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US20060035924A1 - Daily melatonin dosing units - Google Patents

Daily melatonin dosing units Download PDF

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Publication number
US20060035924A1
US20060035924A1 US10/533,517 US53351705A US2006035924A1 US 20060035924 A1 US20060035924 A1 US 20060035924A1 US 53351705 A US53351705 A US 53351705A US 2006035924 A1 US2006035924 A1 US 2006035924A1
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Prior art keywords
container
melatonin
agent
derivative
arrangement
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Abandoned
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US10/533,517
Inventor
Hans Schmid
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ASAT AG Applied Science and Technology
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ASAT AG Applied Science and Technology
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Priority claimed from DE10250646A external-priority patent/DE10250646A1/en
Priority claimed from DE20217814U external-priority patent/DE20217814U1/en
Application filed by ASAT AG Applied Science and Technology filed Critical ASAT AG Applied Science and Technology
Priority to US10/533,517 priority Critical patent/US20060035924A1/en
Assigned to ASAT AG APPLIED SCIENCE & TECHNOLOGY reassignment ASAT AG APPLIED SCIENCE & TECHNOLOGY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SCHMID, HANS W.
Publication of US20060035924A1 publication Critical patent/US20060035924A1/en
Priority to US12/116,484 priority patent/US8017645B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
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    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
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    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4906—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom
    • A61K8/4913—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom having five membered rings, e.g. pyrrolidone carboxylic acid
    • A61K8/492—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom having five membered rings, e.g. pyrrolidone carboxylic acid having condensed rings, e.g. indol
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    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
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    • A61K8/67—Vitamins
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/67—Vitamins
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    • A—HUMAN NECESSITIES
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    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9771—Ginkgophyta, e.g. Ginkgoaceae [Ginkgo family]
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
    • A—HUMAN NECESSITIES
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    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/87—Application Devices; Containers; Packaging

Definitions

  • 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.
  • Melatonin-containing agents can be used for various medical and cosmetic purposes.
  • the document DE 101 10 418.9 discloses melatonin-containing compositions for topical application on the skin and in the hair.
  • 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.
  • 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.
  • melatonin or melatonin derivative 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-methoxy-indole-3-acetic acid and 6-hydroxymelatonin.
  • 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.
  • 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.
  • a single dose can be applied once or several times daily.
  • the single dose corresponds to a daily dose, particularly preferably a daily dose to be used in the evenings.
  • the medicament or cosmetic agent is preferably present as a liquid formulation.
  • 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.
  • 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).
  • 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.
  • 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 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.
  • 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.
  • 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.
  • the medicament or cosmetic agent can also contain one or more cosmetic and/or pharmaceutical auxiliaries or additives, for example thickeners, minerals or perfumes.
  • composition according to the invention can be used to promote hair growth, in particular to prevent and/or treat alopecia in men or in women.
  • Particularly preferred indications are male pattern androgenetic alopecia, female pattern androgenetic alopecia, male pattern diffuse alopecia and female pattern diffuse alopecia.
  • the disposable container according to the invention can contain different volumes of the medicament or cosmetic agent.
  • 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.
  • 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.
  • the disposable container according to the invention can in principle be made of any desired material, in particular a material approved for packaging of food products and pharmaceutical products.
  • suitable materials are plastics and mixtures of plastics.
  • particularly suitable plastics are polyethylene, polyvinyl chloride, polystyrene, polypropylene, polycycloolefins or mixtures or copolymers thereof, with particular preference being given to polyethylene or polycycloolefins.
  • 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.
  • 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.
  • 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.
  • 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.
  • the disposable container carries lettering either printed on or embossed and/or is provided with a label.
  • Two or more disposable containers can furthermore be connected to one another in a detachable manner.
  • 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.
  • aluminum bag includes bags made of aluminum and also bags which for example are coated with aluminum on the outside or inside.
  • 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.
  • 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.
  • an aluminum bag in which one or more disposable containers are packed can be printed on and/or provided with a label.
  • a package unit comprising several arrangements of disposable containers is provided.
  • FIGS. 1 and 2 The invention is further explained by attached FIGS. 1 and 2 and examples.
  • FIG. 1 shows an arrangement of 5 disposable containers connected to one another in a detachable manner and in a preferred configuration.
  • 1 A shows a front view, 1 B a plan view, 1 C a side view, and 1 D a perspective view obliquely from above.
  • FIG. 2A shows a front view of an individual disposable container in a preferred configuration.
  • 2 B shows a front view of an arrangement of 10 disposable containers connected to one another in a detachable manner
  • 2 C shows a side view
  • 2 D shows a plan view of said arrangement.
  • the composition contains 0.05% by weight of gingko biloba dry extract, 0.01% by weight of biotin, 0.0033% by weight of melatonin and other additives, water, and ethanol.
  • the pH of the composition is between 3.5 and 4.
  • Example 1 The composition described in Example 1 was tested on 8 healthy female patients in a randomized double-blind study with placebo control and a crossover design.
  • the daily dose was 0.1 mg of melatonin (3 ml of the composition) which was applied to the scalp each day before bedtime, for a period of 14 days.
  • Urine and blood samples were taken from the patients and were assayed for melatonin and the metabolite 6-hydroxymelatonin sulfate.
  • compositions for 14 days did not increase the plasma concentration of melatonin, or the concentration of 6-hydroxymelatonin sulfate in urine, above physiological concentrations.
  • Topical application of the melatonin-containing composition was not associated with side effects. Nor were any effects found on reaction times or on cortical excitation parameters.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Birds (AREA)
  • Dermatology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Botany (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biotechnology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Dispersion Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medical Informatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Packages (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Medicinal Preparation (AREA)
  • Indole Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

