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.
• thermoplastics made of polypropylene, polyethylene, polyethylene terephthalate, polycarbonate and laminates of these polymers, particularly preferably polyethylene-coated paper, sticking of the individual film pieces produced later is effectively avoided in the stack.
• 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.
• hydrophilic raw materials can include polymers such as starch and their derivatives, agar-agar, gelatin, cellulose and cellulose derivatives, alginic acid, galactomannan, carrageenan, other vegetable gums permissible for the respective field of application, pullulan and other glucans, dextran, polyvinylpyrrolidone, Polyvinyl alcohol or polyacrylic acid ho o and copolymers.
• the polyvinyl alcohol used is advantageously a partially hydrodysed form in which between 1 and 20%, particularly preferably approximately 12%, of the hydroxyl groups are replaced by acetyl groups.
• the method according to the invention has an effect in particular in the case of problematic compositions which contain high proportions of pullulan, carrageenan or cellulose esters.
• Hydrophilic additives of low molecular weight can also be used as structure formers; they mostly meet application-specific goals.
• Sugar Sugar alcohols, sugar substitutes, organic acids, polyethylene glycol in question.
• 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.
• Examples include, for example, phenylethanol as a component of rose fragrances, menthol, eucalyptol (cineol), camphene and pinene in peppermint-like aromas, appetizing aroma substances (spice aromas) such as n-butyl phthalide or cineol, but also aroma substances with medicinal use such as eucalyptus - And called thyme oil, methyl salicylate, turpentine oil and chamomile oil.
• phenylethanol as a component of rose fragrances, menthol, eucalyptol (cineol), camphene and pinene in peppermint-like aromas, appetizing aroma substances (spice aromas) such as n-butyl phthalide or cineol, but also aroma substances with medicinal use such as eucalyptus - And called thyme oil, methyl salicylate, turpentine oil and chamomile oil.
• 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 surface facing the coating composition does not have a smooth, but rather a contoured, matted, in any case rough surface contour.
• the roughness can be in the range from 0.1 ⁇ m to approximately 10 ⁇ m, preferably between 0.5 and 3 ⁇ m.
• Rounded elevations, which further reduce sliding friction, are advantageous in the microscopic fine structure.
• 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 equivalent air humidity is determined as follows: A freshly manufactured product strip of approx. 0.1 m a surface is quickly folded with rubber gloves and placed in a wide-necked glass vessel, the lid of which is drilled so that the measuring head of a hygrometer is inserted becomes. After approximately one minute, depending on the type of device, the measured value can be read off.
• 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.

Landscapes

• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Chemical & Material Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Epidemiology (AREA)
• Medicinal Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Pharmacology & Pharmacy (AREA)
• Polymers & Plastics (AREA)
• Nutrition Science (AREA)
• Manufacturing & Machinery (AREA)
• Food Science & Technology (AREA)
• Organic Chemistry (AREA)
• Biomedical Technology (AREA)
• Birds (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Physiology (AREA)
• Dermatology (AREA)
• Materials Engineering (AREA)
• Medicinal Preparation (AREA)
• Application Of Or Painting With Fluid Materials (AREA)
• Laminated Bodies (AREA)
• Cosmetics (AREA)
• General Preparation And Processing Of Foods (AREA)
• Compositions Of Macromolecular Compounds (AREA)
• Separation Using Semi-Permeable Membranes (AREA)
• Wrappers (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Applications Claiming Priority (3)

Publications (1)

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Family Applications (1)

Country Status (22)

Families Citing this family (5)

Family Cites Families (6)

• 1999
  • 1999-02-12 DE DE19905801A patent/DE19905801B4/de not_active Expired - Fee Related
• 2000
  • 2000-01-27 TW TW089101364A patent/TWI254725B/zh not_active IP Right Cessation
  • 2000-01-31 JP JP2000598143A patent/JP2002536402A/ja active Pending
  • 2000-01-31 KR KR1020017010143A patent/KR100620068B1/ko not_active IP Right Cessation
  • 2000-01-31 TR TR2001/02056T patent/TR200102056T2/xx unknown
  • 2000-01-31 CZ CZ20012900A patent/CZ301872B6/cs not_active IP Right Cessation
  • 2000-01-31 NZ NZ513465A patent/NZ513465A/en not_active IP Right Cessation
  • 2000-01-31 CN CNB008028656A patent/CN1147293C/zh not_active Expired - Fee Related
  • 2000-01-31 PL PL349857A patent/PL202678B1/pl unknown
  • 2000-01-31 MX MXPA01007867A patent/MXPA01007867A/es not_active IP Right Cessation
  • 2000-01-31 WO PCT/EP2000/000739 patent/WO2000047190A2/de not_active Application Discontinuation
  • 2000-01-31 BR BRPI0009962-7A patent/BR0009962B1/pt not_active IP Right Cessation
  • 2000-01-31 RU RU2001118268/15A patent/RU2226389C2/ru not_active IP Right Cessation
  • 2000-01-31 IL IL14476700A patent/IL144767A0/xx active IP Right Grant
  • 2000-01-31 CA CA002362756A patent/CA2362756C/en not_active Expired - Fee Related
  • 2000-01-31 EP EP00909123A patent/EP1150663A2/de not_active Ceased
  • 2000-01-31 HU HU0202877A patent/HUP0202877A2/hu unknown
  • 2000-01-31 AU AU31514/00A patent/AU777898B2/en not_active Ceased
  • 2000-02-11 AR ARP000100610A patent/AR022580A1/es active IP Right Grant
• 2001
  • 2001-08-07 IL IL144767A patent/IL144767A/en not_active IP Right Cessation
  • 2001-08-09 NO NO20013892A patent/NO20013892L/no not_active Application Discontinuation
  • 2001-08-10 ZA ZA200106580A patent/ZA200106580B/en unknown
• 2002
  • 2002-01-31 HK HK02100760.6A patent/HK1039069A1/zh unknown

Non-Patent Citations (1)

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