WO2006046933A1 - Agent therapeutique a action sedative et spasmolytique et procede de production de celui-ci (variantes) - Google Patents

Agent therapeutique a action sedative et spasmolytique et procede de production de celui-ci (variantes) Download PDF

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Publication number
WO2006046933A1
WO2006046933A1 PCT/UA2005/000046 UA2005000046W WO2006046933A1 WO 2006046933 A1 WO2006046933 A1 WO 2006046933A1 UA 2005000046 W UA2005000046 W UA 2005000046W WO 2006046933 A1 WO2006046933 A1 WO 2006046933A1
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WO
WIPO (PCT)
Prior art keywords
phenobarbital
drug
cyclodextrin
coating
mixture
Prior art date
Application number
PCT/UA2005/000046
Other languages
English (en)
Russian (ru)
Inventor
Viktor Olexandrovych Rybchuk
Original Assignee
Viktor Olexandrovych Rybchuk
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from UA20041008756A external-priority patent/UA81623C2/ru
Application filed by Viktor Olexandrovych Rybchuk filed Critical Viktor Olexandrovych Rybchuk
Publication of WO2006046933A1 publication Critical patent/WO2006046933A1/fr

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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • A61K31/515—Barbituric acids; Derivatives thereof, e.g. sodium pentobarbital
    • 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
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • 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
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534—Mentha (mint)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/08—Vasodilators for multiple indications

