IL141399A - Active ingredient support in the form of a film - Google Patents

Active ingredient support in the form of a film

Info

Publication number
IL141399A
IL141399A IL141399A IL14139901A IL141399A IL 141399 A IL141399 A IL 141399A IL 141399 A IL141399 A IL 141399A IL 14139901 A IL14139901 A IL 14139901A IL 141399 A IL141399 A IL 141399A
Authority
IL
Israel
Prior art keywords
active substance
film
carrier
shaped
particles
Prior art date
Application number
IL141399A
Other languages
Hebrew (he)
Original Assignee
Lohmann Therapie Syst Lts
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 Lohmann Therapie Syst Lts filed Critical Lohmann Therapie Syst Lts
Publication of IL141399A publication Critical patent/IL141399A/en

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
    • 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
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Manufacture Of Macromolecular Shaped Articles (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Cosmetics (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Laminated Bodies (AREA)
  • Polishing Bodies And Polishing Tools (AREA)
  • Absorbent Articles And Supports Therefor (AREA)

Description

Active Ingredient Supporting In The Form Of A Film LTS LOHMANN THERAPIE-SYSTEME AG Film-shaped active substance carriers The invention relates to a film-shaped active substance carrier with particles of an active substance-containing substrate, which particles can be applied to the surface thereof .
Administration forms to be applied in the oral region and on the mucous membranes thereof are known.
US 3,444,858 describes medicament strips based on a gelatinlike material.
Already in 1937, film-shaped medicaments were described in the "New England Journal of Medicine", volume 289, pages 533 to 535.
From DE-OS 24 49 865 are known medicinal active substance carriers in the form of films containing, side by side, different active substances and active substance concentrations .
EP 0 216 762 describes a water-soluble film of starch, gelatin, glycerin or sorbite which is coated by means of a roll coating process . It is mentioned in this connection that these administration forms can also be produced for chemical reagents, flavourings, etc.
Canadian patent application 492 040 describes a process for making film-shaped preparations using active substances, along with gelatin or agar, gluten, carboxyvinyl polymer, polyvalent alcohol, a vegetable mucilage, or wax and water. EP 0 460 588 discloses a formulation suitable for the manufacture of film-shaped systems. Here, a preparation of 20 to 60¾-wt. of film former, 2 to 40¾-wt. of gel former, 0.1 to 35%-wt of active substance and maximally 40%-wt. of an inert filler is of particular advantage. Among other substances, polyvinyl alcohol is mentioned as a gel former.
According to DE-OS 36 30 603 it is particularly advantageous to apply a flat-shaped dosage form to a carrier material, which is formed as a release film, in such a manner that it can be peeled off in doses.
US 4,128,445 and US 4,197,289 discuss possible technical solutions of loading carrier material with active substance. They describe loading processes in dry and moist environment, which aim at attaining a uniform distribution of active substances on these layers, or can be carried out making use of electrostatics.
US Re 31764 discloses a detailed description of possibilities of applying pharmaceutical active substances on flat substrates in drops. In this connection the document describes mechanisms of piezoelectrical application of active substances with the aid of electrical fields.
US 5,089,307 describes a hot-sealable, edible film based on water-soluble polysaccharides, polyvalent alcohols and water. However, only food applications but not medicinal applications are described therein.
From US 5,714,007 it is known to supply surfaces of pharmaceutical formulations with pulverulent active substances. To this end, active substance loading of planar layers is carried through by means of electrostatic charging of active substance particles, with the active substance carrier having opposite charge, said loading being controlled by voltage, polarity or duration.
US 4,851,394 describes edible films based on glucomaimane and glycerin as a covering of soft capsules or as food packages which dissolve when being consumed.
US 5,232,704 discloses oral pharmaceutical forms wherein a lifting force caused by the generation of gas brought about by admission of liquid is used as a means for attaining a prolonged retention time in the stomach with the aim of achieving a prolonged duration of action.
US 5,047,244 describes film-shaped systems which, advantageously, have a two-layer structure of a water-swellable layer and a water-insoluble barrier layer. The document reports on the use of polymers such as polyethylene glycol, the use of colloidal silicon dioxide, bioadhesive, e.g. carboxyfunctional, polymers, polyvinyl alcohol and other auxiliaries .
