WO2013045352A1 - Procédé de fabrication d'agents de pelliculage solides contenant des pigments, sous forme de granulés à base d'agents filmogènes gastrorésistants pour l'enrobage de formes galéniques - Google Patents

Procédé de fabrication d'agents de pelliculage solides contenant des pigments, sous forme de granulés à base d'agents filmogènes gastrorésistants pour l'enrobage de formes galéniques Download PDF

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Publication number
WO2013045352A1
WO2013045352A1 PCT/EP2012/068603 EP2012068603W WO2013045352A1 WO 2013045352 A1 WO2013045352 A1 WO 2013045352A1 EP 2012068603 W EP2012068603 W EP 2012068603W WO 2013045352 A1 WO2013045352 A1 WO 2013045352A1
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Prior art keywords
weight
granules
pigments
enteric
plasticizer
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PCT/EP2012/068603
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German (de)
English (en)
Inventor
Angelika Maschke
Karl Kolter
Kathrin MEYER-BÖHM
Thorsten Schmeller
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Basf Se
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Publication of WO2013045352A1 publication Critical patent/WO2013045352A1/fr

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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/501—Inorganic compounds

Definitions

  • the present invention relates to a novel process for the preparation of solid pigment-containing film coating compositions in the form of granules based on enteric film formers for coating pharmaceutical dosage forms. Furthermore, the invention relates to the corresponding granules and their use for the production of gastric juice-resistant coated dosage forms.
  • Enteric film-forming agents and pigment-containing granules obtained therefrom for the production of pharmaceutical film coatings are known per se.
  • enteric are referred to in the prior art polymers that are insoluble in acidic and soluble from a pH in the range of 4.5 to 6.5 by dissociation of the carboxylic acid group with salt formation, so that at 37 +/- 0.5 ° C from After 2 hours, only a maximum of 10% by weight of the amount of active substance is released into a polymer-coated active substance-containing core in 750 ml of 0.1N HCl, in phosphate buffer, at pH 6.8, but the release of at least 90% by weight within 45 minutes.
  • the pigment-containing granules should also be stable on storage, do not stick together and, above all, do not segregate, since this adversely affects the meterability during further processing.
  • EP-A 152038 describes the preparation of pigmented pharmaceutical coating compositions based on enteric polymers, the coating composition being obtained by mixing an aqueous dispersion of the enteric polymer with a pigment suspension.
  • DE-A 3127237 describes the preparation of pigmented coating compositions based on (meth) acrylic acid polymers, in which an aqueous dispersion of the polymers is mixed with polyethylene glycol, talc and titanium dioxide. Similar aqueous coating agents are also described in US 3,935,326.
  • EP-A 342 106 describes aqueous coating compositions comprising PEG 6000 based on (meth) acrylic acid copolymers such as Eudragit L30D and Eudragit NE 30D, which are obtained using the aqueous dispersions of the copolymers.
  • EP 194 838 describes aqueous coating compositions which are obtained by adding microcrystalline cellulose, PEG 6000 and water to an aqueous Eudragit L30D-55 dispersion and subsequent mixing in a high-speed mixer.
  • WO 2007/006353 describes the use of acidic (meth) acrylate copolymers in partially neutralized form for the preparation of coating compositions, wherein the coating compositions may in principle also comprise relatively high molecular weight polyethylene glycols as plasticizers. Specifically described, however, are only aqueous coating compositions containing triacetin as a plasticizer.
  • WO 2009/004649 describes the preparation of an enteric coating agent in which an aqueous dispersion of a methacrylic acid copolymer is admixed with PEG 6000, talc, titanium dioxide, polysorbate 80 and sodium hydroxide. US Pat. No.
  • 4,556,552 describes the preparation of enteric coating compositions in which a dry mixture of polyvinyl acetate phthalate, PEG 3350, aluminum lakes and other constituents is mixed in a double-walled mixer and subsequently ground in a hammer mill.
  • dry powdered pharmaceutical coating compositions are obtained by mixing a dry mixture of a polymer with titanium dioxide, PEG 400 and other ingredients in a mixer and then comminuted by grinding.
  • WO 2010/132204 describes the preparation of pulverulent coating compositions of polyvinyl alcohol, methacrylic acid / ethyl acrylate copolymer, sodium bicarbonate, talc, titanium dioxide and solid polyethylene glycol by dry mixing of the components in a mixer.
