Conversion of liquid filled gelatin capsules into controlled release systems by multiple coatings
First Claim
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1. A dosage form comprising (a) a gelatin capsule containing a liquid, active agent formulation;
- (b) a multilayer wall superposed on the gelatin capsule comprising, in outward order from the capsule;
(i) a barrier layer, (ii) an expandable layer, and (iii) a semipermeable layer; and
(c) an orifice formed or formable through the wall.
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Abstract
A dosage form comprising a gelatin capsule formed with a composite wall and containing a liquid, active agent formulation where the wall comprises a barrier layer formed over the external surface of the gelatin capsule, an expandable layer formed over the barrier layer and a semipermeable layer formed over the expandable layer is described. The dosage forms and methods provide for the conversion of standard gelatin, liquid formulation capsules into controlled, release dosage forms that permit the controlled release of the active agent into the environment of use over time.
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Citations
20 Claims
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1. A dosage form comprising (a) a gelatin capsule containing a liquid, active agent formulation;
- (b) a multilayer wall superposed on the gelatin capsule comprising, in outward order from the capsule;
(i) a barrier layer, (ii) an expandable layer, and (iii) a semipermeable layer; and
(c) an orifice formed or formable through the wall. - View Dependent Claims (2, 4, 5, 6, 7, 12, 16, 17, 18, 19, 20)
- (b) a multilayer wall superposed on the gelatin capsule comprising, in outward order from the capsule;
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3. The dosage form of claim 3 wherein the expandable layer is an osmotic layer.
- 8. A method of converting a gelatin capsule containing a liquid active agent formulation into a controlled release dosage form which comprises forming a composite wall over the gelatin capsule by sequentially forming a barrier layer on the external surface of the gelatin capsule, an expandable layer over the barrier layer and a semipermeable layer over the expandable layer.
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11. A method of manufacturing a controlled release dosage form comprising a gelatin capsule containing a liquid active agent formulation, which method comprises the steps of (1) forming a barrier layer surrounding the gelatin capsule;
- (2) forming an expandable layer surrounding the barrier layer-gelatin capsule;
(3) removing a portion of the expandable layer in an area in which an exit orifice is to be located without compromising the integrity of the barrier layer in the area;
(4) forming a semipermeable layer surrounding the intermediate dosage form prepared through step (4); and
forming an exit orifice in the area exposing at least a portion of the gelatin capsule. - View Dependent Claims (14, 15)
- (2) forming an expandable layer surrounding the barrier layer-gelatin capsule;
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13. A dosage form comprising a gelatin capsule containing a liquid, active agent formulation, the gelatin capsule being surrounded by a barrier layer contacting the external surface of the gelatin capsule, an expandable layer contacting at least a portion of the barrier layer, a semipermeable layer surrounding at least the expandable layer, and an exit orifice formed or formable in the dosage form extending from the external surface of the gelatin capsule to the environment of use.
Specification