WO1998036732A2 - Preparation combinee pour antibiotiques administrables par voie orale - Google Patents

Preparation combinee pour antibiotiques administrables par voie orale

Info

Publication number
WO1998036732A2
WO1998036732A2 PCT/EP1998/000029 EP9800029W WO9836732A2 WO 1998036732 A2 WO1998036732 A2 WO 1998036732A2 EP 9800029 W EP9800029 W EP 9800029W WO 9836732 A2 WO9836732 A2 WO 9836732A2
Authority
WO
WIPO (PCT)
Prior art keywords
combination preparation
active ingredient
preparation according
component
groups
Prior art date
Application number
PCT/EP1998/000029
Other languages
German (de)
English (en)
Other versions
WO1998036732A3 (fr
Inventor
Ulrich Posanski
Original Assignee
Lindopharm Gmbh
Simon, Dirk
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 Lindopharm Gmbh, Simon, Dirk filed Critical Lindopharm Gmbh
Priority to AU60926/98A priority Critical patent/AU6092698A/en
Priority to EP98905269A priority patent/EP0971691A2/fr
Publication of WO1998036732A2 publication Critical patent/WO1998036732A2/fr
Publication of WO1998036732A3 publication Critical patent/WO1998036732A3/fr

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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Definitions

  • the invention relates to a combination preparation in the sense of a "kit-of-parts" for the oral administration of antibiotics as an aqueous suspension containing a coated active ingredient and a syrup base.
  • Filming, coating or coating active ingredient particles for example active ingredients which are in the form of crystals, agglomerates, granules, pellets or microtablets, is a common method in pharmaceutical technology to improve the stability of the active ingredient in an aqueous environment.
  • the choice of coating agent is adapted to the therapeutic task.
  • Coating with a high permeability polymer e.g. B .magensaftlöslichem Dimethylaminoethylmethacry- lat methacrylate copolymer of the type Eudragit ® E (Röhm GmbH Chemical Factory), and a suitable layer thickness, allows drug release in the acidic environment of gastric juice.
  • the rapid release of the active substance is important if infectious conditions are to be treated within a short time immediately after their appearance and rapid onset of action with higher doses is desired.
  • a coating with a lower permeability for example acrylic ester-methacrylic acid ester copolymer of the EUDRAGIT ® NE type, and possibly a greater layer thickness, the release of active ingredient in the stomach can be delayed with a corresponding prolongation of the duration of action. This effect is desirable with a longer therapy duration.
  • Coated active ingredient particles are also only stable for a limited time in aqueous suspension.
  • the undesired diffusion of the active ingredient into the suspension liquid takes place immediately after the suspension has been prepared. This results in the hydrolytic decomposition of the active ingredient and the significantly increasing deterioration in taste during the period of use of the suspension.
  • the object of the present invention is to produce pharmaceutical suspensions (dry juices) with acceptable taste properties and sufficient stability for orally administrable antibiotics.
  • the invention relates to a combination preparation for the oral administration of antibiotics as an aqueous suspension containing
  • active ingredient component a) consists of coated active ingredient particles which are combined with component b), the suspending agent, before use.
  • the two components are contained in two separate containers, which are packaged in a common package in the sense of a "kit of parts".
  • the contents of the two containers are combined in a suitable container immediately before use.
  • the two separate containers can be designed so that a single dose can be found in each case.
  • the contents of the two containers can be combined in a storage vessel from which the measured amount of liquid can be removed until the end of the therapy.
  • the storage container can be one of the two containers.
  • the suspension produced in this way is characterized by favorable taste and stability properties. After the suspension has been prepared, the pleasant taste of the liquid and the effectiveness of the active ingredient are retained until the end of therapy.
  • An oral antibiotic is administered as a single active ingredient or as a combination of active ingredients.
  • Suitable active substances are selected from the group of penicillins, cephalosporins, quinolones, aminoglycosides and macrolides and can be combined with another active substance from the substance groups mentioned.
