Classifications

• • C—CHEMISTRY; METALLURGY
  • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
  • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
  • C09D101/00—Coating compositions based on cellulose, modified cellulose, or cellulose derivatives
  • C09D101/08—Cellulose derivatives
  • C09D101/26—Cellulose ethers
  • C09D101/28—Alkyl ethers
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L1/00—Compositions of cellulose, modified cellulose or cellulose derivatives
  • C08L1/08—Cellulose derivatives
  • C08L1/10—Esters of organic acids, i.e. acylates
• • A—HUMAN NECESSITIES
  • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
  • A01C—PLANTING; SOWING; FERTILISING
  • A01C1/00—Apparatus, or methods of use thereof, for testing or treating seed, roots, or the like, prior to sowing or planting
  • A01C1/06—Coating or dressing seed
• • 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
  • A23P20/10—Coating with edible coatings, e.g. with oils or fats
  • A23P20/105—Coating with compositions containing vegetable or microbial fermentation gums, e.g. cellulose or derivatives; Coating with edible polymers, e.g. polyvinyalcohol
• • 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
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/282—Organic compounds, e.g. fats
  • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
• • 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
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/2833—Organic macromolecular compounds
  • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
  • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L71/00—Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers
  • C08L71/02—Polyalkylene oxides

Definitions

• the present invention relates to the field of aqueous film coating of pharmaceutical, food, confectionery forms, and agricultural products, and is specifically concerned with providing coatings from a combination of a cellulosic polymer and lactose for coating such things as pharmaceutical tablets, pieces of candy, cereals, and agricultural seeds.
• Film coating is a process of depositing a thin layer of material onto a substrate.
• Two goals of film coating substrates such as pharmaceutical tablets and the like are (1) to provide a functional protective barrier covering the outer surface of the substrate, and (2) to provide a pleasing appearance.
• the process of film coating pharmaceutical, food, confectionery, and agricultural pieces usually involves rolling the pieces in a pan, or suspending the pieces on a cushion of air, and continuously spraying a fine mist of atomized droplets of a coating suspension onto the pieces, the droplets coalescing on the surface of the pieces to form a film coating.
• Coating suspensions having an organic solvent are undesirable since these solvents are often flammable, often toxic, and hazardous to the health of film coating workers. Further, reclaiming organic solvent fumes, which are given off during spraying, from exhaust air ducting systems is expensive and often required by law.
• Water-based coating suspensions are desirable to avoid the drawbacks of organic solvent -based coating suspensions.
• a major problem with aqueous coating suspensions is poor adhesion of the film to the substrate.
• agricultural seeds, and the like comprises a dry mixture of a cellulosic polymer and lactose.
• composition may include a
• plasticizer and/or a pigment are examples of plasticizer and/or a pigment.
• pharmaceutical tablets, food and confectionery forms, agricultural seeds, and the like comprises mixing a cellulosic polymer and lactose into water to form an aqueous coating suspension, spraying the coating suspension onto said substrates to form a film coating on said substrates, and drying the film coating on said substrates.
• the invention also includes the coated
• substrates such as coated pharmaceutical tablets, and methods of making the dry film coating
• composition and of making a coating suspension are provided.
• cellulosic polymer examples include
• plasticizer examples include polyethylene glycol having a molecular weight of 200 to 20,000, propylene glycol, or glycerol .
• any of the pigments heretofore used in making coating dispersions for coating tablets, food, confectionery forms, agricultural seeds, and the like may be used.
• Examples are FD&C and D&C lakes, titanium dioxide, iron oxides or natural pigments.
• the quantity of the cellulosic polymer is within a range of about 11% to about 56% by weight of the dry film coating composition and of the non- water ingredients of the aqueous coating suspension. A range of about 20% to 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
• the quantity of the lactose is within a range of about 11% to about 56% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 25% to 45% by weight of the dry film coating
• composition and of the non-water ingredients of the aqueous coating suspension is preferred.
• the quantity of the plasticizer is within a range of 0% to about 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 5% to 20% by weight of the dry film coating
• composition and of the non-water ingredients of the aqueous coating suspension is preferred.
• the quantity of the pigment is within a range of 0% to about 55% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 15% to 40% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
• a preferred formula for the present inventive dry film coating composition is:
• compositions which may be mixed into water to form an aqueous coating suspension effective to coat pharmaceutical tablets, food and confectionery pieces, and agricultural seeds. Seeds are
• coated forms include medicinal tablets, vitamin tablets, aspirin tablets, capsules, chewing gum balls, candy pieces, breakfast cereals, and agricultural seeds.
• hydroxypropyl methylcellulose (Methocel E15 made by Dow Chemical Company)
• 100.50 grams of lactose, 60.00 grams of titanium dioxide, and 2.50 grams of Indigo carmine aluminum lake 14% are loaded into a dry powder blender such as a P.K. blender and mixed vigorously for 25 minutes to form an homogenous mixture.
• 20.00 grams of a plasticizer, polyethylene glycol 4000 (PEG 4000 made by Union Carbide) is added to the homogenous mixture and gently blended into it.
• the homogenous mixture containing the plasticizer is granulated using a planetary mixer, such as a Hobart planetary mixer.
• a planetary mixer such as a Hobart planetary mixer.
• sufficient water is slowly added until the composition forms slightly adherent granules.
• These granules are then passed through a 1-2 mm screen and then dried in a 30°C oven until the moisture content is below 5%.
• the composition is then sieved again through a 1-2mm screen and is then ready for use in a non-dusting, granular form.
• the powder may be milled such as in a hammer mill (Apex Machinery, Dartford, England), for example.
• Example 2 shows different formulations of the dry film coating composition of the invention, further illustrate the invention.
• a dry film coating composition is made using the procedure of Example 1.
• Methocel E15 and Methocel E50 are hydroxypropyl methylcellulose (HPMC) made by Dow Chemical Company.
• PEG 200, PEG 400, PEG 4000, PEG 8000, and PEG 20000 are polyethylene glycol made by Union Carbide.
• Klucel EF is hydroxypropyl cellulose made by Hercules Co.
• a dry film coating composition having the following formula is made as in example 1, except that no plasticizer is blended into the composition:
• a dry film coating composition having the following formula is made as in example 1, except that no pigment is blended into the composition:
• a dry film coating composition having the following formula is made as in Example 1, except that no plasticizer and no pigment are blended into the composition:
• Examples 1-20 is constituted in water to form a coating suspension.
• 170 grams of the dry film coating composition is dispersed into 830 grams of purified water.
• this is accomplished by placing the 830 grams of purified water into a mixing vessel having the diameter that is about equal to the depth of the final suspension.
• a low shear mixer is lowered into the water and turned on.
• the mixing head of the mixer is about one third the diameter of the mixing vessel and creates a vortex from the edge of the vessel down to just above the mixing head.
• the 170 grams of the dry film coating composition is then added to the vortex at a rate where there is no excessive build-up of the dry film coating
• composition The speed and depth of the mixing head is adjusted to avoid air being drawn into the suspension which would result in foaming.
• the suspension is stirred for 45 minutes and is then ready for spraying.
• inventive coating suspensions are then sprayed onto medicinal tablets, vitamin tablets, aspirin tablets, capsules, chewing gum balls, candy pieces, breakfast cereals, and agricultural seeds, and allowed to dry.
• the film coatings so produced have an excellent appearance and adhere extremely well to the substrates.
• the inventive film coating is provided.
• the film coating suspension is formed by blending together all the dry ingredients of the coating formula, and then dispersing the mixture of the dry ingredients into water.
• the film coating suspension may be prepared by stirring the ingredients of the coating formulation one by one into water to form a coating suspension.
• inventive coating suspension may be spray-granulated to form a dry edible film coating composition that may be remixed into water when desired to form a coating suspension.
• composition dramatically and unexpectedly improves adhesion of the film coating onto substrates such as pharmaceuticals, food, confectionery forms,
• the dry film coating composition of the invention when constituted in water has a viscosity lower than that of a conventional polymer coating system having the same total solids.
• a coating dispersion may be produced under the invention which has a higher solids loading, and consequently a lower solvent content. Accordingly, since the film coating suspensions of the invention may be sprayed at a higher solids level, spraying times are lower than the spraying times for conventional systems, which results in lower processing time cost.
• lactose in the inventive formulation improves the light stability of organic pigments and natural colors commonly used in film coatings.

