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WO1998003188A1 - Formes medicamenteuses contenant des extraits de plantes - Google Patents

Formes medicamenteuses contenant des extraits de plantes Download PDF

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Publication number
WO1998003188A1
WO1998003188A1 PCT/EP1997/003572 EP9703572W WO9803188A1 WO 1998003188 A1 WO1998003188 A1 WO 1998003188A1 EP 9703572 W EP9703572 W EP 9703572W WO 9803188 A1 WO9803188 A1 WO 9803188A1
Authority
WO
WIPO (PCT)
Prior art keywords
extracts
cellulose
drugs
plant
extract
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.)
Ceased
Application number
PCT/EP1997/003572
Other languages
German (de)
English (en)
Inventor
Gunther Berndl
Joerg Rosenberg
Axel Sanner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BASF SE
Original Assignee
BASF SE
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
Application filed by BASF SE filed Critical BASF SE
Priority to EP97931788A priority Critical patent/EP0912190A1/fr
Priority to AU35420/97A priority patent/AU3542097A/en
Publication of WO1998003188A1 publication Critical patent/WO1998003188A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • 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)
    • A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Definitions

  • the present invention relates to solid active substance preparations comprising, as active substances, plant extracts, with the exception of extracts of gingko biloba, Glycyrrhiza glabra and Eucalyptus globulus, which can be obtained by extrusion of a mixture of at least one plant extract and at least one meltable polymer and subsequent shaping.
  • the invention further relates to a method for producing such dosage forms. It is known to produce pharmaceutical forms by extrusion of polymer melts containing active ingredients and subsequent shaping.
  • DE-A 12 29 248 describes the extrusion of polymer melts containing active ingredients, followed by shaping by injection molding.
  • EP-A 240 904 describes the extrusion of active substance-containing melts of homopolymers or copolymers of N-vinylpyrrolidone.
  • EP-A 240 906 discloses the continuous production of solid dosage forms by extrusion of polymer melts containing active ingredients, followed by shaping the still thermoplastic strand by calendering.
  • Plant extracts in the sense of this invention are understood to mean the solvent-containing or dry extracts obtained by means of recognized pharmaceutical methods with the aid of water, organic solvents and supercritical gases.
  • Extracts in the sense of this invention are also understood to mean shredded plant material which has not been treated further.
  • Plant extracts differ from defined chemical active substances in that the total extract of a plant is a multi-substance system that is predetermined by nature and consists of active substances, secondary substances, ballast substances and builders. Often s i the therapeutic effect another, possibly a more favorable if not only an isolated drug acts on the organism, but the main and secondary materials a t Plant extracts act together. (Voigt, Textbook of Pharm. Technology, 440, (1987)).
  • Plant extracts also often contain enzymes, which affects the storage stability of the medicinal products. This applies in particular to those enzymes which lead to the partial or total inactivation of pharmacologically active compounds.
  • melt extrusion as a thermal process with a possible water removal (evacuation) should also have a stabilizing effect on such formulations, since enzymes as mostly high molecular weight proteins can often be irreversibly damaged by temperatures above 60 ° C (Voigt, textbook of pharm Technologie, 442f (1987)), can also be inactivated by dehydration (vacuum mode on the extruder).
  • both bitter-containing drugs, flavonoid drugs, coumarin drugs, tannin drugs, carbohydrate drugs, lipid-containing drugs, cardiac glycoside drugs, saponin drugs, anthrone and anthraquinone drugs, alkaloid drugs, arbutin drugs, essential oil Drugs and numerous other unclassifiable drugs are used.
  • Flavonoid drugs, coumarin drugs, tannin drugs, carbohydrate drugs, lipid-containing drugs, cardiac glycoside drugs, saponin drugs, anthrone and anthraquinone drugs, alkaloid drugs, arbutin drugs are preferred.
  • cardiac glycoside drugs, anthrone and anthraquinone drugs, alkaloid drugs and arbutin drugs can be used with particular preference.
  • the method according to the invention is suitable, for example, for processing extracts from the following plants, extracts from Gingko biloba, Glycyrrhiza glabra, and Eucalyptus globulus being excluded: Extracts from plants containing ethereal oils, such as: Mentha piperita, Melissa officinalis, Orthosiphon aristatus, Salvia officinalis, Lavandula angustifolia, Elettaria cardamomum, Thyus vulgaris, Rosmarinus officinalis, Citrus aurantium, i Juniperus communis, Matricaria recutita, Achilleaaumumumiumin, Achilleaaumumumumin , Cinna omu verum, Coriandrum sativum, Carum carvi, Pimpinella anisum, Foeniculum vulgäre, Petroselini crispum, Apiu graveolens, Valeriana officinalis.