  • the penicillins or cephalosporins can be combined with a ⁇ -lactamase inhibitor, for example clavulanic acid or sulbactam or tazobactam.
  • a ⁇ -lactamase inhibitor for example clavulanic acid or sulbactam or tazobactam.
  • the active ingredient component can be made of amoxicillin and clavulanic acid (Augmentan ® ) or. Ampicillin and Sulbactam (Unacid ® ) or Piperacillin and Tazobactam (Tazobac ® ) exist.
  • penicillins such as amoxicillin, ampicillin, bacampicillin, nacillin-Na, propicillin-K, phenoxymethylpenicillin-K, flucloxacillin, dicloxacillin, oxacillin, or pivampicil-lin.
  • cephalosporins such as cefaclor, cefadroxil, cefalexin, cefamandole, cefatrizine, cefazolin, cefepim, cefetamet, cefradrin, cefazedone, cef- tazidime, cefbuperazone, cefuroxim, cefiximefefone, cefiximefone , Cefotaxim, Cefotetan, Cefotiam, Cefoxitin, Cefmetazol, Cefperazon, Cefpimizol, Cefpiramide, Cefadroxil, Cefpo- doxim, Cefpodoxim-Proxetil, Cefuroxim-Axitil, Cefpodoxim-Proxitil, Cefterefoxitil, Cefterefoxitil, Cefterefoxamit , Cefuroxim, Cefuroxim-Axe
  • the active ingredient component can also be selected from the group of aminoglycosides. Examples of these are neomycin sulfate or paromomycin.
  • Macrolides such as azithromycin, clarithromycin, roxithromycin, josamycin or spiramycin I / II / III can also be used as active ingredient.
  • rifampicin such as quinolones / nalixidic acid derivatives (gyrase inhibitors), such as e.g. Ciprofloxacin, Norfloxacin, Cinoxacin, Lomefloxacin, Moxifloxacin, Ofloxacin, Fleroxacin, Enoxacin, Perfloxacin, Trovafloxacin, Geprafloxacin, Sparfloxacin, Tusofloxacin, Enrofloxacin or Pipemidklare.
  • quinolones / nalixidic acid derivatives such as e.g. Ciprofloxacin, Norfloxacin, Cinoxacin, Lomefloxacin, Moxifloxacin, Ofloxacin, Fleroxacin, Enoxacin, Perfloxacin, Trovafloxacin, Geprafloxacin, Sparfloxacin, Tusofloxacin, Enrofloxacin or Pipemidklare.
  • clindamycin or lincomycin can also be used as an active ingredient in the combination preparation according to the invention.
  • the active substances mentioned which have a salt-forming group, can, if not already stated, be present as pharmaceutically acceptable salts, for example alkali metal salts (sodium or potassium salts), alkaline earth metal salts (calcium or gastric salts), plasticites, starates, propionates, Choline salts, citrates, embonates, mesila te, sulfates or hydrochloride.
  • the active ingredients can additionally contain half to ten moles of water of crystallization.
  • the active substances mentioned, or their combinations are present in the dosages prescribed for oral administration.
  • a suitable permeable, gastric juice-soluble coating agent consists of a film-like material which is permeable to acidic, aqueous systems, such as the contents of the stomach, and is swellable and / or soluble in these liquids.
  • Suitable are e.g. hydrophilic polyacrylates with an average molecular weight of approx. 1.0 x 10 to 1.0 x 10, consisting of acrylic acid polymers or acrylic acid-methacrylic acid copolymers.
  • the acid groups of the acrylic acid and / or methacrylic acid monomers are partially or completely esterified by C ⁇ -C4-alkyl groups, especially by methyl and / or ethyl groups, whereby these ester groups can be replaced by hydrophilic groups, especially trimethylammoniumethyl or dimethylaminoethyl.
  • EUDRAGIT ® Preferred polyacrylates are available under the registered trademark EUDRAGIT ® from Röhm Chemische Fabrik GmbH.
  • EUDRAGIT ® commercial forms are particularly preferred for rapidly disintegrating film coatings, for example swellable, permeable types based on acrylic acid ester / methacrylic acid ester copolymer, in particular ethyl acrylate / methyl methacrylate ester copolymer, for example gastric juice-soluble types such as EUDRAGIT ® E.
  • ethyl cellulose methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinyl acetate, polyvinyl alcohol, copolymers of methacrylic acid and methacrylic acid esters (Eudragit ® S / L) aminomethacrylate copolymers (Eudragit ® RS / RL), and acrylic acid polymers of the Carbopol type (eg Carbopol ® 934).
  • polymers such as ethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinyl acetate, polyvinyl alcohol, copolymers of methacrylic acid and methacrylic acid esters (Eudragit ® S / L) aminomethacrylate copolymers (Eudragit ® RS / RL), and acrylic acid polymers of the Carbopol type (eg Carbopol ® 934).
  • the permeability of the polymeric coatings can be changed by adding plasticizers.
  • plasticizers e.g. Triethyl citrate, acetyl triethyl citrate, tributyl citrate, acetyl tributyl citrate, triacetin, diethyl phthalate, dibutyl phthalate, glyceryl monocaprylate, monoglycerides and acetylated monoglycerides can be used.
