US5053032A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of signalling a patient during buccal agent delivery
Assignee: Individual
•
Filing: 1990-12-21
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Granted: 1991-10-01
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Expires: 2010-12-21
Abstract
Abstract An osmotic device for delivering a beneficial drug, such as an anti-fungal, into the mouth of a human patient is disclosed. The device has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device comprises a wall surrounding a compartment housing a layer of an agent that is insoluble to very soluble in aqueous biological fluids, e.g., saliva, and a layer of a fluid swellable, hydrophilic polymer. A passageway in the wall connects the agent with the exterior of the device. The wall is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer. In one embodiment the beneficial agent has a different color than the hydrophilic polymer. The wall is sufficiently translucent to permit the patient to see the amount of drug/beneficial agent remaining to be delivered. Marking lines may be provided on the wall indicating the amount of drug/agent which has been delivered and/or the amount remaining to be delivered.
Inventors
- 👤 Brian L. Barclay
- 👤 Jerry D. Childers
- 👤 Jeri Wright
- 👤 Virgil A. Place
- 👤 Patrick S. L. Wong
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-31 22:27
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/0002; A61K9/0004
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
228 words
A method of signaling an animal when a predetermined dose of a beneficial agent has been delivered from an osmotic device for delivering a beneficial agent to an oral cavity of the animal over an extended delivery period, comprising: (a) providing the device with a size and shape suitable for comfortably retaining the device in the oral cavity for the extended delivery period; (b) forming a wall around a compartment containing (i) a layer of a dose of the beneficial agent and a gelling agent, the beneficial agent being insoluble to very soluble in an exterior aqueous fluid present in the oral cavity, and (ii) a layer of a hydrophilic polymer; (c) forming a passageway in the semipermeable wall communicating with the layer of beneficial agent in the compartment and with the exterior of the device; (d) providing the layer of the beneficial agent with a color which contrasts with the hydrophilic polymer layer; (e) forming the semipermeable wall from a material which is (i) permeable to the passage of the aqueous fluid, (ii) substantially impermeable to the passage of the hydrophilic polymer, and (iii) sufficiently translucent to permit visual inspection of the beneficial agent present in the compartment; (f) placing the device in the oral cavity of the animal; and (g) periodically inspecting the device to determine when the predetermined dose of beneficial agent has been delivered.
Claim 2
Independent Claim
228 words
A method of signaling an animal when a predetermined dose of a beneficial agent has been delivered from an osmotic device for delivering a beneficial agent to an oral cavity of the animal over an extended delivery period, comprising: (a) providing the device with a size and shape suitable for comfortably retaining the device in the oral cavity for the extended delivery period; (b) forming a wall around a compartment containing (i) a layer of a dose of the beneficial agent and a gelling agent, the beneficial agent being insoluble to very soluble in an exterior aqueous fluid present in the oral cavity, and (ii) a layer of a hydrophilic polymer; (c) forming a passageway in the semipermeable wall communicating with the layer of beneficial agent in the compartment and with the exterior of the device; (d) providing the layer of the beneficial agent with a color which contrasts with the hydrophilic polymer layer; (e) forming the semipermeable wall from a material which is (i) permeable to the passage of the aqueous fluid, (ii) substantially impermeable to the passage of the hydrophilic polymer, and (iii) sufficiently translucent to permit visual inspection of the beneficial agent present in the compartment; (f) placing the device in the oral cavity of the animal; and (g) periodically inspecting the device to determine when the predetermined dose of beneficial agent has been delivered.
Claim 3
Independent Claim
213 words
A method of signaling an animal when a predetermined dose of a beneficial agent has been delivered from an osmotic device for delivering a beneficial agent to an oral cavity of an animal over an extended delivery period, comprising: (a) providing the device with a size and shape suitable for comfortably retaining the device in the oral cavity for the extended delivery period; (b) forming a wall around a compartment containing (i) a layer of a dose of the beneficial agent and a gelling agent, the beneficial agent being insoluble to very soluble in an exterior aqueous fluid present in the oral cavity, and (ii) a layer of a hydrophilic; (c) forming a passageway in the semipermeable wall communicating with the layer of beneficial agent in the compartment and with the exterior of the device; (d) forming the wall of a semipermeable material which is (i) permeable to the passage of the aqueous fluid and (ii) substantially impermeable to the passage of the hydrophilic polymer; (e) providing the layer of the beneficial agent with a taste which contrasts with the hydrophilic polymer layer taste; (f) placing the device in the oral cavity of the animal; and (g) periodically tasting the device to determine when the predetermined dose of beneficial agent has been delivered.
