EP0281513A1 - Swellable pellets - Google Patents

Swellable pellets Download PDF

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Publication number
EP0281513A1
EP0281513A1 EP88810046A EP88810046A EP0281513A1 EP 0281513 A1 EP0281513 A1 EP 0281513A1 EP 88810046 A EP88810046 A EP 88810046A EP 88810046 A EP88810046 A EP 88810046A EP 0281513 A1 EP0281513 A1 EP 0281513A1
Authority
EP
European Patent Office
Prior art keywords
drugs
pellets
swellable
pellets according
core
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Withdrawn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
EP88810046A
Other languages
German (de)
English (en)
French (fr)
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 EP0281513A1 publication Critical patent/EP0281513A1/en
Withdrawn legal-status Critical Current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
    • A61K9/48—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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings

Definitions

  • the present invention relates to the oral administration of pharma­ceutically active substances. Especially, it is concerned with the problem of formulating pellets, preferably coated pellets, e.g. such with controlled release or taste masking properties or enterically coated ones, as liquids.
  • the invention relates to improved pellets, advantageously multi-layer pellets, which contain at least one pharmaceutically active substance and a swellable outer layer. In contact with water, the outer layer of the pellets swells and rapidly becomes jellified. Thus the suspension formed can be swallowed easily by any person who is in need of the pharma- ceutically active substance(s) without having any unpleasant hoarse feeling in the mouth.
  • This route of administration of pharmaceutically active substances is particularly advantageous, when a relatively large single dose must be applied orally, 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 fluoride.
  • Tablets which rapidly disintegrate in water and contain coated pellets are known in the art, e.g. from EP-A-52 076 or WO-A-86/04 817: However, these tablets suffer from some 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 perceived as individual grains in the mouth in an unpleasant manner and may be caught on the spaces between the teeth. Generally spoken, 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 reasons of avoiding increase in weight. (2) Drug absorption may be influenced by the food taken in simultaneously in an undesired manner.
  • pellets which can be manufactured solely from conventional materials known in the art, e.g. from particles of up to e.g. 3.0 mm diameter, which form a perfectly homogeneous dispersion when put into water, and in which, when taken up by mouth and swallowed, no individual grains can be perceived any more. Moreover, this goal is to be achieved without the need of any liquid foods. Finally, the pellets of the invention are to be manufactured without the use of organic solvents, because that is highly desirable for a modern, ecologically orientated pharmaceutical production.
  • the present invention relates to pellets comprising
  • microparticles of the pharmaceutically active substances used are e.g. granules, crystals or pellets of said active substances.
  • Their size is e.g. 0.2-3.0 mm diameter, preferably 0.3-1.5 mm and especially 0.6-1.2 mm diameter.
  • the core (a) optionally contains usual excipients, e.g. binders, plasticizers, glidants, absorbing substances and/or swellable materials as defined below.
  • excipients e.g. binders, plasticizers, glidants, absorbing substances and/or swellable materials as defined below.
  • methyl-xanthines e.g. proxyphylline, dipro­phylline and/or theophylline, e.g. as bronchodilators
  • a mixture of 0- ⁇ -hydroxyethyl-rutosides e.g. in the treatment of venous diseases
  • antitussive drugs e.g. butamirate or a salt thereof, such as butamirate citrate, codeine or a derivate thereof, noscapine, or dextromethorphan or a salt thereof, such as dextromethorphan hydrobromide
  • antipyretics e.g.
  • cardiovascular and vascular drugs such as all the betablockers known in the art, or e.g. 1-0-ethyl-3-0-propyl-5,6-di-o-(4-chlorobenzyl)-D-gluco­furanoside,
  • drugs especially used against elderlys' or childrens diseases e.g. pyrisucci­deanol or a salt thereof, such as pyrisuccideanol dimaleate, ticlopidine, dipyridamole or diazepam
  • drugs useful to balance the hydroelectrolytes e.g.
  • diarrhoea e.g. sodium or potassium salts
  • antibiotic drugs e.g. erythromycin, or a salt thereof, or doxycycline, or a salt thereof
  • noo­tropica e.g. piracetam
  • anthelmintica e.g. mebendazole
  • histamine H2 receptor antagonists e.g. cimetidine or ranitidine. All the salts mentioned above must of course be pharmaceutically acceptable so as to be used in the pellets of the invention.
  • the core (a) is surrounded by one or more, especially one, coating layer(s) (b).
  • coating layer(s) may consist of any material which is known in the art to be suitable for the intended purpose, or mixtures of different materials, e.g. polymeric mate­rials.
  • the coating material is dissolved in organic solvents or dispersed in water as a latex and then sprayed on the cores.
  • the intended purpose of the coating may be e.g. either any kind of controlled release of a certain pharma­ceutically active compound as well-known in the art, or masking of any undesired, e.g. bitter, taste of such a compound.
  • the coating materials can be e.g. water-insoluble or water-soluble polymers, or mixtures thereof.
  • the coating may contain usual auxili­aries, e.g. plasticizers and/or glidants.