Definitions

  • the invention relates to medicine, in particular to medicines containing organic active ingredients, namely, drugs exhibiting a sedative, vasodilator and antispasmodic effect, and methods for their preparation, and can be used to treat neurosis with increased irritability, increased irritability , insomnia, neurocirculatory dystonia, early stages of hypertension, not pronounced spasm of the heart vessels, spasms of the digestive tract, sv neurovegetative disorders associated with.
  • organic active ingredients namely, drugs exhibiting a sedative, vasodilator and antispasmodic effect
  • myotropic drugs antispasmodics
  • neurotropic drugs acting on the nervous system - sedatives, hypnotics, tranquilizers.
  • Sedatives are divided into herbal and synthetic. Sedative herbal remedies are obtained from medicinal valerian, canine nettle, lemon balm, peppermint, passionflower.
  • the rhizomes and roots of Valerian officinalis contain an essential oil, the main component of which is the ester of borneol and isovalerianic acid, as well as valerianic acid, borneol, organic acids, tannins, which exhibit a sedative and antispasmodic effect.
  • Synthetic sedative drugs include bromide, barbiturates in small doses.
  • Corvalol which contains: ethyl ester of ⁇ -bromisovalerianic acid 20.0 g; phenobarbital 18.26 g; peppermint oil 1, 42 g; rectified ethyl alcohol 580 ml; stabilizer 0.2 g; purified water to 1.0 l.
  • Ethyl ⁇ -bromisovalerianic acid which is part of Corvalol and Corvaldin, is a sedative and antispasmodic and acts like an extract of valerian.
  • Phenobarbital which is ingested when taking Corvalol, Corvaldin, and Valocordin, has a mild sedative and vasodilating effect.
  • Peppermint oil which has a reflex vasodilator and antispasmodic effect, it is recommended to use for nervous agitation, insomnia, various neurotic conditions as a vasodilator in angina pectoris and diseases associated with spasms of the cerebral vessels.
  • Hop oil which is part of Corvaldin and Valocordin, has a mild sedative effect.
  • Ethyl bromisovalerianate which is part of Valocordin, has a sedative antispasmodic effect.
  • ethyl ester of ⁇ -bromisovalerianic acid 0.5 to 3.0; phenobarbital 1.5-2.0; sodium hydroxide 0.2 to 0.4; peppermint oil 0.08 - 0.16; nifedipine 0.8 - 2.0 ethyl alcohol 96% 45 - 65; water 30 to 50.
  • Nifedipine which is part of Nikorval, has a vasodilating and anti-ischemic effect, lowers blood pressure.
  • the specified prototype like all previous analogues, is available in the form of a solution and is used as drops with a small amount of water.
  • the use of drops is not always convenient because of the impossibility of ensuring the exact dosage, indiscretion or inexperience of the patient preparing the drug, or its critical condition, or inconvenience when using the drug on the road.
  • ethyl alcohol of 96% was used to dissolve ethyl ester of ⁇ -bromisovalerianic acid, which, when used, leads to drying of the mucous membranes of the mouth and throat.
  • Nikorval includes ethyl ester of ⁇ -bromisovalerianic acid, which is a liquid that is easily volatile and insoluble in water, up to now it has not been possible to create a solid dosage form in tablets or capsules on the basis of this substance. In addition, volatiles are not stable when stored.
  • the specified method does not make it possible to transfer into the solid dosage form liquid components that are in the composition of the product, that is, tablets or capsules.
  • the method is only suitable for the manufacture of "Nikorval".
  • the basis of the invention is the task of creating a selection of components and their amount of the drug sedative and antispasmodic action of a solid form in the form of tablets, which in its sedative and antispasmodic action would correspond to drops of a similar action and ensure stability of volatile ingredients.
  • the second task which is the basis of the invention, is to create due to the selection of the components of the modes and parameters, the sequence of steps in the technological cycle of a method for producing a solid form of a sedative and antispasmodic drug.
  • the problem is solved in that the sedative and antispasmodic drug containing ethyl ester of ⁇ -bromisovalerianic acid, phenobarbital and peppermint oil, according to the invention, additionally contains microcrystalline cellulose, auxiliary substances for creating a solid dosage form in the form of tablets in the following ratio of components, May. %: ethyl ester of ⁇ -bromisovalerianic acid 1.37 - 8.2 phenobarbital 1.25 - 7.5 peppermint oil 0.16 - 0.58 microcrystalline cellulose 2 - 15 excipients the rest, and the tablets are coated with a coating of includes ⁇ -cyclodextrin or its derivatives.
  • the drug may further contain powders with advanced crystal surface in a dose until May 6. %
  • Aerosil, calcium alginate, pectin and / or mixtures thereof are used as powders with a developed surface.
  • fillers As excipients, fillers, disintegrants, glidants are used.
  • the fillers used are lactose, starch, glycine, calcium diphosphate, calcium dihydrogen phosphate, glucose, sorbitol and / or mixtures thereof.
  • Starch and its derivatives: crospovidone, croscarmellose and / or mixtures thereof are used as disintegrants.
  • the shell used film sugar coating and / or combinations thereof.
  • the film may include Oradru II from Kolorkon and ⁇ -cyclodextrin or its derivatives in the following ratio, May. %: ⁇ -cyclodextrin or its derivatives up to 10
  • the following components may be part of the sugar coating, May. %: magnesium carbonate up to 15.0 polyvinylpyrrolidone up to 2.0 talc up to 1.0 aerosil up to 1.0 titanium dioxide up to 2.0 ⁇ -cyclodextrin or its derivatives up to 3.0. sugar rest.
  • compositions of the components that are used in the pharmaceutical industry for coating tablets are also possible to use other compositions of the components that are used in the pharmaceutical industry for coating tablets.
  • hop oil may be added.
  • phenobarbital is first mixed with excipient-filler, separately prepared a mixture of ethyl ester of ⁇ -bromisovalerianic acid and peppermint oil, and the mixture of essential oils is less than 4.5% of the weight of the tablet, tablet- kernels or masses of the contents of the capsule, add microcrystalline cellulose, powders with a developed surface of the crystals, excipients, disintegrants and glidants, the resulting mixture is added to a mixture of phenobarbital with a filler and tablets are pressed and then coated with a coating containing ⁇ -cyclodextrin
  • Aerosil, calcium alginate, pectin and / or mixtures thereof are used as powders with a developed surface.
  • Magnesium stearate, sodium fumarate, talc, polyvinylpyrrolidone and / or mixtures thereof are used as glidants.
  • the tablets are heated and treated with heated air.
  • a shell As a shell, a film, a sugar shell, or combinations thereof are used.
  • the film is made by mixing the film-forming substance and a 1% solution of ⁇ -cyclodextrin.
  • a film-forming substance Oradru II of the Colorcon firm is used.
  • a sugar shell is made by mixing sugar, magnesium carbonate, aerosil, polyvinylpyrrolidone, titanium dioxide, talc and a solution of ⁇ -cyclodextrin.
  • microcrystalline cellulose reduces volatility and also improves the physicomechanical properties of medicinal substances (solubility, stability, bioavailability) intended for oral use.
  • microcrystalline cellulose which is characterized by more plastic deformation, reduces the necessary pressure forces in the tablets. presses, and having lower specific gravity at high flow rates, increases the fluidity of the tablet mixture.
  • the quantitative content of ethyl ester of ⁇ -bromisovalerianic acid in the claimed agent is determined by the dose necessary to achieve the optimal therapeutic effect, and the quantitative content of phenobarbital is dose-dependent.
  • Violation of the quantitative and qualitative composition of the drug leads to a decrease in the level and narrowing of the spectrum of its specific activity, as well as to technological complications.
  • fillers The choice of fillers is determined by the weight of the tablet and the possibility of using direct compression technology or granulation of powders. In turn, these factors determine the choice of substances for the manufacture of granules, the distribution of disintegrants between the phases of the tablet. All components together affect the final result - the mechanical properties of the tablets, their uniformity and appearance.
  • Phenobarbital is mixed with calcium diphosphate, a mixture of ethyl ester of ⁇ -bromisovalerianic acid and peppermint oil, microcrystalline cellulose, aerosil, starch, polyvinylpyrrolidone, magnesium stearate, talc are added and tablets with an average weight of 200 mg are pressed. The tablets are coated with a film coating from Oradrou-P, Kolorcon company. In the manufacture of the Oradr-II solution, a 1% aqueous solution of ⁇ -cyclodextrin or its derivatives is used instead of water.
  • composition per tablet is shown in table 1.
  • Oradru II 3.14 ⁇ -cyclodextrin 0.3.
  • ⁇ -bromisovalerianic acid ethyl ester is mixed with peppermint oil, the resulting mixture is added to moistened cyclodextrin and mixed for 1-2 minutes, dried and granulated, after which the granulate is mixed with powders of phenobarbital, glucose, starch, microcrystalline cellulose, lactose, magnesium stearate. The resulting mixture was tabletted.
  • Table 2 shows the ratio of the components of the claimed composition.
  • Oradru II 3.14 ⁇ -cyclodextrin 0.3.
  • the inventive composition is obtained analogously to example 1.
  • the composition per tablet is shown in table 3.
  • the inventive composition is obtained analogously to example 2.
  • the composition per tablet is shown in table 4.
  • the inventive composition is obtained analogously to example 2.
  • the composition per tablet is shown in table 5.
  • Phenobarbital is mixed with lactose, a mixture of ethyl ester of ⁇ -bromisovalerianic acid and peppermint oil, microcrystalline cellulose, aerosil, starch, talc, polyvinylpyrrolidone, magnesium stearate are added and tablets with an average weight of 100 mg are pressed. The resulting tablets are sugar coated. Coating weight 100 mg.
  • composition per tablet is shown in table 7 Table 7
  • Phenobarbital is mixed with lactose, a mixture of ethyl ester of ⁇ -bromisovalerianic acid, peppermint oil and hop oil is added.
  • Microcrystalline cellulose, aerosil, starch, talc, polyvinylpyrrolidone, magnesium stearate are added and tablets with an average weight of 100 mg are pressed. The resulting tablets are sugar coated. Coating weight 100 mg.
  • the data presented indicate the multifunctional action of the excipient system, which ensures the optimality of the physicomechanical properties of the solid dosage form.
  • the solid dosage form which is obtained according to the claimed invention, has advantages over the prototype.
  • the claimed invention fulfills the task of creating tablets of a combined preparation of sedative and antispasmodic action, which according to the kinetics of antispasmodic action correspond to the dosage form - drops and have an advantage over it in the accuracy and affordability of the dosage.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Alternative & Traditional Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Organic Chemistry (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