  • the coating of the drug particles takes place in a conventional manner using conventional coating methods (Rowe, RC, Int. J. Pharm. Tech. & Prod. Mfr., 3. (1) 27-32 (1982)) by dispersing or dissolving the coating agent in the desired ratio in a solvent or mixture, for example in methanol, ethyl acetate, ethanol, isopropanol, tert. Butanol, acetone, methylene chloride, chloroform, water, or mixtures thereof. If necessary, auxiliaries such as Mg stearate, stearic acid, talc or can be added to improve the technical implementation of the coating process
  • Silicon dioxide (Syloid® 244 FP, / Cab-o-sil ® , / Aerosil ® 200).
  • the solution or dispersion is applied to the active ingredient in powder form using known methods, such as spray coating in the fluidized bed. sprayed.
  • the processes and devices are known under the names Aeromatic, Freund, Glatt, Wurster or Weg-Coater), 'and in the boiler under the names Accela Cota process or dip pipe process (Kala, H., et al, Pharmazie, 3_4 ( 11) 755-765 (1979)).
  • the coated product is then dried or the solvents are removed.
  • process conditions must be selected which allow the process temperatures to be reduced and / or the process times to be shortened. This can e.g. by working at reduced atmospheric pressure (Luy, B., et al, Pharm. Ind., 51, 89-94 (1989)) and / or by using conditioned air.
  • the usual grinding processes are used, e.g. Grinding in ball mills, pin mills, mortar mills or air jet mills.
  • the preparation of the suspending agent b) is carried out in manner known per se, which is described, for example for the production of conventional syrup bases (Temperli, M., et al, Pharm. Act. Helv., 3. 9, 741 ff (1964)).
  • the syrup base is adjusted to a pH between 5 and 10 with a suitable acid or base or a buffer system.
  • acids, bases or salts or their combinations can be used for this, such as amino acids, benzoic acid, citric acid, tartaric acid, succinic acid, malic acid, acetic acid, carbonic acid, hydrochloric acid, phosphoric acid or Ren Na + , K + , or Ca ++ salts, sodium hydroxide solution, glycylglycine, glycine, diisopropanolamine, tris (hydroxymethyl) amino methane (HCl), ethylenediamine, and triethanolamine (HCl).
  • the syrup can contain viscosity-influencing substances (for example macrogols), wetting agents, preservatives, antioxidants, colorants, taste correctives (flavors), sugar and / or sweeteners.
  • sugar or sugar substitutes which can serve as a syrup base are, for example, glucose, hydrogenated glucose (Lycasin ®), sucrose, xylitol, D-xylose, maltose, D-glucose, sorbitol, glycerol, mannitol, dulcitol, maltitol, lactitol, fructose, Dextrose, lactulose or lactose or their combinations.
  • Sweeteners which may be included to further round off the taste, are saccharin-Na, dulcin, glycyrrhizin, ammonium glycyrrhizinate, neosperperidine dihydrochalcone, neohesperidin-HCl, glycine, stevioside, L-asparagyl-L-phenylalanamethyl ester (aspartyl ® ), sodium cyclamate or their combinations.
  • the combination preparation according to the invention has valuable pharmacological properties and can be used for the therapy of infections of various origins for which the active substance or combination of active substances used is suitable.
  • the granules are leveled through a 0.8 mm sieve and the residual solvents are removed in a vacuum drying cabinet.
  • the dried granules are mixed with 5 5 kg Syloid 244 FP ®. Finally, the mixture is portioned into sachets of 11.065 g each.
  • the dried granulate is passed through a sieve with a mesh size of 1 mm and mixed with 1.1 kg of Aerosil ® .
  • the finished mixture can be filled in portions in sachets or in brown glass bottles.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une préparation combinée pour administration orale d'antibiotiques en suspension aqueuse, renfermant a) un composant formé d'une matière active, sous forme de particules enrobées par un agent d'enrobage polymère, perméable, apte au gonflement et/ou soluble dans les sucs gastriques, et b) une base de sirop, de pH 5 à 10, en tant que deuxième composant séparé du premier composant a). Les deux composants sont contenus dans deux réceptacles séparés qui sont présentés dans un emballage commun du type 'nécessaire d'éléments composants'.
PCT/EP1998/000029 1997-02-21 1998-01-05 Preparation combinee pour antibiotiques administrables par voie orale WO1998036732A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU60926/98A AU6092698A (en) 1997-02-21 1998-01-05 Combination preparation for orally administered antibiotics
EP98905269A EP0971691A2 (fr) 1997-02-21 1998-01-05 Preparation combinee pour antibiotiques administrables par voie orale

