WO2000047190A2 - Procede permettant de produire des presentations galeniques en forme de feuilles - Google Patents

Procede permettant de produire des presentations galeniques en forme de feuilles Download PDF

Info

Publication number
WO2000047190A2
WO2000047190A2 PCT/EP2000/000739 EP0000739W WO0047190A2 WO 2000047190 A2 WO2000047190 A2 WO 2000047190A2 EP 0000739 W EP0000739 W EP 0000739W WO 0047190 A2 WO0047190 A2 WO 0047190A2
Authority
WO
WIPO (PCT)
Prior art keywords
film
drying
dosage forms
drying phase
producing film
Prior art date
Application number
PCT/EP2000/000739
Other languages
German (de)
English (en)
Other versions
WO2000047190A3 (fr
Inventor
Michael Horstmann
Wolfgang Laux
Horst Dzekan
Katja Zinndorf
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
Priority to IL14476700A priority Critical patent/IL144767A0/xx
Priority to BRPI0009962-7A priority patent/BR0009962B1/pt
Priority to JP2000598143A priority patent/JP2002536402A/ja
Priority to EP00909123A priority patent/EP1150663A2/fr
Priority to NZ513465A priority patent/NZ513465A/en
Priority to MXPA01007867A priority patent/MXPA01007867A/es
Priority to HU0202877A priority patent/HUP0202877A2/hu
Priority to AU31514/00A priority patent/AU777898B2/en
Application filed by Lts Lohmann Therapie-Systeme Ag filed Critical Lts Lohmann Therapie-Systeme Ag
Priority to CA002362756A priority patent/CA2362756C/fr
Publication of WO2000047190A2 publication Critical patent/WO2000047190A2/fr
Publication of WO2000047190A3 publication Critical patent/WO2000047190A3/fr
Priority to IL144767A priority patent/IL144767A/en
Priority to NO20013892A priority patent/NO20013892L/no
Priority to HK02100760.6A priority patent/HK1039069A1/zh