Landscapes

• Chemical & Material Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Medicinal Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Organic Chemistry (AREA)
• Polymers & Plastics (AREA)
• Food Science & Technology (AREA)
• Environmental Sciences (AREA)
• Materials Engineering (AREA)
• Biotechnology (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Wood Science & Technology (AREA)
• Soil Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Medicinal Preparation (AREA)
• Compositions Of Macromolecular Compounds (AREA)
• Paints Or Removers (AREA)
• Pretreatment Of Seeds And Plants (AREA)
• Coating Of Shaped Articles Made Of Macromolecular Substances (AREA)
• Application Of Or Painting With Fluid Materials (AREA)

Priority Applications (2)

Applications Claiming Priority (4)

Publications (1)

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Family Applications (1)

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Cited By (2)

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Citations (2)

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• 1993
  • 1993-01-15 AU AU35839/93A patent/AU674840B2/en not_active Expired
  • 1993-01-15 KR KR1019940702463A patent/KR940703886A/ko active Granted
  • 1993-01-15 WO PCT/US1993/000383 patent/WO1993014158A1/en not_active Ceased
  • 1993-01-15 JP JP51042193A patent/JP3703481B2/ja not_active Expired - Fee Related
• 1995
  • 1995-03-06 US US08/400,134 patent/US5630871A/en not_active Expired - Lifetime
• 1997
  • 1997-05-19 US US08/858,787 patent/US5743947A/en not_active Expired - Lifetime

Patent Citations (3)

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