Dosage form

• US 3,972,995 A
• Filed: 04/14/1975
• Issued: 08/03/1976
• Est. Priority Date: 04/14/1975
• Status: Expired due to Term

• Current Assignee: American Home Products Corporation (Pfizer Inc.)
• Original Assignee: American Home Products Corporation (Pfizer Inc.)
• Inventors: Martin, Frederick H., Tsuk, Andrew G.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US05/567,788
• Time in Patent Office: 477 Days
• Field of Search: 424/28, 424/14, 424/15, 424/16, 128/268, 128/260, 128/156
• US Class Current: 424/435
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

The disclosure is directed to dosage forms for buccal administration of a drug and are directly applicable to the interior surfaces of the mouth. The dosage form is comprised of a support member, which is water insoluble, waterproof and flexible, a moisture activated, adhesive precursor applied to one surface of the support member and an active ingredient applied to the central portion of the support member either directly or dispersed in a matrix. In one embodiment, a recess is provided in the support member to receive the active ingredient. When the dosage form is applied directly to the interior surface of the mouth, contact with saliva activates the adhesive and causes the support member to adhere to the interior surface of the mouth, thereby exposing the active ingredient to a limited area of the oral mucosa while isolating the active ingredient from the remainder of the oral environment.

Claims

1. A buccal dosage form for buccal administration of a buccally effective medicament comprising:

a. a preshaped, planar, water-insoluble support member comprised of an inert flexible film;

b. a concave recess defined in a portion of one surface of said support member further defining a planar margin of the support member surface surrounding the concave recess,

c. a moisture-activated adhesive precurser comprised of a hydrocolloid admixed with polyvinylpyrrolidone applied to at least the planar margin of the support member surface surrounding the concave recess.

d. a medicament effective buccally supported in said concave recess, the top surface of said medicament being below or coplanar with the margin of said support member surface surrounding the concave recess.

2. A buccal dosage form for buccal administration of a buccally effective medicament comprising:

a. a preshaped, planar water-insoluble support member comprised of a film of ethylcellulose plasticized with castor oil;

b. a concave recess defined in a portion of one surface of said support member further defining a planar margin of the surface of said support member surrounding the concave recess,

c. a moisture-impervious layer comprised of an isobutyleneisoprene copolymer applied to the side of said support member wherein the concave recess is defined;

d. a moisture activated adhesive precursor comprised of finely powdered Karaya gum in a viscous solution of polyvinylpyrrolidone in polyethylene glycol applied to at least the planar margin of the support member surface surrounding the concave recess;

e. a medicament effective buccally supported in said concave recess, the top surface of said medicament being below or coplanar with the margin of the surface of said support member surrounding the concave surface.