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.

Description

  • 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.
  • 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.
  • 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.
  • 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.
  • 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-methoxy-indole-3-acetic acid and 6-hydroxymelatonin.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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 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.
  • 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.
  • The medicament or cosmetic agent can also contain one or more cosmetic and/or pharmaceutical auxiliaries or additives, for example thickeners, minerals or perfumes.
  • The composition according to the invention can be used to promote hair growth, in particular to prevent and/or treat alopecia in men or in women. Particularly preferred indications are male pattern androgenetic alopecia, female pattern androgenetic alopecia, male pattern diffuse alopecia and female pattern diffuse alopecia.
  • 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.
  • 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.
  • The disposable container according to the invention can in principle be made of any desired material, in particular a material approved for packaging of food products and pharmaceutical products. Examples of preferred materials are plastics and mixtures of plastics. Examples of particularly suitable plastics are polyethylene, polyvinyl chloride, polystyrene, polypropylene, polycycloolefins or mixtures or copolymers thereof, with particular preference being given to polyethylene or polycycloolefins.
  • 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.
  • 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.
  • 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.
  • Depending on the intended use, the disposable container carries lettering either printed on or embossed and/or is provided with a label.
  • 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.
  • 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.
  • 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.
  • 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.
  • In a further embodiment of the invention, a package unit comprising several arrangements of disposable containers is provided.
  • The invention is further explained by attached FIGS. 1 and 2 and examples.
  • 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.
  • 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.
    • EXAMPLES Example 1 Composition of a Formulation According to the Invention Containing Melatonin, Gingko Biloba and Biotin as Active Substances
  • The composition contains 0.05% by weight of gingko biloba dry extract, 0.01% by weight of biotin, 0.0033% by weight of melatonin and other additives, water, and ethanol. The pH of the composition is between 3.5 and 4.
    • Example 2 Clinical Study
  • The composition described in Example 1 was tested on 8 healthy female patients in a randomized double-blind study with placebo control and a crossover design. The daily dose was 0.1 mg of melatonin (3 ml of the composition) which was applied to the scalp each day before bedtime, for a period of 14 days.
  • Urine and blood samples were taken from the patients and were assayed for melatonin and the metabolite 6-hydroxymelatonin sulfate.
  • It was found that the melatonin plasma profiles of the patients treated with melatonin or placebo corresponded to the concentration/time profiles described in the literature for endogenous melatonin. This confirms that topical application of the melatonin-containing composition for 14 days does not alter endogenous melatonin secretion.
  • Administration of the composition for 14 days did not increase the plasma concentration of melatonin, or the concentration of 6-hydroxymelatonin sulfate in urine, above physiological concentrations. Topical application of the melatonin-containing composition was not associated with side effects. Nor were any effects found on reaction times or on cortical excitation parameters.
  • All things considered, it must be concluded that administration of the composition does not induce any systemic effects.

