US20040094449A1 - Melatonin daily dosage units - Google Patents

Melatonin daily dosage units Download PDF

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Publication number
US20040094449A1
US20040094449A1 US10/353,056 US35305603A US2004094449A1 US 20040094449 A1 US20040094449 A1 US 20040094449A1 US 35305603 A US35305603 A US 35305603A US 2004094449 A1 US2004094449 A1 US 2004094449A1
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US
United States
Prior art keywords
container
melatonin
agent
derivative
arrangement
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US10/353,056
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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Filing date
Publication date
Application filed by ASAT AG Applied Science and Technology filed Critical ASAT AG Applied Science and Technology
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.
Priority to JP2005501814A priority Critical patent/JP2006513255A/en
Priority to DK03769477.5T priority patent/DK1562585T3/en
Priority to SI200331508T priority patent/SI1569724T1/en
Priority to CN2009102541491A priority patent/CN101897736A/en
Priority to CA002504361A priority patent/CA2504361A1/en
Priority to KR1020057007281A priority patent/KR20050083836A/en
Priority to PCT/EP2003/012097 priority patent/WO2004039454A1/en
Priority to CNA200380102359XA priority patent/CN1708301A/en
Priority to CA002504341A priority patent/CA2504341A1/en
Priority to ES03775265T priority patent/ES2315541T3/en
Priority to CN2011101545581A priority patent/CN102283835A/en
Priority to CNA2003801023960A priority patent/CN1708331A/en
Priority to AT03775265T priority patent/ATE419038T1/en
Priority to ES03769477.5T priority patent/ES2353865T5/en
Priority to EP03775265A priority patent/EP1569724B1/en
Priority to AT03769477T priority patent/ATE489073T1/en
Priority to NZ539871A priority patent/NZ539871A/en
Priority to DK03775265T priority patent/DK1569724T3/en
Priority to EP03769477.5A priority patent/EP1562585B2/en
Priority to PT03775265T priority patent/PT1569724E/en
Priority to KR1020057007293A priority patent/KR100849916B1/en
Priority to PL376226A priority patent/PL224878B1/en
Priority to PT03769477T priority patent/PT1562585E/en
Priority to BR0315878-0A priority patent/BR0315878A/en
Priority to DE50313285T priority patent/DE50313285D1/en
Priority to US10/533,516 priority patent/US8062648B2/en
Priority to MXPA05004535A priority patent/MXPA05004535A/en
Priority to AU2003283327A priority patent/AU2003283327A1/en
Priority to MXPA05004537A priority patent/MXPA05004537A/en
Priority to AU2003278164A priority patent/AU2003278164A1/en
Priority to PL375507A priority patent/PL212984B1/en
Priority to DE50311024T priority patent/DE50311024D1/en
Priority to JP2005501815A priority patent/JP2006510556A/en
Priority to US10/533,517 priority patent/US20060035924A1/en
Priority to PCT/EP2003/012099 priority patent/WO2004039369A1/en
Priority to BR0315927-2A priority patent/BR0315927A/en
Priority to SI200331934T priority patent/SI1562585T1/en
Priority to NZ539872A priority patent/NZ539872A/en
Publication of US20040094449A1 publication Critical patent/US20040094449A1/en
Priority to IS7820A priority patent/IS7820A/en
Priority to IL168288A priority patent/IL168288A/en
Priority to IL168287A priority patent/IL168287A/en
Priority to HR20050385A priority patent/HRP20050385A2/en
Priority to HR20050386A priority patent/HRP20050386A2/en
Priority to CR7819A priority patent/CR7819A/en
Priority to NO20052494A priority patent/NO334680B1/en
Priority to NO20052490A priority patent/NO335547B1/en
Priority to EC2005005819A priority patent/ECSP055819A/en
Priority to EC2005005820A priority patent/ECSP055820A/en
Priority to HK05107183.7A priority patent/HK1074793A1/en
Priority to US12/116,484 priority patent/US8017645B2/en
Priority to CY20111100147T priority patent/CY1111179T1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61J1/06—Ampoules or carpules
    • A61J1/067—Flexible ampoules, the contents of which are expelled by squeezing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—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
    • 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
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q7/00—Preparations for affecting hair growth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • 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-methoxyindole-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 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.
  • 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.
  • 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.
  • preferred materials are plastics and mixtures of plastics.
  • particularly suitable plastics are polyethylene, polyvinyl chloride, polystyrene or polypropylene, with particular preference being given to polyethylene.
  • 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.
  • 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.

