Coated particles with prolonged release and tablets containing same
First Claim
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1. A multiparticulate tablet comprising sustained-release coated particles and a mixture of excipients, wherein said mixture of excipients comprises:
- a disintegrant and/or swelling agent,at least one diluent, anda lubricant,and said sustained-release coated particles comprise;
a core comprising at least one active principle and at least one binder,a coating film consisting of ethylcellulose which ensures sustained release of the active principle and none, one or more of a pore-forming agent, a surfactant, an antistatic agent and a lubricant, andat least one thermoplastic agent which is applied as a protective coating onto the coating film, wherein said thermoplastic agent is selected from the group consisting of partially hydrogenated oils, beeswax, carnauba wax, paraffin waxes, silicone waxes, fatty alcohols, C12-C18 fatty acids, solid semisynthetic glycerides, glyceryl monoesters, diesters or triesters, polyoxyethylene glycols, polyoxyethylenated glycosyl glycerides, and mixtures thereof, and wherein said thermoplastic agent has a melting point of from about 25°
C. to about 100°
C.,and wherein a proportion of the mixture of excipients relative to the coated particles is from 1 to 5 parts by weight.
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Abstract
The invention concerns coated particles with prolonged release, a method for preparing same and multiparticulate tablets comprising said coated particles.
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Citations
23 Claims
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1. A multiparticulate tablet comprising sustained-release coated particles and a mixture of excipients, wherein said mixture of excipients comprises:
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a disintegrant and/or swelling agent, at least one diluent, and a lubricant, and said sustained-release coated particles comprise; a core comprising at least one active principle and at least one binder, a coating film consisting of ethylcellulose which ensures sustained release of the active principle and none, one or more of a pore-forming agent, a surfactant, an antistatic agent and a lubricant, and at least one thermoplastic agent which is applied as a protective coating onto the coating film, wherein said thermoplastic agent is selected from the group consisting of partially hydrogenated oils, beeswax, carnauba wax, paraffin waxes, silicone waxes, fatty alcohols, C12-C18 fatty acids, solid semisynthetic glycerides, glyceryl monoesters, diesters or triesters, polyoxyethylene glycols, polyoxyethylenated glycosyl glycerides, and mixtures thereof, and wherein said thermoplastic agent has a melting point of from about 25°
C. to about 100°
C.,and wherein a proportion of the mixture of excipients relative to the coated particles is from 1 to 5 parts by weight. - View Dependent Claims (2, 3, 4, 7, 8, 9, 10, 11, 14, 18)
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5. A multiparticulate tablet comprising sustained-release coated particles and a mixture of excipients, wherein said mixture of excipients comprises:
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at least one disintegrant, at least one diluent, a lubricant, and optionally a swelling agent, a permeabilizer, sweeteners, and flavorings, and said sustained-release coated particles comprise; a core comprising at least one active principle and at least one binder, a coating film consisting of ethylcellulose which ensures sustained release of the active principle and none, one or more of a pore-forming agent, a surfactant, an antistatic agent and a lubricant, and at least one thermoplastic agent which is applied as a protective coating onto the coating film, wherein said thermoplastic agent is selected from the group consisting of partially hydrogenated oils, beeswax, carnauba wax, paraffin waxes, silicone waxes, fatty alcohols, C12-C18 fatty acids, solid semisynthetic glycerides, glyceryl monoesters, diesters or triesters, polyoxyethylene glycols and polyoxyethylenated glycosyl glycerides, and mixtures thereof, and wherein said thermoplastic agent has a melting point of from about 25°
C. to about 100°
C.,wherein the multiparticulate tablet is adapted to disintegrate in a mouth on contact with saliva in less than 60 seconds, forming a suspension that is easy to swallow, and wherein a proportion of the mixture of excipients relative to the coated particles is from 1 to 5 parts by weight. - View Dependent Claims (6, 22)
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12. A multiparticulate tablet comprising sustained-release coated particles and a mixture of excipients, wherein said mixture of excipients comprises:
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a disintegrant and/or swelling agent, at least one diluent, a lubricant, and an antistatic agent, a permeabilizer, sweeteners, flavorings and colorants, and said sustained-release coated particles comprise; a core comprising at least one active principle and at least one binder, a coating film consisting of ethylcellulose which ensures sustained release of the active principle and none, one or more of a pore-forming agent, a surfactant, an antistatic agent and a lubricant, and at least one thermoplastic agent which is applied as a protective coating onto the coating film, wherein said thermoplastic agent is selected from the group consisting of partially hydrogenated oils, beeswax, carnauba wax, paraffin waxes, silicone waxes, fatty alcohols, C12-C18 fatty acids, solid semisynthetic glycerides, glyceryl monoesters, diesters or triesters, polyoxyethylene glycols and polyoxyethylenated glycosyl glycerides, and mixtures thereof, and wherein said thermoplastic agent has a melting point of from about 25°
C. to about 100°
C.,and wherein a proportion of the mixture of excipients relative to the coated particles is from 1 to 5 parts by weight. - View Dependent Claims (13, 15, 16, 17, 19, 20, 21, 23)
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Specification