Oral osmotic device with hydrogel driving member

• US 5,869,096 A
• Filed: 12/09/1994
• Issued: 02/09/1999
• Est. Priority Date: 07/14/1989
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wright, Jeri, Place, Virgil A., Wong, Patrick S. L., Barclay, Brian L., Childers, Jerry D.
• Primary Examiner(s): Bawa, Raj
• Application Number:
  US08/353,568
• Time in Patent Office: 1,523 Days
• Field of Search: 424/422, 424/435, 424/468, 424/472, 424/473, 424/474
• US Class Current: 424/468
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An osmotic device (10) for delivering a beneficial drug, such as an anti-fungal, into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a wall (12) surrounding a compartment (13) housing a layer of an agent (14) that is insoluble to very soluble in aqueous biological fluids, e.g., saliva, and a layer (16) of a fluid swellable, hydrophilic polymer. A passageway (17) in the wall (12) connects the agent (14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer (16). In one embodiment the beneficial agent (14) has a different color than the hydrophilic polymer (16). The wall (12) is sufficiently translucent to permit the patient to see the amount of drug/beneficial agent (14) remaining to be delivered. Marking lines (19) may be provided on the wall (12) indicating the amount of drug/agent (14) which has been delivered and/or the amount remaining to be delivered.

Claims

1. An osmotic device for treatment of Parkinson'"'"'s disease by the controlled delivery of a drug comprising levodopa to the mucosa of the oral cavity of a patient over an extended delivery period of between 0.5 to 12 hours, the device comprising:

a wall defining a compartment and an exit passageway, the wall being formed of a semipermeable material;

a drug layer comprising a dose of 0.05 ng to 500 mg levodopa and a suspending agent therefore located in the compartment adjacent the exit passageway, the exit passageway communicating the drug layer with the exterior, and a driving layer comprising a hydrophilic polymer located in the compartment adjacent the drug layer and opposite the exit passageway;

wherein the device has a smooth oval shape with an aspect ratio in the range of about 1.2;

1 to about 3;

1, a height of about 0.5 to about 10 mm, and a volume of less than about 2 cm³ and delivers levodopa through the exit passageway to the mucosa within the oral cavity.

2. The osmotic device of claim 1, wherein the device further comprises up to 20 wt % of a flavoring agent in the drug-containing layer said flavoring agent having a taste which contrasts with the hydrophilic polymer layer taste for signaling the patient when the dose of the drug has been delivered from the device.

3. The osmotic device of claim 1, wherein the device further comprises a coloring agent in the hydrophilic polymer layer, said coloring agent having a color which contrasts with the color of the drug-containing layer for signaling the patient when the dose of the drug has been delivered from the device, and wherein the semipermeable wall comprises a material which permits visual inspection of the drug present in the compartment.

4. The osmotic device of claim 3, that also displays the amount of drug present in the device.

5. The osmotic device of claim 1, wherein the semipermeable wall has an overcoating containing drug.

6. The osmotic device of claim 1, wherein the drug containing layer also contains an osmagent.

7. The osmotic device of claim 6, wherein the osmagent comprises mannitol.

8. The osmotic device of claim 1, wherein the suspending agent comprises a cellulosic polymer.

9. The osmotic device of claim 8, wherein the cellulosic polymer is selected from the group consisting of sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, and hydroxyproplymethyl cellulose.

10. The osmotic device of claim 8, wherein the suspending agent comprises hydroxypropyl cellulose.

11. The osmotic device of claim 1, wherein the hydrophilic polymer comprises a polysaccharide.