MULTI-LAYER PREPARATION IN FILM FORM, CONSISTING OF HYDROPHILIC POLYMERS, FOR THE RAPID RELEASE OF ACTIVE INGREDIENTS

• US 20080057087A1
• Filed: 10/31/2007
• Published: 03/06/2008
• Est. Priority Date: 11/11/1999
• Status: Active Grant

• Current Assignee: LTS Lohmann Therapie-Systeme AG
• Original Assignee: LTS Lohmann Therapie-Systeme AG
• Inventors: Krumme, Markus
• Granted Patent: US 7,803,430 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• 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: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: Y10T 428/31913 Monoolefin polymer
• CPC Class Codes: Y10T 428/31928 Ester, halide or nitrile of addition polymer

Abstract

A multilayer preparation in the form of films of hydrophilic polymers for rapid release of substances present in the film layers into liquid surroundings is characterized in that adjacent layers differ from one another in that in each case one layer is soluble in a nonaqueous solvent in which the respective adjacent layer is insoluble or only slightly soluble.

Claims

1. A process for the production of a preparation, comprising:

producing a polymer solution that contains active ingredient(s);

coating the polymer solution onto an inert substrate by knife or roller application or a spraying process and subsequently drying to produce an initial film;

producing a second active ingredient-containing polymer solution in a solvent or solvent mixture which does not attack or dissolve the initial layer;

coating the second solution onto one or both sides of the initial film by knife or roller application or a spraying process and subsequently drying to produce a film composite;

coating the film composite with a next layer or with further layers in an analogous way using solvents which do not attack or dissolve the layer(s) previously produced.

2. A process for the production of a preparation comprising:

producing a polymer melt that contains active ingredient(s);

coating the polymer melt onto an inert substrate by knife or roller coating, or by spraying or extrusion processes and subsequently cooling and/or drying to produce an initial film;

producing an active ingredient-containing polymer solution in a solvent or solvent mixture that does not attack or dissolve the initial layer;

coating the active ingredient-containing solution onto one or both sides of the initial film by knife or roller coating or spraying processes and subsequently drying to produce a film composite;

coating the film composite with a next layer or with further layers in an analogous way using solvents that do not attack or dissolve the layer(s) produced previously.