U.S. patent application number 10/353056 was filed with the patent office on 2004-05-20 for melatonin daily dosage units.
Invention is credited to Schmid, Hans W..
Application Number | 20040094449 10/353056 |
Document ID | / |
Family ID | 32103506 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040094449 |
Kind Code |
A1 |
Schmid, Hans W. |
May 20, 2004 |
Melatonin daily dosage units
Abstract
The present invention relates to a disposable container for a
medicament or cosmetic agent for topical application, containing a
single dose of melatonin or of a melatonin derivative which
corresponds to a locally effective dose but which does not cause
any systemic effect.
Inventors: |
Schmid, Hans W.; (Zug,
CH) |
Correspondence
Address: |
ROTHWELL, FIGG, ERNST & MANBECK, P.C.
1425 K STREET, N.W.
SUITE 800
WASHINGTON
DC
20005
US
|
Family ID: |
32103506 |
Appl. No.: |
10/353056 |
Filed: |
January 29, 2003 |
Current U.S.
Class: |
206/524.1 ;
206/528; 206/581 |
Current CPC
Class: |
A61Q 7/00 20130101; A61J
1/067 20130101; A61K 8/492 20130101; A61K 31/4188 20130101; A61K
31/4188 20130101; A61K 31/4045 20130101; A61K 36/16 20130101; A61K
9/0014 20130101; A61K 36/16 20130101; A61K 47/10 20130101; A61K
2800/87 20130101; A61Q 19/00 20130101; A61K 47/46 20130101; A61K
2300/00 20130101; A61K 2300/00 20130101; A61M 35/003 20130101 |
Class at
Publication: |
206/524.1 ;
206/528; 206/581 |
International
Class: |
B65D 085/84 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 18, 2002 |
DE |
202 17 814.5 |
Claims
1. A disposable container for a medicament or cosmetic agent for
topical application, containing a single dose of melatonin or of a
melatonin derivative which corresponds to a locally effective dose
but which does not cause any systemic effect.
2. The container as claimed in claim 1, wherein the single dose is
0.001-1.0 mg of melatonin or melatonin derivative.
3. The container as claimed in claim 1 or 2, wherein the single
dose is 0.01-0.2 mg of melatonin or melatonin derivative.
4. The container as claimed in one of claims 1 through 3, wherein
the single dose corresponds to a daily dose.
5. The container as claimed in one of claims 1 through 4, wherein
the agent is present as a liquid formulation.
6. The container as claimed in claim 5, wherein the liquid
formulation has a concentration of 0.001-0.01% (by weight) of
melatonin.
7. The container as claimed in claim 6, wherein the liquid
formulation has a concentration of 0.003-0.004% (by weight) of
melatonin.
8. The container as claimed in one of the preceding claims, wherein
the agent contains, as sole active substance, melatonin or a
melatonin derivative.
9. The container as claimed in one of claims 1 through 7, wherein
the agent contains, as active substances, a combination of
melatonin or a melatonin derivative together with biotin and/or
gingko biloba.
10. The container as claimed in one of claims 1 through 7, wherein
the agent contains, as active substance, a combination of melatonin
or a melatonin derivative and vitamin A, vitamin A acid, or another
derivative of vitamin A.
11. The container as claimed in one of the preceding claims,
wherein it contains 2.5-3.5 ml of the agent.
12. The container as claimed in claim 11, wherein it contains
2.9-3.2 ml of the agent.
13. The container as claimed in one of the preceding claims,
wherein the agent is filled into the container under GMP
conditions.
14. The container as claimed in one of the preceding claims,
wherein it is made of a plastic.
15. The container as claimed in claim 14, wherein it is made of
polyethylene, polypropylene, polyvinyl chloride, polystyrene or a
mixture of these.
16. The container as claimed in one of claims 1 through 15, wherein
it is colorless.
17. The container as claimed in one of claims 1 through 15, wherein
it is colored.
18. The container as claimed in one of claims 1 through 17, wherein
it is transparent.
19. The container as claimed in one of claims 1 through 17, wherein
it is non-transparent.
20. The container as claimed in one of the preceding claims,
wherein it has, on its head, a disposable closure piece which is
opened by turning it.
21. The container as claimed in one of the preceding claims,
wherein, after opening, the agent emerges only when pressure is
applied.
22. The container as claimed in one of the preceding claims,
wherein it carries lettering either printed on or embossed and/or
is provided with a label.