  • ethereal oils such as
  • Extracts from plants containing sharp substances such as:
  • Extracts from plants containing bitter substances such as: Gentiana lutea, Artemisia absinthium, Cnicus benedictus, Centaurium erythraea, Marsdenia condurango, Humulus lupulus.
  • Extracts from plants containing cardiac glycosides such as:
  • Digitalis lanata Digitalis purpurea, Strophantus gratus, Strophantus kobe, Convallaria ajalis, Adonis vernalis, Nerium Oleander, Urginea maritima, Helleborus niger, Xysmalobium undulatum.
  • Extracts from saponin-containing plants such as:
  • Extracts from alkaloid-containing plants such as: Papaver somniferum, Chelidoniu majus, Fumaria officinalis, Hydrastis canadensis, Berberis vulgaris, Atropa belladonna, Hyoscyamus niger, Datura stramonium, Mandragora officinarum, Nicotiana tabacum, Claviceaelis cephalecis aconacis, cephalic acacenus, cephalic acacenus, cephalic acacenus, cephalic acacenus, cephalic acupuncture, cephalic acupuncture, cephalic acupuncture, cephalic acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupuncture acupunctur
  • Extracts from arbutin-containing plants such as: Arctostaphylos uva-ursi.
  • Extracts from flavonoid-containing plants such as: Crataegus onogyna, Arnica ontana, Tilia cordata, Sambucus nigra, Silybum marianum, Verbascum phlomoides, Viola tricolor, Ononis spinosa, Equisetum arvense, Betula pendula, Fagopyrum esculentis, Filendendula ulia, Filendula officia
  • Extracts from plants containing coumarin such as: Ammi visnaga, Angelica archangelica, Levisticu officinale, Melilotus officinale, Herniara glabra.
  • Extracts from plants containing tannins such as:
  • Juglans regia Solidago virgaurea, Prunus spinosa, Ammi visnaga, Hamamelis virginiana, Quercus robur, Krameria triandra, Potentilla erecta, Vaccinium myrtillus.
  • Extracts from plants containing carbohydrates such as: Cetraria islandica, Althaea officinalis, Plantago lanceolata, plantago psyllium, Malva sylvestris, Tussilago farfara, Linum usitatissimum, Trigonella foenum-graecum.
  • Extracts of other commercial herbal drugs such as: Avena sativa, Barosma betulina, Ci icifuga racemosa, Cynara scolymus, Drosera ramentacea, Euphrasia officinalis, Fucus vesiculosus, Gelsemiu se pervirens, Hibiscus sabdariffa, Hypericums perforatlora, P ⁇ , Rubia tinctörum, Sabal serrulata, Taraxacu officinale, ürtica dioica, iscum album, Vitex agnus castus, Echinacea angustifolia, Echinacea purpurea, Thuja occidentalis.
  • the amount of extract per dose unit and the concentration can vary within wide limits depending on the effectiveness and the rate of release.
  • the extract content can be in the range from 0.1 to 95, preferably from 20 to 90, in particular 30 to 70% by weight.
  • the combination of different extracts can also be used.
  • At least one plant extract with a meltable, physiologically compatible binder and, if appropriate, further customary galenical auxiliaries is used at a temperature in the range from 50 to 180 ° C, preferably 60 to 160 ° C, processed.
  • the mixing of the active ingredient or the active ingredients with the polymeric binders and optionally galenical additives can be carried out before or after the melting of the polymeric binder by the methods customary in the art. Mixing is preferably carried out in the extruder, preferably a twin-screw extruder or a single-screw extruder with a mixing compartment.
  • the processing is carried out without solvents.
  • moist plant materials or extract solutions the solvents can be removed during the extrusion process with the help of a vacuum.
  • the glass transition temperature of the mixture should be below 180, preferably below 130 ° C. If necessary, it is replaced by customary pharmacologically acceptable plasticizing auxiliaries, such as long-chain alcohols, ethylene glycol, propylene glycol, trimethylol propane, triethylene glycol, butanediols, pentanols, hexanols, polyethylene glycols, silicones, aromatic carboxylic acid esters (eg dialkyl phthalates, trimellitic acid esters or benzoate thalate acid esters, benzoates) Dicarboxylic acid esters (eg dialkyl adipates, sebacic acid esters, azelaic acid esters, citric and tartaric acid esters) or fatty acid esters are reduced.
  • plasticizing auxiliaries such as long-chain alcohols, ethylene glycol, propylene glycol, trimethylol propane, triethylene glycol, butanediols, pentanols, hexano
  • thermoplastic polymers for example polyvinylpyrrolidone (PVP), or preferably copolymers of N-vinylpyrrolidone (NVP) and vinyl acetate.
  • PVP polyvinylpyrrolidone
  • NDP N-vinylpyrrolidone
