Dosage form for delivering acid sensitive beneficial agent

• US 4,743,248 A
• Filed: 08/11/1986
• Issued: 05/10/1988
• Est. Priority Date: 08/11/1986
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S. L., Barclay, Brian, Bartoo, Marc L., Theeuwes, Felix
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rose, Sharon E.
• Application Number:
  US06/895,551
• Time in Patent Office: 638 Days
• Field of Search: 604/890-892, 604/896, 424/19-21, 424/451, 424/455, 424/456, 424/457, 424/458, 424/459, 424/464, 424/465, 424/468, 424/472, 424/473, 424/474, 424/475, 424/482
• US Class Current: 604/892.1
• 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 dosage form is disclosed, which dosage form comprises an outside wall and an inside wall, which inside wall comprises means for changing its structural integrity in response to fluid having a pH greater than 5 that enters the dosage form, thereby changing the pH environment inside the dosage form and concomitantly causing the inside wall to change its structural integrity, thus causing the outside wall to collapse and be easily eliminated from a host.

Claims

1. A dosage form for dispensing a beneficial agent formulation to an environment of use, the dosage form comprising:

(a) a first wall that permits the passage of fluid and comprises means for keeping its chemical integrity in a first fluid environment exhibiting a pH less than 5 and for losing its chemical integrity in a second fluid environment exhibiting a pH greater than 5;

(b) a second wall that permits the passage of fluid and comprises means for keeping its chemical integrity in a first fluid environment exhibiting a pH less than 5 and for keeping its chemical integrity in a second environment exhibiting a pH greater than 5;

(c) a compartment formed by the first wall and the second wall with the first wall surrounding and facing the inside of the compartment and the second wall surrounding the first wall and facing the environment of use;

(d) a beneficial agent formulation in the compartment, which agent formulation forms with fluid that enters the compartment a fluid environment exhibiting a pH less than 5;

(e) at lease one passageway through the walls for dispensing the beneficial agent formulation from the dosage form to the environment of use over time; and

,

(f) wherein, fluid from the environment exhibiting a pH greater than 5 enters the dosage form causing the first wall at the end of the dispensing of the beneficial agent to lose its chemical integrity for facilitating discharge of the dosage form from the environment of use.

2. The dosage form for dispensing the beneficial agent formulation according to claim 1, wherein the second wall contact the first wall.

3. The dosage form for dispensing the beneficial agent formulation according to claim 1, wherein the beneficial agent is a pharmaceutically acceptable acidic drug.

4. The dosage form for dispensing the beneficial agent formulation according to claim 1, wherein the beneficial agent is a drug comprising its pharmaceutically acceptable acid addition salt.

5. The dosage form for dispensing the beneficial agent formulation according to claim 1, wherein the first wall initially is thicker than the second wall.

6. A dosage form for dispensing a beneficial agent formulation to a biological environment of use, the dosage form comprising:

(a) a first wall that pemits the passage of fluid and comprises means for keeping its chemical integrity in a first fluid envirnoment inside the dosage form exhibiting a pH less than 5 and for losing its chemical integrity in a second fluid environment inside the dosage form exhibiting a pH greater than 5;

(b) a second wall that permits the passage of fluid and comprises means for keeping its chemical integrity in a first fluid environment exhibiting a pH less than 5 and for keeping its chemical integrity in a second environment exhibiting a pH greater than 5;

(c) a compartment formed by the first wall and by the second wall which first wall surrounds and faces the inside of the compartment and which second wall surrounds the first wall and faces the biological environment of use;

(d) a beneficial agent formulation in the compartment, which agent formulation forms with fluid that enters the compartment a fluid environment exhibiting a pH less than 5, and a hydrophilic hydrogel formulation in the compartment that aids in dispensing the agent formulation from the dosage form;

(e) at least one passageway through the walls connecting the compartment with the biological environment of use for dispensing the beneficial agent formulation from the dosage form over a prolonged period of time; and

,

(f) wherein fluid from the environment having a pH greater than 5 enters the dosage form through the passageway causing the first wall at the end of the dispensing of the beneficial agent to lose its chemical interity for facilitating discharge of the dosage form from the environment of use.

7. The dosage form for dispensing the beneficial agen formulation according to claim 6, wherein the second wall contacts the first wall.

8. The dosage form for dispensing the beneficial agent formulation according to claim 6, wherein the beneficial agent is a pharmaceutically acceptable acidic drug.

9. The dosage form for dispensing the beneficial agent formulation according to claim 6, wherein the beneficial agent is a drug comprising its pharmaceutically acceptable acid addition salt.

10. The dosage form for dispensing the beneficial agent formulation according to claim 6, wherein the first wall initially is thicker than the second wall.