Pharmaceutical Formulation And Method For Treating Acid-Caused Gastrointestinal Disorders
Pharmaceutical formulations in the form of a powder for suspension comprising at least one proton pump inhibitor in micronized form; at least one antacid; and at lest one suspending agents are provided herein. Also provided herein are methods for making and using pharmaceutical formulations comprising at least one proton pump inhibitor and at least one antacid.
1 . A method of making pharmaceutical formulation for oral administration comprising:
(a) making a first blend by dry blending at least one acid-labile substituted bicyclic aryl-imidazole proton pump inhibitor in micronized form with at least one bicarbonate salt of a Group IA metal, wherein (i) at least 80% of the micronized proton pump inhibitor is less than 40 μm in diameter; and (ii) the dry blending coats at least some of the micronized proton pump inhibitor with the bicarbonate salt; and
(b) blending the first blend with at least one other excipient.
2 . The method according to claim 1 , wherein said pharmaceutical formulation is a dosage form selected from a powder, a tablet, a bite-disintegration tablet, a chewable tablet, a caplet, a capsule, an effervescent powder, a rapid-disintegration tablet, and an aqueous suspension produced from a powder.
3 . The method according to claim 1 , wherein said proton pump inhibitor is selected from the group consisting of omeprazole, hydroxyomeprazole, esomeprazole, tenatoprazole, lansoprazole, pantoprazole, rabeprazole, dontoprazole, habeprazole, perprazole, ransoprazole, pariprazole, leminoprazole; or a free base, free acid, salt, hydrate, ester, amide, enantiomer, isomer, tautomer, and polymorph thereof.
4 . The method according to claim 1 , wherein said bicarbonate salt of the Group IA metal is a soluble antacid.
5 . The method according to claim 3 , wherein the soluble antacid is sodium bicarbonate.
6 . The method according to claim 4 , wherein the sodium bicarbonate is present in an amount of about 500 mgs to about 3000 mgs.
7 . The method according to claim 2 , wherein the pharmaceutical formulation is a powder or an aqueous suspension produced from a powder.
8 . The method according to claim 1 , wherein the at least one other excipient comprises Xanthan gum.
9 . The method according to claim 8 , wherein the Xanthan Gum is present in an amount of about 50 mg to about 150 mgs.
10 . The method according to claim 1 , wherein the average particle size of any substantially insoluble material in the pharmaceutical formulation is less than 150 μm in diameter.
11 . The method according to claim 1 , wherein the at least one acid-labile substituted bicyclic aryl-imidazole proton pump inhibitor is omeprazole.