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Dosage form comprising time-pulsatile release beads
专利权人:
INC.;APTALIS PHARMATECH
发明人:
VENKATESH, GOPI
申请号:
NZ59168806
公开号:
NZ591688A
申请日:
2006.05.01
申请国别(地区):
NZ
年份:
2012
代理人:
摘要:
Disclosed is a pharmaceutical composition comprising one or more populations of timed, pulsatile release beads, wherein at least one population of time-pulsatile release beads comprises: (a) a core particle comprising a basic active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof, wherein said core particle comprises: (i) an inert particle coated with said basic active pharmaceutical ingredient and optionally a polymeric binder, wherein said polymeric binder is selected from the group consisting of polyvinylpyrrolidone, methylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, corn starch, pregelatinized starch, and mixtures thereof; or (ii) a pellet, mini- or micro-tablet, microgranule, or granular particle containing said basic active pharmaceutical ingredient; (b) an inner barrier coating comprising a water-insoluble polymer in combination with a water-soluble/pore-forming polymer, wherein said water-insoluble polymer is selected from the group consisting of ethylcellulose, cellulose acetate, cellulose acetate butyrate, polyvinyl acetate, methylmethacrylate ester polymers, neutral copolymers based on ethylacrylate and methylmethacrylate, copolymers of acrylic and methacrylic acid esters, and mixtures thereof, and wherein said water-soluble/pore-forming polymer is selected from the group consisting of polyvinylpyrrolidone, methylcellulose, hydroxypropylcellulose, hydroxypropyl ethylcellulose, polyethylene glycol, and mixtures thereof; and(c) an outer lag-time coating comprising a water-insoluble polymer in combination with an enteric polymer, wherein said enteric polymer is selected from the group consisting of cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose succinate, polyvinyl acetate phthalate, pH-sensitive methacrylic acid-methylmethacrylate copolymers, shellac, derivatives thereof, and mixtures thereof; wherein the population of timed, pulsatile release beads provides a
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