EP0000015B1 - Medicament for the treatment of depressions - Google Patents
Medicament for the treatment of depressions Download PDFInfo
- Publication number
- EP0000015B1 EP0000015B1 EP78100027A EP78100027A EP0000015B1 EP 0000015 B1 EP0000015 B1 EP 0000015B1 EP 78100027 A EP78100027 A EP 78100027A EP 78100027 A EP78100027 A EP 78100027A EP 0000015 B1 EP0000015 B1 EP 0000015B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- acid
- tablets
- medicament
- treatment
- depressions
- 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.)
- Expired
Links
Classifications
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61P25/24—Antidepressants
-
- 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
- A61P25/26—Psychostimulants, e.g. nicotine, cocaine
Definitions
- the invention relates to a medicament for the treatment of depression, which contains a compound of the formula I or their acids (active ingredient A) and 7-chloro-1-methyl-5-phenyl-1 H-1,5-benzodiazepine-2,4- (3H, 5H) -dione (active ingredient B).
- the compound used as active ingredient A is known from DBP 1 670 694 and bears the name "Nomifensin” (INN).
- Nomifensin is used in the form of hydrogen maleate as a medicine for the therapy of depressive conditions. It is the first powerful antidepressant that is not derived from a tricyclic ring system. In contrast to the known tricyclic antidepressants, nomifensin is free from serious side effects, see e.g. "Drug Research", 23, (1973), 45-50.
- the active ingredient A is a basic compound, which in most cases is used advantageously in the form of a physiologically acceptable salt.
- Acids suitable for salts are e.g. Hydrochloric, bromic and hydroiodic acid, phosphoric acid, sulfuric acid, amidosulfonic acid, methylsulfuric acid, nitric acid, formic acid, acetic acid, propionic acid, succinic acid, tartaric acid, lactic acid, malonic acid, fumaric acid, citric acid, malic acid, mucic acid, benzoic acid, naphthalic acid, acetic acid, acetic acid, acetonic acid, acetic acid 1,5 - disulfonic acid, ascorbic acid, hydroxyethanesulfonic acid, benzenesulfonic acid, or synthetic resins containing acidic groups.
- the active ingredient B is a neutral compound that is sparingly soluble in water. Ciobazam is therefore advantageously used in micronized form.
- the active ingredient combination according to the invention can be used in the customary use forms, such as tablets, powders, capsules, suppositories or coated tablets. Capsules, tablets and coated tablets are preferably used.
- the usual pharmaceutical auxiliaries for example inert diluents and binders such as milk sugar, microcrystalline cellulose, calcium carbonate, di- and tricalcium phosphate, polyethylene glycol 4,000-6,000, gelatin, starch gum, disintegrants such as starches, ultraamylopectin, cellulose and cellulose derivatives, aerosil, lubricants such as Talc, magnesium stearate, calcium stearate, stearic acid added.
- Tablets which consist of several layers can also be used as tablets. They are produced, for example, by mixing the active ingredients with the pharmaceutical auxiliaries using customary pharmaceutical manufacturing methods.
- Dragees can be made, for example, by coating cores with agents commonly used in coated tablets, e.g. Cane sugar, gelatin, gum arabic, talc, calcium carbonate, cera alba, cera carnauba, aerosil can be obtained.
- Capsules are also produced in a manner known per se, inert carriers such as corn starch, talc, Aerosil being mixed and preferably gelatin capsules being used.
- the combination according to the invention can also be used in the form of suppositories, the usual carriers such as triglycerides of saturated fatty acids and hydrogenated vegetable fats being added.
- the preferred form of administration for the antidepressant pharmaceutical preparation according to the invention is oral administration.
- the active ingredient A comes into consideration in a dose of 5 to 50 mg per administration unit.
- Clobazam, active ingredient B uses 2 to 25 mg. In cases that require a higher dosage, a corresponding multiple of the above doses can be administered. Examples:
- micronized active ingredients 1. and 2. are with the supplements 3.-7. homogeneously mixed.
- the mixture is filled into hard gelatin capsules in a known manner.
- the tablet mixture of substances 1-9. is granulated and compressed into biconvex tablets.
- the tablets are coated with one of the usual film varnishes.
- the granules made for the production of tablets are pressed into coated tablets.
- the coated tablets are coated in a known manner.