  • the K values (according to Fikentscher, Cellulose-Chemie 13 (1932), pages 58 to 64 and 71 and 74) of such polymers are in the range from 10 to 100, preferably 12 to 70, in particular 12 to 35, for PVP preferably 12 to 35, in particular 12 to 17, are furthermore copolymers of vinyl acetate and crotonic acid, partially saponified polyvinyl acetate, polyvinyl alcohol, ethylene / vinyl acetate copolymers, polyhydroxyethyl methacrylate, cellulose esters such as cellulose acetate, cellulose acetate propionate, cellulose acetate phthalate ethyl acetate, cellulose ethyl cellulose, cellulose ethyl cellulose, cellulose ethyl cellulose, cellulose ethyl cellulose, cellulose ethyl cellulose, cellulose ethyl cellulose, cellulose ethyl cellulose, cellulose ethyl cellulose,
  • Extenders such as silicates or silica, stearic acid or their salts with e.g. Magnesium or calcium, methyl cellulose, sodium carboxymethyl cellulose, talc, sucrose, lactose, cereal or corn starch, potato flour, sugar alcohols, e.g. Maltitol, mannitol, sorbitol, xylitol, isomalt, polyvinyl alcohol, also wetting agents, preservatives, disintegrants, adsorbents, colorants, flavorings (see e.g. H. Sucker et al., Pharmaceutical Technology, Thieme Verlag, Stuttgart 1978).
  • Extenders such as silicates or silica, stearic acid or their salts with e.g. Magnesium or calcium, methyl cellulose, sodium carboxymethyl cellulose, talc, sucrose, lactose, cereal or corn starch, potato flour, sugar alcohols, e.g. Maltito
  • the solid active ingredient-containing molds following extrusion can be produced, for example, by injection molding or by shaping the still thermoplastic strand in accordance with the process described in EP-A 240 906, by passing the strand between two counter-rotating rollers with opposing depressions in the roller jacket, the design of which determines the tablet shape.
  • pellets or granules can also be produced from the extrudate.
  • the preparations produced according to the invention can also be provided with a customary coating to improve the appearance and / or taste (dragee) or for the purpose of additionally delaying the release of active ingredient.
  • a customary coating to improve the appearance and / or taste (dragee) or for the purpose of additionally delaying the release of active ingredient.
  • the term solid form in the sense of the invention is not tied to a specific form or to oral use. Rather, it also includes suppositories (not melting at body temperature) for rectal use.
  • the preparations according to the invention are suitable for use in human medicine or veterinary medicine. They can also be used for other purposes that allow the use of herbal ingredients.
  • solid active ingredient forms with good stability can be produced in a simple manner.
  • the good meterability of the plant-based active substances is advantageous, particularly with regard to the incorporation of comminuted plant material which has not been treated further.
  • so-called "solid solutions” of plant extracres can also be produced in a polymer.
  • the presence of solid solutions can be determined by DSC measurement solutions.
  • Such "solid solutions” have advantages in terms of bioavailability and stability.
  • a powder extract of Hyperici herba with the following composition was used as the plant extract:
  • a mixture of 90% by weight of a copolymer with a K value of 30 and 60% by weight of N-vinylpyrrolidone and 40% by weight of vinyl acetate (Kollidon VA 64) and 10% by weight of Hyperici herba extract was mixed in a twin-screw extruder mixed and extruded and then calendered. Shot temperature: 40, 80, 125, 125, 130, 120 ° C. Nozzle: 122 ° C.
  • Shot temperature 40, 80, 120, 122, 124, 120 ° C.
  • Nozzle 124 ° C.
  • a mixture of 5 wt -.% Of an N-vinylpyrrolidone homopolymer (PVP, Kollidon ® K30), 33 wt .-% Isomalt F (Palatinit ®, Fa Südzucker.), 2 wt -.% Explotab ® (disintegrant -Natriumrestlycolat, Mendell) and 60% by weight extract from Hyperici herba were mixed and extruded in a twin-screw extruder and then calendered into oblong tablets. Shot temperature: 48, 82, 88, 86, 86, 81 ° C. Nozzle: 81 ° C.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne des préparations de principes actifs solides contenant pour principes actifs des extraits de plantes, à l'exception des extraits de gingko biloba, de glycyrrhiza glabra et d'eucalyptus globulus. Ces préparations s'obtiennent par extrusion d'un mélange comprenant au moins un extrait de plante et au moins un polymères fusible, puis par modelage.
PCT/EP1997/003572 1996-07-19 1997-07-07 Formes medicamenteuses contenant des extraits de plantes Ceased WO1998003188A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP97931788A EP0912190A1 (fr) 1996-07-19 1997-07-07 Formes medicamenteuses contenant des extraits de plantes
AU35420/97A AU3542097A (en) 1996-07-19 1997-07-07 Medicaments containing plant extracts