  • the coating layer(s) (b) is (are) an optional measure, and also cores (a) only coated by the swellable outer layer (c) are an embodiment of the present invention.
  • the swellable outer layer (c) may contain any swellable material which is pharmaceutically acceptable. It may be e.g. a naturally occurring or a chemically obtained swellable polymer. Examples for useful swellable materials are xanthan gum and derivatives thereof; guar gum and derivatives thereof, e.g. hydroxypropyl guar or carboxymethylhydroxypropyl guar (e.g. Jaguar® gums); alginates, polysaccharides, e.g. dextran; pectins; cellulose derivatives, such as sodium or calcium carboxymethylcellulose, hydroxypropylcellulose or hydroxypropylmethylcellulose (e.g. Methocel E4M Prem., Methocel K15M Prem.
  • swellable material which is pharmaceutically acceptable. It may be e.g. a naturally occurring or a chemically obtained swellable polymer. Examples for useful swellable materials are xanthan gum and derivatives thereof; guar gum and derivative
  • swellable acrylic polymers such as the polymers and copolymers mentioned in US Patent 4,277,582, come into consideration as the swellable material of the outer layer (c).
  • the preferred material for the swellable outer layer (c) is guar gum.
  • the swellable outer layer (c) optionally contains usual auxiliaries, e.g. binders.
  • binders all polymers with high binding properties can be used, either in dispersion in organic solvents or preferably in aqueous medium.
  • Typical examples of binders are shellac, ethyl­cellulose, polyvinylpyrrolidone, gelatine, hydroxypropylcellulose or neutral acrylic polymers, such as poly(H or meth)-acrylic acid (methyl or ethyl) ester, and mixtures thereof.
  • Preferred as binder is a 1:1 mixture of 7 % w/w hydroxypropylcellulose in water, e.g. Klucel®-LF, and an ethyl acrylate/methyl methacrylate copolymer, such as Eudragit® NE-30-D.
  • pellets of the invention in addition may contain e.g. fla­vourings and/or sweeteners, preferably in the swellable outer layer (c).
  • the pellets of the invention can be used to prepare pharmaceutical prepa­rations for oral administration.
  • they can be formulated as a dry suspension containing the pellets of the invention and optionally appropriate excipients.
  • Excipients suitable for that purpose are e.g. granules of a swellable material as defined above which optionally contain flavourings and/or sweeteners.
  • Such a dry suspension can e.g. be packed into sachets for reconstitution with water for single dose oral administration.
  • the pharmaceutical preparations of the invention When put into water, e.g. water in a spoon or a cup of water, the pharmaceutical preparations of the invention are rapidly dispersed so as to generate a viscous, homogenous suspension which can be swallowed easily without any unpleasant hoarse feeling in the mouth.
  • a viscous, homogenous suspension which can be swallowed easily without any unpleasant hoarse feeling in the mouth.
  • even microparticles of big size - e.g. up to 3 mm diameter - can be used for this purpose due to the unique composition of the pellets of the invention.
  • Administering pharmaceutically active compounds as a viscous, homogeneous suspension - like jam or jelly - e.g. in a spoon represents an advantageous, new approach for orally administering medicine, especially to children.
  • the pellets according to the invention are manufactured in a manner known per se.
  • the materials forming the core (a) are intimately mixed and then processed to cores of a suitable size by conventional methods.
  • the cores obtained are coated by one or more coating layer(s) (b) in a manner known per se.
  • the swellable material is fixed on the pellets obtained as the outer layer e.g. in a rotating high speed mixer allowing simultaneous drying e.g. with the aid of a binder, which preferably is suspended in water.
  • the binder suspension is e.g. continuously sprayed on the pellets rotating in the mixer, while simultaneously the swellable material, e.g. guar gum, is added.
  • Suitable equipments are e.g.: "Rotoprocessor” (Aeromatic AG, Bubendorf, CH), “Roto­granulator” (Glatt AG, Binzen, FRG), “CF-Granulator” (Freund, Tokyo, Japan).
  • Sachets containing a dry suspension of multi-layer swellable controlled release pellets with particularly good organoleptic properties for the administration to elderly people and children are obtained - after (a) preparing suitable pellets containing methyl-­xanthines and (b) coating the latter with a layer for controlled release purposes - by (c) overcoating the coated pellets obtained with the swellable material and finally mixing the obtained multi­layer pellets with granulated guar gum.
  • Granules of guar gum are obtained by granulation of a mixture consisting of 212 g guar gum (Meyprogat®-150), 235 g sorbitol powder and a solution of 2.5 g saccharine sodium (sweetener) in 200 g water. Spray granulation is used with the co-current technique, with a spray rate of 7 g/min and an inlet air temperature of 40°. The granules obtained are dried for 30 h at 75° and then calibrated through a sieve with openings of 1.0 mm size.
  • a dry suspension which can be filled into sachets is obtained after mixing 179 g of multi-layer swellable pellets with 90 g of granula­ted guar gum and 10 g of orange flower for 20 min.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP88810046A 1987-02-03 1988-01-28 Swellable pellets Withdrawn EP0281513A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8702411 1987-02-03
GB878702411A GB8702411D0 (en) 1987-02-03 1987-02-03 Swellable pellets