The above-described preparations, however, do not meet the below listed requirements of pharmaceutical administration forms of the kind mentioned at the outset, or they meet these requirements only in a very dissatisfactory manner. Said requirements comprise: it must be possible to prepare the active substance preparation in an extremely accurate and in a precisely reproducible manner; the finished administration form must contain the active substance unchangeably as to the amount and quality thereof, and it is to have a the desired mechanical stability; the administration forms must release the active substance to the organism in a predetermined manner, not immediately and uncontrollably, but evenly and over a prolonged period of time; in the case of oral application, the retention time in the stomach must be increased in accordance with a desired duration of action; the dissolution rate of slightly soluble active substance components should be increased; where film pieces are used as a finished administration form for oral application, these should retain their flat shape and avoid curling, such curling being a phenomenon frequently to be expected in the case of cast films.
These requirements are not satisfactorily met by the systems and formulations of the prior art mentioned. Consequently, the invention has the object of providing a film-shaped active substance carrier of the kind mentioned in the introductory portion of Claim 1 which enables both an accurate and a precisely reproducible active substance dosage as well as an accurate and a precisely reproducible active substance release at a predetermined delivery rate, and which contains the active substance, protected against premature detachment, on or in a mechanically stable film-shaped active substance carrier.
This object is achieved by the invention in a film-shaped active substance carrier of the kind mentioned initially in that the particles of the active substance-containing substrate are fixedly connected with the said substrate.
One embodiment of the invention provides for the particles to be fixed on the substrate with the aid of a solvent.
In this case the anchoring of the particles on the carrier film is effected by preliminary interaction with moisture or solvent vapor, or under action of pressure and/or temperature .
One advantageous embodiment of the invention makes use of the fact that by applying a further film-shaped layer one achieves an encapsulation of the drug particles.
Application of this additional layer can be effected by calendering with or without the use of solvent or heat. It is also of advantage that by using fusible particles of an active substance-containing preparation, the adhesion of the particles on or in the carrier layer can be optimally realized. In this embodiment of the film-shaped active substance carrier it is of essential importance with regard to the invention that the further film-shaped layer is water vapour-diffusible. Here, the second film-shaped layer applied provides for additional protection of the particles applied to the surface of a carrier, and when selecting a suitable film the rate of active substance release is controlled by reason of the fact that it is possible to adjust the active substance release characteristics, which characteristics can be predetermined in the process and which, in particular, are retarded.
When in this process the two films which are used for lamination are sealed upon each other at their edge contour, it is possible - by employing gas-generating components in, for example, aqueous environment - to use the laminate as a gas-filled, floatable pouch in the stomach as a gastroretentive system.
A further retardation of the active substance release can be achieved by a specific embodiment of the invention in that at least one further film-shaped body is contained in the space of the active substance carrier, which space is inflated due to the generation of gas, on whose surface are present active substance-containing particles which are fixedly connected with the said body.
Furthermore, additional film-shaped bodies may be present in the cavity of the active substance carrier which are adapted as auxiliary substance carriers for the generation of gas.
The use of the film-shaped active substance carrier is provided for as an administration form for cosmetic, pharmaceutical or food-technological products.
Further details and advantages of the invention will become evident from the following explanation of some of the examples of embodiments schematically shown in the drawings . The drawings show: Figure 1 to Figure 6: sectional and side views of different but similar embodiments of film-shaped active substance carriers according to the invention.
Figure 1: a sectional view of a film-shaped active substance carrier (2) provided with particles (1) of an active substance-containing substrate, which particles are fixedly anchored on the carrier. When using slightly soluble active substances it is possible here to employ the measure of homogeneously applying to the surface a micronized form of the active substance at particle sizes of below 50 um, preferably below 5 um, and - avoiding agglomeration - fixing the same on the surface. In this case, a base may be chosen for the film-shaped drug carrier which is freely soluble in water.
