/02 20130101; A45D 40/04 20130101 |
Class at
Publication: |
221/289 |
International
Class: |
B65H 003/30 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 15, 2001 |
DE |
101 28 956.1 |
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.
Description
[0001] 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.
[0002] 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.
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] Flow-regulating agents improve the slippage and flow
characteristics of the tablet bar mass. Highly dispersed silicon
dioxide is largely used here.
[0013] 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.
[0014] 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.
[0015] Therefore, the invention relates to the therapeutic use of
the dosing pen containing a tablet bar according to this
invention.
[0016] 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. 2a, b, c). The
required length can be ascertained by means of a dosing
indicator.
[0017] 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) (1). The
dosing pen feed is actuated by an adjusting mechanism.
[0018] The advanced dose amount is indicated in every position by a
dose indicator (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.
[0019] 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).
[0020] Additional suitable adjusting mechanisms:
[0021] b) Pressure Mechanism (FIG. 3)
[0022] A metal or plastic pin (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).
[0023] c) Pumping Mechanism (FIG. 4)
[0024] 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 (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).
[0025] d) Pulley Mechanism (FIG. 5)
[0026] 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 (1). A filament of flexible plastic material or rubber is
tensioned with the aid of a rotary bobbin (2).
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] The cutting means (FIG. 1) (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.
[0032] The cutting blades may be diagonal (FIG. 2a), 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.
[0033] 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).
[0034] 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.
[0035] 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.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] FIG. 1 Dosing pen containing a tablet bar with a screw-type
adjusting mechanism
[0042] FIG. 2 Cutting means
[0043] FIG. 3 Pressure mechanism
[0044] FIG. 4 Pumping mechanism
[0045] FIG. 5 Pulley mechanism
* * * * *