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Psychiatry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
Die Erfindung betrifft ein Arzneimittel zur Behandlung von Depressionen, das durch einen Gehalt an einer Verbindung der Formel I
Die als Wirkstoff A verwendete Verbindung ist aus DBP 1 670 694 bekannt und trägt den Namen "Nomifensin" (INN).The compound used as active ingredient A is known from DBP 1 670 694 and bears the name "Nomifensin" (INN).
Nomifensin wird in Form des Hydrogenmaleinates als Arzneimittel für die Therapie depressiver Zustände eingesetzt. Es ist das erste stark wirksame Antidepressivum, das sich nicht von einem tricyclischen Ringsystem ableitet. Im Gegensatz zu den bekannten tricyclischen Antidepressiva ist Nomifensin frei von ernsthaften Nebenwirkungen, vergl. z.B. "Arzneimittelforschung", 23, (1973), 45-50.Nomifensin is used in the form of hydrogen maleate as a medicine for the therapy of depressive conditions. It is the first powerful antidepressant that is not derived from a tricyclic ring system. In contrast to the known tricyclic antidepressants, nomifensin is free from serious side effects, see e.g. "Drug Research", 23, (1973), 45-50.
Bei Depressionen, die mit ausgeprägten Angstzuständen einhergehen, hat es sich als günstig erwiesen, neben der Ba sismedikation mit Nomifensin eine Begleittherapie mit einem ausgesprochen anxiolytisch wirkenden Präparat durchzuführen.In depression, which is accompanied by pronounced anxiety, it has proven to be beneficial to carry out concomitant therapy with a pronounced anxiolytic preparation in addition to the basic medication with nomifensin.
Für die anxiolytische Begleittherapie hat sich das 7 - Chlor - 1 - methyl - 5 - phenyl - 1 H - 1,5-benzodiazepin - 2,4 - (3H, 5H) - dion bewährt, das unter dem Namen Clobazam (INN) bekannt geworden ist (vergl. z.B. La Chimica e I'Industria 51, (1969), 479-483).7-chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4- (3H, 5H) -dione, which is known under the name Clobazam (INN), has proven itself for accompanying anxiolytic therapy (see e.g. La Chimica e I'Industria 51, (1969), 479-483).
Es hat sich nun als vorteilhaft herausgestellt, die beiden Wirkstoffe A und B in einem pharmazeutischen Präparat zu kombinieren. Die Verwendung dieses Kombinationspräparates bedingt nicht nur eine Vereinfachung der Medikation, sondem es hat sich darüber hinaus gezeigt, daß überraschenderweise von den kombinierten Wirkstoffen für den gleichen Therapieerfolg geringere Mengen erforderlich sind als bei separater Medikation.It has now proven to be advantageous to combine the two active ingredients A and B in one pharmaceutical preparation. The use of this combination preparation not only simplifies the medication, but it has also been found that, surprisingly, smaller amounts of the combined active ingredients are required for the same therapeutic success than with separate medication.
Der Wirkstoff A ist eine basische Verbindung, die in den meisten Fällen vorteilhaft in Form eines physiologisch verträglichen Salzes verwendet wird. Für Salze in Betracht kommende Säuren sind z.B. Chlor-, Brom- und Jodwasserstoffsäure, Phosphorsäure, Schwefelsäure, Amidosulfonsäure, Methylschwefelsäure, Salpetersäure, Ameisensäure, Essigsäure, Propionsäure, Bernsteinsäure, Weinsäure, Milchsäure, Malonsäure, Fumarsäure, Zitronensäure, Äpfelsäure, Schleimsäure, Benzoesäure, Salicylsäure, Acetursäure, Embonsäure, Naphthalin-1,5 - disulfonsäure, Ascorbinsäure, Hydroxy- äthansulfonsäure, Benzolsulfonsäure, oder auch synthetische Harze, die saure Gruppen enthalten.The active ingredient A is a basic compound, which in most cases is used advantageously in the form of a physiologically acceptable salt. Acids suitable for salts are e.g. Hydrochloric, bromic and hydroiodic acid, phosphoric acid, sulfuric acid, amidosulfonic acid, methylsulfuric acid, nitric acid, formic acid, acetic acid, propionic acid, succinic acid, tartaric acid, lactic acid, malonic acid, fumaric acid, citric acid, malic acid, mucic acid, benzoic acid, naphthalic acid, acetic acid, acetic acid, acetonic acid, acetic acid 1,5 - disulfonic acid, ascorbic acid, hydroxyethanesulfonic acid, benzenesulfonic acid, or synthetic resins containing acidic groups.
