EP0273005A1 - Comprimé dispersible dans l'eau - Google Patents

Comprimé dispersible dans l'eau Download PDF

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Publication number
EP0273005A1
EP0273005A1 EP87810688A EP87810688A EP0273005A1 EP 0273005 A1 EP0273005 A1 EP 0273005A1 EP 87810688 A EP87810688 A EP 87810688A EP 87810688 A EP87810688 A EP 87810688A EP 0273005 A1 EP0273005 A1 EP 0273005A1
Authority
EP
European Patent Office
Prior art keywords
water
drugs
dispersible tablet
tablet according
swellable material
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.)
Withdrawn
Application number
EP87810688A
Other languages
German (de)
English (en)
Inventor
Kimon Dr. Ventouras
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.)
GSK Consumer Healthcare SARL
Original Assignee
Zyma SA
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 Zyma SA filed Critical Zyma SA
Publication of EP0273005A1 publication Critical patent/EP0273005A1/fr
Withdrawn legal-status Critical Current

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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
    • A61K9/0087—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50

Definitions

  • the present invention relates to improved tablet which contains at least one pharmaceutically active substance and rapidly dis­integrates in contact with water so as to generate a viscous, homogeneous suspension.
  • the dispersion formed after contact with water can be swallowed easily by any person who is in need of the pharmaceutically active substance(s).
  • This route of administration of pharmaceutically active substances is particularly advantageous, when a relatively large single dose must be applied oraly, since a tablet or another shaped form, e.g. a capsule, would be too voluminous for oral intake. Also in cases where no particularly large single dose must be applied, the route of administration described above can be advantageous, because it is more convenient especially for children and elderly people, and other people too, who often have troubles swallowing medicines in solid form, such as tablets or other shaped forms. Furthermore, there are certain drugs, where multiple unit dosage forms are particularly advantageous to overcome a local irritation of the gastrointestinal tract after peroral administration, e.g., non-­steroidal antiinflammatory drugs, such as ibuprofen, or other drugs, e.g. potassium chloride or sodium floride.
  • non-­steroidal antiinflammatory drugs such as ibuprofen
  • other drugs e.g. potassium chloride or sodium floride.
  • Rapidly disintegrating tablets are known in the art, e.g. from EP-A-52076 or WO-A-86/04817:
  • the known tablets suffer from the following disadvantages: After disintegration, they form a dispersion containing the isolated - mostly coated - microparticles. Even in those cases where the microparticles used are of small size - e.g. of 0.3 to 0.6 mm diameter -, when swallowed, they are preceived as individual grains in the mouth in an unpleasent manner and may be caught on the spaces between the teeth.
  • the dispersion prepared from such tablets produces a certain feeling of hoarseness in the mouth.
  • liquid foods e.g. apple sauce or marmalade
  • the use of the latter has the following disadvantages: (1) The person in need of the drug always has to take in food simultaneously when swallowing a formulation of the invention. But food intake can often be complete­ly undesired in such situations, e.g. for reason of avoiding increase of weight. (2) Drug absorption may be infulenced by the food taken in simultaneously in an undesired manner.
  • the present invention relates to a water-dispersible tablet essentially consisting of
  • the microparticles (a) can be coated mircroparticles, a mixture of coated and uncoated microparticles, or uncoated microparticles, preferably such with controlled release or taste masking prop­erties.
  • the coated microparticles consist of a granule or crystal of a pharmaceutically active substance, which is coated or encapsulated by any material which is known in the art to be suitable for the intended purpose, e.g. by polymeric materials dissolved in organic solvents or dispersed in water as latex.
  • the intended purpose of the coating may be e.g. the control of the release of a certain pharmaceutically active compound as well-known in the art, or the masking of any undesired, e.g. bitter, taste of such a compound.
  • the polymeric material mentioned above can be applied either alone or in admixture with other insoluble or soluble polymers.
  • the coating may contain e.g. plasticizers, glidants and/or flavours.
