Two-stage transmucosal medicine delivery system for symptom relief

Abstract

A two-stage medicine delivery system provides an initial dose of medicine and a second dose of medicine. The initial and second doses are capable of achieving a rapid pharmacological effect and a prolonged pharmacological effect, respectively. The two-stage medicine delivery system preferably delivers a craving reduction substance, in which case, the rapid and prolonged pharmacological effects include a rapid and prolonged craving reduction. Preferably, the delivery system is a nicotine delivery system which is provided in chewing gum form or lozenge form and which provides the nicotine in a transmucosally absorbable form. The two-stage medicine delivery system preferably releases a buffering agent which increases a pH level in a user's mouth to facilitate absorption of the medicine when the delivery system is placed in the user's mouth. A method of making the medicine delivery system also is provided. The system and apparatus can be adapted to reduce cravings for alcohol, food, drugs (e.g., cocaine, opiates and the like) and tobacco products, especially tobacco products containing nicotine.

1 . A two-stage medicine delivery system comprising: 
 Means for providing an initial dose of medicine capable of achieving a rapid pharmacological effect; and    means for providing a second dose of medicine capable of achieving a prolonged pharmacological effect.    
   
   
       2 . The two-state medicine delivery system of  claim 1 , wherein said system is in chewing gum form.  
   
   
       3 . The two-stage medicine delivery system of  claim 2 , wherein the medicine is nicotine.  
   
   
       4 . The two-stage medicine delivery system of  claim 1 , wherein said system is in lozenge form.  
   
   
       5 . The two-stage medicine delivery system of  claim 1 , wherein the medicine is nicotine.  
   
   
       6 . The two-stage medicine delivery system of  claim 1 , wherein said means for providing an initial dose and said means for providing a second dose are adapted to provide transmucosal absorption of said initial and second doses when said means for providing an initial dose and said means for providing a second dose are placed in a user's mouth.  
   
   
       7 . The two-stage medicine delivery system of  claim 6 , wherein said medicine is nicotine.  
   
   
       8 . The two-stage medicine delivery system of  claim 7 , wherein said means for providing an initial dose is adapted to release between 0.2 and 0.7 milligrams of nicotine within 5 minutes of having been placed in the user's mouth.  
   
   
       9 . The two-stage medicine delivery system of  claim 8 , wherein said means for providing a second dose is adapted to maintain, for at least 20 minutes after said means for providing a second dose has been inserted into the user's mouth, a prolonged concentration of nicotine in the user's blood which is at least as high as a loaded nicotine concentration achieved in the user's blood by said initial dose.  
   
   
       10 . The two-stage medicine delivery system of  claim 9 , wherein said loaded nicotine concentration is at least 2 nanograms of nicotine per milliliter of blood.  
   
   
       11 . The two-stage medicine delivery system of  claim 10 , wherein said prolonged concentration of nicotine is at least 10 nanograms of nicotine per milliliter of blood.  
   
   
       12 . The two-stage medicine delivery system of  claim 11 , further comprising means for releasing a buffering agent which increases a pH level in the user's mouth to facilitate transmucosal absorption of said nicotine.  
   
   
       13 . The two-stage medicine delivery system of  claim 1 , further comprising means for releasing a buffering agent which increases a pH level in a user's mouth to facilitate absorption of said medicine when said two-stage medicine delivery system is placed in the user's mouth.  
   
   
       14 . The two-stage medicine delivery system of  claim 13 , wherein said medicine is nicotine.  
   
   
       15 . The two-stage medicine delivery system of  claim 14 , wherein: 
 said buffering agent is adapted to elevate the pH level in the user's mouth to between about 7.5 and 9.5 within 5 minutes of having been placed in the user's mouth;    said means for providing an initial dose is adapted to achieve a loaded nicotine concentration in the user's blood between 2 nanograms of nicotine per milliliter of blood and 7 nanograms of nicotine per milliliter of blood, within 5 minutes of having been placed in the user's mouth; and    said means for providing a second dose is adapted to increase the concentration of nicotine in the user's blood beyond the loaded nicotine concentration to achieve a prolonged concentration of nicotine in the user's blood of at least  10  nanograms of nicotine per milliliter of blood, and is further adapted to maintain said prolonged concentration of nicotine for at least 20 minutes.    
   
   
       16 . The two-stage medicine delivery system of  claim 1 , wherein said medicine is a craving counteracting substance, and said rapid and prolonged therapeutic effects include a rapid and prolonged reduction of a craving.  
   
   
       17 . A two-stage nicotine delivering product for use in counteracting cravings for nicotine-containing tobacco products, comprising: 
 a base,    a nicotine loading compound mixed with the base so that oral actuation of the base causes the nicotine loading compound to be released in a user's mouth for transmucosal absorption within the first 5 minutes after oral actuation begins; and    a nicotine maintenance compound mixed with the base so that oral actuation of the base causes the nicotine maintenance compound to be released into the user's mouth for prolonged transmucosal absorption which lasts at least 20 minutes beyond said first five minutes.    
   
   
       18 . The two-stage nicotine delivering product of  claim 17 , wherein said nicotine loading compound is 0.2 to 0.7 milligrams of a nicotine salt.  
   
   
       19 . The two-stage nicotine delivering product of  claim 18 , wherein said nicotine salt is nicotine tartrate.  
   
   
       20 . The two-stage nicotine delivering product of  claim 17 , wherein said nicotine maintenance compound is 1 to 4 milligrams of nicotine in an ion exchange resin gum.  
   
   
       21 - 37 . (canceled)