Dosage form for lessening irritation of mocusa

• US 4,971,790 A
• Filed: 06/22/1989
• Issued: 11/20/1990
• Est. Priority Date: 02/07/1986
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Theeuwes, Felix, Wong, Patrick S. L., Guittard, George V., Magruder, Paul R.
• Primary Examiner(s): Cashion, Jr., Merrell C.
• Assistant Examiner(s): Horne, Leon R.
• Application Number:
  US07/370,313
• Time in Patent Office: 516 Days
• Field of Search: 424/486, 424/484, 424/422, 424/434, 424/438, 424/78
• US Class Current: 424/78.05
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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

A composition of matter comprising a drug, a neutral hydrogel and an ionic hydrogel. The composition can be administered from a delivery system to a biological receptor over time.

Claims

1. A dosage form for lessening the incidence of irritation of a mucosal environment of an animal, which irritation is associated with the delivery of a beneficial drug that produces irritation of the mucosal environment, the dosage form comprising:

(a) a wall comprising in at least a part a composition permeable to the passage of fluid and substantially impermeable to the passage of drug, which wall surrounds and forms;

(b) a compartment containing a composition comprising (1) from 25 ng to 1.5 g of a beneficial drug associated with irritation of the mucosal environment blended with (2) a first hydrogel that is essentially neutral in the presence of fluid in the mucosal environment with (3) a second hydrogel that ionically dissociates in the presence of fluid in the mucosal environment, which first (2) and second (3) hydrogels in the presence of fluid in the mucosal environment reduce direct contact of the drug with the mucosal tissue, thereby lessening the incidence of irritation associated with the delivery of the beneficial drug; and

,

(c) at least one passageway in the wall connecting the exterior of the dosage form with the compartment for delivering the drug and the hydrogels from the dosage form over time.

2. The dosage form for delivering the beneficial drug according to claim 1, wherein the dosage form collapses under pressure of 40 mm H_g to 270 mm H_g.

3. The dosage form for delivering the beneficial drug according to claim 1, wherein the first (2) hydrogel is polyethylene oxide.

4. The dosage form for delivering the beneficial drug according to claim 1, wherein the second (3) hydrogel is carboxypolymethylene.

5. The dosage form for delivering the beneficial drug according to claim 1, wherein the passageway is formed in the fluid environment of use.

6. The dosage form for delivering the beneficial drug according to claim 1, wherein the first (2) hydrogel exhibits solution viscosity in the presence of fluid that enters the dosage form.

7. The dosage form for delivering the beneficial drug according to claim 1, wherein the second (3) hydrogel is contained in the first hydrogel.

8. The dosage form for delivering the beneficial drug according to claim 1, wherein the first (2) hydrogel forms a viscous solution in the presence of the beneficial drug thereby enabling the second hydrogel to be delivered simultaneously from the dosage form.

9. The dosage form for delivering the beneficial drug according to claim 1, wherein the wall comprises a microporous composition.