La présente invention relève du domaine de la médecine et concerne en particulier un agent thérapeutique à actions sédative et spasmolytique contenant un éther éthylique de l'acide α-bromisovalérianique, du phénobarbital, de l'huile de menthe poivrée, de la cellulose microcristalline et des adjuvants permettant de former une forme thérapeutique solide (comprimés), lesquels comprimés sont recouverts d'une enveloppe renfermant de la β-cyclodextrine ou des dérivés de celle-ci. La première variante de ce procédé de production de cet agent thérapeutique consiste: à mélanger l'éther éthylique de l'acide α-bromisovalérianique avec l'huile de menthe poivrée, ce mélange constituant 4,5 % de la masse totale du comprimé; à ajouter ce mélange à de la β-cyclodextrine humidifiée; à mélanger le tout pendant 1 à 2 minutes, puis à le faire sécher et à le granuler, après quoi le granulat est mélangé à des poudres de phénobarbital et de cellulose microcristalline et à des adjuvants. Le procédé consiste ensuite à compresser le comprimé et à le recouvrir d'une enveloppe renfermant de la β-cyclodextrine. La seconde variante de ce procédé consiste à mélanger le phénobarbital avec un adjuvant-charge; à préparer séparément le mélange d'éther éthylique de l'acide α-bromisovalérianique et d'huile de menthe poivrée; à ajouter la cellulose microcristalline, des poudres présentant une surface développée de cristaux, des purgatifs et des substances de glissement; à ajouter ce mélange au mélange de phénobarbital et de charge; à compresser le comprimé et à le recouvrir d'une enveloppe renfermant de la β-cyclodextrine.
PCT/UA2005/000046 2004-10-26 2005-10-26 Agent therapeutique a action sedative et spasmolytique et procede de production de celui-ci (variantes) WO2006046933A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
UA20041008755 2004-10-26
UA20041008755 2004-10-26
UA20041008756A UA81623C2 (ru) 2004-10-26 2004-10-26 Способ получения лечебного средства седативного и спазмолитического действия
UA20041008756 2004-10-26