Publications (1)

Publication Number Publication Date
EP0281513A1 true EP0281513A1 (en) 1988-09-07

Family

ID=10611656

Family Applications (1)

Application Number Title Priority Date Filing Date
EP88810046A Withdrawn EP0281513A1 (en) 1987-02-03 1988-01-28 Swellable pellets

Country Status (13)

Country Link
US (1) US4882169A (da)
EP (1) EP0281513A1 (da)
JP (1) JPS63196511A (da)
AU (1) AU1119488A (da)
DK (1) DK51688A (da)
FI (1) FI880440A (da)
GB (1) GB8702411D0 (da)
HU (1) HUT46208A (da)
IE (1) IE880281L (da)
NZ (1) NZ223372A (da)
PH (1) PH25177A (da)
PT (1) PT86674B (da)
ZA (1) ZA88726B (da)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991011178A1 (de) * 1990-01-26 1991-08-08 Fluntera Ag Einkapselung von wirkstoffen mittels stärke
WO1998006385A1 (de) * 1996-08-15 1998-02-19 Losan Pharma Gmbh Gut schluckbare orale arzneiform
WO2003020241A2 (en) * 2001-09-05 2003-03-13 Vectura Limited Functional powders for oral delivery
WO2016083278A1 (en) * 2014-11-26 2016-06-02 Evonik Röhm Gmbh Pharmaceutical or nutraceutical composition with resistance against the influence of ethanol

