Sustained release dosage form

• US 5,196,202 A
• Filed: 10/02/1989
• Issued: 03/23/1993
• Est. Priority Date: 09/01/1986
• Status: Expired due to Term

• Current Assignee: Teikoku Seiyaku Kabushiki Kaisha
• Original Assignee: Teikoku Seiyaku Kabushiki Kaisha
• Inventors: Konishi, Ryoji
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Hulina, Amy
• Application Number:
  US07/415,769
• Time in Patent Office: 1,268 Days
• Field of Search: 424/435, 424/447, 424/448, 424/449, 424/473, 604/304, 604/307, 604/897
• US Class Current: 424/448
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches

Abstract

A drug reservoir containing an active substance such as a drug is formed on an adhesive layer which can adhere to an oral mucosal membrane. A polymer, which does not dissolve with saliva, is further coated on the drug reservoir as a drug release controlling layer to form an entire oral cavity sustained release dosage form. A drug impermeable layer can be formed between the adhesive layer and the drug reservoir.

Claims

1. A method for preparing a controlled release form for the controlled release of an active substance, said dosage form including an adhesive layer, a reservoir containing the active substance, and a controlled release layer in contact with the reservoir, the method comprising the steps of placing said controlled release layer around a first portion of the reservoir, placing a layer impermeable to the passage of said active substance around the remaining portion of the reservoir and placing the adhesive layer over said impermeable layer wherein the impermeable layer is interposed between the reservoir and the adhesive layer.

2. A method for preparing a controlled release dosage form for application to tissue of the oral cavity, comprising the steps of:

(a) forming a reservoir layer containing an active substance;

(b) forming a controlled release layer;

(c) forming an impermeable layer which is impermeable to said active substance;

(d) forming an adhesive layer;

(e) positioning and securing one side of said reservoir layer to a first side of said impermeable layer;

(f) positioning and securing said adhesive layer to said impermeable layer on a second side of said impermeable layer opposite said first side, said adhesive layer having an uncovered area for direct attachment to a tissue of the oral cavity;

(g) positioning and securing said controlled release layer on another side of said reservoir layer opposite said one side, thereby forming a four-layered laminate; and

(h) cutting said laminate into separate dosage forms.

3. A method as claimed in claim 2, wherein said cutting step forms an exposed edge on each of said dosage forms, and wherein said method further includes coating the edge of each of said dosage forms with a controlled release layer.