Method and Dosage Form to Confirm Compliant Use of a Bioactive Agent
First Claim
1. An oral medication comprising a dose of at least one bioactive agent and a substance incorporated in the dose in a manner that, when the oral medication is properly administered, leaves a stain or mark in a patient'"'"'s mouth, by itself or when combined with a reagent, visible in normal light or when exposed to a special frequency light source in order for medical personnel to determine if a person is in compliance with taking the medication.
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Accused Products
Abstract
A dosage form includes a dose of at least one bioactive agent and a substance that can be readily confirmed by medical personnel to determine if the patient is compliant with taking the dosage form. The substance is at least one member selected from the group consisting of (a) a material incorporated in the dose in a manner that when the dosage form is properly administered is by itself or when combined with a reagent visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light or when exposed to a special frequency light source, (b) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but by itself or when combined with a reagent is readily visible when exposed to a special frequency light source, (c) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but when combined with a reagent is readily visible in normal light and (d) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but by itself or when combined with a reagent is readily detected by a non-visual detection method.
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Citations
31 Claims
- 1. An oral medication comprising a dose of at least one bioactive agent and a substance incorporated in the dose in a manner that, when the oral medication is properly administered, leaves a stain or mark in a patient'"'"'s mouth, by itself or when combined with a reagent, visible in normal light or when exposed to a special frequency light source in order for medical personnel to determine if a person is in compliance with taking the medication.
- 13. A dosage form comprising a dose of at least one bioactive agent and a substance incorporated in the dose in a manner that, when the dosage form is properly administered, is, by itself or when combined with a reagent, visible to a normal light or to a special light source in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or excretion of a patient in order for medical personnel to determine if the patient is being compliant with taking the dosage form, wherein the substance is either coating the at least one bioactive agent or intermixed with the at least one bioactive agent in a delivering body.
- 27. An oral medication comprising a dose of at least one bioactive agent and a substance that is excreted by the body such that the presence of the substance in an excretion of the body can be readily confirmed by medical personnel to determine if the patient is compliant with taking the oral medication, wherein the substance is at least one member selected from the group consisting of (a) a material incorporated in the dose in a manner that when the oral medication is properly administered is by itself or when combined with a reagent visible in normal light or when exposed to a special frequency light source, (b) a material that is by itself not readily visible in the excretion in normal light but by itself or when combined with a reagent is readily visible when exposed to a special frequency light source, (c) a material that is by itself not readily visible in the excretion in normal light but when combined with a reagent is readily visible in normal light and (d) a material that is by itself not readily visible in the excretion in normal light but by itself or when combined with a reagent is readily detected by a non-visual detection method.
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30. A dosage form comprising a dose of at least one bioactive agent and a substance that can be readily confirmed by medical personnel to determine if the patient is compliant with taking the dosage form, wherein the substance is at least one member selected from the group consisting of (a) a material incorporated in the dose in a manner that when the dosage form is properly administered is by itself or when combined with a reagent visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light or when exposed to a special frequency light source, (b) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but by itself or when combined with a reagent is readily visible when exposed to a special frequency light source, (c) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but when combined with a reagent is readily visible in normal light and (d) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but by itself or when combined with a reagent is readily detected by a non-visual detection method.
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31. A method of using a Closed Loop Diagnostic System in order discern the presence of an analyte directly or by reference to another bound entity, comprising administering to a patient a dose of at least one bioactive agent and administering a substance that can be readily confirmed by medical personnel to determine if the patient is compliant with taking the dosage form, wherein the substance is at least one member selected from the group consisting of (a) a material incorporated in the dose in a manner that when the dosage form is properly administered is by itself or when combined with a reagent visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light or when exposed to a special frequency light source, (b) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but by itself or when combined with a reagent is readily visible when exposed to a special frequency light source, (c) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but when combined with a reagent is readily visible in normal light and (d) a material that is by itself not readily visible in the buccal, vaginal, nasal, rectal, aural, ophthalmic or ostomic cavity of a patient or an excretion of a patient in normal light but by itself or when combined with a reagent is readily detected by a non-visual detection method, and detecting the presence of the substance.
Specification