Process for lessening irritation caused by drug

• US 5,254,349 A
• Filed: 10/21/1992
• Issued: 10/19/1993
• Est. Priority Date: 12/06/1991
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Burkoth, Terry L., Dong, Liang C., Wong, Patrick S. L., Barclay, Brian L., Childers, Jerry D., Dealey, Michael H.
• Primary Examiner(s): Michl, Paul R.
• Assistant Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US07/963,962
• Time in Patent Office: 363 Days
• Field of Search: 424/473
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Claims

1. A process for lessening the irritation caused by a drug delivered from a dosage form, wherein the process comprises:

(a) admitting a dosage form into a biological fluid environment of use, the dosage form comprising;

(1) a wall comprising a composition permeable to the passage of fluid, which wall surrounds;

(2) a compartment;

(3) a drug composition in the compartment comprising 20 wt % to 85 wt % of a hydrophilic polymer having a critical solution temperature of 35°

C. to 50°

C., 10 wt % to 45 wt % of a dehydrating agent having an affinity for water, and a drug;

(4) a displacement composition in the compartment comprising a composition that imbibes fluid, expands and thereby displaces the first composition from the dosage form;

(5) an exit passageway in the wall that connects the compartment with the environment of use;

(b) imbibing fluid into the displacement composition causing it to expand and displace the drug composition from the dosage form, whereby the drug is delivered to the biological environment of use; and

wherein the process is characterized by;

(c) imbibing fluid into the drug composition inducing the hydrophilic polymer to flocculate in the presence of the dehydrating agent and the drug, which flocculates, when delivered to the biological environment, results in a lessening of drug irritation of the biological environment.

2. A process for lessening the irritation caused by a drug, wherein the process comprises:

(a) admitting orally into the patient a dosage form comprising;

(1) a drug composition comprising 10 ng to 1200 mg of a drug that causes irritation of a biological environment, 20 wt % to 85 wt % of a hydrophilic polymer possessing a critical solution temperature of 35°

C. to 50°

C., and 10 wt % to 45 wt % of a dehydrating agent having an affinity for water;

(2) a polymer that aides in releasing the drug composition from the dosage form; and

(b) administering the drug composition at a rate controlled for drug therapy over an extended time to the patient.