  • No. 6,420,473 describes solid pulverulent coating compositions which are obtained by mixing methacrylic acid-ethyl acrylate copolymer powder with sodium bicarbonate and other solid constituents such as titanium dioxide, talc and other auxiliaries in a mixer in a first step, and the resulting product solid mixture then mixed with the plasticizer triethyl citrate.
  • the dry powder thus obtained is then redispersed in water in a vortex mixer.
  • such dry mixtures are not satisfactorily storage stable.
  • the object of the present invention was to provide dry powdery free-flowing granules with low dust contents for pharmaceutical enteric coating compositions which do not have the disadvantages of the prior art ,
  • a process for the production of pigment-containing granules for pharmaceutical applications based on film-forming enteric polymers which is characterized in that the granules are produced by a spray process in which the enteric polymer film former in a fluidized bed and an aqueous pigment suspension containing a solid at 20 ° C plasticizer is sprayed onto the fluidized bed.
  • enteric polymers are polymers which under normal conditions (room temperature 20 to 25 ° C., atmospheric pressure) have a solubility of less than 1% by weight at pH values below 4.5 and a pH of above 6.5 in water Have solubility of more than 10 wt .-% and up to 70 wt .-%.
  • cellulose derivatives such as, for example, hydroxypropylmethylcellulose phthalates, cellulose acetate phthalates or hydroxypropylmethylcellulose acetate succinates.
  • methacrylic acid-acrylate copolymers are used as enteric film formers.
  • methacrylic acid acrylates according to the invention generally copolymers of methacrylic acid are referred to, which are enteric-soluble.
  • copolymers of methacrylic acid and ethyl acrylate in the monomer ratio of 1: 1 can be used as enteric film formers.
  • methacrylic acid acrylate polymers are commercially available. Particular preference is given to copolymers of methacrylic acid and ethyl acrylate in the monomer ratio 1: 1 (PMEA 1: 1) with average molecular weights M w in the range from 250,000 to 280,000. The molecular weight distribution was determined by gel permeation chromatography in comparison with a polymethyl methacrylate (PMMA) standard. The copolymers can also be used partially neutralized.
  • Kollicoat® MAE 100P is a commercially available powdered PMEA 1: 1 copolymer that has been partially neutralized with sodium hydroxide so that the acid groups are present in the range of 6 mol% neutralized.
  • This powdery polymer has particle sizes of 155 ⁇ m ((d (4.3) volume average) as determined by light diffraction The measurement can be carried out with a Malvern Mastersizer.
  • enteric polymers which have not previously been partially neutralized, for example Eudragit® L100 types
  • an addition of alkali takes place during the agglomeration in order to ensure adequate redispersibility of the granules.
  • alkali may in this case be given as a powder to the template consisting of solid enteric polymer or it may be dissolved in the spray solution.
  • the template consisting of solid enteric polymer is first sprayed with an aqueous solution of the alkali additive and only then does the spraying of the other components take place.
  • Suitable alkali additions are: alkali metal or alkaline earth metal hydroxides, alkali metal or alkaline earth metal carbonates, alkali metal or alkaline earth metal bicarbonates, basic salts of physiologically tolerated acids, such as. Trisodium phosphate, trisodium citrate
  • the enteric polymers can be used in amounts such that 50 to 93 wt .-%, based on the solids content, preferably 70 to 90 wt .-% of enteric polymer contained in the finished granular film coating agent.
  • the enteric polymers are submitted according to the invention as a powder in a fluidized bed.
  • the pulverulent polymers used can have particle sizes in the range from 50 ⁇ m to 800 ⁇ m.
  • inorganic pigments or organic pigments or mixtures thereof can be used as pigments in the granular film coating agent.
  • White pigments are preferably used as pigments.
  • Particularly suitable pigments are titanium dioxide, zinc oxide, kaolin, calcium or magnesium phosphates, silicon dioxide, bentonite or silicates.
  • Talcum is also basically suitable as a pigment, but is referred to as a detackifying agent in the context of this invention.
  • the pigments can be added in amounts such that from 2 to 30% by weight, preferably from 2 to 18% by weight, based on the solids content, of pigment are contained in the finished film coating composition.
  • plasticizers are added to the aqueous pigment dispersions.
  • the granular film coating agent already contains the plasticizers.