Der Wirkstoff B ist eine neutrale Verbindung, die in Wasser schwer löslich ist. Ciobazam wird daher vorteilhaft in mikronisierter Form verwendet.The active ingredient B is a neutral compound that is sparingly soluble in water. Ciobazam is therefore advantageously used in micronized form.
Die erfindungsgemäße Wirkstoffkombination kann in den üblichen Anwendungsformen wie Tabletten, Pulver, Kapseln, Suppositorien oder Dragees zur Anwendung kommen. Vorzugsweise verwendet man Kapseln, Tabletten und Dragees. Es werden die üblichen pharmazeutischen Hilfsstoffe, beispielsweise inerte Verdünnungsmittel und Bindemittel wie Milchzucker, mikrokristalline Zellulose, Calciumcarbonat, Di- und Tricalciumphosphat, Polyäthylenglykol 4 000 - 6 000, Gelatine, Stärkeschleim, Sprengmittel wie Stärken, Ultraamylopektin, Zellulose und Zellulosederivate, Aerosil, Schmiermittel wie Talkum, Magnesiumstearat, Calciumstearat, Stearinsäure hinzugefügt.The active ingredient combination according to the invention can be used in the customary use forms, such as tablets, powders, capsules, suppositories or coated tablets. Capsules, tablets and coated tablets are preferably used. The usual pharmaceutical auxiliaries, for example inert diluents and binders such as milk sugar, microcrystalline cellulose, calcium carbonate, di- and tricalcium phosphate, polyethylene glycol 4,000-6,000, gelatin, starch gum, disintegrants such as starches, ultraamylopectin, cellulose and cellulose derivatives, aerosil, lubricants such as Talc, magnesium stearate, calcium stearate, stearic acid added.
Als Tabletten können auch solche eingesetzt werden, die aus mehreren Schichten bestehen. Ihre Herstellung erfolgt beispielsweise durch Mischen der Wirkstoffe mit den pharmazeutischen Hilfsstoffen nach üblichen galenischen Fertigungsmethoden.Tablets which consist of several layers can also be used as tablets. They are produced, for example, by mixing the active ingredients with the pharmaceutical auxiliaries using customary pharmaceutical manufacturing methods.
Dragees können beispielsweise durch Überziehen von Kernen mit üblicherweise in Dragee- überzügen verwendeten Mitteln, z.B. Rohrzucker, Gelatine, Gummi arabicum, Talkum, Calciumkarbonat, Cera alba, Cera Carnauba, Aerosil erhalten werden. Die Herstellung von Kapseln erfolgt ebenfalls in an sich bekannter Weise, wobei inerte Träger wie Maisstärke, Talkum, Aerosil gemischt werden und vorzugsweise Gelatinekapseln Verwendung finden. Auch in Form von Zäpfchen kann die erfindungsgemäße Kombination Einsatz finden, wobei die üblichen Trägermittel wie Triglyceride gesättigter Fettsäuren, hydrierte pflanzliche Fette zuzugeben sind.Dragees can be made, for example, by coating cores with agents commonly used in coated tablets, e.g. Cane sugar, gelatin, gum arabic, talc, calcium carbonate, cera alba, cera carnauba, aerosil can be obtained. Capsules are also produced in a manner known per se, inert carriers such as corn starch, talc, Aerosil being mixed and preferably gelatin capsules being used. The combination according to the invention can also be used in the form of suppositories, the usual carriers such as triglycerides of saturated fatty acids and hydrogenated vegetable fats being added.
Die bevorzugte Applikationsform für das erfindungsgemäße antidepressiv wirksame pharmazeutische Präparat ist die orale Gabe. Hierzu kommt der Wirkstoff A in einer Dosis von 5 bis 50 mg pro Verabreichungseinheit in Betracht. Von Clobazam, dem Wirkstoff B, werden 2 bis 25 mg verwendet. In Fällen, die eine höhere Dosierung erfordern, kann ein entsprechendes Mehrfaches der vorstehend genannten Dosierungen verabfolgt werden. Ausführungsbeispiele:
Die mikronisierten Wirkstoffe 1. und 2. werden mit den Zuschlägen 3.-7. homogen gemischt. Die Mischung wird in bekannter Weise in Hartgelatine-Steckkapseln abgefüllt.
