Coated fine particles containing drug for intrabuccally fast disintegrating tablet
The present invention makes it possible to provide drug-containing coated microparticles for quick-disintegrating oral tablets wherein microparticles containing a drug with an unpleasant taste are coated with a film composed of (1) a pH-independent water-insoluble polymer accounting for 60% or more but less than 80% of the film and (2) a pH-independent water-soluble substance accounting for more than 20% to 40% or less of the film, these microparticles being characterized in that the rate of dissolution of the drug from the drug-containing microparticles is 0% to 10% in one minute and 80% to 100% in 30 minutes, and the average particle diameter is 350 μm or less, in order to realize sufficient control of oral drug dissolution and fast gastrointestinal drug dissolution.
1 . Drug-containing coated microparticles for quick-disintegrating oral tablets wherein microparticles containing a drug with an unpleasant taste are coated with a film composed of
(1) a pH-independent water-insoluble polymer accounting for 60% or more but less than 80% of the film and
(2) a pH-independent water-soluble substance accounting for more than 20% to 40% or less of the film,
these microparticles being characterized in that the rate of dissolution of the drug from the drug-containing microparticles is 0% to 10% in one minute and 80% to 100% in 30 minutes, and the average particle diameter is 350 μm or less.
2 . The drug-containing coated microparticles for quick-disintegrating oral tablets according to claim 1 , characterized in that the pH-independent water-insoluble polymer is one or more selected from the group consisting of ethyl cellulose, aminoalkyl methacrylate copolymer RL, aminoalkyl methacrylate copolymer RS, and ethyl acrylate-methyl methacrylate copolymer.
3 . The drug-containing coated microparticles for quick-disintegrating oral tablets according to claim 1 , characterized in that the pH-independent water-soluble substance is one or more selected from the group consisting of hydroxypropylmethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, polyvinyl pyrrolidone, polyethylene glycol, polyethylene oxide, lactose, sucrose, mannitol, and maltose.
4 . The quick-disintegrating oral tablets containing drug-containing coated microparticles for quick-disintegrating oral tablets according to claim 1.