  • uncoated microparticles may exhibit control release properties, e.g. in case the substance used is only very poorly soluble in water.
  • the size of the microparticles used is e.g. 0.2 to 1.0 mm diameter, preferably 0.3 to 0.8 and especially 0.3 to 0.5 mm diameter.
  • pharmaceutically active substances used in the tablet of the invention come into consideration all those which are suitable for peroral administrtion. This applies for example for (a) potassium chloride administered e.g. in the treatment of hypolkaliaemia, (b) lithium salts administered e.g. in psychotherapy, (c) non-­steroidal antiinflammatory drugs, e.g. ibuprofen, (d) calcium salts e.g. in the therapy of hypocalcemic states or for calcium supplemen­tation, (e) sodium fluoride e.g. in the treatment of osteoporosis, (f) pridinol, or a salt thereof, e.g.
  • di­methindene or a salt thereof, e.g. as an antihistaminicum, (h) methyl-xanthines, e.g. proxyphylline, dipropylline and/or theo­phylline, e.g. as bronchodilators, (i) a mixture of O- ⁇ -hydroxy­ethyl-rutosides (Venoruton®) e.g. in the treatment of venous diseases, (j) antitussive drugs, e.g. butamirate or a salt thereof, such as butamirate citrate, codeine or a derivative thereof, or noscapine, (k) antipyretics, e.g.
  • acetaminophen (l) vitamines or multivitamines preparations, (m) cardiovascular and vascular drugs, such as all the betablockers known in the art, or e.g. 1-O-ethyl-3-­O-propyl-5,6-di-O-(4-chlorbenzyl)-D-glucofuranoside, (n) drugs especially used against elderlys' or childrens' diseases (geriatric or pediatric drugs), e.g. pyrisuccideanol or a salt thereof, such as pyrisuccideanol dimaleate, ticlopidine, dipyridamole or diazepam, (o) drugs useful to balance the hydroelectroytes e.g.
  • diarrhoea e.g. sodium or potassium salts
  • anti­biotic drugs e.g. erythromycin or a salt therof or doxycycline or a salt thereof
  • nootropica e.g. piracetam
  • the disintegrant (b) is preferably crospovidone (a cross-linked homopolymer of N-vinyl-2-pyrrolidone) known e.g. under the trade names Polyplasdone-XL® (supplied by GAF Corp., New York, USA) and Kollidon-CL®.
  • crospovidone a cross-linked homopolymer of N-vinyl-2-pyrrolidone
  • other known disintegrants e.g. sodium starch glykolate (e.g. Primojel®, Explotab®), sodium croscarmellose (a cross-linked polymer of carboxymethylcellulose sodium), e.g. Ac-di-sol® (supplied by FMC Corp., Philadelphia, USA), starches or anionic or kationic resins, can also be useful as disintegrants.
  • the swellable material (c) is preferably guar gum, e.g. Meyprogat®-150, supplied by Meyhall Chem., Kreuzlingen (Switzerland), especially in granulated form, but may be also any other swellable material allowed for human administration. It may be a naturally occurring or a chemically obtained polymer. Examples for useful swellable materials are xanthan gum, alginates, dextran, pectins, pregelatinzed starches, polysaccharides, cellulose derivatives such as sodium or calcium carboxymethylcellulose, hydroxypropylcellulose or hydroxypropylmethylcellulose.
  • additives well-known in the art can be also incorporated into the table.
  • These can be for example electro­lytes, i.e. compounds forming species in water which carry a charge, e.g. ionic substances, such as sodium chloride.
  • acids especially organic acids, e.g. citric acid, and bases, such as sodium hydrogen carbonate, can be mentioned.
  • compounds forming no ions in water are suitable for the intended purpose, e.g. sugars, such as sorbitol.
  • the tablets of the invention may also contain auxiliaries custom strictlyarily used for tabletting production, e.g. fillers, binders, lubricants, antisticking agents and flavours.
  • auxiliaries custom strictlyarily used for tabletting production e.g. fillers, binders, lubricants, antisticking agents and flavours.
  • Rapid disintegration in water means e.g. such within two minutes, preferably such within one minute and especially such in less than one minute.
  • guar gum within the tablet is very important, because complete disintegration of the tablet has to take place before the swelling of the swellable material prevents the disintegration.
  • a normally fine powder of guar gum is used in the table formulation of Example 1, a voluminous hydrophilic matrix tablet impossible to be swallowed is formed in the water due to the guar gum present.
  • the normally fine powder of guar gum can be used successfully in a formulation according to the invention. For doing so, e.g. larger amounts of the additives mentioned above for promoting disintegration and avoiding a too rapid swelling of the swellable material have to be applied so as to reduce the rate of swelling of the guar gum.