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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J5/00—Manufacture of articles or shaped materials containing macromolecular substances
    • C08J5/18—Manufacture of films or sheets
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/70—Fixation, conservation, or encapsulation of flavouring agents
    • A23L27/79—Fixation, conservation, or encapsulation of flavouring agents in the form of films
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
    • A23P20/20—Making of laminated, multi-layered, stuffed or hollow foodstuffs, e.g. by wrapping in preformed edible dough sheets or in edible food containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0208—Tissues; Wipes; Patches
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • the present invention relates to film-like dosage forms for use as cosmetic, pharmaceutical or food products.
  • EP 0 216 762 presents a water-soluble film made of starch, gelatin, glycerin or sorbitol, which is coated by means of a roller application process. It is mentioned briefly that such dosage forms can also be produced for chemical reagents, flavorings and the like.
  • a formulation that is fundamentally suitable for the production of film-shaped systems is presented in EP 0 460 588.
  • particular advantages are seen in the composition of 20 to 60 percent by weight film former, 2 to 40% gel former, 0.1 to 35 percent by weight of active ingredient (here: flavoring) and a maximum of 40 percent by weight of an inert filler.
  • DE 36 30 603 sees particular advantages in designing the flat dosage form on a carrier material (separating film) in a dose-wise manner.
  • the object of this invention is to provide processes for the production of sheet-like active substance carriers which enable an exact and reproducible coating quality, prevent the finally produced film pieces from adhering to one another in the stack and avoid contamination and too high heat loads are available at high process speeds.
  • the object is achieved according to the present invention in that the coating of the solution of hydrophilic polymers with added active ingredients and other auxiliaries is immediately followed by an overflow of moderately warm (30-50 ° C.) air, then the temperature is slightly increased (35 -80 ° C), followed by a reconditioning phase at 25-50 ° C.
  • the process speed is advantageously regulated in such a way that a relative substrate moisture (equivalent moisture or equivalent air humidity) of 50-75% RH, preferably 60-68% RH, is not left in any case.
  • the method according to the invention can be applied to any form of sheet-like products, for example for use as food, pharmaceuticals or cosmetics, which in a coating process consist of a solvent, in particular re water, liquefied mass, which contains solid, hydrophilic raw materials and optionally further components, can be produced.
  • Suitable substances are, for example, carbonates, phosphates, silicates, or sulfates of alkaline earth metals, zinc oxide, titanium dioxide or other color pigments, talc, lactose, cyclodextrins or starch and starch derivatives, provided that they form their own, solid, disperse phase in the end product.
  • Aromas which can be used with this invention are essentially essential oils (volatile, water-insoluble distillates from fragrant plant components) and other volatile, fragrant substances which have a limited miscibility with water.
  • the mass is obtained, for example, by sprinkling, kneading or slowly digesting the solid components in the solvent (usually water, but also, for example, ethanol, Acetone and other compatible, physiologically acceptable solvents and their mixtures are used). If contained in the recipe, the pre-weighed amount of flavoring and other liquid, lipophilic additives are added to this phase with slow stirring. In the interest of the objective of the invention, it has proven to be very advantageous with regard to a more uniform nature to homogenize the mass before coating via a high-speed homogenizer.
  • the solvent usually water, but also, for example, ethanol, Acetone and other compatible, physiologically acceptable solvents and their mixtures are used.
  • the mass is coated onto a substrate by brushing, knife coating or extrusion processes and is dried in a drying channel consisting of at least three independently temperature-controlled zones.
  • the substrate can in principle be made from substrates known to those skilled in the art and widely used, e.g. Polyethylene terephthalate, polyethylene, polypropylene, polycarbonate, polyurethane exist. Laminates of these materials with other polymers, paper, glass fibers and other structure formers are also used to increase the tear resistance. Measures such as siliconization, fluorination, acid treatment or corona treatment can be useful to regulate the surface adhesion, but in individual cases they need to be clarified as to their physiological compatibility for the respective application.
  • the aim of the invention is regularly achieved when the drying with initially increasing, at the latest in in the last zone then process temperature reduced by 10 ° C again.
  • the process speed is advantageously set so that a product with an equivalent air humidity of 50-75% RH, preferably 60-68% RH, is obtained.
  • the products obtained proved to be surface-stable, flexible and unbreakable and largely tear-resistant.
  • the resulting surfaces have practically no "cold flow", so they are basically dimensionally stable.
  • the film can be removed from the base without noticeable stretching and processed separately.
  • the film-shaped products produced preferably have a thickness between 20 and 300 ⁇ m; their size can advantageously be 0.5 to 12 cm 2 .
  • the subsequent packaging can be done individually or in a stack, for example in sealed bags or dispensers.

Abstract

L'invention concerne un procédé permettant de produire des présentations galéniques, qui consiste à laminer et à sécher sur un substrat une masse contenant un solvant et pouvant être étalée. Le procédé est caractérisé en ce que le séchage se fait dans une première phase entre 30 et 50 DEG C, dans une deuxième phase entre 35 et 80 DEG C et dans une troisième phase entre 25 et 50 DEG C.
PCT/EP2000/000739 1999-02-12 2000-01-31 Procede permettant de produire des presentations galeniques en forme de feuilles WO2000047190A2 (fr)

Priority Applications (12)

