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WO2000067682A1 - Forme d'administration permettant de reduire le volume gastrique - Google Patents

Forme d'administration permettant de reduire le volume gastrique Download PDF

Info

Publication number
WO2000067682A1
WO2000067682A1 PCT/EP2000/003826 EP0003826W WO0067682A1 WO 2000067682 A1 WO2000067682 A1 WO 2000067682A1 EP 0003826 W EP0003826 W EP 0003826W WO 0067682 A1 WO0067682 A1 WO 0067682A1
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
preparation
gastric
substance
expandable
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/EP2000/003826
Other languages
German (de)
English (en)
Inventor
Frank Becher
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.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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 LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Publication of WO2000067682A1 publication Critical patent/WO2000067682A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the invention relates to an orally administrable dosage form for reducing the gastric volume.
  • gastric volume reduction consists of partial gastric resection, in which part of the stomach is surgically removed. This reduction in gastric volume cannot be reversed.
  • US 5,296,233 describes a capsule-like medicament comprising a dual underlayer with an initial underlayer of a water-soluble film-forming polymer, for example Providon, and a second underlayer of a mixture of two film-forming polymers, for example Providon and hydroxypropylmethyl cellulose and a hydrophobic plasticizer, for example castor oil, which is used for a smooth , uniform and substantially bubble-free outer layer, eg gelatin for a capsule-like medication, which can be swallowed without problems despite the comparatively large volume.
  • a water-soluble film-forming polymer for example Providon
  • a second underlayer of a mixture of two film-forming polymers for example Providon and hydroxypropylmethyl cellulose
  • a hydrophobic plasticizer for example castor oil
  • US 4,983,401 describes a pharmaceutical preparation for long-term release of active substance using a pH-controllable diffusion membrane, consisting of a pH-sensitive film-forming polymer.
  • a pH-controllable diffusion membrane consisting of a pH-sensitive film-forming polymer.
  • This may contain phthalic acid with a carboxyl group as the starting polymer, bound to the starting polymer through an ester bond, while the second carboxyl group remains as the free acid, so that the modified film-forming polymer is hydrophobic at low pH and hydrophilic at higher pH.
  • EP 0 326 816 A discloses a buoyant therapeutic active ingredient dosage form including at least one structural element with cavities.
  • the structural element can be a foamed or microporous polymer matrix, for example of polyolefin, polyamide, polyester, polystyrene, polyacrylate, PTFE, PVC, polyvinylidene chloride or polysiloxane, optionally in the form of a foldable or rollable film, tablet core or in layer form.
  • the structural elements can be hollow particles, for example made of glass or ceramic, embedded in a matrix composition containing an active ingredient, in particular for use in capsules.
  • the structures can be provided with a membrane which controls the release of active substance which guarantees a long stay in the gastrointestinal tract.
  • the object of the invention is to provide an oral administration form which, with the avoidance of an operative intervention, serves to temporarily, painlessly and without complaints reduce the gastric volume under neutral conditions, that is to say without releasing an active ingredient or auxiliary to realize.
  • the substances or the preparation are material which forms gas or foam in the acidic environment of the gastric juice, as a result of which the bag or capsule swells and thus prevents the passage of the pylorus.
  • the administration form according to the invention which can be administered orally, by covering a predeterminable portion of the stomach volume with inert substances, the usable stomach volume is temporarily reduced without surgery, without pain or complaints.
  • the expandable substance in the environment of gastric juice causes an increase in the volume of the dosage form and a reduction in the specific weight, so that this dosage form floats and at the same time prevents its passage through the pyloric passage due to its increased volume. This means that part of the stomach volume is filled with neutral material and the usable stomach volume is reduced accordingly.
  • An embodiment of the dosage form according to the invention provides that the shell consists of a microporous polymer material. This allows liquid to pass from the inside of the stomach into the pouch or capsule, whereupon the liquid reacts chemically with the expandable substance and initiates the expansion of the substance.
  • Another embodiment of the dosage form provides that the expandable substance or the expandable preparation is foamable material by the entry of gastric juice.
  • the dosage form according to the invention provides that the expandable substance or the expandable preparation is a gas generator such as a bicarbonate.
  • the expandable preparation is active substance-free and can moreover have a basicity which reacts with the gastric acid. In addition to the volume, this also reduces the acidity of the gastric juice, which is advantageous in many cases for the therapeutic indication.
  • the object is achieved according to the invention in that the expansion of the bag (through which the pyloric passage is prevented) is not carried out by a gas generator but by volume-expanding swellable polymers, so-called superabsorbers.
  • the sheath for such superabsorbers is, as in conventional systems, completely or partially permeable to liquids, so that the polymer can absorb a corresponding amount of water and thus increase the volume of the bag to the desired size.
  • the sides of the bag or capsule can be glued together so that they come off by themselves after a predetermined period of use.
  • a bag with several chambers is created. These chambers are made up of several superimposed walls. Due to the access of the gastric fluid, one of the chambers initially expands and prevents the pyloric passage. Another chamber in front or behind is initially inaccessible to the gastric juice, since access to the inside is closed with a substance that is initially impenetrable for the gastric juice. This substance is of such a nature that it dissolves very slowly in the stomach over the course of time and releases the access of the gastric fluid to another chamber. In the further chamber - as in the first chamber and as in conventional gastroretentive systems - there is also a gas generator, foam generator or a super absorber. This therefore only swells after a long time when the gas generation in the first chamber has been exhausted or the chamber has become empty.
  • a bag consists of a front and rear chamber, which interact in the manner described.
  • the walls of the chamber are so thin that the bag takes on a flat shape and can therefore be placed in the appropriate capsule in the usual way and can thus be introduced into the body by swallowing.
  • three such chambers are formed in the manner described.
  • the gas generator is first activated in one of the outer chambers. This increases the volume of the bag.
  • the other two chambers are close to the second outer wall and do not interfere with the shape of a small balloon.
  • the gas formation in the first chamber is ended, for example also in that the connection between the outer wall and the middle chamber is released by the action of the gastric juice and the gas is released or the superabsorber is activated.
  • the gastric juice is allowed to access the second outer chamber, so that the latter swells again.
  • the second outer wall can in turn be blown off, so that the third, inner chamber becomes free and the inflation there starts.
  • Such a multilayer gastroretentive system can be combined in a known manner with a microencapsulated preparation of the active substance located in the interior of one or more chambers, or by applying abrasive or other matrix layers containing the active substance.
  • all of the chambers can be activated simultaneously, so that the displaced volume is particularly large.
  • the invention is straightforward and expedient and in many cases saves an operative intervention.
  • the invention optimally achieves the object stated at the outset.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nursing (AREA)
  • Obesity (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une forme d'administration qui peut être administrée par voie orale et qui sert à réduire le volume gastrique de façon temporaire. Cette forme d'administration se caractérise en ce qu'elle se présente sous la forme d'un système de rétention gastrique constitué d'une poche pourvue d'une enveloppe en matériau semi-perméable, en ce qu'elle comprend une substance ou une préparation qui peut gonfler dans le milieu du suc gastrique et en ce qu'elle empêche, à l'état gonflé, le passage à travers le pylore.
PCT/EP2000/003826 1999-05-06 2000-04-27 Forme d'administration permettant de reduire le volume gastrique Ceased WO2000067682A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19920855.7 1999-05-06
DE1999120855 DE19920855A1 (de) 1999-05-06 1999-05-06 Magenvolumenreduzierende Darreichungsform