Claims (29)

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, characterized in that the single dose is 0.001 to 1.0 mg of melatonin or melatonin derivative.
3. The container as claimed in claim 1, characterized in that the single dose is 0.01 to 0.2 mg of melatonin or melatonin derivative.
4. The container as claimed in claim 1, characterized in that the single dose corresponds to a daily dose.
5. The container as claimed in claim 1, characterized in that the agent is present as a liquid formulation.
6. The container as claimed in claim 5, characterized in that the liquid formulation has a concentration of 0.001 to 0.01% (by weight) of melatonin.
7. The container as claimed in claim 6, characterized in that the liquid formulation has a concentration of 0.003 to 0.004% (by weight) of melatonin.
8. The container as claimed in claim 1, characterized in that the agent contains, as sole active substance, melatonin or a melatonin derivative.
9. The container as claimed in claim 1, characterized in that 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 claim 1, characterized in that 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 claim 1, characterized in that it contains 2.5 to 3.5 ml of the agent.
12. The container as claimed in claim 11, characterized in that it contains 2.9 to 3.2 ml of the agent.
13. The container as claimed in claim 1, characterized in that the agent is filled into the container under GMP conditions.
14. The container as claimed in claim 1, characterized in that it is made of a plastic.
15. The container as claimed in claim 14, characterized in that it is made of polyethylene, polypropylene, polyvinyl chloride, polystyrene or a mixture of these.
16. The container as claimed in claim 1, characterized in that it is colorless.
17. The container as claimed in claim 1, characterized in that it is colored.
18. The container as claimed in claim 1, characterized in that it is transparent.
19. The container as claimed in claim 1, characterized in that it is non-transparent.
20. The container as claimed in claim 1, characterized in that it has, on its head, a disposable closure piece which is opened by turning it.
21. The container as claimed in claim 1, characterized in that, after opening, the agent emerges only when pressure is applied.
22. The container as claimed in claim 1, characterized in that it carries lettering either printed on or embossed and/or is provided with a label.
23. An arrangement of several containers, as claimed in claim 1, which are connected to one another in a detachable manner.
24. The arrangement as claimed in claim 23, characterized in that 5 containers are connected to one another in a detachable manner.
25. The arrangement as claimed in claim 23, characterized in that 10 containers are connected to one another in a detachable manner.
26. The arrangement as claimed in claim 23, characterized in that it is packed into an aluminum bag.
27. The arrangement as claimed in claim 26, characterized in that 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, characterized in that the aluminum bag is printed on and/or is provided with a label.
29. A package unit comprising several arrangements as claimed in claim 23.
US10/533,517 2002-10-30 2003-10-30 Daily melatonin dosing units Abandoned US20060035924A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US10/533,517 US20060035924A1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
US12/116,484 US8017645B2 (en) 2002-10-30 2008-05-07 Melatonin daily dosage units

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
DE10250646A DE10250646A1 (en) 2002-10-30 2002-10-30 Cosmetic and/or pharmaceutical hair treatment compositions, especially for promoting hair growth, containing melatonin (or derivative) and Gingko biloba and biotin as potentiating agents
DE10250646.9 2002-10-30
DE20217814.5 2002-11-18
DE20217814U DE20217814U1 (en) 2002-11-18 2002-11-18 Melatonin daily dosage units
US10/353,056 2003-01-29
US10/353,056 US20040094449A1 (en) 2002-11-18 2003-01-29 Melatonin daily dosage units
US10/533,517 US20060035924A1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
PCT/EP2003/012099 WO2004039369A1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units

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US10/353,056 Continuation-In-Part US20040094449A1 (en) 2002-10-30 2003-01-29 Melatonin daily dosage units

Related Child Applications (1)

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US12/116,484 Continuation US8017645B2 (en) 2002-10-30 2008-05-07 Melatonin daily dosage units

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US20060035924A1 true US20060035924A1 (en) 2006-02-16

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US10/533,517 Abandoned US20060035924A1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
US10/533,516 Active 2027-10-30 US8062648B2 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
US12/116,484 Expired - Lifetime US8017645B2 (en) 2002-10-30 2008-05-07 Melatonin daily dosage units

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US10/533,516 Active 2027-10-30 US8062648B2 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
US12/116,484 Expired - Lifetime US8017645B2 (en) 2002-10-30 2008-05-07 Melatonin daily dosage units

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AT (1) ATE419038T1 (en)
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DK (1) DK1569724T3 (en)
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AU2003283327A1 (en) 2004-05-25
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US20080293803A1 (en) 2008-11-27
HRP20050386A2 (en) 2006-06-30
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BR0315927A (en) 2005-09-20
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US8062648B2 (en) 2011-11-22
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US8017645B2 (en) 2011-09-13
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