  • a mixture of the components (a) and (c) of the tablet of the invention in the form of a powder, a granulate and/or e.g. coated microparticles is similarly useful as the tablet itself.
  • Such a mixture can e.g. be packed in sachets for reconstitution with water for single dose oral aministration, see Example 2.
  • Such mixtures form another embodiment of the instant invention.
  • the tablets of the invention can be produced in a manner known per se by compressing the intimately mixed components of the tablet in a usual tablet-compressing machine. For sachet preparation, the intimately mixed components are filled into sachets, and then the sachets are closed in a manner known per se.
  • Water-dispersible micropellets tablets for preparing extemporaneous suspensions of methyl-xanthines - with particulary good organoleptic properties for the administration to elderly people and children - are obtained by tabletting a suitable mixture of (a) coated micropellets containing the methyl-xanthines, (b) granules of acidified guar gum and (c) dry granules.
  • Prejel®-PA-5 pregelatinized slightly oxidized potato starch, supplied by AVEBE, Weendam, Netherlands
  • Avicel®-PH-105 microcrystalline cellulose, particle size 20 ⁇ , supplied by FMC Corporation, Philadelphia, USA
  • This mixture is humidified with a mixture of 10 g silicone emulsion, 40 g Eudragit®-NE30D (a 30 % aqueous dispersion of an ethyl acrylate/methyl methacrylate copolymer 70:30 having a molecular weight of about 800 000 supplied by Röhm Pharma, Darmstadt, FRG) and 60 g of Aquacoat®-ECD-30 [ethylcellulose, as a 30 % aqueous poly­meric dispersion having a low particle size (latex form) and a narrow particle-size distribution, supplied by FMC Corporation, Philadelphia, USA] in 20 g of water.
  • This mass is kneaded for about 5 minutes and then extruded through a screen with holes size of 0.5 mm diameter (apparatus Fuji Paudal EXKS-1).
  • the extruded mass is spheronised in a marumerizer Q-230 with a speed of 900 rpm for 30 seconds.
  • micropellets obtained are dried for 20 minutes at 50°. 300 g of these micropellets are coated in a fluidised-bed (Aeromatic Strea-1) in a co-current technique with a suspension mixture of 214 g Eudragit®-NE30D and 36 g of Aquacoat®-ECD-30. The spray rate of the coating suspension is 5 g/minute and the inlet air temperature is 45°. The coated micropellets are treated in the fluidised-bed for 2 hours at 70° and then cooled with air of 22°.
  • a fluidised-bed Aral Strea-1
  • the spray rate of the coating suspension is 5 g/minute and the inlet air temperature is 45°.
  • the coated micropellets are treated in the fluidised-bed for 2 hours at 70° and then cooled with air of 22°.
  • Tablets of 1.3 g weight are obtained, which are then screened into a granular shape by forcing them through a screen of 4 mm and further 1 mm size.
  • Water-dispersible controlled-release methyl-xanthines tablets are obtained by tabletting in a KORSCH-EKO press a mixture of 650 g coated micropellets of methyl-xanthines (a), 275 g of acidified guar gum granules (b), 785 g of dry granules (c), 35 g of powdered banana flavour, 1.25 g magnesium stearate and 1.25 g of Aerosil®-200.
  • the tablets obtained are characterised by a weight of 3495 mg with a coefficient variation of 1.4 %, a hardness of 100 N, a diameter of 25 mm and a dispersion time to obtain an extempor­aneous suspension in a cup of water of approximately 1 minute.
  • Microparticles of a mixture of O- ⁇ -hydroxyethyl-rutosides are prepared by wet granulation in a fluidised-bed (Aeromatic S-2, 10 bar). Approximately 8 kg of granules are obtained by wet granulation of 6 kg O- ⁇ -hydroxyethyl-rutosides and 1.116 kg of Prejel®-PA-5 with a solution of 0.753 kg O- ⁇ -hydroxyethyl-­rutosides in 2.8 kg of water in a fluidised-bed with the counter-­current technique. The spray rate of the solution is 40 g/minute, the inlet air temperature is 40° and the inlet air flow is 280 m3/hour. At the end, these granules are dried in the fluidised-­bed.
  • Microgranules of 0.2-0.5 mm are collected by sieving, and 400 g of these particles are coated in a fluidised-bed (Aeromatic Strea-1) in a co-current technique with a dispersion mixture of 228 g Eudragit®-NE30D and 39 g Aquacoat®-ECD-30.
  • the spray rate of coating is 5 g/minute and the inlet air temperature is 40°.
  • the coated microparticles are dried for 10 minutes at 40°. Then they are treated in the fluidised-bed for 2 hours at 70° and finally cooled with air of 22°.
EP87810688A 1986-11-27 1987-11-23 Comprimé dispersible dans l'eau Withdrawn EP0273005A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8628359 1986-11-27
GB868628359A GB8628359D0 (en) 1986-11-27 1986-11-27 Galenical formulation