Publications (1)

Publication Number Publication Date
WO2000067682A1 true WO2000067682A1 (fr) 2000-11-16

Family

ID=7907168

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2000/003826 Ceased WO2000067682A1 (fr) 1999-05-06 2000-04-27 Forme d'administration permettant de reduire le volume gastrique

Country Status (2)

Country Link
DE (1) DE19920855A1 (fr)
WO (1) WO2000067682A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009128882A1 (fr) * 2008-04-14 2009-10-22 Gore Enterprise Holdings, Inc. Dispositif occupant un volume intra-gastrique

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008039186A2 (fr) * 2006-09-26 2008-04-03 Plensat, Llc Méthode et système de traitement de troubles de l'alimentation
EP2231212A2 (fr) 2007-12-20 2010-09-29 7L, Llc Dispositif autodilatable à avaler occupant l'espace gastrique

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0103481A1 (fr) * 1982-09-14 1984-03-21 Ainsworth Nominees Proprietary Limited Traitement et réduction de l'obésité humaine
DE3540936C1 (de) * 1985-11-19 1986-10-02 Reinhard Dr.Med. Stricker Intragastraler Ballon
WO1987000034A2 (fr) * 1985-07-05 1987-01-15 Thomas Vincent Taylor Bezoar artificiel
WO1990000376A1 (fr) * 1988-07-05 1990-01-25 Cantenys Jose Ballon intragastrique
WO1998031341A1 (fr) * 1997-01-14 1998-07-23 Lts Lohmann Therapie-Systeme Gmbh Systeme therapeutique gastro-retentif pouvant s'expanser, a liberation controlee de principes actifs dans le tractus gastro-intestinal

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0103481A1 (fr) * 1982-09-14 1984-03-21 Ainsworth Nominees Proprietary Limited Traitement et réduction de l'obésité humaine
WO1987000034A2 (fr) * 1985-07-05 1987-01-15 Thomas Vincent Taylor Bezoar artificiel
DE3540936C1 (de) * 1985-11-19 1986-10-02 Reinhard Dr.Med. Stricker Intragastraler Ballon
WO1990000376A1 (fr) * 1988-07-05 1990-01-25 Cantenys Jose Ballon intragastrique
WO1998031341A1 (fr) * 1997-01-14 1998-07-23 Lts Lohmann Therapie-Systeme Gmbh Systeme therapeutique gastro-retentif pouvant s'expanser, a liberation controlee de principes actifs dans le tractus gastro-intestinal

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009128882A1 (fr) * 2008-04-14 2009-10-22 Gore Enterprise Holdings, Inc. Dispositif occupant un volume intra-gastrique

Also Published As

Publication number Publication date
DE19920855A1 (de) 2000-11-16

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