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19706978.9 1997-02-21
DE1997106978 DE19706978A1 (de) 1997-02-21 1997-02-21 Kombinationspräparat für oral applizierbare Antibiotika

Publications (2)

Publication Number Publication Date
WO1998036732A2 true WO1998036732A2 (fr) 1998-08-27
WO1998036732A3 WO1998036732A3 (fr) 1998-10-22

Family

ID=7821094

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/000029 WO1998036732A2 (fr) 1997-02-21 1998-01-05 Preparation combinee pour antibiotiques administrables par voie orale

Country Status (4)

Country Link
EP (1) EP0971691A2 (fr)
AU (1) AU6092698A (fr)
DE (1) DE19706978A1 (fr)
WO (1) WO1998036732A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000003695A1 (fr) * 1998-07-17 2000-01-27 Lek Pharmaceutical & Chemical Co. Dd Preparation pharmaceutique a base de suspension comprenant amoxicilline, acide clavulanique et cellulose
WO2001047499A1 (fr) * 1999-12-23 2001-07-05 Smithkline Beecham P.L.C. Preparations pharmaceutiques comprenant de l'amoxycilline de sodium et du clavulanate de potassium
US6872407B2 (en) 1997-04-11 2005-03-29 Abbott Laboratories Extended release formulations of erythromycin derivatives
WO2014122248A1 (fr) 2013-02-11 2014-08-14 Boehringer Ingelheim Vetmedica Gmbh Kit d'éléments
US9289390B2 (en) 2011-08-12 2016-03-22 Boehringer Ingelheim Vetmedica Gmbh Taste masked pharmaceutical composition

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003053399A2 (fr) * 2001-12-21 2003-07-03 Pfizer Products Inc. Procedes de granulation par voie humide d'azithromycine

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2122490A (en) * 1982-06-24 1984-01-18 Astra Laekemedel Ab Controlled release formulation
EP0069097B1 (fr) * 1981-06-18 1986-09-10 Astra Läkemedel Aktiebolag Mélange pharmaceutique
WO1993000898A1 (fr) * 1991-07-11 1993-01-21 Smithkline Beecham Plc Formulation pharmaceutique comprenant une beta-lactamine et de l'acide clavulanique ou un sel de celui-ci soluble dans l'eau
EP0551820A1 (fr) * 1992-01-15 1993-07-21 Bayer Ag Compositions pharmaceutiques masquant le mauvais goût
WO1993017667A1 (fr) * 1992-03-12 1993-09-16 Taisho Pharmaceutical Co., Ltd. Composition pour preparations buvables
WO1996001628A1 (fr) * 1994-07-07 1996-01-25 Recordati Industria Chimica E Farmaceutica S.P.A. Composition pharmaceutique pour la liberation regulee de moguisteine sous forme de suspension liquide

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0069097B1 (fr) * 1981-06-18 1986-09-10 Astra Läkemedel Aktiebolag Mélange pharmaceutique
GB2122490A (en) * 1982-06-24 1984-01-18 Astra Laekemedel Ab Controlled release formulation
WO1993000898A1 (fr) * 1991-07-11 1993-01-21 Smithkline Beecham Plc Formulation pharmaceutique comprenant une beta-lactamine et de l'acide clavulanique ou un sel de celui-ci soluble dans l'eau
EP0551820A1 (fr) * 1992-01-15 1993-07-21 Bayer Ag Compositions pharmaceutiques masquant le mauvais goût
WO1993017667A1 (fr) * 1992-03-12 1993-09-16 Taisho Pharmaceutical Co., Ltd. Composition pour preparations buvables
WO1996001628A1 (fr) * 1994-07-07 1996-01-25 Recordati Industria Chimica E Farmaceutica S.P.A. Composition pharmaceutique pour la liberation regulee de moguisteine sous forme de suspension liquide

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0971691A2 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6872407B2 (en) 1997-04-11 2005-03-29 Abbott Laboratories Extended release formulations of erythromycin derivatives
WO2000003695A1 (fr) * 1998-07-17 2000-01-27 Lek Pharmaceutical & Chemical Co. Dd Preparation pharmaceutique a base de suspension comprenant amoxicilline, acide clavulanique et cellulose
US6511972B1 (en) 1998-07-17 2003-01-28 Lek Pharmaceutical & Chemical Company D.D. Pharmaceutical suspension formulation comprising amoxycillin clavulanic acid and cellulose
WO2001047499A1 (fr) * 1999-12-23 2001-07-05 Smithkline Beecham P.L.C. Preparations pharmaceutiques comprenant de l'amoxycilline de sodium et du clavulanate de potassium
US9289390B2 (en) 2011-08-12 2016-03-22 Boehringer Ingelheim Vetmedica Gmbh Taste masked pharmaceutical composition
WO2014122248A1 (fr) 2013-02-11 2014-08-14 Boehringer Ingelheim Vetmedica Gmbh Kit d'éléments

Also Published As

Publication number Publication date
AU6092698A (en) 1998-09-09
EP0971691A2 (fr) 2000-01-19
DE19706978A1 (de) 1998-08-27
WO1998036732A3 (fr) 1998-10-22

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