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19629040A DE19629040A1 (de) 1996-07-19 1996-07-19 Pflanzenextrakthaltige Arzneiformen
DE19629040.6 1996-07-19

Publications (1)

Publication Number Publication Date
WO1998003188A1 true WO1998003188A1 (fr) 1998-01-29

Family

ID=7800206

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1997/003572 Ceased WO1998003188A1 (fr) 1996-07-19 1997-07-07 Formes medicamenteuses contenant des extraits de plantes

Country Status (6)

Country Link
EP (1) EP0912190A1 (fr)
AU (1) AU3542097A (fr)
DE (1) DE19629040A1 (fr)
HR (1) HRP970392A2 (fr)
WO (1) WO1998003188A1 (fr)
ZA (1) ZA976363B (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000025606A1 (fr) * 1998-11-04 2000-05-11 Firmenich Sa Systeme de liberation solide pour ingredients aromatiques
WO2001017372A1 (fr) * 1999-09-06 2001-03-15 Firmenich S.A. Procede relatif a l'elaboration de granules pour la liberation controlee de composes volatils
CN115089636A (zh) * 2022-07-06 2022-09-23 新领医药技术(深圳)有限公司 一种中药组合物、包含该组合物的无过敏性透皮贴剂及其制备方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6077534A (en) * 1997-09-02 2000-06-20 Klinge Pharma Gmbh Production of pharmaceutical formulations for treatment of edema and venous disorders

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3432592A (en) * 1962-08-31 1969-03-11 Ciba Geigy Corp Injection-moulded oral medicament in solid form
EP0240904A2 (fr) * 1986-04-11 1987-10-14 BASF Aktiengesellschaft Procédé pour la préparation de formes pharmaceutiques solides
EP0240906A2 (fr) * 1986-04-11 1987-10-14 BASF Aktiengesellschaft Procédé pour pastiller en continu
DE4416927C1 (de) * 1994-05-13 1995-08-31 Lohmann Therapie Syst Lts Vorrichtung zur Abgabe von Wirkstoffen aus Haftschmelzklebern, Verfahren zu ihrer Herstellung und ihre Verwendung
EP0702957A1 (fr) * 1994-09-24 1996-03-27 Krewel-Werke Gmbh Extraits d'herbe de la Saint-Jean

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3432592A (en) * 1962-08-31 1969-03-11 Ciba Geigy Corp Injection-moulded oral medicament in solid form
EP0240904A2 (fr) * 1986-04-11 1987-10-14 BASF Aktiengesellschaft Procédé pour la préparation de formes pharmaceutiques solides
EP0240906A2 (fr) * 1986-04-11 1987-10-14 BASF Aktiengesellschaft Procédé pour pastiller en continu
DE4416927C1 (de) * 1994-05-13 1995-08-31 Lohmann Therapie Syst Lts Vorrichtung zur Abgabe von Wirkstoffen aus Haftschmelzklebern, Verfahren zu ihrer Herstellung und ihre Verwendung
EP0702957A1 (fr) * 1994-09-24 1996-03-27 Krewel-Werke Gmbh Extraits d'herbe de la Saint-Jean

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000025606A1 (fr) * 1998-11-04 2000-05-11 Firmenich Sa Systeme de liberation solide pour ingredients aromatiques
US6607778B2 (en) 1998-11-04 2003-08-19 Firmenich Sa Solid delivery systems for aroma ingredients
WO2001017372A1 (fr) * 1999-09-06 2001-03-15 Firmenich S.A. Procede relatif a l'elaboration de granules pour la liberation controlee de composes volatils
US6607771B2 (en) 1999-09-06 2003-08-19 Firmenich Sa Process for the preparation of granules for the controlled release of volatile compounds
CN115089636A (zh) * 2022-07-06 2022-09-23 新领医药技术(深圳)有限公司 一种中药组合物、包含该组合物的无过敏性透皮贴剂及其制备方法
CN115089636B (zh) * 2022-07-06 2023-12-08 深圳市古方中药饮片有限公司 一种中药组合物、包含该组合物的无过敏性透皮贴剂及其制备方法

Also Published As

Publication number Publication date
ZA976363B (en) 1999-01-19
AU3542097A (en) 1998-02-10
DE19629040A1 (de) 1998-01-22
HRP970392A2 (en) 1998-06-30
EP0912190A1 (fr) 1999-05-06

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