PROCESS FOR THE MANUFACTURING OF A MULTILAYER DRUG DELIVERY CONSTRUCT

• US 20150246001A1
• Filed: 10/23/2013
• Published: 09/03/2015
• Est. Priority Date: 10/23/2012
• Status: Abandoned Application

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Inventors: Zupancich, John Andrew, Berard, Julien Franois
• Application Number:
  US14/432,899
• Publication Number:
  US 20150246001A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61K 9/7069 obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
• CPC Class Codes: B32B 2037/243 Coating
• CPC Class Codes: B32B 2367/00 Polyesters, e.g. PET, i.e. polyethylene terephthalate
• CPC Class Codes: B32B 2377/00 Polyamides
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 37/24 with at least one layer not being coherent before laminating, e.g. made up from granular material sprinkled onto a substrate B32B37/15 takes precedence
• CPC Class Codes: B32B 38/0012 Mechanical treatment, e.g. roughening, deforming, stretching
• CPC Class Codes: B32B 38/10 Removing layers, or parts of layers, mechanically or chemically
• CPC Class Codes: Y10T 156/1051 by folding

Abstract

The present invention relates to a process for the manufacturing of a multilayer construct comprising layering at least one drug loaded film from which each film comprises a polymer and at least a drug manufactured by the steps of dissolving the polymer in an organic solvent, mixing the dissolved polymer with the drug, laminating the mixture between at least two polymeric sheets, whereby at least one sheet is permeable to the organic solvent, removing the sheets to provide the drug loaded film, layering the drug loaded film and fusing the drug loaded films into a multilayer construct. The present invention also relates to the multilayer construct obtainable by the process according to the present invention and to the use of the multilayer construct in ophthalmology, cardiovascular, pain management, musculoskeletal, cancer treatment or in vaccine delivery.

Claims

1. Process for the manufacturing of a multilayer drug delivery construct comprising at least one drug loaded film manufactured by the following steps:

(a) dissolving the polymer in a solvent

(b) mixing the dissolved polymer with a drug

(c) laminating the mixture between at least two polymeric sheets, whereby at least one polymeric sheet is permeable to the solvent,

(d) removing the sheets to provide the drug loaded film

(e) layering the drug loaded film

(f) fusing the layered film into a multilayer construct

2. Process for the manufacturing of a multilayer construct according to claim 1 in which the layering (e) occurs via folding or rolling of one drug loaded film.

3. Process for the manufacturing of a multilayer construct according to claim 1 whereby at least two drug loaded films are layered.

4. Process for the manufacturing of a multilayer construct according to claim 3 whereby the drug loaded films may comprise the same or a different polymer and/or the same or a different drug.

5. Process for the manufacturing of a multilayer construct according to claim 1 in which the multilayer construct further comprises at least a non-drug loaded polymeric film.

6. Process for the manufacturing of a multilayer construct according to claim 1 in which the non-drug loaded film comprises the same or a different polymer as the drug loaded films.

7. Process for the manufacturing of a multilayer construct according to claim 1 wherein the overall thickness of the multilayer construct ranges from 500 nm-2 cm.

8. Process for the manufacturing of a multilayer construct according to claim 1 whereby the drug is selected from the group of small molecule drugs or a biologic.

9. Process for the manufacturing of a multilayer construct according to claim 8 whereby the biologic is selected from the group of proteins, peptides or polynucleotides.

10. Process according to claim 1 whereby at least one of the polymeric sheets comprises an elastomeric material.

11. Process according to claim 1 whereby the polymer is a bioerodable or biodegradable polymer selected from the group consisting of polyesters or polyesteramides.

12. Process according to claim 11 whereby the polymer is selected from a polyesteramide comprising amino-acids.

13. Process according to claim 12 whereby the polyesteramide (PEA) has a chemical formula according to formula (I),

14. Process according to claim 12 whereby the polyesteramide (PEA) has a chemical formula according to formula (I),

15. Process according to claim 1 in which the multilayer construct is further processed into a subsequent implantable or injectable drug delivery system such as a fiber, rod, disc, coating, tube or rolled film.

16. Process according to claim 1 wherein the multilayer construct or the implantable or injectable drug delivery system is used for the release of drugs in ophthalmology, cardiovascular, pain management, musculoskeletal, cancer treatment, in central nerve system or in vaccine delivery.