Application Number Priority Date Filing Date Title
HU0202877A HUP0202877A2 (hu) 1999-02-12 2000-01-31 Eljárás fólia alakú adagolási formák elõállítására
JP2000598143A JP2002536402A (ja) 1999-02-12 2000-01-31 シート状投与剤の製造方法
EP00909123A EP1150663A2 (fr) 1999-02-12 2000-01-31 Procede permettant de produire des presentations galeniques en forme de feuilles
NZ513465A NZ513465A (en) 1999-02-12 2000-01-31 Process for producing film-type dosage forms
MXPA01007867A MXPA01007867A (es) 1999-02-12 2000-01-31 Metodo para la fabricacion de formas de administracion laminares.
IL14476700A IL144767A0 (en) 1999-02-12 2000-01-31 Method for producing film-type dosage forms
AU31514/00A AU777898B2 (en) 1999-02-12 2000-01-31 Method for producing film-type dosage forms
BRPI0009962-7A BR0009962B1 (pt) 1999-02-12 2000-01-31 Processo para a produção de formas em forma de lâminas para a ministração de um produto
CA002362756A CA2362756C (fr) 1999-02-12 2000-01-31 Procede permettant de produire des presentations galeniques en forme de feuilles
IL144767A IL144767A (en) 1999-02-12 2001-08-07 Method for producing dosage forms in film-format
NO20013892A NO20013892L (no) 1999-02-12 2001-08-09 Fremgangsmate for fremstilling av folieformede administreringsformer
HK02100760.6A HK1039069A1 (zh) 1999-02-12 2002-01-31 製造薄片狀施用形式之方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19905801.6 1999-02-12
DE19905801A DE19905801B4 (de) 1999-02-12 1999-02-12 Verfahren zur Herstellung folienförmiger Darreichungsformen

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US09913089 A-371-Of-International 2001-08-27
US10/314,549 Continuation US6800329B2 (en) 1999-02-12 2002-12-09 Method for producing film-type dosage

Publications (2)

Publication Number Publication Date
WO2000047190A2 true WO2000047190A2 (fr) 2000-08-17
WO2000047190A3 WO2000047190A3 (fr) 2000-12-14

Family

ID=7897244

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2000/000739 WO2000047190A2 (fr) 1999-02-12 2000-01-31 Procede permettant de produire des presentations galeniques en forme de feuilles

Country Status (22)

Country Link
EP (1) EP1150663A2 (fr)
JP (1) JP2002536402A (fr)
KR (1) KR100620068B1 (fr)
CN (1) CN1147293C (fr)
AR (1) AR022580A1 (fr)
AU (1) AU777898B2 (fr)
BR (1) BR0009962B1 (fr)
CA (1) CA2362756C (fr)
CZ (1) CZ301872B6 (fr)
DE (1) DE19905801B4 (fr)
HK (1) HK1039069A1 (fr)
HU (1) HUP0202877A2 (fr)
IL (2) IL144767A0 (fr)
MX (1) MXPA01007867A (fr)
NO (1) NO20013892L (fr)
NZ (1) NZ513465A (fr)
PL (1) PL202678B1 (fr)
RU (1) RU2226389C2 (fr)
TR (1) TR200102056T2 (fr)
TW (1) TWI254725B (fr)
WO (1) WO2000047190A2 (fr)
ZA (1) ZA200106580B (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005513140A (ja) * 2001-12-11 2005-05-12 セアプロ インク 穀類βグルカン組成物、その調製方法及び使用
US10568839B2 (en) 2011-01-11 2020-02-25 Capsugel Belgium Nv Hard capsules
US11319566B2 (en) 2017-04-14 2022-05-03 Capsugel Belgium Nv Process for making pullulan
US11576870B2 (en) 2017-04-14 2023-02-14 Capsugel Belgium Nv Pullulan capsules

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10114509A1 (de) * 2001-03-23 2002-10-02 Haarmann & Reimer Gmbh Verfahren zur Herstellung von Einkapselungen

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5456745A (en) * 1988-08-13 1995-10-10 Lts Lohmann Therapie-Systeme Gmbh & Co. Kg Flexible, hydrophilic gel film, the process for its production and the use of it
WO1995029664A1 (fr) * 1994-05-03 1995-11-09 Alkermes Controlled Therapeutics, Inc. Liberation modulee de polymeres biocompatibles
WO1998026764A1 (fr) * 1996-12-16 1998-06-25 Lts Lohmann Therapie-Systeme Gmbh Forme galenique a dosage individuel, sous forme pelliculaire, contenant un principe actif et notamment une substance aromatique, se desagregeant rapidement au contact de liquide