Publications (1)

Publication Number Publication Date
EP0273005A1 true EP0273005A1 (fr) 1988-06-29

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP87810688A Withdrawn EP0273005A1 (fr) 1986-11-27 1987-11-23 Comprimé dispersible dans l'eau

Country Status (13)

Country Link
US (1) US4886669A (fr)
EP (1) EP0273005A1 (fr)
JP (1) JPS63211224A (fr)
AU (1) AU603624B2 (fr)
DK (1) DK619987A (fr)
FI (1) FI875209A (fr)
GB (1) GB8628359D0 (fr)
HU (1) HU201867B (fr)
IE (1) IE873213L (fr)
IL (1) IL84569A (fr)
NZ (1) NZ222701A (fr)
PT (1) PT86212B (fr)
ZA (1) ZA878882B (fr)

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EP0349103A1 (fr) * 1988-05-04 1990-01-03 Smith Kline & French Laboratories Limited Comprimé à mâcher
US5275823A (en) * 1989-04-27 1994-01-04 Smith Kline & French Laboratories Ltd. Pharmaceutical compositions
EP0399435A2 (fr) * 1989-05-25 1990-11-28 Aqualon Company Désagrégeant pour comprimés à base de carboxyméthylguar réticulé
EP0399435A3 (fr) * 1989-05-25 1991-03-27 Aqualon Company Désagrégeant pour comprimés à base de carboxyméthylguar réticulé
FR2722408A1 (fr) * 1994-07-15 1996-01-19 Vacher Dominique Nouveau procede de realisation de formes pharmaceutiques seches a delitement quasiment instantane etles formes pharmaceutiques ainsi realisees
WO1996002237A1 (fr) * 1994-07-15 1996-02-01 Dominique Vacher Nouveau procede de realisation de formes pharmaceutiques seches a delitement quasiment instantane et les formes pharmaceutiques ainsi realisees
US5780055A (en) * 1996-09-06 1998-07-14 University Of Maryland, Baltimore Cushioning beads and tablet comprising the same capable of forming a suspension
US6106861A (en) * 1997-07-21 2000-08-22 Laboratoires Prographarm Multiparticulate tablet disintegrating in less than 40 seconds in the mouth
CN1309374C (zh) * 1997-07-21 2007-04-11 爱的发 改进的快速崩解的多颗粒片剂
US6673123B2 (en) 1999-12-20 2004-01-06 Henkel Kommanditgesellschaft Auf Aktien (Henkel Kgaa) Solid colorant for keratin fibers
WO2001045647A3 (fr) * 1999-12-20 2002-01-10 Henkel Kgaa Preformage de systemes d'epaississement
US6790240B2 (en) 1999-12-20 2004-09-14 Henkel Kommanditgesellschaft Aug Aktien Solid colorant for keratin fibers
US6797012B2 (en) 1999-12-20 2004-09-28 Henkel Kommanditgesellschaft Auf Aktien Solid colorant for keratin fibers
WO2001045647A2 (fr) * 1999-12-20 2001-06-28 Henkel Kommanditgesellschaft Auf Aktien Preformage de systemes d'epaississement
US7204856B2 (en) 1999-12-20 2007-04-17 Henkel Kommanditgesellschaft Auf Aktien (Henkel Kgaa) Shaped bodies for forming cosmetic preparations
CN100387225C (zh) * 1999-12-20 2008-05-14 汉高两合股份公司 稠化体系的制片方法
WO2007052289A3 (fr) * 2005-07-22 2007-12-27 Rubicon Res Pvt Ltd Nouvelle composition de comprime dispersible
WO2007052289A2 (fr) * 2005-07-22 2007-05-10 Rubicon Research Pvt Ltd. Nouvelle composition de comprime dispersible
US9198862B2 (en) 2005-07-22 2015-12-01 Rubicon Research Private Limited Dispersible tablet composition
EP1906937B1 (fr) 2005-07-22 2016-10-19 Rubicon Research Pvt Ltd. Nouvelle composition de comprimé dispersible
WO2008040665A2 (fr) * 2006-10-06 2008-04-10 F. Hoffmann-La Roche Ag Comprimés pédiatriques de capécitabine
WO2008040665A3 (fr) * 2006-10-06 2008-06-19 Hoffmann La Roche Comprimés pédiatriques de capécitabine
CN101522168B (zh) * 2006-10-06 2011-09-28 霍夫曼-拉罗奇有限公司 卡培他滨儿科片剂

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IL84569A0 (en) 1988-04-29
HUT45193A (en) 1988-06-28
AU8182387A (en) 1988-06-02
GB8628359D0 (en) 1986-12-31
FI875209A0 (fi) 1987-11-25
JPS63211224A (ja) 1988-09-02
IE873213L (en) 1988-05-27
ZA878882B (en) 1989-07-26
FI875209A (fi) 1988-05-28
US4886669A (en) 1989-12-12
DK619987A (da) 1988-05-28
IL84569A (en) 1991-06-10
PT86212B (pt) 1990-11-07
AU603624B2 (en) 1990-11-22
DK619987D0 (da) 1987-11-26
NZ222701A (en) 1990-06-26
PT86212A (en) 1987-12-01
HU201867B (en) 1991-01-28

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