Figure 2 shows another embodiment of the film-shaped active substance carrier, with active substance particles (1), the film-shaped carrier (2) and a further film-shaped carrier (3) laminated thereon.
Figure 3 shows an alternative embodiment of the film-shaped active substance carrier (2), with active substance particles (1) fixedly connected with the surface thereof, which active substance carrier (2) is covered or encapsulated with a film-shaped layer (3), thus forming a cavity (4).
According to Figure 4 the film-shaped active substance carrier (2) and the film-shaped layer (3) covering said carrier form a cavity (4) wherein an additional film-shaped element (2'), comprising active substance particles (1) fixed on the surface thereof, is embedded. In the cavity (4) are provided film-shaped auxiliary substance carriers (5, 6) for generation of gas. To render the latter activatable by admission of moisture, the film-shaped layer (3) is formed using water vapour-diffusible material. The active substance carrier (2) may be provided with active substance particles fixed on the surface thereof.
As shown in Figure 5, a further alternative embodiment of the device according to the invention is provided with a film-shaped active substance carrier (2) and a water vapour-diffusible layer (3), forming a cavity (4) which contains film-shaped active substance carriers (5, 6) . The active substance particles (1) are fixed on the inner surfaces of the layers (2, 3).
Figure 6 shows the separation of a strand consisting of layers (2, 3) and provided with active substance particles (1), using a separating device (7).
The drug carriers (2, 2') shown in Figures 1 to 6 consist of a film of film-forming materials such as, for example, polyvinyl alcohol, preferably in partially hydrolized form, wherein between 1 and 20%, particularly preferred 12%, of the hydroxyl groups are replaced by acetyl groups, of cellulose derivatives, gelatin, pullulan or other saccharides, vegetable gums and polyvinylpyrrolidone. Furthermore, sugar, glucose, sorbite, polyethylene glycol and other water-soluble additives may advantageously be added to regulate the dissolution properties. Additives of up to 30%-wt. of a surfactant can improve the wetting to the active substance-containing particles (1) .
Adding up to 40%-wt. of a filler does not eliminate the advantages of the invention and is likewise suitable for modification of the dissolution properties. Without claiming to be exhaustive, suitable substances for this purpose are silicon dioxide, titanium dioxide, calcium carbonate, calcium sulfate, calcium phosphate, talcum or mixtures of these substances .
To improve acceptance, it is also possible to add flavours which advantageously form a drop-shaped internal phase in the layer.
Furthermore, flavour-enhancing substances such as sodium saccharinate, other sweeteners, salt or sugar derivatives can be used to improve the impression of taste, such as also, for example, low-molecular organic acids, for example malic acid, adipic acid or citric acid. Further, stabilizers such as antioxidants improve the shelf-life of the adhering active substance particles .
These may consist of the above-mentioned base components of the film itself but also of more lipophile, e.g. wax- or resin-like, portions.
Thermoplastic components, as well as water-soluble polymers such as polyethylene, are suitable for embedding after application onto a carrier film.
Typically the active substances may be applied to a carrier in pure and optionally in micronized form.
The film-shaped products or initial products preferably have a thickness of 20 to 300 urn; their size is advantageously 0.5 to 8 cm2.
Through the application according to the invention of a second film-shaped layer (3) to an active substance carrier (2) it is possible to protect and encapsulate the particles (1) applied on the surface. Depending on the base material as well as the sensitivity to temperature, this can be effected by hot-calendering, bonding with the aid of solvents, or other methods known to those skilled in the art.
By further processing, for example by means of contour rolls or similar shaping devices, the film laminate can obtain a desired geometrical contour, for example a shape suitable for filling into capsules. In this manner, it is possible to obtain, for example, markedly delayed active substance release characteristics.
If two films intended for lamination are sealed with each other at the edge contour, it is thereby possible to achieve further special effects.
On the one hand, it is thereby possible to achieve an extreme delay of the active substance release rate, and on the other hand the laminate can be used as a gastroretentive therapeutic product in the stomach or the intestinal tract by employing gas-generating components in the interior space of a device according to the invention which is shaped as a pouch and has water vapour-diffusible layers.
The film-shaped active substance carrier according to the invention has a wide range of applications, it can be produced in industrial production processes with high outputs at moderate costs, and it solves the task mentioned at the outset in an optimal manner.

