Coating technique for deposition of drug substance on a substrate
First Claim
1. A multi-layered oral dosage form for pharmaceutically active substances, comprising a central core having a volume;
- a middle layer surrounding said core; and
an outer shell, at least one of said central core, said middle layer and said outer shell includes at least one pharmaceutically active substance, wherein the volume of said central core is selected to obtain a desired volume of said middle layer within a predetermined dimension of said outer shell.
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Abstract
The present invention relates to a multi-layered, physiologically tolerated oral dosage form for pharmaceutically active compounds. The dosage form comprises a central core, a middle layer, and an outer shell, at least one of which includes at least one pharmaceutically active substance. By varying the diameter of the core, a different middle layer volume is obtained within a fixed outer shell dimension. This gives the ability to obtain different dosage strengths for one composition without the need of reformulation work. The oral dosage form is produced in a single-step, continuous process by coating the core with the middle layer and the outer shell.
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Citations
21 Claims
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1. A multi-layered oral dosage form for pharmaceutically active substances, comprising a central core having a volume;
- a middle layer surrounding said core; and
an outer shell, at least one of said central core, said middle layer and said outer shell includes at least one pharmaceutically active substance, wherein the volume of said central core is selected to obtain a desired volume of said middle layer within a predetermined dimension of said outer shell. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
- a middle layer surrounding said core; and
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17. A method for producing a multi-layered oral dosage form for pharmaceutically active substances, wherein the outer dimension of said form is fixed and the volume of a middle layer is selectively variable, comprising the steps of:
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providing a core having a selected volume;
coating said core with said middle layer, wherein the total combined volume of said core and said middle layer is a predetermined volume; and
coating said middle layer with an outer shell to obtain said fixed outer dimension, wherein at least one of said core, said middle layer and said outer shell includes at least one pharmaceutically active substance. - View Dependent Claims (18, 19, 20, 21)
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Specification