Claim 4
Independent Claim
213 words
A method of signaling an animal when a predetermined dose of a beneficial agent has been delivered from an osmotic device for delivering a beneficial agent to an oral cavity of an animal over an extended delivery period, comprising: (a) providing the device with a size and shape suitable for comfortably retaining the device in the oral cavity for the extended delivery period; (b) forming a wall around a compartment containing (i) a layer of a dose of the beneficial agent and a gelling agent, the beneficial agent being insoluble to very soluble in an exterior aqueous fluid present in the oral cavity, and (ii) a layer of a hydrophilic; (c) forming a passageway in the semipermeable wall communicating with the layer of beneficial agent in the compartment and with the exterior of the device; (d) forming the wall of a semipermeable material which is (i) permeable to the passage of the aqueous fluid and (ii) substantially impermeable to the passage of the hydrophilic polymer; (e) providing the layer of the beneficial agent with a taste which contrasts with the hydrophilic polymer layer taste; (f) placing the device in the oral cavity of the animal; and (g) periodically tasting the device to determine when the predetermined dose of beneficial agent has been delivered.
Claim 5
Dependent Claim
25 words
The method of claim 1, wherein the beneficial agent layer and the hydrophilic polymer layer provide an interface which is visible through the semipermeable wall.
Claim 6
Dependent Claim
39 words
The method of claim 3, including providing the semipermeable wall with a mark indicating when a predetermined percentage of the drug dose has been delivered into the oral cavity by comparing the location of the interface with the mark.
Claim 7
Dependent Claim
19 words
The method of claim 1 or 2, including overcoating the semipermeable wall with a composition containing a beneficial agent.
Claim 8
Dependent Claim
49 words
The method of claim 1 or 2, including providing the device with 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 cm 3 .
Claim 9
Dependent Claim
17 words
The method of claim 6, wherein the device has an aspect ratio of about 1.3:1 to 2:1.
Claim 10
Dependent Claim
17 words
The method of claim 6, wherein the device has an aspect ratio of about 1.5:1 to 1.7:1.
Claim 11
Dependent Claim
17 words
The method of claim 6, wherein the device has a height of about 2 to 8 mm.
Claim 12
Dependent Claim
19 words
The method of claim 6, wherein the device has a volume of about 0.1 to 0.5 cm 3 .
Claim 13
Dependent Claim
16 words
The method of claim 6, wherein the extended delivery period is about 0.5 to 12 hours.
Claim 14
Dependent Claim
18 words
The method of claim 1 or 2, wherein the extended delivery period is about 1 to 6 hours.
Claim 15
Dependent Claim
13 words
The method of claim 1 or 2, wherein the animal is a human.
Claim 16
Dependent Claim
45 words
The method of claim 1 or 2, wherein the beneficial agent is a member selected from the group consisting of antifungal agents, antiviral agents, antimicrobial agents, antibiotics, non-steroidal anti-inflammatory agents, anti-dental caries agents, saliva-enhancing agents, smoking cessation agents, oral ulcer healing agents and breath fresheners.
Claim 17
Dependent Claim
37 words
The method of claim 1 or 2, wherein the beneficial agent is a drug selected from the group consisting of nystatin, chlorhexidine, ibuprofen, nicotine base, sodium fluoride, pilocarpine, retin A, gluco-corticosteroids, testosterone, estrogen, nitroglycerin, captopril and clonidine.
Claim 18
Dependent Claim
27 words
The method of claim 1 or 2, wherein the beneficial agent is poorly soluble in the aqueous fluid and the layer of beneficial agent contains an osmagent.
Claim 19
Dependent Claim
60 words
The method of claim 1 or 2, wherein the gelling agent is selected from the group consisting of acacia, agar-agar, calcium carrageenan, alginic acid, algin, agarose powder, collagen, colloidal magnesium silicate, colloidal silicon dioxide, cross-linked polyacrylic acid, polyvinyl pyrrolidone, sodium carboxy methyl cellulose, hydroxy ethyl cellulose, hydroxy propyl cellulose, hydroxy propyl methyl cellulose, polyethylene oxide, pectin, gelatin and calcium silicate.
Claim 20
Dependent Claim
23 words
The method of claim 17, wherein the gelling agent is selected from the group consisting of polyethylene oxide and hydroxy propyl methyl cellulose.
Claim 21
Dependent Claim
15 words
The method of claim 1 or 2, wherein the wall contains a translucent cellulose polymer.
Claim 22
Dependent Claim
15 words
The method of claim 1 or 2, wherein the hydrophilic polymer is a cross-linked hydrogel.
Claim 23
Dependent Claim
29 words
The method of claim 2, wherein the step of providing the layer of beneficial agent with a taste comprises adding a flavoring agent to the layer of beneficial agent.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1994-09-30 | 1995-04-01 | 1995-10-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-09-30 | 1999-04-01 | 1999-10-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-09-30 | 2003-04-01 | 2003-10-01 | $7700.00 | Window Closed / Lapsed |