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US5288500A (en) * 1987-03-13 1994-02-22 Benzon Pharma A/S Oral composition containing particles comprising an active substance
DK130287D0 (da) * 1987-03-13 1987-03-13 Benzon As Alfred Oralt praeparat
US5133974A (en) * 1989-05-05 1992-07-28 Kv Pharmaceutical Company Extended release pharmaceutical formulations
US5084278A (en) * 1989-06-02 1992-01-28 Nortec Development Associates, Inc. Taste-masked pharmaceutical compositions
GB8913889D0 (en) * 1989-06-16 1989-08-02 May & Baker Ltd New compositions of matter
NZ234143A (en) * 1989-06-28 1991-10-25 Mcneil Ppc Inc Aqueous pharmaceutical suspension formulation for administering substantially insoluble pharmaceutical agents
CA2063141C (en) * 1989-08-04 1997-03-04 Edward J. Roche Rotogranulations and taste masking coatings for preparation of chewable pharmaceutical tablets
US6764697B1 (en) * 1991-06-27 2004-07-20 Alza Corporation System for delaying drug delivery up to seven hours
ZA937382B (en) * 1992-10-06 1994-04-29 Warner Lambert Co Novel composition for peroral therapy of cognitionimpairment and a process therefor
FI101039B (fi) * 1992-10-09 1998-04-15 Eeva Kristoffersson Menetelmä lääkepellettien valmistamiseksi
DE4236090C1 (de) * 1992-10-26 1994-01-05 Asta Medica Arzneimittel Pharmazeutische Zubereitung für die Fluoridionen-Versorgung
US5458887A (en) * 1994-03-02 1995-10-17 Andrx Pharmaceuticals, Inc. Controlled release tablet formulation
US5536507A (en) * 1994-06-24 1996-07-16 Bristol-Myers Squibb Company Colonic drug delivery system
US5674529A (en) * 1995-06-06 1997-10-07 Church & Dwight Co., Inc. Alkalinizing potassium salt controlled release preparations
US5891474A (en) * 1997-01-29 1999-04-06 Poli Industria Chimica, S.P.A. Time-specific controlled release dosage formulations and method of preparing same
US5788987A (en) * 1997-01-29 1998-08-04 Poli Industria Chimica Spa Methods for treating early morning pathologies
UA65607C2 (uk) 1998-03-04 2004-04-15 Орто-Макнейл Фармацевтикал, Інк. Фармацевтична композиція (варіанти) та спосіб її приготування
SA99191255B1 (ar) 1998-11-30 2006-11-25 جي دي سيرل اند كو مركبات سيليكوكسيب celecoxib
WO2000033818A1 (en) 1998-12-11 2000-06-15 Nostrum Pharmaceuticals, Inc. Sustained release tablet containing hydrocolloid and cellulose ether
CA2440588C (en) * 2001-03-13 2010-02-09 Penwest Pharmaceuticals Co. Chronotherapeutic dosage forms
BR0215262A (pt) * 2001-12-20 2004-12-28 Pharmacia Corp Formas de dosagem com liberação sustentada de ordem zero e processo para a fabricação das mesmas
US6958161B2 (en) * 2002-04-12 2005-10-25 F H Faulding & Co Limited Modified release coated drug preparation
US20030203027A1 (en) * 2002-04-26 2003-10-30 Ethicon, Inc. Coating technique for deposition of drug substance on a substrate
JP3689681B2 (ja) * 2002-05-10 2005-08-31 キヤノン株式会社 測定装置及びそれを有する装置群
WO2004098571A1 (en) * 2003-04-30 2004-11-18 Zicam, Llc Cold remedy composition comprising zinc salts
EP1670442A4 (en) * 2003-09-19 2011-09-14 Penwest Pharmaceuticals Co DOSAGE FORMS WITH DELAYED RELEASE
AU2004273958A1 (en) * 2003-09-19 2005-03-31 Penwest Pharmaceuticals Co. Chronotherapeutic dosage forms
WO2005044236A1 (en) * 2003-10-27 2005-05-19 Control Delivery Systems, Inc. Suspension delivery system for the sustained and controlled local release of pharmaceuticals
US8383154B2 (en) * 2004-05-11 2013-02-26 Egalet A/S Swellable dosage form comprising gellan gum
US8889184B2 (en) * 2006-09-07 2014-11-18 Losan Pharma Gmbh Particulate form of a pharmaceutical composition which is easy to swallow
US8128460B2 (en) * 2006-09-14 2012-03-06 The Material Works, Ltd. Method of producing rust inhibitive sheet metal through scale removal with a slurry blasting descaling cell
AU2007352009B2 (en) * 2007-03-30 2013-08-01 Lintec Corporation Process for producing preparation for oral administration
CN103263391A (zh) * 2013-06-03 2013-08-28 合肥今越制药有限公司 盐酸多西环素干混悬剂及其制备方法
WO2017145146A1 (en) * 2016-02-25 2017-08-31 Dexcel Pharma Technologies Ltd. Compositions comprising proton pump inhibitors
WO2020065753A1 (ja) * 2018-09-26 2020-04-02 オリンパス株式会社 薬物投与体、薬物投与システム、および薬物投与方法
TW202410886A (zh) 2022-05-23 2024-03-16 日商共和藥品工業股份有限公司 凝膠皮膜及經口固形組成物