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WO2006046933A1 true WO2006046933A1 (fr) 2006-05-04

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GE (1) GEP20084424B (fr)
RU (1) RU2349334C2 (fr)
WO (1) WO2006046933A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2563190C2 (ru) * 2012-06-14 2015-09-20 Открытое Акционерное Общество "Татхимфармпрераты" Лекарственное средство на основе сухих экстрактов лекарственных растений и способ его получения (варианты)
CN107582530A (zh) * 2017-06-01 2018-01-16 合肥远志医药科技开发有限公司 一种苯巴比妥片剂及其制备方法

Families Citing this family (4)

* Cited by examiner, † Cited by third party
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EA021571B1 (ru) * 2013-04-17 2015-07-30 Общество с ограниченной ответственностью "ЮжФарм" Способ получения таблетированной массы из активных фармацевтических субстанций, имеющих седативное и спазмолитическое действия
RU2589833C2 (ru) * 2013-12-12 2016-07-10 Общество С Ограниченной Ответственностью "Фарма Старт" Твердая лекарственная форма препарата седативного и снотворного действия
RU2578432C9 (ru) * 2015-03-02 2016-06-20 Общество с ограниченной ответственностью "Трейдсервис" Способ получения твердой формы лекарственного средства седативного и спазмолитического действия
RU2633064C2 (ru) * 2015-09-18 2017-10-11 Закрытое акционерное общество "Московская фармацевтическая фабрика" Средство седативного и спазмолитического действия и способ его получения

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2563190C2 (ru) * 2012-06-14 2015-09-20 Открытое Акционерное Общество "Татхимфармпрераты" Лекарственное средство на основе сухих экстрактов лекарственных растений и способ его получения (варианты)
CN107582530A (zh) * 2017-06-01 2018-01-16 合肥远志医药科技开发有限公司 一种苯巴比妥片剂及其制备方法

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GEP20084424B (en) 2008-07-10

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