Claims (5)

141399/2 .10 Claims
1. . Film-shaped active substance carrier for controlled release of active substance, comprising - a carrier film to the surface of which particles of an active substance- containing substrate are fixedly connected or into the surface of which the said particles are embedded, as well as - a further film-shaped layer covering the said carrier film, which carrier film is enriched with active substance particles, the said further film-shaped layer being water vapor-diffusible, and - the said carrier film and the said further film shaped layer being sealed on top of one another in their edge contour such that the film-shaped active substance carrier is configured as a pouch in whose interior space there are gas- forming components, characterized In that in the cavity of the active substance carrier there is contained at least one further film-shaped body on whose surface there are located active substance-containing particles which are fixedly connected with the said film-shaped body, and/or that in the said cavity there are additional film-shaped bodies which are configured as active substance carriers for the generation of gas.
2. Film-shaped active substance carrier according to Claim 1 , characterized in that as active substance particles there are applied particles of a slightly soluble active substance which have a particle size of below 50 pm, preferably below 5 pm. 141399/2 11
3. Process for manufacturing a film-shaped active substance carrier for the controlled release of active substance, comprising - a carrier film to the surface of which particles of an active substance- containing substrate are fixedly connected or into the surface of which said particles are embedded, and - a further film-shaped layer which is water vapor-diffusible and covers the car- her film, - said carrier film being enriched with active substance particles, wherein said particles are fixedly connected to the surface ofthe film-shaped active substance carrier or are embedded therein, and anchored on the carrier film under the action of pressure and/or heat, and - wherein said carrier film and the said further film shaped layer are sealed on top of one another in their edge contour such that the film-shaped active substance carrier is configured in the form of a pouch, and gas-forming components are introduced into the interior space of the active substance carrier configured as a pouch, characterized in that at least one further film-shaped body on whose surface there are located active substance-containing particles which are fixedly connected with the said body, and/or additional film-shaped bodies which are configured as active substance carriers for the generation of gas are introduced into the cavity of the active substance carrier, which is configured as a pouch.
4. Process according to claim 3, characterized In that as active substance particles there are applied particles of a slightly soluble active substance which have a particle size of below 50 pm, preferably below 5 prn.
5. Use of a film-shaped active substance carrier according to claim 1 or 2, or of an active substance carrier manufactured by means of a process according to claim 3 or 4, as an administration form for cosmetic, pharmaceutical or food-technological products. FOR THE ΑΡΡϋί
IL141399A 1998-08-17 2001-02-12 Active ingredient support in the form of a film IL141399A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19837073A DE19837073A1 (en) 1998-08-17 1998-08-17 Foil-shaped drug carriers
PCT/EP1999/005549 WO2000010539A1 (en) 1998-08-17 1999-07-31 Active ingredient support in the form of a film

Publications (1)

Publication Number Publication Date
IL141399A true IL141399A (en) 2007-02-11

Family

ID=7877657

Family Applications (2)

Application Number Title Priority Date Filing Date
IL14139999A IL141399A0 (en) 1998-08-17 1999-07-31 Active ingredient support in the form of a film
IL141399A IL141399A (en) 1998-08-17 2001-02-12 Active ingredient support in the form of a film

Family Applications Before (1)

Application Number Title Priority Date Filing Date
IL14139999A IL141399A0 (en) 1998-08-17 1999-07-31 Active ingredient support in the form of a film

Country Status (17)

Country Link
EP (1) EP1109541B8 (en)
JP (2) JP5184725B2 (en)
KR (1) KR100550890B1 (en)
CN (1) CN1312710A (en)
AR (1) AR021768A1 (en)
AT (1) ATE306912T1 (en)
AU (1) AU5729999A (en)
BR (1) BRPI9913444B8 (en)
CA (1) CA2339836C (en)
DE (2) DE19837073A1 (en)
DK (1) DK1109541T3 (en)
ES (1) ES2252968T3 (en)
IL (2) IL141399A0 (en)
MX (1) MXPA01001402A (en)
PL (1) PL346145A1 (en)
TR (1) TR200100564T2 (en)
WO (1) WO2000010539A1 (en)