  • Suitable plasticizers are in principle all plasticizers customary in the field of pharmaceutical formulations, which are solid at 20 ° C. and atmospheric pressure. In small quantities, additional liquid plasticizers may be added.
  • plasticizers are used which have melting points of from 30 to 100.degree
  • polyethylene glycols having molecular weights of greater than 600 g / mol to 15,000 g / mol, preferably 1,500 to 8,000 g / mol, can be used as the plasticizer.
  • polyethylene glycol-polyvinyl alcohol copolymers can be used as plasticizers, for example, the commercially available Kollicoat® IR, BASF SE, a
  • poloxamers ie polyethylene oxide-polypropylene oxide block copolymers, for example Poloxamer 407, commercially Lutrol® F127 (average relative molecular weight 9840-14600) or Poloxamer 188, commercially Lutrol® F86 (average relative molecular weight 7680-9510).
  • PEG polyethylene glycols
  • the plasticizers may be added in amounts such that from 5 to 25% by weight, preferably from 7 to 15% by weight, based on the solids content of the granules, of plasticizer are present in the finished film coating composition.
  • the aqueous pigment dispersions additionally contain detackifying agents. If detackifiers are used, they may be added in amounts of from 1 to 20, preferably from 5 to 20,% by weight, based on the solids content of the granules.
  • Suitable sticking agents are, for example, talc, silicates, glycerol monostearate, stearic acid, stearyl alcohol.
  • talc is used as a detackifier.
  • talcum is calculated in terms of amounts as a detackifier.
  • the starting materials pigments, plasticizers and anti-sticking agents are used in total in amounts such that the aqueous pigment dispersions have contents of from 5 to 40% by weight.
  • compositions are: (vi) 70 to 90% by weight of enteric polymers
  • compositions are:
  • the granules contain from 75 to 80% by weight of a partially neutralized copolymer of methacrylic acid and ethyl acrylate in a monomer ratio of 1: 1, 2 to 8% by weight of pigments, 10 to 15% by weight of a polyethylene glycol Molecular weights in the range of 1500 to 6000 daltons as a plasticizer and 7 to 12 wt .-% talc as a detackifier.
  • the preparation process according to the invention takes place in such a way that an aqueous pigment dispersion containing a plasticizer which is solid at 20.degree. C. is sprayed onto a fluidized bed of the powdery enteric polymer film former.
  • the production takes place by a spray agglomeration process.
  • the spray agglomeration process can be carried out batchwise, semi-continuously or continuously.
  • the method is performed as a batch process, wherein a defined amount of the powdery polymeric film former is presented.
  • the amount of polymeric film former present in the fluidized bed depends on the size of the spray device.
  • the particle size of the enteric polymer introduced in the fluidized bed is in the range of 50 ⁇ m to 800 ⁇ m (average particle diameter, d (4.3) value, weighted volume average), preferably 100 to 400 ⁇ m.
  • the supply air temperature in the spray process is less than 100 ° C, preferably less than 90 ° C, more preferably less than 60 ° C. Which supply air temperature is selected depends on the desired product temperature in the fluidized bed. In particular, the supply air temperature is 20 to 50 ° C.
  • the exhaust air humidity in the spray process is usually in the range of 20 to 50% relative humidity.
  • the product temperature in the fluidized bed can be in the range from 15 to less than 60 ° C., preferably in the range from 20 to 50 ° C., particularly preferably from 25 to 45 ° C.
  • the spray pressure of the aqueous pigment dispersion can be in the range from 0.05 to 0.5 MPa, preferably 0.01 to 0.4 MPa, particularly preferably 0.01 to 0.3 MPa. According to one embodiment of the invention, the spraying process is carried out at Zu Kunststoffem- temperatures of 20 to 50 ° C and a product temperature of 20 to 50 ° C.
  • a further process step can be carried out, in which an aqueous dispersion of the enteric polymer is sprayed onto the preformed granules.
  • an aqueous dispersion of the enteric polymer is sprayed onto the preformed granules.
  • the aqueous dispersions of the enteric polymer can be adjusted to solids contents of 10 to 30% by weight.
  • the aqueous dispersion is not warmer than 40 ° C during processing and is cooled, if necessary, prior to spraying. Preferably cooled to 20-25 ° C.