23. An arrangement of several containers, as claimed in one of
claims 1 through 22, which are connected to one another in a
detachable manner.
24. The arrangement as claimed in claim 23, wherein 5 containers
are connected to one another in a detachable manner.
25. The arrangement as claimed in claim 23, wherein 10 containers
are connected to one another in a detachable manner.
26. The arrangement as claimed in one of claims 23 through 25,
wherein it is packed into an aluminum bag.
27. The arrangement as claimed in claim 26, wherein the bag
consists of an aluminum-containing laminated foil and additionally
includes polyethylene, polyester and/or paper.
28. The arrangement as claimed in claim 26 or 27, wherein the
aluminum bag is printed on and/or is provided with a label.
29. A package unit comprising several arrangements as claimed in
one of claims 23 through 28.
Description
[0001] The present invention relates to a disposable container for
a medicament or cosmetic agent for topical application, containing
a single dose of melatonin or of a melatonin derivative which
corresponds to a locally effective dose but which does not cause
any systemic effect.
[0002] Melatonin-containing agents can be used for various medical
and cosmetic purposes. For example, the document DE 101 10 418.9
discloses melatonin-containing compositions for topical application
on the skin and in the hair.
[0003] The subject of the present invention is a disposable
container for a medicament or cosmetic agent for topical
application, containing a single dose of melatonin or of a
melatonin derivative which corresponds to a locally effective dose
but which does not cause any systemic effect.
[0004] The disposable container according to the invention permits
application of a dose of melatonin or of a melatonin derivative
which is locally effective but which causes no undesired change in
the normal melatonin plasma level. The single dose of melatonin or
of melatonin derivative which is applied according to the invention
causes no significant elevation of the melatonin plasma level for
example.
[0005] The expression "melatonin or melatonin derivative", as it is
used in the context of this application, includes melatonin and/or
melatonin derivatives and salts, esters or complexes thereof.
Preferred melatonin derivatives include, for example,
5-methoxytryptamine, 5-methoxytryptophan, 5-methoxytryptophol,
5-methoxyindole-3-acetic acid and 6-hydroxymelatonin.
[0006] The single dose according to the invention represents a dose
which permits a positive cosmetic and/or therapeutic effect without
significant changes in the plasma level. According to the
invention, a single dose of from approximately 0.001 to
approximately 1.0 mg of melatonin is preferred, and more preferably
a single dose of from approximately 0.01 to approximately 0.2 mg of
melatonin. Depending on the application area or the intended use of
the agent, a single dose can be applied once or several times
daily. In a preferred embodiment, the single dose corresponds to a
daily dose, particularly preferably a daily dose to be used in the
evenings.
[0007] The medicament or cosmetic agent is preferably present as a
liquid formulation. Examples of suitable formulations for topical
application of the agent are solutions, suspensions, emulsions,
microemulsions, nanosystems, creams, gels, lotions, sprays, foams
or ointments, and any other formulation which can be applied
topically. The agent is particularly preferably provided in the
form of a cosmetic solution.
[0008] Depending on its intended use, the medicament or cosmetic
agent contained in the disposable container according to the
invention can have different concentrations of melatonin or of a
melatonin derivative. The agent preferably contains a concentration
of approximately 0.001 to approximately 0.01% (by weight), more
preferably approximately 0.003 to 0.004% (by weight) of melatonin
or of a melatonin derivative. A particularly preferred
concentration is approximately 0.0033% (by weight).
[0009] In one embodiment, the therapeutic or cosmetic agent
contains melatonin or a melatonin derivative as sole active
substance. The agent can, however, also contain one or more further
active substances such as vitamin A, vitamin A acid or other
vitamin A derivatives, biotin and/or gingko biloba.
[0010] In a preferred embodiment, the medicament or cosmetic agent
contains a combination of the active substances melatonin or
melatonin derivative with biotin and/or gingko biloba. The active
substances in this embodiment can be present in different dosages.
A particularly preferred dosage of this combination is from
approximately 0.05 to approximately 0.2 mg, particularly preferably
approximately 0.1 mg of melatonin or melatonin derivative, from
approximately 0.2 to approximately 0.4 mg, particularly preferably
approximately 0.3 mg of biotin, and from approximately 1.3 to
approximately 1.7 mg, particularly preferably approximately 1.5 mg
of gingko biloba. Gingko biloba can in this case be contained for
example as an extract, in particular as a dry extract, and/or in
the form of one or more ingredients.
