Abstract: The invention relates to the compounds of formula I formula II formula III formula IV formula V formula VI formula VII and formula VIII or its pharmaceutical acceptable polymorphs solvates enantiomers stereoisomers and hydrates thereof. The pharmaceutical compositions comprising an effective amount of compounds of formula I formula II formula III formula IV formula V formula VI formula VII and formula VIII and methods for the treatment of mucositis may be formulated for oral mouth wash buccal rectal topical transdermal transmucosal intravenous oral solution buccal mucosal layer tablet parenteral administration syrup or injection. Such compositions may be used to treatment of oral and gastrointestinal mucositis mucosal inflammatory and oral infectious diseases.
WE CLAIM;
1. A compound of formula I:
Formula I
or pharmaceutically acceptable hydrates, solvates, enantiomers, or stereoisomers thereof;
Wherein,
RH independently represents
l-hydroxy-2-naphthoic acid, 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2- oxoglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid, adipic acid, ascorbic acid, aspartic acid, benzenesulfonic acid, benzoic acid, camphoric acid, camphor- 10- sulfonic acid, capric acid (decanoic acid), caproic acid (hexanoic acid), caprylic acid (octanoic acid), carbonic acid, cinnamic acid, citric acid, cyclamic acid, caproic acid, caprilic acid, capric acid, lauric acid, myristic acid, myristoleic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, elaidic acid, linoleic acid, linolenic acid, linolelaidic acid, arachidonic acid, dodecylsulfuric acid, ethane- 1,2-disulfonic acid, ethanesulfonic acid, formic acid, fumaric acid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glutaric acid, glycerophosphoric acid, glycolic acid, hippuric acid, hydrobromic acid, hydrochloric acid, isobutyrie acid, lactic acid, lactobionic acid, lauric acid, maleic acid, malic acid, malonic acid, mandelic acid, methanesulfonic acid, naphthalene-l,5-disulfonic acid, naphthalene-2-sulfonic acid, nicotinic acid, R-Lipoic acid, nitric acid, oleic acid, oxalic acid, palmitic acid, pamoic acid, phosphoric acid, proprionic acid, pyroglutamic acid, salicylic acid, sebacic acid, stearic acid, succinic acid, sulfuric acid, tartaric acid, thiocyanic acid, toluenesulfonic acid, undecylenic acid, n-acetyl cysteine, furoate, methyl furoate, ethyl furoate or aminocaproic acid.
2. A compound of formula V:
Formula V
or pharmaceutically acceptable hydrates, solvates, enantiomers, or stereoisomers thereof;
Wherein,
RH independently represents
l-hydroxy-2-naphthoic acid, 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-oxoglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid, adipic acid, ascorbic acid, aspartic acid, benzenesulfonic acid, benzoic acid, camphoric acid, camphor- 10-sulfonic acid, capric acid (decanoic acid), caproic acid (hexanoic acid), caprylic acid (octanoic acid), carbonic acid, cinnamic acid, citric acid, cyclamic acid, caproic acid, caprilic acid, capric acid, lauric acid, myristic acid, myristoleic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, elaidic acid, linoleic acid, linolenic acid, linolelaidic acid, arachidonic acid, dodecylsulfuric acid, ethane- 1,2-disulfonic acid, ethanesulfonic acid, formic acid, fumaric acid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glutaric acid, glycerophosphoric acid, glycolic acid, hippuric acid, hydrobromic acid, hydrochloric acid, isobutyric acid, lactic acid, lactobionic acid, lauric acid, maleic acid, malic acid, malonic acid, mandelic acid, methanesulfonic acid, naphthalene- 1,5-disulfonic acid, naphthalene-2-sulfonic acid, nicotinic acid, R-Lipoic acid, nitric acid, oleic acid, Oxalic acid, palmitic acid, pamoic acid, phosphoric acid, proprionic acid, pyroglutamic acid, salicylic acid, sebacic acid, stearic acid, succinic acid, sulfuric acid, tartaric acid, thiocyanic acid, toluenesulfonic acid, undecylenic acid, n-acetyl cysteine, furoate, methyl furoate, ethyl furoate or aminocaproic acid.
3. A pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier.
4. A pharmaceutical composition comprising a compound of claim 2 and a pharmaceutically acceptable carrier.
5. A method of treating pain, mucositis, odontostomatology: gingivitis, stomatitis, glossitis, aphthous ulcers, dental surgery, oral ulceration, pharyngitis, tonsillitis, post-tonsillectomy, radiation or intubation mucositis, wherein the method comprises administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 3, and wherein said pharmaceutical composition is administered to the patient in need by oral administration, delayed release or sustained release, transmucosal, syrup, mucoadhesive, spray, buccal formulation, mucoadhesive tablet, topical, parenteral administration, injection, subdermal, oral solution, rectal administration, buccal administration or transdermal administration.
6. A method of treating mucositis, pain, pain associated with oral mucositis, depression, anxiety disorders, pruritus, insomnia, chronic idiopathic urticarial, atopic dermatitis, lichen simplex chronicus and neuropathy, wherein the method comprises administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 4, and wherein said pharmaceutical composition is administered to the patient in need by oral administration, delayed release or sustained release, transmucosal, syrup, mucoadhesive, spray, buccal formulation, mucoadhesive tablet, topical, parenteral administration, injection, subdermal, oral solution, rectal administration, buccal administration or transdermal administration.
