公开(公告)号：EP1429724B1

公开(公告)日：2013-11-06

申请号：EP02766426.7

申请日：2002-09-28

申请人： McNeil-PPC, Inc.

发明人： BUNICK, Frank, J. ,  GILMOR, Timothy, P ,  LABELLA, Gus, B ,  MCNALLY, Gerard, P ,  THOMAS, Martin ,  SOWDEN, Harry, S. ,  LEE, Der-Yang

IPC分类号： A61K9/00 ,  A61K9/20 ,  A23G3/00 ,  A23G3/04 ,  A61J3/06 ,  A61J3/10 ,  A61K9/28 ,  B30B11/08 ,  B30B11/34 ,  B30B15/30 ,  A23G3/36 ,  A23L1/09 ,  A61J3/00 ,  A23G3/54 ,  A23G1/54

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

公开(公告)号：EP1463489A1

公开(公告)日：2004-10-06

申请号：EP02799690.9

申请日：2002-09-28

申请人： McNEIL-PPC, INC.

发明人： BUNICK, Frank, J. ,  LEE, Der-Yang ,  MCNALLY, Gerard, P. ,  SOWDEN, Harry, S. ,  THOMAS, Martin

IPC分类号： A61K9/20

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： A composite dosage form comprises at least one active ingredient, a first portion comprising a first molded material, and a second portion comprising a second material which is compositionally different from the first material. The first and second portions are joined at an interface, and a surface of the first portion at the interface resides substantially conformally upon a surface of the second portion of the interface. Either the first portion, the second portion, or a combination thereof may contain at least one active ingredient. The first portion, second portion or both may also each comprise an insert which may contain at least one active ingredient. The dosage form may also comprise a third portion which is located between the first and second portions.

公开(公告)号：EP1429746A2

公开(公告)日：2004-06-23

申请号：EP02799684.2

申请日：2002-09-28

申请人： McNeil-PPC, Inc.

发明人： BUNICK, Frank, J. ,  SOWDEN, Harry, S. ,  THOMAS, Martin ,  BURKE, John ,  LEE, Der-Yang

IPC分类号： A61K9/28

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： In one embodiment, the dosage form of this invention comprises a core having an outer surface and a shell having outer and inner surfaces, wherein the shell surrounds the core such that the shell inner surface resides substantially conformally upon the core outer surface, the shell thickness is in the range of about 100-400 microns, the relative standard deviation of the shell thickness on the dosage form is less than about 30 %, the shell comprises less than about 50 % crystallizable sugar, and the dosage form is substantially free of charge control agents. In another embodiment, the dosage form comprises a core having an outer surface and a shell having outer and inner surfaces, wherein the shell surrounds the core, the dosage form moisture uptake at 60 minutes exposure to 40 °C and 75 % relative humidity is less than about 0.80 %, the shell thickness is in the range of about 100-400 microns, the relative standard deviation of the shell thickness on the dosage form is less than about 30 %, the dosage form is substantially free of charge control agents and the shell is substantially free of a raised seam.

公开(公告)号：EP1429724A1

公开(公告)日：2004-06-23

申请号：EP02766426.7

申请日：2002-09-28

申请人： McNeil-PPC, INC.

发明人： BUNICK, Frank, J. ,  GILMOR, Timothy, P ,  LABELLA, Gus, B ,  MCNALLY, Gerard, P ,  THOMAS, Martin ,  SOWDEN, Harry, S. ,  LEE, Der-Yang

IPC分类号： A61K9/00 ,  A61K9/20 ,  A23G3/00

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： A dosage form comprises an active ingredient and a confectionery composition. In one embodiment the relative standard deviation of the weight of the dosage form is less than 1%, and the dosage form has at least one face. In another embodiment, a dosage form comprising an active ingredient and a confectionery composition wherein the dosage form has at least one face, does not have a free formed surface, and has a mean polarized light transmission at the angle of maximum extinction which is not greater than the mean polarized light transmission of the dosage form at the angle of maximum transmission. The active ingredient may be a pharmaceutically active agent.

公开(公告)号：EP1438028A1

公开(公告)日：2004-07-21

申请号：EP02799682.6

申请日：2002-09-28

申请人： McNEIL-PPC, INC.

发明人： LEE, Der-Yang ,  LI, Shun-Por ,  SOWDEN, Henry, S. ,  THOMAS, Martin ,  WYNN, David

IPC分类号： A61K9/20

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： In one embodiment a dosage form comprises at least one active ingredient and a molded matrix which comprises from 10 to 100% of a material having a melting point of less than about 100 degrees C selected from the stamp consisting of thermoplastic polyalkylene oxides, low melting hydrophobic materials, thermoplastic polymers, thermoplastic starches and combinations thereof, and the matrix is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium. The dosage form may additionally comprise uncoated particles which may contain at least one active ingredient. In another embodiment, a dosage form comprises at least one active ingredient, a plurality of particles and a molded matrix, wherein at least a portion of the particles are coated. The coated particles, the matrix or both may comprise at least one active ingredient, and the coated particles or the matrix or a combination thereof is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium.

公开(公告)号：EP1429743A1

公开(公告)日：2004-06-23

申请号：EP02773676.8

申请日：2002-09-28

申请人： McNEIL-PPC, INC.

发明人： BUNICK, Frank, J. ,  LEE, Der-Yang ,  MCNALLY, Gerard, P. ,  THOMAS, Martin ,  SOWDEN, Harry, S.

