Bioadhesive extruded film for intra-oral drug delivery and process

Claim 2

A pharmaceutically acceptable controlled-releasing medicament-containing extruded single or multi-layered thin film, capable of adhering to a wet mucous surface, comprising a water soluble or swellable polymer matrix bioadhesive layer which can adhere to a wet mucous surface and which bioadhesive layer consists essentially of 40-95% by weight of a hydroxypropyl cellulose having a molecular weight above 100,000, 5-60% of a homopolymer of ethylene oxide having a molecular weight from 3,000,000 to 5,000,000, 0-10% of a water-insoluble polymer selected from the group consisting of ethyl cellulose, propyl cellulose, polyethylene and polypropylene, and 2-10% of a plasticizer, said film having incorporated therein a pharmaceutically effective amount of said medicament.

Claim 3

The extruded film of claim 1, made in a form which is so thin and flexible when wet as to be unobtrusive to the patient when properly positioned and placed in the patients mouth.

Claim 4

The extruded film of claim 2 having a thickness no greater than 0.25 millimeters.

Claim 5

The extruded film of claim 1, in single layer form, which also contains up to 10% by weight of a non-soluble polymer selected from the group consisting of ethyl cellulose, polyethylene, polypropylene and carboxymethyl cellulose free acid.

Claim 6

The extruded film of claim 1, in multi-layer laminated form, which is addition to the bioadhesive layer also contains a reservoir layer in which at least a major portion of the medicament is contained.

Claim 7

The extruded multi-layer film of claim 5 in which the reservoir layer consists essentially of a polymer matrix comprised of both a water soluble or swellable polymer and a non-water soluble polymer selected from the group consisting of ethyl cellulose, propyl cellulose, polyethylene and polypropylene, and also hydroxypropyl cellulose.

Claim 8

The extruded film of claim 1 in multi-layer laminated form, which in addition to the bioadhesive layer also contains an outer protective-barrier membrane layer.

Claim 9

The extruded multi-layer film of claim 7 in which the outer protective-barrier membrane layer is thinner than the bioadhesive layer, and said outer protective barrier layer consists essentially of a polymer matrix of a major proportion of a non-water-soluble polymer selected from the group consisting of ethyl cellulose, propyl cellulose, polyethylene and polypropylene, and a minor proportion of hydroxypropyl cellulose.

Claim 10

The extruded multi-layer film of claim 1 in the form of a triple layered laminate containing sodium fluoride for anticaries protection having the following composition: ______________________________________ Outer Protective Bio- % w/w Barrier adhesive Reservoir Membrane Layer Layer Layer Ingredients (0.1 mm) (0.025 mm) (0.025 mm) ______________________________________ Polyethylene oxide 60.0 -- -- homopolymer (MW 3,000,000 minimum) Hydroxypropyl Cellulose 30.0 20.0 24.0 (MW 1,000,000) Polyethylene (Low Density) 5.0 -- -- Propylene Glycol, U.S.P. 3.0 -- -- Polyethylene Glycol 2.0 -- -- (MW 400) Ethyl Cellulose -- 59.0 69.6 Caprylic/Capric -- 5.0 6.0 Triglyceride Sodium Fluoride -- 16.0 0.4 100.0 100.0 100.0 ______________________________________