US2016051540A1PendingUtilityA1

Method and dosage regimens for eliminating a chemical substance in blood

Individually held — no corporate assignee on recordPriority: Aug 20, 2008Filed: Nov 5, 2015Published: Feb 25, 2016
Est. expiryAug 20, 2028(~2.1 yrs left)· nominal 20-yr term from priority
A61P 43/00A61P 39/02A61K 31/485A61K 9/20A61P 25/30A61K 31/00A61P 25/36A61K 31/4709A61K 31/439A61K 31/49
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Claims

Abstract

A kit or plurality of dosing regimens formulated for treating opioid dependence while minimizing withdrawal symptoms includes a plurality of dosage forms of an opioid or a pharmaceutically acceptable salt thereof containing an initial dosing series of the opioid sufficient to minimize withdrawal symptoms and a dosing amount of the opioid in each subsequent decreasing dosing series provides doses to be taken at least two times per day and for at least two days that when administered ensures that the lowest concentration level in the blood of the opioid for the subsequent dosing series is equal to at least ninety-five percent of the lowest concentration level in the blood of the immediately preceding dosing series and wherein the quantity of dosage forms is sufficient for administration for no less than sixty days.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A kit for treating opioid dependence in a patient while minimizing withdrawal symptoms, the kit comprising:
 a plurality of dosage forms of an opioid or a pharmaceutically acceptable salt thereof selected from the group consisting of morphine, codeine, thebaine, hydromorphone, hydrocodone, oxycodone, oxymorphone, desomorphine, nicomorphine, dipropanoylmorphine, benzylmorphine, ethylmorphine, fentanyl, pethidine, propoxyphene, and methadone that the patient has dependence on, the plurality of dosage forms being packaged in a plurality of decreasing dosing series, the plurality of dosage forms contains an initial dosing amount of the opioid for an initial dosing series sufficient to minimize withdrawal symptoms wherein the initial dosing series provides doses to be taken at least two times per day and for at least two days and a dosing amount of the opioid in each subsequent decreasing dosing series provides doses to be taken at least two times per day and for at least two days that when administered ensures that the lowest concentration level in the blood of the opioid for the subsequent dosing series is equal to at least ninety-five percent of the lowest concentration level in the blood of the immediately preceding dosing series and wherein the quantity of dosage forms is sufficient for administration for no less than sixty days; and   instructions to administer the initial dosing amount for an initial dosing series to minimize withdrawal symptoms, and to determine the lowest concentration level of the opioid in the blood immediately before the end of the initial dosing series whereby the determined lowest concentration level in the blood of the initial dosing series is the value used for determining a dosing amount of the opioid in each subsequent decreasing dosage series to provide a concentration of the opioid in the blood that is at least ninety-five percent of the lowest concentration level of the opioid in the blood of the previous dosing series.   
     
     
         2 . The kit of  claim 1  wherein the quantity of dosage forms is sufficient for administration for seventy days or more. 
     
     
         3 . The kit of  claim 1  wherein the quantity of dosage forms is sufficient for administration for ninety days or more. 
     
     
         4 . The kit of  claim 1  wherein the quantity of dosage forms is sufficient for administration for one hundred twenty days or more. 
     
     
         5 . The kit of  claim 1  wherein the initial dosing amount is sufficient to stabilize the concentration of the opioid in the blood of the patient during the initial dosing series. 
     
     
         6 . The kit of  claim 1  wherein a last dosage of the opioid of a last dosing series is a dose of 0.01 mg or less. 
     
     
         7 . The kit of  claim 1  wherein the amount of the opioid being administered in each dosage in the plurality of subsequent dosing series is an amount sufficient to minimize or eliminate withdrawal symptoms in the patient being treated. 
     
     
         8 . The kit of  claim 1  wherein each dosage of the opioid being administered is administered approximately twelve hours after the immediately preceding dosage. 
     
     
         9 . The kit of  claim 1  further comprising one or more dosages of quinine for administration after the last dosage of the opioid. 
     
     
         10 . A plurality of dosing regimens formulated for treating opioid addiction in a patient that provides for minimizing withdrawal symptoms, the plurality of dosing regimens comprising:
 a quantity of an opioid or a pharmaceutically acceptable salt thereof selected from the group consisting of morphine, codeine, thebaine, hydromorphone, hydrocodone, oxycodone, oxymorphone, desomorphine, nicomorphine, dipropanoylmorphine, benzylmorphine, ethylmorphine, fentanyl, pethidine, propoxyphene, and methadone that the patient has dependence on, contained in each of a plurality of dosing regimens wherein the plurality of dosing regimens includes an initial dosing regimen of at least two days with doses taken at least two times per day wherein the initial dosing regimen contains an amount of the opioid sufficient to minimize withdrawal symptoms and a plurality of subsequent decreasing dosing regimens wherein each subsequent dosing regimen contains a dosing amount of the opioid for at least two days with doses taken at least two times per day that when administered ensures that the lowest concentration level of the opioid in the blood plasma for a subsequent dosing regimen is equal to at least ninety-five percent of the lowest concentration level of the opioid in the blood plasma of the immediately preceding dosing regimen and wherein the quantity of the opioid is sufficient for administration for no less than sixty days.   
     
     
         11 . The plurality of dosing regimens of  claim 10  wherein the quantity of the opioid is sufficient for administration for seventy days or more. 
     
     
         12 . The plurality of dosing regimens of  claim 10  wherein the quantity of the opioid is sufficient for administration for ninety days or more. 
     
     
         13 . The plurality of dosing regimens of  claim 10  wherein the quantity of the opioid is sufficient for administration for one hundred twenty days or more. 
     
     
         14 . The plurality of dosing regimens of  claim 10  wherein the initial dosing regimen is an amount sufficient to stabilize the concentration of the opioid in the blood of the patient during the initial dosing regimen. 
     
     
         15 . The plurality of dosing regimens of  claim 10  wherein a last dosage of the opioid of a last dosing regimen is a dose of 0.01 mg or less. 
     
     
         16 . The plurality of dosing regimens of  claim 10  wherein the amount of the opioid being administered in each dosage in the plurality of subsequent dosing regimens is an amount sufficient to minimize or eliminate withdrawal symptoms in the patient being treated. 
     
     
         17 . The plurality of dosing regimens of  claim 10  wherein each dosage of the opioid being administered is administered approximately twelve hours after the immediately preceding dosage. 
     
     
         18 . The plurality of dosing regimens of  claim 10  further comprising one or more dosages of quinine for administration after the last dosage of the opioid.

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