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6055039A (ja) * 1983-09-07 1985-03-29 Mitsubishi Acetate Co Ltd 水溶性多糖類フイルム
DE3333240A1 (de) * 1983-09-12 1985-03-28 Schering AG, 1000 Berlin und 4709 Bergkamen Mittel zur transdermalen applikation von arzneimittelwirkstoffen
JPH0744940B2 (ja) * 1986-12-24 1995-05-17 ライオン株式会社 口腔貼付用基材

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5456745A (en) * 1988-08-13 1995-10-10 Lts Lohmann Therapie-Systeme Gmbh & Co. Kg Flexible, hydrophilic gel film, the process for its production and the use of it
WO1995029664A1 (fr) * 1994-05-03 1995-11-09 Alkermes Controlled Therapeutics, Inc. Liberation modulee de polymeres biocompatibles
WO1998026764A1 (fr) * 1996-12-16 1998-06-25 Lts Lohmann Therapie-Systeme Gmbh Forme galenique a dosage individuel, sous forme pelliculaire, contenant un principe actif et notamment une substance aromatique, se desagregeant rapidement au contact de liquide

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005513140A (ja) * 2001-12-11 2005-05-12 セアプロ インク 穀類βグルカン組成物、その調製方法及び使用
US8632798B2 (en) 2001-12-11 2014-01-21 Ceapro Inc. Cereal β glucan compositions, methods of preparation and uses thereof
US10568839B2 (en) 2011-01-11 2020-02-25 Capsugel Belgium Nv Hard capsules
US11319566B2 (en) 2017-04-14 2022-05-03 Capsugel Belgium Nv Process for making pullulan
US11576870B2 (en) 2017-04-14 2023-02-14 Capsugel Belgium Nv Pullulan capsules
US11878079B2 (en) 2017-04-14 2024-01-23 Capsugel Belgium Nv Pullulan capsules

Also Published As

Publication number Publication date
DE19905801B4 (de) 2008-03-13
CZ20012900A3 (cs) 2002-01-16
IL144767A (en) 2006-08-20
EP1150663A2 (fr) 2001-11-07
NO20013892D0 (no) 2001-08-09
AU777898B2 (en) 2004-11-04
CA2362756A1 (fr) 2000-08-17
MXPA01007867A (es) 2002-07-02
AR022580A1 (es) 2002-09-04
WO2000047190A3 (fr) 2000-12-14
PL349857A1 (en) 2002-09-23
CN1147293C (zh) 2004-04-28
BR0009962A (pt) 2002-04-16
NZ513465A (en) 2003-05-30
ZA200106580B (en) 2002-02-14
KR20010102050A (ko) 2001-11-15
TR200102056T2 (tr) 2001-11-21
JP2002536402A (ja) 2002-10-29
KR100620068B1 (ko) 2006-09-05
TWI254725B (en) 2006-05-11
CA2362756C (fr) 2009-11-24
CN1336820A (zh) 2002-02-20
RU2226389C2 (ru) 2004-04-10
HK1039069A1 (zh) 2002-04-12
DE19905801A1 (de) 2000-08-17
BR0009962B1 (pt) 2014-07-29
NO20013892L (no) 2001-08-09
PL202678B1 (pl) 2009-07-31
CZ301872B6 (cs) 2010-07-14
IL144767A0 (en) 2002-06-30
AU3151400A (en) 2000-08-29
HUP0202877A2 (hu) 2003-03-28