  • the particle sizes of the resulting granules in the range of 200 to 1000 ⁇ (d (4.3) value, weighted volume average, determined by light diffraction), preferably in the range of 250 to 600 ⁇ .
  • the granules thus obtained are suitable for the production of coating compositions for the production of enteric coated drug forms.
  • dosage forms which are also referred to as “Delayed Release Dosage Forms" in Anglo-American terminology, release less than 10% of the active substance within 120 minutes after oral administration The release is determined according to USP ⁇ 71 1>: 120 min gastric juice. then rebuffering (0.08 M HCL as gastric juice, after 2 h rebuffering to pH 6.8 with phosphate buffer).
  • the granules according to the invention which have a white or whitish appearance due to their titanium dioxide content, can also be mixed with further pigments or pigment preparations to obtain colored coatings.
  • the coating compositions according to the invention are suitable for mixing with commercially available colored ready-to-use
  • Coating compositions based on polyether-polyvinyl alcohol graft copolymers which are obtainable under the brand name Kollicoat® IR Coating Systems from BASF SE. It acts it is colored ready-to-use coating agent from 58.1 wt .-% Kollicoat IR (graft polymer polyethylene glycol-polyynyl alcohol in the ratio 25:75, average molecular weight 45,000) 6.4% Kollidon® VA 64, 8.4% Ti0 2 , 1 .9% sodium lauryl sulfate, 9.9% color pigment , Although these colored finish coaters are intended for the use of instant release dosage forms, they can be mixed in appropriate amounts with the granules of the invention without the resulting colored coatings losing their gastroresistance.
  • Kollicoat® IR Coating Systems from BASF SE. It acts it is colored ready-to-use coating agent from 58.1 wt .-% Kollicoat IR (graft polymer polyethylene glycol-polyynyl alcohol in the ratio 25:
  • the colored finished mixtures are preferably mixed with the granules according to the invention in amounts such that the resulting colored coating composition contains from 70 to 98% by weight, preferably from 80 to 95% by weight, based on the solids content, of granules according to the invention.
  • plasticizers such as, for example, triacetin, triethyl citrate, diethyl sebacate, acetyl triethyl citrate, propylene glycol, polyethylene glycol 300-600 can be added to the redispersed granular coating compositions.
  • auxiliaries can be used:
  • Viscosity increasing polymers such as e.g. Xanthan, carrageenan, alginate, pectin, hydroxypropyl-imethylcellulose, surfactants such as e.g. Sodium lauryl sulfate, Cremophor® RH 40, Polysorbate 80, Eurulgin® 2 PH, brighteners, dispersing agents protective colloids antioxidants (e.g., butylhydroxytoluene, butylhydroxyanisole, N-acetylcysteine), lipophilizing agents.
  • surfactants such as e.g. Sodium lauryl sulfate, Cremophor® RH 40, Polysorbate 80, Eurulgin® 2 PH, brighteners, dispersing agents protective colloids antioxidants (e.g., butylhydroxytoluene, butylhydroxyanisole, N-acetylcysteine), lipophilizing agents.
  • the granules according to the invention are stirred with a simple stirrer, e.g. a paddle stirrer, redispersed in water. This redispersion is usually complete after 10 minutes and the spray suspension can be used. Due to the special granular structure there is no clumping.
  • the granules of the invention can be added in large quantities in a short time.
  • the coating agents can be used to coat tablets, hard capsules, soft capsules, pellets, granules, crystals, extrudates.
  • granules obtained by the process according to the invention can be processed into aqueous coating compositions whose properties avoid the problems of the prior art. Above all, the very good redispersibility was surprising.
  • the very good flow properties offer great advantages in processing, above all because of the good metering. This is of fundamental importance for reasons of drug safety. Particularly noteworthy is the absence of dust granules of the invention, which is particularly important when processing under GMP conditions (Good Manufacturing Practice) because of the risk of cross-contamination. Furthermore, it leads to time savings due to the avoidance of expensive cleaning procedures with dust contaminated equipment and environment. In addition, the staff does not breathe dust.
  • the light components at the top and the heavy ones at the bottom collect with simple powder mixtures. Also, a separation often takes place according to size and structure of the particles. As a result, the polymer can separate from the pigment and the plasticizer with the aforementioned fatal consequences.
  • the granules of the invention are completely stable against segregation.
  • the pigments T1O2 and talc were dispersed in water and then the plasticizer was dissolved in this pigment suspension.