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. [0001]
  • 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. [0002]
  • 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. [0003]
  • 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. [0004]
  • 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. [0005]
  • 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. [0006]
  • 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. [0007]
  • 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). [0008]
  • 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.[0009]
  • 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. [0010]
  • 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. [0011]
  • The medicament or cosmetic agent can also contain one or more cosmetic and/or pharmaceutical auxiliaries or additives, for example thickeners, minerals or perfumes. [0012]
  • 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. [0013]
  • 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. [0014]
  • 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. [0015]
  • 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. [0016]
  • 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. [0017]
  • 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. [0018]
  • Depending on the intended use, the disposable container carries lettering either printed on or embossed and/or is provided with a label. [0019]
  • 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. [0020]
  • 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. [0021]
  • 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. [0022]
  • 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. [0023]
  • In a further embodiment of the invention, a package unit comprising several arrangements of disposable containers is provided. [0024]
  • The invention is further explained by attached FIGS. 1 and 2. [0025]
  • FIG. 1 shows an arrangement of 5 disposable containers connected to one another in a detachable manner and in a preferred configuration. [0026] 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. [0027] 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.

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

Priority Applications (51)

Application Number Priority Date Filing Date Title
JP2005501814A JP2006513255A (en) 2002-10-30 2003-10-30 Preparations containing melatonin, ginkgo and biotin
DK03769477.5T DK1562585T3 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
SI200331508T SI1569724T1 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
CN2009102541491A CN101897736A (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
CA002504361A CA2504361A1 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
KR1020057007281A KR20050083836A (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba and biotin
PCT/EP2003/012097 WO2004039454A1 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
CNA200380102359XA CN1708301A (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
CA002504341A CA2504341A1 (en) 2002-10-30 2003-10-30 Melatonin daily dosing units
ES03775265T ES2315541T3 (en) 2002-10-30 2003-10-30 FORMULATIONS CONTAINING MELATONINE, GINKGO BILOBA AND BIOTINE.
CN2011101545581A CN102283835A (en) 2002-10-30 2003-10-30 Melatonin daily dosage units
CNA2003801023960A CN1708331A (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
AT03775265T ATE419038T1 (en) 2002-10-30 2003-10-30 FORMULATIONS CONTAINING MELATONIN, GINKGO BILOBA AND BIOTIN
ES03769477.5T ES2353865T5 (en) 2002-10-30 2003-10-30 Melatonin daily dosage units
EP03775265A EP1569724B1 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
AT03769477T ATE489073T1 (en) 2002-10-30 2003-10-30 MELATONIN DAILY DOSAGE UNITS
NZ539871A NZ539871A (en) 2002-10-30 2003-10-30 Daily melatonin dosing units of 0.01 to 0.2 mg of melatonin or melatonin derivative, for promoting hair growth
DK03775265T DK1569724T3 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, gingko biloba and biotin
