Omeprazole solution and method for using same

Abstract

A pharmaceutical composition includes an aqueous solution/suspension of omeprazole or other substituted benzimidazoles and derivatives thereof in a pharmaceutically acceptable carrier comprising a bicarbonate salt of a Group IA metal. A method for treating and/or preventing gastrointestinal conditions by administering to a patient a pharmaceutical composition including an aqueous solution/suspension of omeprazole or other substituted benzimidazoles and derivatives thereof in a pharmaceutically acceptable carrier including a bicarbonate salt of a Group IA metal wherein the administering step consists of a single dosage form without requiring further administering of the bicarbonate salt of the Group IA metal. A pharmaceutical composition for making a solution/suspension of omeprazole or other substituted benzimidazoles and derivatives thereof includes omeprazole or other substituted benzimidazoles and derivatives thereof and a bicarbonate salt of a Group IA metal in a form for convenient storage whereby when the composition is dissolved in aqueous solution, the resulting solution is suitable for enteral administration.

We claim: 
     
       1. A method for treating gastric acid disorders selected from the group consisting of active duodenal ulcers, gastric ulcers, gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive systematic GERD, and Zollinger Ellison Syndrome by administering to a patient in a single dose of a pharmaceutical composition of omeprazole or lansoprazole powder in a pharmaceutically acceptable carrier consisting essentially of a bicarbonate salt of a Group IA metal wherein said administering step consists of providing to the patient orally in a single dose of of an aqueous solution or, suspension of the pharmaceutical composition without requiring further administration of the bicarbonate salt of the Group IA metal, wherein upon oral administration of the suspension at least some of the omeprazole or lansoprazole is absorbed within about 10 to about 12 minutes after administration. 
     
     
       2. A method according to  claim 1 , wherein the Group IA metal is sodium. 
     
     
       3. A method according to  claim 1 , wherein the Group IA metal is potassium. 
     
     
       4. A method according to  claim 1 , wherein the concentration of omeprazole in the composition range ranges from approximately 0.5 mg/ml to approximately 6.0 mg/ml. 
     
     
       5. A method according to  claim 3 , wherein the concentration of omeprazole in said composition range ranges from approximately 1.0 mg/ml to approximately 4.0 mg/ml. 
     
     
       6. A method as set forth in  claim 5 , wherein the concentration of omeprazole in the composition is approximately 2.0 mg/ml. 
     
     
       7. A method as set forth in  claim 1 , wherein the concentration of the bicarbonate salt of the Group IA metal in the composition ranges from approximately 5.0% to approximately 60.0%. 
     
     
       8. A method as set forth in  claim 7 , wherein the concentration of the bicarbonate salt of the Group IA metal in the composition ranges from approximately 7.5% to approximately 10.0%. 
     
     
       9. A method as set forth in  claim 8 , wherein the concentration of the bicarbonate salt of the Group IA metal is approximately 8.4%. 
     
     
       10. A method as set forth in  claim 1 , wherein the single dosage form pharmaceutical composition includes a concentration of bicarbonate ranging from approximately 0.75 meq mEq to 1.5 meq mEq per milliliter. 
     
     
       11. A method as set forth in  claim 10 , wherein the amount of the bicarbonate in the single dosage form pharmaceutical composition is less than approximately 12 mEq/20 mEq per 20 mg dose of omeprazole. 
     
     
       12. A method as set forth in  claim 1 , wherein the single dosage form pharmaceutical composition is administered in a volume of between approximately 10 ml and 20 ml. 
     
     
       13. A method for treating gastric acid disorders selected from the group consisting of active duodenal ulcers, gastric ulcers, gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive systematic GERD, and Zollinger Ellison Syndrome by administering to a patient in a single dose a pharmaceutical composition of omeprazole powder in a pharmaceutically acceptable carrier consisting essentially of a bicarbonate salt of a Group IA metal wherein said administering step consists of providing to the patient orally in a single dose an aqueous solution or suspension of the pharmaceutical composition without requiring further administration of the bicarbonate salt of the Group IA metal, wherein the concentration of omeprazole in said composition ranges from approximately 1.0 mg/ml to approximately 4.0 mg/ml.  
     
     
       14. A method for treating gastric acid disorders selected from the group consisting of active duodenal ulcers, gastric ulcers, gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive systematic GERD, and Zollinger Ellison Syndrome by administering to a patient in a single dose a pharmaceutical composition of omeprazole powder in a pharmaceutically acceptable carrier consisting essentially of a bicarbonate salt of a Group IA metal wherein said administering step consists of providing to the patient orally in a single dose an aqueous solution or suspension of the pharmaceutical composition without requiring further administration of the bicarbonate salt of the Group IA metal, wherein the concentration of omeprazole in said composition is approximately 2.0 mg/ml.  
     
     
       15. A method for treating gastric acid disorders selected from the group consisting of active duodenal ulcers, gastric ulcers, gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive systematic GERD, and Zollinger Ellison Syndrome by administering to a patient in a single dose a pharmaceutical composition of omeprazole powder in a pharmaceutically acceptable carrier consisting essentially of a bicarbonate salt of a Group IA metal wherein said administering step consists of providing to the patient orally in a single dose an aqueous solution or suspension of the pharmaceutical composition without requiring further administration of the bicarbonate salt of the Group IA metal, wherein the amount of the bicarbonate in the single dose is less than approximately 12 mEq/20 mg dose of omeprazole.  
     
     
       16. A method for treating gastric acid disorders selected from the group consisting of active duodenal ulcers, gastric ulcers, gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive systematic GERD, and Zollinger Ellison Syndrome by administering to a patient in a single dose a pharmaceutical composition of omeprazole or lansoprazole powder in a pharmaceutically acceptable carrier consisting essentially of a bicarbonate salt of a Group IA metal wherein said administering step consists of providing to the patient orally in a single dose an aqueous solution or suspension of the pharmaceutical composition without requiring further administration of the bicarbonate salt of the Group IA metal, wherein the single dose is administered in a volume of between approximately 10 ml and approximately 20 ml.  
     
     
       17. The method of claim 1, wherein the solution or suspension further includes a thickening agent.  
     
     
       18. The method of claim 17, wherein the pharmaceutically acceptable carrier consists essentially of sodium bicarbonate.  
     
     
       19. The method of claim 17, wherein the sodium bicarbonate is present in an amount of approximately 0.75 mEq (mmol) to approximately 1.5 mEq (mmol) sodium bicarbonate per 2 mg of omeprazole powder.  
     
     
       20. The method of claim 18, wherein the sodium bicarbonate is present in an amount of approximately 0.75 mEq (mmol) to approximately 1.5 mEq (mmol) sodium bicarbonate per 2 mg of omeprazole powder.  
     
     
       21. The method of claim 19, wherein the omeprazole powder is present in an amount of about 20 mg per 10 ml solution.  
     
     
       22. The method of claim 20, wherein the omeprazole powder is present in an amount of about 20 mg per 10 ml solution.  
     
     
       23. The method of claim 21, wherein upon oral administration a therapeutically effective amount of the omeprazole is absorbed within about 10 to about 12 minutes after administration.  
     
     
       24. The method of claim 22, wherein upon oral administration a therapeutically effective amount of the omeprazole is absorbed within about 10 to about 12 minutes after administration.