Die Tabletten-Mischung aus den Substanzen 1.-9. wird granuliert und zu bikonvexen Tabletten verpresst.The tablet mixture of substances 1-9. is granulated and compressed into biconvex tablets.
Die Tabletten werden mit einem der üblichen Filmlacke überzogen.The tablets are coated with one of the usual film varnishes.
Das zur Herstellung von Tabletten angefertigte Granulat wird zu Drageekernen verpreßt. Die Drageekerne werden in bekannter Weise dragiert.The granules made for the production of tablets are pressed into coated tablets. The coated tablets are coated in a known manner.
Claims (1)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19772724683 DE2724683A1 (en) | 1977-06-01 | 1977-06-01 | ANTIDEPRESSIVE EFFECTIVE PHARMACEUTICAL PREPARATIONS |
| DE2724683 | 1977-06-01 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP0000015A1 EP0000015A1 (en) | 1978-12-20 |
| EP0000015B1 true EP0000015B1 (en) | 1980-07-23 |
Family
ID=6010390
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP78100027A Expired EP0000015B1 (en) | 1977-06-01 | 1978-06-01 | Medicament for the treatment of depressions |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US4189478A (en) |
| EP (1) | EP0000015B1 (en) |
| JP (1) | JPS545045A (en) |
| AT (1) | AT362491B (en) |
| AU (1) | AU517779B2 (en) |
| CA (1) | CA1102242A (en) |
| DE (2) | DE2724683A1 (en) |
| DK (1) | DK242078A (en) |
| IL (1) | IL54809A (en) |
| IT (1) | IT1094898B (en) |
| ZA (1) | ZA783123B (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6153404A (en) * | 1984-08-23 | 1986-03-17 | Toshiba Corp | Manufacturing method of nozzle diaphragm for steam turbine |
| JPS6355307A (en) * | 1986-07-16 | 1988-03-09 | Kawasaki Heavy Ind Ltd | Method for manufacturing turbine diaphragm |
| BG45572A1 (en) * | 1986-10-23 | 1989-07-14 | Druzhestven N Izsledovatelski | Antiulcer means |
| US20180344648A1 (en) * | 2015-11-30 | 2018-12-06 | Piramal Enterprises Limited | Clobazam tablet formulation and process for its preparation |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE1670694B2 (en) * | 1966-05-05 | 1976-07-22 | Hoechst Ag, 6000 Frankfurt | METHOD FOR MANUFACTURING TETRAHYDROISOCHINOLINES |
-
1977
- 1977-06-01 DE DE19772724683 patent/DE2724683A1/en not_active Withdrawn
-
1978
- 1978-05-30 US US05/910,782 patent/US4189478A/en not_active Expired - Lifetime
- 1978-05-30 ZA ZA00783123A patent/ZA783123B/en unknown
- 1978-05-30 IL IL54809A patent/IL54809A/en unknown
- 1978-05-30 IT IT23995/78A patent/IT1094898B/en active
- 1978-05-31 AU AU36704/78A patent/AU517779B2/en not_active Expired
- 1978-05-31 DK DK242078A patent/DK242078A/en not_active Application Discontinuation
- 1978-05-31 AT AT395178A patent/AT362491B/en not_active IP Right Cessation
- 1978-05-31 CA CA304,493A patent/CA1102242A/en not_active Expired
- 1978-06-01 DE DE7878100027T patent/DE2860033D1/en not_active Expired
- 1978-06-01 EP EP78100027A patent/EP0000015B1/en not_active Expired
- 1978-06-01 JP JP6499378A patent/JPS545045A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| IT1094898B (en) | 1985-08-10 |
| ZA783123B (en) | 1979-06-27 |
| DK242078A (en) | 1978-12-02 |
| DE2724683A1 (en) | 1978-12-14 |
| CA1102242A (en) | 1981-06-02 |
| IL54809A (en) | 1981-10-30 |
| AU517779B2 (en) | 1981-08-27 |
| IT7823995A0 (en) | 1978-05-30 |
| EP0000015A1 (en) | 1978-12-20 |
| US4189478A (en) | 1980-02-19 |
| ATA395178A (en) | 1980-10-15 |
| DE2860033D1 (en) | 1980-11-13 |
| AU3670478A (en) | 1979-12-06 |
| JPS545045A (en) | 1979-01-16 |
| AT362491B (en) | 1981-05-25 |
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