EP03769477.5A EP1562585B2 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
PT03775265T PT1569724E (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
KR1020057007293A KR100849916B1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
PL376226A PL224878B1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
PT03769477T PT1562585E (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
BR0315878-0A BR0315878A (en) 2002-10-30 2003-10-30 Melatonin in Cosmetic Formulations
DE50313285T DE50313285D1 (en) 2002-10-30 2003-10-30 MELATONIN DAILY DOSAGE UNITS
US10/533,516 US8062648B2 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
MXPA05004535A MXPA05004535A (en) 2002-10-30 2003-10-30 Daily melatonin dosing units.
AU2003283327A AU2003283327A1 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
MXPA05004537A MXPA05004537A (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin.
AU2003278164A AU2003278164A1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
PL375507A PL212984B1 (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
DE50311024T DE50311024D1 (en) 2002-10-30 2003-10-30 FORMULATIONS CONTAINING MELATONIN, GINKGO BILOBA AND BIOTIN
JP2005501815A JP2006510556A (en) 2002-10-30 2003-10-30 Melatonin-daily dose unit
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
BR0315927-2A BR0315927A (en) 2002-10-30 2003-10-30 Single dose daily melatonin units
SI200331934T SI1562585T1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
NZ539872A NZ539872A (en) 2002-10-30 2003-10-30 Formulations containing melatonin, ginkgo biloba, and biotin
IS7820A IS7820A (en) 2002-10-30 2005-04-25 Compositions containing melatonin, temple and biotin
IL168288A IL168288A (en) 2002-10-30 2005-04-28 Formulations containing melatonin, ginkgo biloba and biotin for promoting hair growth
IL168287A IL168287A (en) 2002-10-30 2005-04-28 Disposable medicament/cosmetic container for topical application and arrangements and package units comprising the same
HR20050385A HRP20050385A2 (en) 2002-10-30 2005-04-29 Formualations containing melatinon, ginkgo biloba, and biotin
HR20050386A HRP20050386A2 (en) 2002-10-30 2005-04-29 Daily melatonin dosing units
CR7819A CR7819A (en) 2002-10-30 2005-04-29 UNIT FOR DAILY DOSAGE OF MELATONIN
NO20052494A NO334680B1 (en) 2002-10-30 2005-05-24 Compositions such as topical formulation for use in hair containing melatonin, gingko biloba and biotin as well as its use.
NO20052490A NO335547B1 (en) 2002-10-30 2005-05-24 Disposable container containing drug or cosmetic for topical application, multiple container assembly and packaging unit comprising multiple devices.
EC2005005819A ECSP055819A (en) 2002-10-30 2005-05-26 FORMULATIONS CONTAINING MELATONINE, GINKGO BILOBA AND BIOTINE
EC2005005820A ECSP055820A (en) 2002-10-30 2005-05-26 UNIT FOR DAILY DOSAGE OF MELATONIN
HK05107183.7A HK1074793A1 (en) 2002-10-30 2005-08-18 Daily melatonin dosing units
US12/116,484 US8017645B2 (en) 2002-10-30 2008-05-07 Melatonin daily dosage units
CY20111100147T CY1111179T1 (en) 2002-10-30 2011-02-09 Daily melatonin dosage units

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE20217814.5 2002-11-18
DE20217814U DE20217814U1 (en) 2002-11-18 2002-11-18 Melatonin daily dosage units

Related Child Applications (4)

Application Number Title Priority Date Filing Date
PCT/EP2003/012099 Continuation-In-Part WO2004039369A1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
US10533517 Continuation-In-Part 2003-10-30
US10/533,517 Continuation-In-Part US20060035924A1 (en) 2002-10-30 2003-10-30 Daily melatonin dosing units
US10533516 Continuation-In-Part 2003-10-30

Publications (1)

Publication Number Publication Date
US20040094449A1 true US20040094449A1 (en) 2004-05-20

Family

ID=32103506

Family Applications (1)

Application Number Title Priority Date Filing Date
US10/353,056 Abandoned US20040094449A1 (en) 2002-10-30 2003-01-29 Melatonin daily dosage units

Country Status (3)

Country Link
US (1) US20040094449A1 (en)
DE (1) DE20217814U1 (en)
IT (1) ITTO20030053U1 (en)

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