Dosage forms having an inner core and outer shell with different shapes
First Claim
1. A dosage form comprising:
- 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 which is substantially different than the first shape, wherein 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, and the shell surrounds at least a portion of the core.
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Accused Products
Abstract
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.
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Citations
60 Claims
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1. A dosage form comprising:
- 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 which is substantially different than the first shape, wherein 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, and the shell surrounds at least a portion of the core. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)
- an active ingredient;
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2. A dosage form comprising:
- an active ingredient;
a core having an outer surface with a first topography; and
a shell having an inner surface and an outer surface with a second topography which is different than the first topography, wherein at least one of the first or second topographies includes indentations or protrusions greater than about 20 microns in width, depth or height, and the shell surrounds at least a portion of the core.
- an active ingredient;
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3. A dosage form comprising:
- an active ingredient;
a core having an outer surface having indentations or protrusions greater than about 20 microns in width, depth, or height; and
a shell having an inner surface and an outer surface, wherein the shell resides substantially conformally upon at least a portion of the core outer surface, such that the inner surface of the shell has protrusions and indentations corresponding substantially inversely to the major protrusions and indentations of the outer surface of the core, and the outer surface of the shell does not substantially conform to the major protrusions and indentations of the outer surface of the core.
- an active ingredient;
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4. A dosage form comprising:
- an active ingredient;
a core having an outer surface having indentations or protrusions; and
a shell which surrounds at least a portion of the core, wherein the shell has an inner surface, an outer surface and a thickness, the ratio of the width of one or more indentations or protrusions in the core surface to the thickness of the shell at one or more locations is at least about 1;
1, the shell resides substantially conformally upon the core outer surface such that the inner surface of the shell has protrusions and indentations correspond substantially inversely to the major indentations and protrusions of the outer surface of the core, and the outer surface of the shell does not substantially conform to the major protrusions and indentations of the outer surface of the core.
- an active ingredient;
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5. A dosage form comprising:
- an active ingredient;
a first core having an outer surface with a first topography;
a second core having an outer surface with a second topography; and
a shell having an inner surface and outer surface with a third topography which is different than the first topography, wherein at least one of the first, second, or third topographies includes indentations or protrusions greater than about 20 microns in width, depth or height, and the shell surrounds at least a portion of the core.
- an active ingredient;
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6. A dosage form comprising:
- an active ingredient;
a core comprising a first and second core portion having outer surfaces with a first and second topographies, respectively;
a first shell portion having an outer surface with a third topography; and
a second shell portion having an outer surface with a fourth topography, wherein at least one of the third or fourth shell surface topographies is different from the underlying core portion topography, at lease one of the first, second, third, or fourth topographies includes indentations or protrusions greater than about 20 microns in width, depth or height, and the shell surrounds at least a portion of the core.
- an active ingredient;
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7. A dosage form comprising:
- 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 which is substantially different than the first shape, wherein the shell is substantially free of pores having a pore diameter of 0.5 to 5.0 microns, and the shell surrounds at least a portion of the core.
- an active ingredient;
Specification