[0011] In a further preferred embodiment, the agent contains a
combination of the active substances melatonin or melatonin
derivative and vitamin A, vitamin A acid or another derivative of
vitamin A. In this preferred active substance combination, the
dosage of melatonin or melatonin derivative is preferably from
approximately 0.05 to 0.2 mg, particularly preferably approximately
0.1 mg of melatonin.
[0012] The medicament or cosmetic agent can also contain one or
more cosmetic and/or pharmaceutical auxiliaries or additives, for
example thickeners, minerals or perfumes.
[0013] Depending on the intended application or use, the disposable
container according to the invention can contain different volumes
of the medicament or cosmetic agent. In a preferred embodiment, the
disposable container contains approximately 2.5 to approximately
3.5 ml, preferably approximately 2.9 to approximately 3.2 ml of the
agent. A particularly preferred volume is approximately 3.0 ml.
[0014] The therapeutic or cosmetic agent can be filled into the
container using any suitable method known in the prior art. The
agent is preferably filled into the container under GMP conditions.
In this way it is possible to ensure that the agent is sterile and
that, when the agent is applied, no problems arise in respect of
bacterial contamination.
[0015] The disposable container according to the invention can in
principle be made of any desired material. Examples of preferred
materials are plastics and mixtures of plastics. Examples of
particularly suitable plastics are polyethylene, polyvinyl
chloride, polystyrene or polypropylene, with particular preference
being given to polyethylene.
[0016] Depending on its desired outward appearance, the disposable
container can be transparent, non-transparent, colorless or
colored. Any desired dyes can for example be added to the plastic
in order to obtain a colored container. A non-transparent container
is preferred for use if the agent contains light-sensitive
substances, because a non-transparent container additionally
affords protection from light.
[0017] The disposable container according to the invention can in
principle have any desired shape. Examples of preferred containers
are shown in FIGS. 1 and 2. A suitable disposable container
preferably comprises a part in which the agent is contained, and a
disposable closure piece which is connected to the lower part via a
predetermined break line.
[0018] Simple and safe handling of the container is advantageously
ensured by the fact that it preferably has, on its head, a
disposable closure piece which is opened by turning it. The
container can thus be easily opened. In addition, after opening,
the agent can emerge only if pressure is applied. This pressure can
for example be exerted by hand during the application. This
property allows the user to correctly dose the agent and position
it in a targeted manner. If the agent is to be applied to the scalp
or hair, the opened container can be guided directly through the
hair like a comb. This permits straightforward and safe handling of
the container and correct dosing of the agent.
[0019] Depending on the intended use, the disposable container
carries lettering either printed on or embossed and/or is provided
with a label.
[0020] Two or more disposable containers can furthermore be
connected to one another in a detachable manner. For example, 5 or
10 containers are preferably connected to one another and form an
arrangement. A container or an arrangement of containers can also
be packed, preferably in a lightproof package, particularly
preferably in an aluminum bag for example.
[0021] The expression "aluminum bag", as it is used here, includes
bags made of aluminum and also bags which for example are coated
with aluminum on the outside or inside. For example, bags made of
one or more layers of plastic and/or paper can be coated with
aluminum. A preferred bag comprises, for example, an
aluminum-containing laminated foil which additionally includes
polyethylene, polyester and/or paper.
[0022] A package, in particular a lightproof package, permits
storage over a fairly long period of time without loss of efficacy
of the agent. Furthermore, such a package can provide protection
against gas loss.
[0023] Depending on the intended use, an aluminum bag in which one
or more disposable containers are packed can be printed on and/or
provided with a label.
[0024] In a further embodiment of the invention, a package unit
comprising several arrangements of disposable containers is
provided.
[0025] The invention is further explained by attached FIGS. 1 and
2.
[0026] FIG. 1 shows an arrangement of 5 disposable containers
connected to one another in a detachable manner and in a preferred
configuration. 1A shows a front view, 1B a plan view, 1C a side
view, and 1D a perspective view obliquely from above.
[0027] FIG. 2A shows a front view of an individual disposable
container in a preferred configuration. 2B shows a front view of an
arrangement of 10 disposable containers connected to one another in
a detachable manner, 2C shows a side view, and 2D shows a plan view
of said arrangement.
* * * * *