IPC分类号： A61K9/28

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： A dosage form comprises an active ingredient, a core having an outer surface and a first shape and a shell having outer and inner surfaces and a second shape, in which the shell surrounds at least a portion of the core, and the first and second shapes are substantially different. In one embodiment the shell comprises at least about 80% of a flowable material selected from the group consisting of film formers, gelling polymers, thermoplastic materials, low melting hydrophobic materials, non-crystallizable sugars, non-crystallizable sugar-alcohols, and mixtures thereof. In another embodiment the shell is substantially free of pores having a diameter of 0.5 to 5.0 microns. In another embodiment, the core and shell each having a different number of planes of symmetry with respect to the same reference axis. In another embodiment, the distance from the core outer surface to the shell outer surface is different at two different points located on the core outer surface and the difference is greater than about 125 microns. Either the core, the shell, or a combination thereof may contain at least one active ingredient. The core and shell may each be molded or compressed. The core may also comprise an insert which may contain at least one active ingredient. The shape of the core may be chosen so as to permit modified release of active material in the core upon breach of the shell or provides a modified release profile for the active material in the core.

公开(公告)号：EP1429738A2

公开(公告)日：2004-06-23

申请号：EP02783988.5

申请日：2002-09-28

申请人： McNeil-PPC, INC.

发明人： LEE, Der-Yang ,  LI, Shun-Por ,  PARIKH, Narendra ,  SOWDEN, Harry, S. ,  THOMAS, Martin ,  WYNN, David

IPC分类号： A61K9/20

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： A dosage form comprises: (a) a core comprising at least one active ingredient; and (b) a molded shell which surrounds the core, wherein the shell provides a predetermined time delay of greater than one hour for the onset of dissolution of the active ingredient upon contacting of the dosage form with a liquid medium and the delay is independent of the pH of the liquid medium. The weight of the shell may be at least 50 percent of the weight of the core, and the shell may have a thickness of about 500-4000 microns, or be substantially free of pores having a diameter of 0.5 to 5 microns.

摘要翻译： 剂型包含：（a）包含至少一种活性成分的核心; 和（b）围绕核心的模制外壳，其中该外壳提供大于一小时的预定时间延迟，用于活性成分在剂型与液体介质接触时开始溶解，延迟独立于 液体介质的pH值。 壳的重量可以是芯的重量的至少50％，并且壳可以具有约500-4000微米的厚度，或者基本上不具有直径为0.5-5微米的孔。

公开(公告)号：EP1429742B1

公开(公告)日：2011-05-04

申请号：EP02766427.5

申请日：2002-09-28

申请人： McNeil-PPC, Inc.

发明人： LEE, Der-Yang ,  LI, Shun-Por ,  PARIKH, Narendra ,  MCTEIGUE, Dan ,  SOWDEN, Harry, S. ,  THOMAS, Martin ,  WYNN, David

IPC分类号： A61K9/28

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： In one embodiment, a dosage form comprises: (a) at least one active ingredient; (b) a molded core which is solid at room temperature; and (c) a shell which is in contact with at least a portion of the core, wherein the dosage form provides modified release of the active ingredient upon contacting of the dosage form with a liquid medium. In another embodiment of this invention, a dosage form comprises: (a) at least one active ingredient; (b) a molded core comprising a plurality of particles; and (c) a shell which is in contact with at least a portion of the core, wherein the dosage form provides modified release of the active ingredient upon contacting of the dosage form with a liquid medium.

公开(公告)号：EP1429738B1

公开(公告)日：2007-10-31

申请号：EP02783988.5

申请日：2002-09-28

申请人： McNEIL-PPC, Inc.

发明人： LEE, Der-Yang ,  LI, Shun-Por ,  PARIKH, Narendra ,  SOWDEN, Harry, S. ,  THOMAS, Martin ,  WYNN, David

IPC分类号： A61K9/20

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

公开(公告)号：EP1429745A2

公开(公告)日：2004-06-23

申请号：EP02782085.1

申请日：2002-09-28

申请人： McNEIL-PPC, INC.

发明人： LEE, Der-Yang ,  SOWDEN, Harry, S. ,  THOMAS, Martin

IPC分类号： A61K9/28

CPC分类号： A23G3/04 ,  A23G1/54 ,  A23G3/0029 ,  A23G3/368 ,  A23G3/54 ,  A23L29/30 ,  A61J3/005 ,  A61J3/06 ,  A61J3/10 ,  A61K9/0004 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2068 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/209 ,  A61K9/2095 ,  A61K9/282 ,  A61K9/2826 ,  A61K9/284 ,  A61K9/286 ,  A61K9/2873 ,  A61K9/2886 ,  A61K9/2893 ,  A61K9/5084 ,  B30B11/08 ,  B30B11/34 ,  B30B15/302 ,  Y10T428/1352

摘要： A dosage form comprises at least one active ingredient, a first portion which comprises an exterior surface and one or more cavities defining at least one interior surface having indentations and an exterior surface, and a second molded portion which is inlaid into the cavities of the first portion and has an exterior surface. The first and second portions are in contact at an interface, the second portion comprises a solidified thermoplastic material, and the second portion resides substantially conformally upon the indentations of the first portion. In another embodiment, a dosage form comprises at least one active ingredient, a core having an outer surface and a shell residing on at least a portion of the core outer surface, wherein the shell comprises a first shell portion and a second molded shell portion which is inlaid into the first shell portion. In another embodiment, a dosage form comprises at least one active ingredient, a core, and a shell having a first molded shell portion which is discontinuous, and a second molded shell portion which is continuous, such that the discontinuities of the first shell portion are due to the presence of the second molded shell portion, and the first and second shell portions are compositionally different.