  • the spray suspension was adjusted to solids contents of 35 or 40% solids content, the dynamic viscosity was in the range of 25-35 mPas as determined by a rotational viscometer (Haake Rheowin 322) at 23 ° C.
  • Kollicoat MAE 100 P from BASF SE, in the fluidized bed (PMEA 1: 1 copolymer partially neutralized with sodium hydroxide so that the acid groups are neutralized in the range of 6 mol%, Mw 250,000) was introduced as a gastric juice-resistant film former.
  • the polymer powders contain, based on the total solids content, 0.7% sodium lauryl sulfate and 2.3% by weight polysorbate 80.
  • composition of the resulting agglomerates figures in% by weight
  • Example 1 the resulting granules had particle sizes in the range of 329 ⁇ (weighted volume average d (4.3), light diffraction).
  • the agglomeration was carried out in a Glatt device (Glatt GPCG 3).
  • the loading of the fluidized bed, the spray rates and the supply air temperatures were varied as indicated below.
  • Product temperature is maintained in the range of 25-30 ° C
  • composition of the tabletting mixture (in% by weight)
  • Tablet format 9 mm, arched with engraving
  • aqueous spray suspensions were prepared with the agglomerates obtained according to Examples 1 to 5, the agglomerates being stirred at room temperature for 120 minutes. The concentration was chosen to give spray suspensions with solids contents of 20% by weight.
  • a Manesty XL Lab 01 laboratory tablet coater was used. Process Parameters Manesty XL Lab 01
  • Drum size 7 I tablet volume (middle drum)
  • the coated tablets were subjected to a mechanical stress test by loading for 4 minutes in the Friabilator.
  • the conditions and the device were used, according to the PharmEur. 7.0. , Chapter 2.9.7. for friability determinations on uncoated tablets. Brittle films would be damaged and would show a poorer gastric juice resistance.
  • Titanium dioxide 2.65% 45g
  • a 20 wt .-% spray suspension was prepared by adding the appropriate amount of granules in deionized water and stirred for 90 min at room temperature.
  • the tablets were loaded in the friabilator for 4 minutes to check the influence of the burden on the gastric juice resistance.
  • the preparation was carried out as in Example 1, except that the amount of Kollicoat MAE in the fluidized bed was reduced by 5% by weight, based on the total amount of Kollicoat MAE. This portion was dispersed in water and sprayed as a 20 wt .-% tige spray suspension on the finished granules.
  • a granulate obtained according to Example 1 was mixed with a colored finished coating composition +) in the mixing ratios of granules to Kollicoat IR CS of 80:20 and 90:10 and with triacetin as plasticizer as indicated below and sprayed onto the tablet cores described above.
  • Kollicoat® IR Coating Systems from BASF SE (Kollicoat IR CS): colored, ready-to-use coating compositions comprising 58.1% by weight of Kollicoat IR (graft polymer of polyethylene glycol)
  • Triacetin 7.4% 8.2% The aqueous spray suspension was prepared so that the solids content was 20% by weight. To prepare the spray suspension, the water was first weighed, then the plasticizer was added and dissolved. Subsequently, the granules were added according to Example 1 and stirred for 4 hours with a paddle stirrer until a homogeneous dispersion was achieved. Then the respective amounts of Kollicoat IR Brilliant Blue or Yellow were added and stirred overnight under room conditions. The tablet cores were coated with the finished colored spray suspension as indicated below.
  • the preparation was carried out analogously to Examples 1 to 5.

Abstract

Procédé de fabrication de granulés contenant des pigments pour applications pharmaceutiques, à base de polymères filmogènes gastrorésistants, caractérisé en ce que les granulés sont fabriqués par un procédé de pulvérisation selon lequel l'agent filmogène polymère gastrorésistant est placé dans un lit fluidisé et une suspension de pigments aqueuse contenant un plastifiant solide à 20 °C est pulvérisée sur le lit fluidisé.
PCT/EP2012/068603 2011-09-30 2012-09-21 Procédé de fabrication d'agents de pelliculage solides contenant des pigments, sous forme de granulés à base d'agents filmogènes gastrorésistants pour l'enrobage de formes galéniques WO2013045352A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10912835B2 (en) 2012-03-09 2021-02-09 Basf Se Production of pharmaceutical protective coatings with good resistance in a neutral environment

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