Classifications

• • 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
  • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
  • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
• • 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
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/465—Nicotine; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

Definitions

• the invention is directed to a method and an apparatus for treating schizophrenia.
• Schizophrenia is a mental illness that was first developed by E. Kraepelin by summarizing individual characteristics, e.g. B. paranoid and catatons
• Condition pictures has been described as a disease.
• the main deficit underlying this condition is a division of mental functions.
• schizophrenia has different faces and the different symptoms appear in different forms and combinations. Typical forms are paranoid-hallucinatory schizophrenia, catatonic schizophrenia, schizophrenia simplex and Hebephrenia.
• Symptoms of schizophrenia include disorders of the course of thought, content-related thinking disorders, illusions, so-called "ego disorders", disorders of the emotional world (affect disorders) as well as disorders of movement and drive.
• the schizoaffective psychoses occupy a middle position between the schizophrenia and the cyclothymia.
• the basic symptoms include disturbances in thinking (embarrassment, termination of thoughts, changes in the chain of thoughts), disturbances in affectivity (indifference, hypersensitivity, irritability, loss of contact, ambivalence of feelings) and disturbances in one's own experience (depersonalization, experiences of alienation and influence, cleavage of personality ).
• the accessory symptoms include hallucinations (acoustic, visual, olfactory and taste hallucinations), delusion (persecution, poisoning, sexual delusion, etc.), motor and drive disorders (immobility, mutism, drive inhibition) and language changes (mannerisms , playful expressions, word formations, constant repetitions).
• hallucinations acoustic, visual, olfactory and taste hallucinations
• delusion persecution, poisoning, sexual delusion, etc.
• motor and drive disorders immobility, mutism, drive inhibition
• language changes mannerisms , playful expressions, word formations, constant repetitions.
• Schizophrenia is considered to be incurable, i.e. causal treatment is considered - as is the case with many organic diseases, such as B. Diabetes - as not possible.
• a pal ative treatment is possible, so that in a majority of the patients the symptoms can be suppressed at least so much that hospitalization is unnecessary or the patient's regular everyday life is facilitated.
• the invention is therefore based on the object of providing a method and a medicament which make it possible to treat the symptoms of patients with schizophrenia and which is suitable for use in addition or as part of psychotherapy and / or sociotherapy, as a result of which the Disadvantages of treatment with neuroleptics or other psychologically active substances can be reduced or avoided. Even the weaknesses of the intermittent nicotine intake by means of nicotine chewing gum and the disadvantages of the mucous membrane irritant effect of nicotine when administered orally are to be avoided.
• the object is achieved by a method and a medicament which is used for the continuous administration of nicotine, preferably to and through the skin over a longer period, for example over a 16 or 24 hour period and preferably over a period of several days, e.g. B. 3-day period is suitable.
• TTS transdermal therapeutic systems
• EP 400 078 EP 427 741 and EP 708 627.
• TTS transdermal therapeutic systems
• the active ingredient nicotine via a 16th hours (EP 400 078), or a 24-hour period.
• TTS can be produced which also contain the active ingredient nicotine over a longer period of time, e.g. B. can give 3 days.
• the active substance content and the thickness of the matrix containing the active substance and the skin contact surface of the TTS types used have to be adapted for the desired application time.
• the active ingredient nicotine means the naturally occurring (-) - nicotine. Nicotine has two nitrogen atoms.
• the pharmaceutically acceptable salts of nicotine include the mono salts of saiicylic acid, phenylpropionic acid or dodecanoic acid. Nicotine monoacetate, nicotine sulfate, nicotine hydrochloride, nicotine valerate, nicotine pivalate, nicotine lactate etc. are also preferred as active ingredients. Of course, this list cannot be exhaustive.
• the mixture of nicotine (as a free base) with a nicotine seed is also suitable as an active ingredient. This can be the case with a longer planned application period. Free nicotine base permeates through the skin faster than many of the nicotine salts. After a certain time, this leads to exhaustion of the nicotine in the active substance reservoir of the TTS. The nicotine salt content in the drug reservoir slows down when the free base in the drug reservoir is exhausted. The salt then plays a greater role in nicotine delivery and maintenance of nicotine blood plasma levels later in the application of the TTS.
• the constructive elements of the TTS are a backing layer, a layer containing the active ingredient and a layer that causes adhesion to the skin.
• the TTS can also be constructed in such a way that the functions "layer containing active ingredient” and "layer causing adhesion to the skin” are realized in a single layer.
• the TTS can have a control membrane, which is between the
• the control membrane has the function of controlling the rate of release of the active ingredient from the TTS.
• the active ingredient can also be present in microencapsulated form in the active ingredient-containing layer.
• the capsule material enveloping the active substance would then take on this function which controls the release.
• the backing layer is impermeable to the active substance and preferably impermeable to light and oxygen in order to avoid chemical decomposition of the active substance by substances penetrating from outside.
• the TTS can also have separate drug reservoirs in a surrounding matrix.
• the TTS is able to reach a nicotine blood plasma level above 2 ng / ml within a period of 4 hours after application.
• a TTS is suitable to achieve an essentially constant nicotine biutplasma level between 2 and 20 ng / ml after a period of 4 hours after application.
• a TTS is preferred which is suitable for achieving a substantially constant nicotine blood plasma level of between 2 and 10 ng / ml after a period of 4 hours after application.
• the method for treating schizophrenia is to stick a TTS according to the invention on the patient's skin and after the remove the intended duration of use.
• This application time for a single TTS can be 16 hours or 24 hours.
• Multi-day TTS, e.g. B. are suitable for a three-day application.
• Long-term therapy is meaningful, ie an application of such nicotine TTS according to the invention, possibly for months or years.
• This type of long-term drug therapy using transdermal nicotine can be used simultaneously with psychotherapy and / or sociotherapy and / or drug therapy, especially with drugs that specifically block the receptors for dopamine (olanzapine, risperidone, etc.).

Landscapes

• Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Bioinformatics & Cheminformatics (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Chemical & Material Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Medicinal Chemistry (AREA)
• Epidemiology (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Psychiatry (AREA)
• General Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Neurosurgery (AREA)
• Neurology (AREA)
• Biomedical Technology (AREA)
• Organic Chemistry (AREA)
• Dermatology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medicinal Preparation (AREA)

Priority Applications (6)

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Publications (1)

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• 1998
  • 1998-10-16 DE DE19847715A patent/DE19847715A1/de not_active Withdrawn
• 1999
  • 1999-10-02 EP EP99948923A patent/EP1121126A1/de not_active Ceased
  • 1999-10-02 JP JP2000576851A patent/JP2002527478A/ja active Pending
  • 1999-10-02 AU AU61992/99A patent/AU6199299A/en not_active Abandoned
  • 1999-10-02 KR KR1020017004649A patent/KR20010080135A/ko not_active Application Discontinuation
  • 1999-10-02 BR BR9914570-7A patent/BR9914570A/pt not_active IP Right Cessation
  • 1999-10-02 CA CA002341855A patent/CA2341855A1/en not_active Abandoned
  • 1999-10-02 CN CN99812210A patent/CN1323210A/zh active Pending
  • 1999-10-02 WO PCT/EP1999/007320 patent/WO2000023077A1/de not_active Application Discontinuation
  • 1999-10-14 AR ARP990105204A patent/AR020815A1/es unknown

Patent Citations (3)

Non-Patent Citations (8)

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