CONTROLLED RELEASE DOSAGE FORMS
1 Assignment
0 Petitions
Accused Products
Abstract
Dosage forms having a core having a surface having means for controlling release(s) on an active agent(s); methods of manufacturing, tools used in manufacturing; and uses of the dosage forms are described.
11 Citations
94 Claims
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1-37. -37. (canceled)
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38. A controlled release dosage form comprising:
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a core comprising an active agent and having a surface with at least one structure, wherein the surface of the core is coated with a coating comprising a controlled release material, the coating (i) completely covering the core and the at least one structure, and (ii) having at least one weak point in a portion of the coating immediately above or proximal to the at least one structure, such that the coating ruptures at the weak point(s) at a predetermined time after the dosage form is placed in an aqueous medium to provide at least one passageway in the portion of the coating immediately above or proximal to the at least one structure, wherein the active agent is then released from the dosage form substantially through the at least one passageway at a predetermined rate for about 6 or more hours. - View Dependent Claims (39, 50, 51, 53, 54, 55, 56, 57, 58, 60, 67, 93)
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40-47. -47. (canceled)
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48. A controlled release dosage form comprising
a core comprising an active agent and having a surface with at least one release initiating means, the core and the at least one release initiating means coated with a coating comprising a controlled release material, wherein the coating completely covers the core and the at least one release initiating means, and the at least one release initiating means creates a weak point in a portion of the coating immediately above the at least one release initiating means such that upon placement in an aqueous medium the coating ruptures and forms a passageway in the portion of the coating immediately above the at least one release initiating means, wherein the active agent is released from the dosage form through the passageway at a predetermined rate for about 6 or more hours.
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52. (canceled)
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59. (canceled)
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61-66. -66. (canceled)
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68-69. -69. (canceled)
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71-89. -89. (canceled)
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90. A method of controlling a rate of release of an active agent from a pharmaceutical dosage form, the dosage form comprising a substrate coated with a coating, the method comprising
altering surface morphology of the substrate before the substrate is coated with the coating by creating at least one structure on the surface of the substrate, coating the substrate and at least one structure on the surface of the substrate with a coating, wherein the at least one structure are of a height, width, shape and/or size which causes a rupture and formation of at least one passageway in a portion of the coating immediately above the at least one structure at a predetermined time after the dosage form is placed in an aqueous medium, and such that the active agent is released from the dosage form substantially through the at least one passageway at a controlled rate for about 6 or more hours.
Specification