GASTRIC AND COLONIC FORMULATIONS AND METHODS FOR MAKING AND USING THEM
In alternative embodiments, the invention provides compositions, e.g., formulations, used for gastric, gastrointestinal and/or colonic treatments or lavage, e.g., orthostatic lavage, e.g., for inducing the purgation (e.g., cleansing) of a gastrointestinal (GI) tract, including a colon; and methods for making and using them. In alternative embodiments, compositions and methods of the invention are used for the amelioration, treatment and/or prevention of constipation, for the treatment of abdominal pain, particularly non-specific abdominal pain, and diarrhea, including diarrhea caused by a drug side effect, a psychological condition, a disease or a condition such as Crohn's Disease, a poison, a toxin or an infection, e.g., a toxin-mediated traveler's diarrhea. In alternative embodiments, the invention provides pharmaceuticals and products (articles) of manufacture for delivering these compositions and formulations to an individual, e.g., a human or an animal.
1 . (canceled)
2 . A composition comprising:
(i) bisoxatin, or bisoxatin acetate,
(ii) erythritol,
(iii) at least one disintegrant, and
(iv) one or more pharmaceutically acceptable salts, wherein the pharmaceutically acceptable salt or salts comprise at least one sodium salt, at least one potassium salt and at least one magnesium salt.
3 . The composition of claim 2 , wherein the composition is formulated in at least 9 unit dosages.
4 . The composition of claim 2 , wherein the disintegrant comprises a natural starch, a maize starch or potato starch; a directly compressible starch; a modified or pre-gelatinized starch, a carboxymethyl starch, a sodium starch glycolate; a natural or a chemically-modified cellulose, a crosslinked sodium carboxymethyl cellulose, a croscarmellose sodium, a low substituted hydroxypropyl cellulose; a microcrystalline cellulose; a gum, an agar gum, a guar gum; an alginic acid or salts thereof; an acetate or a citrates; an aluminum oxide; a synthetic polymer, a cross-linked polyvinylpyrrolidone and/or a crospovidone.
5 . The composition of claim 2 wherein the composition comprises about 240 milligrams (mg) of bisoxatin, or bisoxatin acetate.
6 . The composition of claim 2 , wherein the composition comprises about 1 g of erythritol.
7 . The composition of claim 2 , wherein the composition comprises about 25 g or more of the one or more pharmaceutically acceptable salts.
8 . The composition of claim 2 , wherein the sodium salt is a sodium sulfate.
9 . The composition of claim 2 , wherein the sodium salt is a sodium starch glycolate.
10 . The composition of claim 2 , wherein the potassium salt is potassium sulfate.
11 . The composition of claim 2 , wherein the magnesium salt is magnesium sulfate.
12 . The composition of claim 2 , wherein the composition is formulated for use as a purgative, a colonic cleanser, or for orthostatic lavage.
13 . A pharmaceutical composition comprising a composition as defined in claim 2 and a pharmaceutically acceptable excipient.
14 . The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition is manufactured, labeled or formulated as a plurality of tablets or capsules.
15 . The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition is administered in a dosing regimen of about 36 tablets or capsules.
16 . The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition or formulation is manufactured with an encapsulating material.
17 . A method of performing a procedure involving the intestine or colon on a subject, comprising administering a first composition comprising the composition of claim 2 , optionally wherein the subject is a human or an animal.
18 . The method of claim 17 , wherein the procedure comprises a colonoscopy, an enteroscopy, an endoscopy, a capsule endoscopy, a viewing of the intestinal or colonic mucosa, a surgical procedure involving the intestine or colon, or a radiological procedure involving the intestine or colon to an individual in need thereof.
19 . A method for the amelioration, treatment and/or prevention of constipation or bloating in a subject, comprising administering the composition of claim 2 to the subject in need thereof.
20 . A method for the treatment of abdominal pain in a subject, comprising administering the composition of claim 2 to the subject in need thereof.
21 . A method for the amelioration or treatment of a bowel disease in a subject, comprising administering a composition of claim 2 to the subject in need thereof.
22 . A package or kit comprising: the composition of claim 2 and instructions for its use.
23 . The package or kit of claim 22 , wherein the composition is contained within a first container, wherein the package or kit further comprises at least a second container comprising the composition of claim 2 , and the contents of the two containers are designed to be taken in sequence.