Similar Documents

Publication Publication Date Title
US6800329B2 (en) Method for producing film-type dosage
EP0460588B1 (fr) Procédé d'obtention de formes d'administration en forme de feuille et à désagrégation rapide
EP0949909B1 (fr) Forme galenique a dosage individuel, sous forme pelliculaire, contenant un principe actif et notamment une substance aromatique, se desagregeant rapidement au contact de liquide
EP0766556B1 (fr) Forme galenique plate expansible pouvant etre utilisee comme excipient, notamment pour administration par voie orale
DE19646392A1 (de) Zubereitung zur Anwendung in der Mundhöhle mit einer an der Schleimhaut haftklebenden, Pharmazeutika oder Kosmetika zur dosierten Abgabe enthaltenden Schicht
DE2012775C3 (de) Salbenfohe und Verfahren zu ihrer Herstellung
DE4002281C2 (fr)
WO2001035934A1 (fr) Preparation sous forme de film pour liberation selon deux phases de substances pharmacologiquement actives ou d'autres substances
WO1994008571A2 (fr) Emplatre pour administration percutanee d'ingredients volatils, chimiquement basiques, pharmaceutiquement actifs, et son procede de preparation
DE2356098C3 (de) Zusammensetzung für Umschläge
DE19905801B4 (de) Verfahren zur Herstellung folienförmiger Darreichungsformen
EP1087759B1 (fr) Procede de realisation d'un stratifie constitue de plusieurs couches individuelles
US20040126497A1 (en) Method for producing film-type dosage
DE102004049740A1 (de) Selbstklebende Zahnfolie
DE19702314A1 (de) Ablösbare Schutzfolie für wirkstoffhaltige, insbesondere selbstklebende Pflastersysteme
WO2024017639A1 (fr) Revêtement antiadhésif à faible coefficient de frottement
DE19728279A1 (de) Ketoprofen-Pflaster mit Langzeit/Sofort-Wirkung und Verfahren zu seiner Herstellung

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 00802865.6

Country of ref document: CN

AK Designated states

Kind code of ref document: A2

Designated state(s): AU BR CA CN CZ HU IL IN JP KR MX NO NZ PL RU TR US ZA

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
AK Designated states

Kind code of ref document: A3

Designated state(s): AU BR CA CN CZ HU IL IN JP KR MX NO NZ PL RU TR US ZA

AL Designated countries for regional patents

Kind code of ref document: A3

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE

WWE Wipo information: entry into national phase

Ref document number: 2000909123

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 31514/00

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 2001/02056

Country of ref document: TR

ENP Entry into the national phase

Ref document number: 2000 598143

Country of ref document: JP

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: PA/a/2001/007867

Country of ref document: MX

Ref document number: IN/PCT/2001/00690/DE

Country of ref document: IN

WWE Wipo information: entry into national phase

Ref document number: 144767

Country of ref document: IL

WWE Wipo information: entry into national phase

Ref document number: 513465

Country of ref document: NZ

WWE Wipo information: entry into national phase

Ref document number: PV2001-2900

Country of ref document: CZ

ENP Entry into the national phase

Ref document number: 2362756

Country of ref document: CA

Ref document number: 2362756

Country of ref document: CA

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 2001/06580

Country of ref document: ZA

Ref document number: 1020017010143

Country of ref document: KR

Ref document number: 200106580

Country of ref document: ZA

WWE Wipo information: entry into national phase

Ref document number: 09913089

Country of ref document: US

WWP Wipo information: published in national office

Ref document number: 2000909123

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1020017010143

Country of ref document: KR

WWP Wipo information: published in national office

Ref document number: PV2001-2900

Country of ref document: CZ

CFP Corrected version of a pamphlet front page

Free format text: UNDER (57) PUBLISHED ABSTRACT IN ENGLISH REPLACED BY CORRECT ABSTRACT

WWG Wipo information: grant in national office

Ref document number: 31514/00

Country of ref document: AU

WWR Wipo information: refused in national office

Ref document number: 1020017010143

Country of ref document: KR