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Claims for Patent: 4,671,953

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Claims for Patent: 4,671,953

Title: Methods and compositions for noninvasive administration of sedatives, analgesics, and anesthetics
Abstract:The present invention is directed to methods and compositions for noninvasively administering drugs having a sedative, analgesic, or anesthetic effect. A drug capable of absorption through mucosal tissues in incorporated into a candy matrix, which is then advantageously formed into a lollipop. A patient is put at ease when given the lollipop, and the drug rapidly enters the patient's bloodstream as the lollipop is sucked. When sedating or anesthetizing the patient, the physician can observe the patient's condition and remove the lollipop when it has had a desired effect on the patient. Alternatively, the physican can alter placement of the lollipop to slow the rate of the drug release for absorption into the patient's system. An analgesic-containing lollipop can be self-administrated by a patient in response to his own subjective experience of pain and to the patient's susceptibility to the particular drug utilized.
Inventor(s): Stanley; Theodore H. (Salt Lake City, UT), Haque; Brian (West Valley City, UT)
Assignee: University of Utah Research Foundation (Salt Lake City, UT)
Application Number:06/729,301
Patent Claims: 1. A method for administering the drug fentanyl in order to induce systemically a sedative, analgesic, or anesthetic effect, the method comprising the steps of:

obtaining a soluble matrix material in the form of a lollipop into which the drug fentanyl has been dispersed, said soluble matrix material being capable of releasing the fentanyl for absorption through mucosal tissue;

providing the drug-containing matrix to a patient to whom the fentanyl is to be administered in order to induce systemically the sedative, analgesic, or anesthetic effect;

administering the drug-containing matrix in a manner such that said matrix is dissolved in the patient's mouth so that said is absorbed through mucosal tissue, thereby entering the patient's bloodstream, said administering step being accomplished in a dose-to-effect manner; and

controlling the rate at which the drug-containing matrix is dissolved in order to obtain and maintain a desired effect.

2. A method for administering defined in claim 1, wherein the patient is initially caused to suck on the drug-containing matrix in a manner capable of effecting rapid dissolution thereof, such that relatively high quantities of drug are rapidly absorbed into the patient's bloodstream, so that the desired effect is obtained rapidly, and wherein the patient is thereafter caused to suck on the drug-containing matrix only as needed to maintain such desired effect.

3. A method for administering fentanyl as defined in claim 2, wherein the dosage of drug dispersed in the soluble matrix material is in the range of from about 1 to about 50 times greater than the dosage that would be given by intravenous injection.

4. A method for administering fentanyl as defined in claim 2, wherein the dosage of drug dispersed in the soluble matrix material is in the range of from about 5 to about 10 times greater than the dosage that would be given by intravenous injection.

5. A method for administering fentanyl as defined in claim 1, wherein the dosage of fentanyl dispersed in the matrix is from about 500 micrograms to about 10 milligrams of fentanyl equivalent.

6. A method for administering fentanyl as defined in claim 1, wherein the soluble matrix material is a carbohydrate mass.

7. A method for administering fentanyl as defined in claim 1, wherein the lollipop is intermittently removed from the patient's mouth in order to prevent an excessive amount of drug from being absorbed through mucous tissue into the patient's bloodstream.

8. A method for administering fentanyl as defined in claim 2, wherein the drug-containing matrix is maintained relatively passively in the patient's mouth after the desired effect is obtained in order to maintain such desired effect.

9. A method for administering systemically the analgesic drug fentanyl, comprising the steps of:

obtaining a soluble matrix material in the form of a lollipop into which the drug fentanyl has been dispersed, said soluble matrix material being capable of releasing the fentanyl for absorption through musocal tissue;

providing the drug-containing matrix to a patient to be treated with the analgesic drug; and

administering systemically the drug-containing matrix in a manner such that said matrix is dissolved in the patient's mouth so that analgesic drug is absorbed through musocal tissue, thereby entering the patient's bloodstream, the patient controlling the rate of dissolution of the drug-containing matrix in a dose-to-effect manner in order to obtain and maintain a suitable level of relief from pain while accounting for the patient's individual susceptibility to the analgesic drug and the patient's individual subjective experience of pain.

10. A method for administering fentanyl as defined in claim 9, wherein the soluble matrix material is a carbohydrate mass.

11. A method for administering fentanyl as defined in claim 9, wherein the lollipop is intermittently removed from the patient's mouth in order to prevent an excessive amount of drug from being absorbed through mucosal tissue into the patient's bloodstream.

12. A method for administering fentanyl as defined in claim 9, wherein the lollipop is sucked on substantially continuously in a passive manner so that relatively small quantities of analgesia enter the patient's bloodstream substantially continuously, and wherein the patient increases the aggressiveness of such sucking in response to increases in the experience of pain so as to increase the quantity of drug entering the patient's bloodstream in order to provide relief from such increases in pain.

13. A method for administering fentanyl as defined in claim 9, wherein the dosage of drug dispersed in the soluble matrix is in the range of from about 1 to about 50 times greater than the dosage that would be given by intravenous injection.

14. A method for administering fentanyl as defined in claim 9, wherein the dosage of drug dispersed in the soluble matrix is in the range of from about 5 to about 10 times greater than the dosage that would be given by intravenous injection.

15. A method for administering fentanyl as defined in claim 9, wherein the dosage of fentanyl dispersed in the matrix is from about 500 micrograms to about 10 milligrams of fentanyl equivalent.

16. A composition for use in systemically inducing a sedative, analgesic or anesthetic effect in a patient, said composition comprising:

an effective dose of the drug fentanyl in a form capable of being absorbed through mucosal tissue, and capable of systemically inducing a condition of sedation, analgesia, or anesthesia in a patient;

a soluble matrix material, the fentanyl being dispersed substantially uniformly within the matrix so that the drug is released for absorption through mucosal tissue as the matrix dissolves when placed in a patient's mouth; and

holder means secured to the drug-containing matrix, said holder means being configured so as to permit convenient insertion of the drug-containing matrix into the mouth of a patient, and convenient removal thereof when a desired condition is obtained.

17. A composition as defined in claim 16, wherein the holder means is a stick.

18. A composition as defined in claim 16, wherein the dosage of drug dispersed in the soluble matrix material is in the range of from about 1 to about 50 times greater than the dosage that would be given by intravenous injection.

19. A composition as defined in claim 16, wherein the dosage of drug dispersed in the soluble matrix material is in the range of from about 5 to about 10 times greater than the dosage that would be given by intravenous injection.

20. A composition as defined in claim 16, wherein the drug is fentanyl and the dosage of fentanyl dispersed in the matrix is from about 500 micrograms to about 10 milligrams of fentanyl equivalent.

21. A composition as defined in claim 16, wherein the drug-containing matrix is in the form of a lollipop.
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