摘要:
The invention relates to a coating composition suitable for the coating of a pharmaceutical or nutraceutical dosage form, comprising a core comprising one or more pharmaceutical or nutraceutical active ingredients, wherein the coating composition is comprising at least 20% by weight of an enteric core/shell polymer composition derived from an emulsion polymerization process, wherein either the core of the core/shell polymer composition is formed by a water-insoluble, not cross-linked polymer or copolymer and the shell of the core/shell polymer composition is formed by an anionic polymer or copolymer or vice versa.
摘要:
The invention relates to a process for preparing a (meth)acrylate copolymer containing quaternary ammonium groups from a monomer mixture selected from: (a) 80 to 99 % by weight of a C1-C4-alkyl ester of acrylic acid or methacrylic acid; and (b) 20 to 1 % by weight of an alkyl ester of acrylic acid or methacrylic acid with a quaternary ammonium group in the alkyl radical; and (c) 0 to 10 % of further copolymerizable vinyl monomers whereby one or more polymerization initiators, optionally one or more molecular weight regulators and one or more solvents or of a solvent mixture are added to the monomer mixture to give a polymerization mixture, which is polymerized at temperatures from 30 to 120 C over a period of 2 to 24 hours, where the polymerization mixture is polymerized to a polymerization syrup with a conversion of the monomers to the copolymer of at least 99 % by weight, where the polymerization syrup is subsequently degassed by distillation or by extrusion and the degassed polymerization syrup is further comminuted to a copolymer preparation in the form of a granulate or powder and where the copolymer preparation is characterized by a molecular weight (Mw) of 25.000 to 50.000, a polydispersity index of 2.0 to 3.0 and a residual solvent concentration of less than 10.000 ppm by weight.
摘要:
The present invention provides a process for converting a solid (meth)acrylate copolymer into a dispersed form by preparing an aqueous dispersion comprising the components (a) a (meth)acrylate copolymer which is composed of free-radical polymerized methyl methacrylate, ethylacrylate and a salt of 2-trimethylammoniumethyl methacrylate, present in solid form as a powder or as a granulate, (b) up to 50% by weight calculated on the (meth)acrylate copolymer (a) of a dispersing agent selected from the groups of (b) i) plasticizers in combination with emulsifiers and/or (b) ii) pharmaceutically acceptable carbohydrates having 6 to 18 carbon atoms with a functional group and (c) water by mixing the components (a), (b) and (c) to give a suspension which becomes an aqueous dispersion during the conversion of the solid (meth)acrylate copolymer into the dispersed form, characterized in that, the (meth)acrylate copolymer is converted into the dispersed form by means of the presence of the dispersing agent at a temperature of less than 50° C.
摘要:
The invention relates to a medicament in a multilayer form, containing a) a core with a pharmaceutical agent, b) an inner coating, 50 to 95 percent by weight of which are composed of a (co)polymer comprising 95 to 100 percent by weight of radically polymerized vinylic monomers with neutral side groups and 0 to 5 percent by weight of monomers with anionic side groups, c) an outer coating made of a copolymer comprising 75 to 95 percent by weight of radically polymerized C 1 to C 4 alkyl esters of acrylic acid or methacrylic acid and 5 to 25 percent by weight of (meth)acrylate monomers with an anionic group in the alkyl radical. Said medicament further contains 5 to 30 percent by weight of common pharmaceutical auxiliaries, particularly emollients. The inventive medicament is characterized in that the inner coating contains 5 to 50 percent by weight of common pharmaceutical auxiliaries which are no expanding agents while the amount of expanding agents provided is less than 5 percent by weight.
摘要:
The invention concerns a macroporous material in the form of plastic pearls, having an average particle diameter ranging between 10 and 1000 νm, containing a copolymer consisting of: a) 5 to 60 wt. % of monomers capable of being subjected to vinyl polymerization, being at least 1 % water soluble at 20 °C; b) 1 to 40 wt. % of monomers capable of being subjected to vinyl polymerization, comprising an additional functional group capable of being covalently bound to nucleophilic groups of ligands, during a polymerization-like reaction; c) 10 to 40 wt. % of hydrophilic monomers capable of being subjected to a crosslinking free radical polymerization, comprising at least two ethylenically unsaturated polymerisable groups; and d) 10 to 60 wt. % of monomers capable of the subjected to vinyl polymerization, not more than 1 % water soluble at 20 °C, the sum of the monomers a) through d) being generally equal to 100 %.
摘要:
The invention relates to a dispersion that is suitable for the use as a coating and binding means for forms of medicaments. The inventive dispersion has a solids content of 10 to 70 wt. % and consists of a) 90 to 99 wt. % of a methacrylate copolymer which consists of at least up to 90 wt. % of (meth)acrylate monomers and detects a glass temperature Tg of 20 °C to +20 °C according to the DSC method, whereby said monomers have neutral radicals. Said dispersion also consists of 1-10 wt. % of a non-ionic emulsifier having an HLB value of 15.2 to 17.3.
摘要:
The invention relates to a dispersion that is suitable for the use as a coating and binding means for forms of medicaments. The inventive dispersion has a solids content of 10 to 70 wt. % and consists of a) 90 to 99 wt. % of a methacrylate copolymer which consists of at least up to 90 wt. % of (meth)acrylate monomers and detects a glass temperature Tg of 20 °C to +20 °C according to the DSC method, whereby said monomers have neutral radicals. Said dispersion also consists of 1-10 wt. % of a non-ionic emulsifier having an HLB value of 15.2 to 17.3.
摘要:
The invention relates to a method for the production of a coating and excipient agent for oral or dermal dosage forms, consisting of (a) 35-98 % by weight of a copolymer consisting of radically polymerized C1-C4 esters of acrylic or methacrylic acid and additional (meth)acrylate monomers having functional tertiary ammonium groups and (b) 1-50 % by weight of a softener and 1-15 % by weight of an emulgator with an HLB value of less than 14, wherein constituents (a), (b) and (c) are mixed with or without adding water and optionally adding a pharmaceutical active substance and other conventional additives and the coating and excipient agent is produced by melting, casting, spreading or spraying. The invention is characterized in that the copolymer (a) is applied in powder form with a mean particle size of 1-40 νm.