Multi-component pharmaceutical dosage form

• US 8,440,224 B2
• Filed: 01/18/2010
• Issued: 05/14/2013
• Est. Priority Date: 07/30/1999
• Status: Expired due to Fees

• Current Assignee: Capsugel Belgium NV (Lonza Group AG)
• Original Assignee: Capsugel Belgium NV (Lonza Group AG)
• Inventors: Clarke, Allan J, Fonio, Teodoro, Harris, Geoffrey Arthur, Kift, Ron, Lightfoot, Donald, McGinley, Shane, Ofsharick, Thomas, Szymczak, Margaret Mary
• Primary Examiner(s): TRAN, SUSAN T
• Application Number:
  US12/689,015
• Publication Number:
  US 20100119597A1
• Time in Patent Office: 1,212 Days
• Field of Search: None
• US Class Current: 424/453
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A multi-component pharmaceutical dosage form comprising a plurality of drug substance—containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Claims

1. A multi-component dosage form comprising:

a plurality of sub-units disposed in end-to-end relationship, each of the plurality of sub-units selected from a group comprising (i) capsule compartment sub-units respectively comprising at least one cavity formed therein and being configured to release a drug-substance contained within the at least one cavity into a gastro-intestinal environment and (ii) solid sub-units comprising a matrix of a polymer;

a first joint formed between a first sub-unit of the plurality of sub-units and a second sub-unit of the plurality of sub-units, the first joint comprising a plug formed as a unitary part of the first sub-unit and a socket formed as a unitary part of the second sub-unit; and

a second joint formed between the first sub-unit and a third sub-unit of the plurality of sub-units, the second joint comprising a socket formed as a unitary part of the first sub-unit and a plug formed as a unitary part of the third sub-unit;

wherein at least one of the first joint and the second joint between respective sub-units is formed such that a relative axial position between respective sub-units is solely delimited by engaging outer wall axial end parts of the respective sub-units;

wherein the first sub-unit is a capsule compartment sub-unit comprising a first cavity including an open end and a closed end and the third sub-unit is a capsule compartment sub-unit comprising a second cavity including an open end and a closed end; and

wherein the open end of the first cavity of the first sub-unit is disposed adjacent the open end of the second cavity of the third sub-unit and the first and second cavities form a combined cavity configured to contain a drug-substance therein.

2. The multi-component dosage form according to claim 1, wherein the plug formed as a unitary part of the first sub-unit is disposed adjacent a first axial end of the first sub-unit and the first sub-unit further includes a socket formed as a unitary part of the first-sub-unit disposed adjacent a second axial end of the first sub-unit.

3. The multi-component dosage form according to claim 1, wherein the second sub-unit is a solid sub-unit comprising a matrix of a polymer.

4. The multi-component dosage form according to claim 1, further including a third joint formed between the second sub-unit and a fourth sub-unit of the plurality of sub-units, the third joint comprising a socket formed as a unitary part of the fourth sub-unit and a plug formed as a unitary part of the second sub-unit.

5. The multi-component dosage form according to claim 4, wherein the fourth sub-unit is a capsule compartment sub-unit comprising at least one cavity formed therein and containing a first drug-substance.

6. The multi-component dosage form according to claim 5, wherein the first sub-unit contains a second drug-substance.

7. The multi-component dosage form according to claim 6, wherein the first drug-substance differs in composition and/or release characteristics from the second drug-substance.

8. The multi-component dosage form according to claim 4, wherein the second and fourth sub-units are capsule compartment sub-units respectively comprising at least one cavity formed therein and containing a drug-substance.

9. The multi-component dosage form according to claim 4, wherein the second sub-unit is a solid sub-unit comprising a matrix of a polymer and the fourth sub-unit is a capsule compartment sub-unit comprising at least one cavity formed therein and containing a drug-substance.

10. The multi-component dosage form according to claim 4, wherein the fourth sub-unit is a solid sub-unit comprising a matrix of a polymer.

11. The multi-component dosage form according to claim 10, wherein the second sub-unit is a capsule compartment sub-unit comprising a cavity formed therein and containing a drug-substance.

12. The multi-component dosage form according to claim 3, wherein the second sub-unit comprises a through-hole formed therein extending from a first axial end of the second sub-unit to a second axial end of the second sub-unit.

13. A multi-component dosage form comprising:

a plurality of sub-units disposed in end-to-end relationship, each of the plurality of sub-units selected from a group comprising (i) capsule compartment sub-units respectively comprising at least one cavity formed therein and being configured to release a drug-substance contained within the at least one cavity into a gastro-intestinal environment and (ii) solid sub-units comprising a matrix of a polymer;

a first joint formed between a first sub-unit of the plurality of sub-units and a second sub-unit of the plurality of sub-units, the first joint comprising a plug formed as a unitary part of the first sub-unit and a socket formed as a unitary part of the second sub-unit; and

a second joint formed between the first sub-unit and a third sub-unit of the plurality of sub-units, the second joint comprising a socket formed as a unitary part of the first sub-unit and a plug formed as a unitary part of the third sub-unit;

wherein the plug formed as a unitary part of the first sub-unit is disposed adjacent a first axial end of the first sub-unit and the socket formed as a unitary part of the first sub-unit is disposed adjacent a second axial end of the first sub-unit;

wherein the first sub-unit is a capsule compartment sub-unit comprising a first cavity including an open end and a closed end and the third sub-unit is a capsule compartment sub-unit comprising a second cavity including an open end and a closed end; and

wherein the open end of the first cavity of the first sub-unit is disposed adjacent the open end of the second cavity of the third sub-unit and the first and second cavities form a combined cavity configured to contain a drug-substance therein.

14. The multi-component dosage form according to claim 13, wherein at least one of the first joint and the second joint between respective sub-units is formed such that a relative axial position between respective sub-units is solely delimited by engaging outer wall axial end parts of the respective sub-units.