The present application claims the benefit of Indian Provisional Patent Application No. 201641038684 filed on l l-November-2016, the entire disclosure of which is relied on for all purposes and is incorporated into this application by reference.

FIELD OF THE INVENTION

[0002] This disclosure generally relates to compounds and compositions for the treatment of gastrointestinal polyps. More particularly, this invention relates to treating subjects with a pharmaceutically acceptable dose of compounds, crystals, solvates, enantiomer, stereoisomer, esters, salts, hydrates, prodrugs, or mixtures thereof.

BACKGROUND OF THE INVENTION

[0003] Familial adenomatous polyposis (FAP) accounts for approximately 1% of all large intestinal tumour diagnoses. The disease occurs de novo with the frequency of somewhere between 1 in 8000 to 1 in 10000 births and the age of disease penetrance varies quite considerably even between siblings.

[0004] FAP symptoms occur earlier than in the most common hereditary predisposition to colorectal cancer, Lynch syndrome and generally start to appear in the second decade of life. Patients have, however been reported to be as young as 5 years of age and in the group of our youngest patients, one was only 3 years old when polyps were diagnosed. The APC gene is a tumour suppressor gene that is involved in the control of β-catenin. Loss of APC function results in the constitutive activation of β-catenin, which culminates in cellular proliferation.

[0005] At the present time patients at risk of disease are screened by sigmoidoscopy every 12 months beginning at puberty. This makes it possible to discover symptoms long before the development of an invasive neoplasm. Once polyps appear, the only effective measure to

prevent the occurrence of the malignant disease is to remove surgically the entire colon and rectum. Prophylactic colectomy performed at an appropriate age prolongs the life expectancy of FAP patients, on average, from 45 to over 60 years of age.

[0006] Chemoprevention using NSAIDs has been proposed in FAP patients. The first drug that was shown to be effective in FAP was sulindac. Long-term use of this drug reduced the number of colorectal adenomas by >50% in the colon as well as in the rectum of patients after colectomy, but not in duodenal polyposis. However, sulindac does not prevent the development of adenomas in FAP. Selective COX-2 inhibitor (cyclooxygenase-2) celecoxib, associated with fewer gastrointestinal side effects than sulindac, was found to reduce the number of colorectal adenomas by 28%, and also reduced the number of duodenal adenomas. However, cardiovascular effects (myocardial infarction or stroke) have been described in long-term users of another selective COX-2 inhibitor (rofecoxib), and therefore the role of these drugs remain controversial, and should be considered only in selected patients without cardiovascular risk factors.

[0007] There is currently a need in the art for new compositions to treatment or delay of the onset of gastrointestinal polyps and its associated complications progression.

SUMMARY OF INVENTION

[0008] The present invention provides compounds, compositions containing these compounds and methods for using the same to treat, prevent and/or ameliorate the effects of the conditions such as gastrointestinal polyps.

[0009] The invention herein provides compositions comprising of formula I or pharmaceutical acceptable salts thereof. The invention also provides pharmaceutical compositions comprising one or more compounds of formula I or intermediates thereof and one or more of pharmaceutically acceptable carriers, vehicles or diluents. These compositions may be used in the treatment of gastrointestinal polyps and its associated complications.

WE CLAIMS

1. A compound of Formula I:
and pharmaceutically acceptable salts, hydrates, solvates, prodrugs, enantiomers, and stereoisomers thereof;

Wherein,

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2. A Pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier.

3. The pharmaceutical composition of claim 2, which is formulated to treat the underlying etiology with an effective amount administering the patient in need by oral administration, delayed release or sustained release, transmucosal, syrup, topical, parenteral administration, injection, subdermal, oral solution, rectal administration, buccal administration or transdermal administration.

4. Compounds and compositions of claim 3 are formulated for the treatment of gastrointestinal polyps, intestinal polyps and inflammation.

5. A method of treating at least one of a gastrointestinal polyps, intestinal polyps and inflammatory disease comprising:

administering the compound of Formula I to patient suffering from at least one of a gastrointestinal polyps, intestinal polyps and inflammatory disease