Continuous single layer film structure including discrete domains
AssigneeMonosol Rx, LLC
InventorsB. Arlie Bogue, Garry L. Myers, Alexander Mark Schobel, Eric Dadey
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Abstract
Disclosed herein is a soft, flexible, continuous, single-layer structural directional active delivery device such as a film product with discrete domains useful for controlled administration of the active to a patient. The discrete domains are substantially inseparable from one another, have different rates of dissolution and advantageously offer superior adhesion to the body of the patient while administering the active directionally and effectively.
Claims59
A film dosage structure suitable to be placed against the body of a patient, said film dosage structure being a single layer structure comprising:
- (a) a first domain comprising a first polymeric carrier material, and
- (b) a second domain comprising an active and a second polymeric carrier material, wherein said second domain has a smaller surface area than the first domain and is at least partially occluded by said first domain, said first domain and said second domain are physically substantially inseparable, and said first domain and said second domain have different rates of dissolution or disintegration when placed in contact with a mucosal surface of the body.
A method of forming a continuous and uniform single layer film product comprising a first domain and second domain, wherein said first and second domains are substantially inseparable, comprising the steps of:
- (a) preparing a first wet film-forming matrix comprising a first solvent and a first polymeric material;
- (b) forming a first wet film by casting said first film-forming matrix;
- (c) preparing a second wet film-forming matrix comprising an active, a second solvent and a second polymeric material;
- (d) depositing a predetermined amount of said second wet film-forming matrix onto selected areas on a surface of said first wet film to form a wet multi-domain film comprising a first domain and a second domain;
- and
- (e) rapidly feeding said wet multi-domain product into a drying apparatus and exposing said wet multi-domain film to a temperature sufficient to flash off said first and second solvents so as to form a multi-domain product.
A method of forming a continuous and uniform single layer film product comprising a first domain and second domain, wherein said first and second domains are substantially inseparable, comprising the steps of:
- (a) preparing a first film-forming matrix comprising a first solvent and a first polymeric material;
- (b) preparing a second film-forming matrix comprising an active, a second solvent and a second polymeric material;
- (c) co-extruding said first film-forming matrix and said second film-forming matrix to form a wet multi-domain film comprising a first domain and a second domain;
- and
- (e) rapidly feeding said wet multi-domain product into a drying apparatus and exposing said wet multi-domain film to a temperature sufficient to flash off said first and second solvents so as to form a multi-domain product,
- wherein said multi-domain product includes a top surface, said top surface comprising a top surface of said first domain and said second domain, wherein said second domain is perimetrically surrounded by said first domain.
Dependencies are inferred from the claim text.