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EP0153104A2 (en) * 1984-02-10 1985-08-28 Benzon Pharma A/S Diffusion coated multiple-units dosage form
EP0181564A1 (de) * 1984-11-05 1986-05-21 Gerhard Dr. Gergely Pharmazeutische Zubereitung mit einem Gehalt an Ibuprofen, sowie Verfahren zu ihrer Herstellung
WO1986006626A1 (en) * 1985-05-08 1986-11-20 Eurand Italia S.P.A. Method of preparing an extemporaneous homogeneous microcapsule suspension

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JPS5858146A (ja) * 1981-10-05 1983-04-06 Tanabe Seiyaku Co Ltd 速放性マイクロカプセル
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IE58110B1 (en) * 1984-10-30 1993-07-14 Elan Corp Plc Controlled release powder and process for its preparation
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Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3946110A (en) * 1974-05-30 1976-03-23 Peter, Strong Research And Development Company, Inc. Medicinal compositions and methods of preparing the same
EP0153104A2 (en) * 1984-02-10 1985-08-28 Benzon Pharma A/S Diffusion coated multiple-units dosage form
EP0181564A1 (de) * 1984-11-05 1986-05-21 Gerhard Dr. Gergely Pharmazeutische Zubereitung mit einem Gehalt an Ibuprofen, sowie Verfahren zu ihrer Herstellung
WO1986006626A1 (en) * 1985-05-08 1986-11-20 Eurand Italia S.P.A. Method of preparing an extemporaneous homogeneous microcapsule suspension

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991011178A1 (de) * 1990-01-26 1991-08-08 Fluntera Ag Einkapselung von wirkstoffen mittels stärke
WO1998006385A1 (de) * 1996-08-15 1998-02-19 Losan Pharma Gmbh Gut schluckbare orale arzneiform
US6709678B2 (en) 1996-08-15 2004-03-23 Losan Pharma Gmbh Easy to swallow oral medicament composition
WO2003020241A2 (en) * 2001-09-05 2003-03-13 Vectura Limited Functional powders for oral delivery
WO2003020241A3 (en) * 2001-09-05 2003-10-16 Vectura Ltd Functional powders for oral delivery
WO2016083278A1 (en) * 2014-11-26 2016-06-02 Evonik Röhm Gmbh Pharmaceutical or nutraceutical composition with resistance against the influence of ethanol
US10111838B2 (en) 2014-11-26 2018-10-30 Evonik Roehm Gmbh Pharmaceutical or nutraceutical composition with resistance against the influence of ethanol

Also Published As

Publication number Publication date
PH25177A (en) 1991-03-27
FI880440A0 (fi) 1988-02-01
JPS63196511A (ja) 1988-08-15
HUT46208A (en) 1988-10-28
AU1119488A (en) 1988-08-04
DK51688D0 (da) 1988-02-02
PT86674B (pt) 1992-04-30
NZ223372A (en) 1990-10-26
US4882169A (en) 1989-11-21
FI880440A (fi) 1988-08-04
DK51688A (da) 1988-08-04
IE880281L (en) 1988-08-03
GB8702411D0 (en) 1987-03-11
PT86674A (pt) 1988-03-01
ZA88726B (en) 1988-08-03

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