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DE19646392A1 (en) 1996-11-11 1998-05-14 Lohmann Therapie Syst Lts Preparation for use in the oral cavity with a layer containing pressure-sensitive adhesive, pharmaceuticals or cosmetics for dosed delivery
DE10032456A1 (en) * 2000-07-04 2002-01-31 Lohmann Therapie Syst Lts Rapidly disintegrating dosage form for the release of active substances in the mouth or in the body cavities
JP4993652B2 (en) * 2004-03-31 2012-08-08 リンテック株式会社 Oral administration
US8268333B2 (en) 2001-04-24 2012-09-18 Lintec Corporation Orally administered agent and an orally administered agent/supporting substrate complex
DE10224607B4 (en) * 2002-06-04 2008-03-13 Lts Lohmann Therapie-Systeme Ag Film-form, disintegratable preparations for drug release and process for their preparation
KR20090125257A (en) * 2007-03-30 2009-12-04 린텍 가부시키가이샤 Agent for oral administration and method for producing the same
WO2010086989A1 (en) 2009-01-29 2010-08-05 日東電工株式会社 Intraoral film-shaped base and preparation
JP2011207847A (en) * 2010-03-30 2011-10-20 Nitto Denko Corp Film-form preparation and method for producing the same
JP5751868B2 (en) 2010-03-30 2015-07-22 日東電工株式会社 Film-form preparation and method for producing the same
JP5841433B2 (en) 2012-01-11 2016-01-13 日東電工株式会社 Intraoral film-form base and preparation
EP3082866A4 (en) 2013-12-16 2017-06-14 The University Of British Columbia Self-fueled particles for propulsion through flowing aqueous fluids
JP2015154716A (en) * 2014-02-19 2015-08-27 日本合成化学工業株式会社 edible film
US11697906B2 (en) 2017-01-27 2023-07-11 The Procter & Gamble Company Active agent-containing articles and product-shipping assemblies for containing the same
US11697905B2 (en) 2017-01-27 2023-07-11 The Procter & Gamble Company Active agent-containing articles that exhibit consumer acceptable article in-use properties
CN115742472A (en) * 2017-01-27 2023-03-07 宝洁公司 Active agent-containing articles exhibiting consumer acceptable article application characteristics
US11697904B2 (en) 2017-01-27 2023-07-11 The Procter & Gamble Company Active agent-containing articles that exhibit consumer acceptable article in-use properties
DE102017127434A1 (en) * 2017-11-21 2019-05-23 Lts Lohmann Therapie-Systeme Ag Pocket-shaped oral-release films with high drug loading

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NZ336691A (en) * 1997-01-14 2000-05-26 Lohmann Therapie Syst Lts Expandable gastro-retentive therapeutic system with controlled active substance release in the gastro-intestinal tract

Also Published As

Publication number Publication date
JP2010280679A (en) 2010-12-16
CN1312710A (en) 2001-09-12
JP2002523359A (en) 2002-07-30
EP1109541B8 (en) 2005-12-28
DK1109541T3 (en) 2006-03-13
JP5184725B2 (en) 2013-04-17
DE19837073A1 (en) 2000-03-23
ATE306912T1 (en) 2005-11-15
BRPI9913444B8 (en) 2021-05-25
PL346145A1 (en) 2002-01-28
TR200100564T2 (en) 2001-07-23
CA2339836C (en) 2007-07-17
EP1109541B1 (en) 2005-10-19
EP1109541A1 (en) 2001-06-27
BR9913444A (en) 2001-09-25
ES2252968T3 (en) 2006-05-16
AR021768A1 (en) 2002-08-07
IL141399A0 (en) 2002-03-10
DE59912684D1 (en) 2006-03-02
AU5729999A (en) 2000-03-14
WO2000010539A1 (en) 2000-03-02
BR9913444B1 (en) 2014-10-14
MXPA01001402A (en) 2002-06-21
KR100550890B1 (en) 2006-02-10
KR20010072683A (en) 2001-07-31
CA2339836A1 (en) 2000-03-02

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