7. A compound of claim 1 > wherein the compound is:
8. A compound of claim 2, wherein the compound is:
| # | Name | Date |
|---|---|---|
| 1 | 201747031123-RELEVANT DOCUMENTS [29-08-2022(online)].pdf | 2022-08-29 |
| 1 | 201747031123-STATEMENT OF UNDERTAKING (FORM 3) [01-09-2017(online)].pdf | 2017-09-01 |
| 2 | 201747031123-FORM 1 [01-09-2017(online)].pdf | 2017-09-01 |
| 2 | 201747031123-RELEVANT DOCUMENTS [06-05-2022(online)].pdf | 2022-05-06 |
| 3 | 201747031123-FIGURE OF ABSTRACT [01-09-2017(online)].pdf | 2017-09-01 |
| 3 | 201747031123-Abstract_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 4 | 201747031123-DRAWINGS [01-09-2017(online)].pdf | 2017-09-01 |
| 4 | 201747031123-Claims_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 5 | 201747031123-Description_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 5 | 201747031123-DECLARATION OF INVENTORSHIP (FORM 5) [01-09-2017(online)].pdf | 2017-09-01 |
| 6 | 201747031123-Drawings_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 6 | 201747031123-COMPLETE SPECIFICATION [01-09-2017(online)].pdf | 2017-09-01 |
| 7 | 201747031123.pdf | 2017-09-07 |
| 7 | 201747031123-IntimationOfGrant16-09-2020.pdf | 2020-09-16 |
| 8 | 201747031123-Marked up Claims_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 8 | 201747031123-FORM-26 [22-09-2017(online)].pdf | 2017-09-22 |
| 9 | 201747031123-PatentCertificate16-09-2020.pdf | 2020-09-16 |
| 9 | Correspondence by Agent_Power of Attorney_03-10-2017.pdf | 2017-10-03 |
| 10 | 201747031123-Annexure [12-09-2020(online)].pdf | 2020-09-12 |
| 10 | 201747031123-Proof of Right (MANDATORY) [04-12-2017(online)].pdf | 2017-12-04 |
| 11 | 201747031123-Response to office action [12-09-2020(online)].pdf | 2020-09-12 |
| 11 | Correspondence by Agent_Proof Of Right_06-12-2017.pdf | 2017-12-06 |
| 12 | 201747031123-PETITION UNDER RULE 137 [13-04-2020(online)].pdf | 2020-04-13 |
| 12 | 201747031123-RELEVANT DOCUMENTS [05-09-2018(online)].pdf | 2018-09-05 |
| 13 | 201747031123-ABSTRACT [11-04-2020(online)].pdf | 2020-04-11 |
| 13 | 201747031123-Changing Name-Nationality-Address For Service [05-09-2018(online)].pdf | 2018-09-05 |
| 14 | 201747031123-CLAIMS [11-04-2020(online)].pdf | 2020-04-11 |
| 14 | Correspondence by Agent_Power Of Attorney_26-09-2018.pdf | 2018-09-26 |
| 15 | 201747031123-COMPLETE SPECIFICATION [11-04-2020(online)].pdf | 2020-04-11 |
| 15 | 201747031123-FORM 3 [08-01-2019(online)].pdf | 2019-01-08 |
| 16 | 201747031123-CORRESPONDENCE [11-04-2020(online)].pdf | 2020-04-11 |
| 16 | 201747031123-FORM 18 [28-01-2019(online)].pdf | 2019-01-28 |
| 17 | 201747031123-FER.pdf | 2019-11-14 |
| 17 | 201747031123-DRAWING [11-04-2020(online)].pdf | 2020-04-11 |
| 18 | 201747031123-FER_SER_REPLY [11-04-2020(online)].pdf | 2020-04-11 |
| 18 | 201747031123-OTHERS [11-04-2020(online)].pdf | 2020-04-11 |
| 19 | 201747031123-FORM 3 [11-04-2020(online)].pdf | 2020-04-11 |
| 19 | 201747031123-FORM FOR STARTUP [11-04-2020(online)].pdf | 2020-04-11 |
| 20 | 201747031123-FORM 3 [11-04-2020(online)].pdf | 2020-04-11 |
| 20 | 201747031123-FORM FOR STARTUP [11-04-2020(online)].pdf | 2020-04-11 |
| 21 | 201747031123-FER_SER_REPLY [11-04-2020(online)].pdf | 2020-04-11 |
| 21 | 201747031123-OTHERS [11-04-2020(online)].pdf | 2020-04-11 |
| 22 | 201747031123-DRAWING [11-04-2020(online)].pdf | 2020-04-11 |
| 22 | 201747031123-FER.pdf | 2019-11-14 |
| 23 | 201747031123-CORRESPONDENCE [11-04-2020(online)].pdf | 2020-04-11 |
| 23 | 201747031123-FORM 18 [28-01-2019(online)].pdf | 2019-01-28 |
| 24 | 201747031123-FORM 3 [08-01-2019(online)].pdf | 2019-01-08 |
| 24 | 201747031123-COMPLETE SPECIFICATION [11-04-2020(online)].pdf | 2020-04-11 |
| 25 | 201747031123-CLAIMS [11-04-2020(online)].pdf | 2020-04-11 |
| 25 | Correspondence by Agent_Power Of Attorney_26-09-2018.pdf | 2018-09-26 |
| 26 | 201747031123-ABSTRACT [11-04-2020(online)].pdf | 2020-04-11 |
| 26 | 201747031123-Changing Name-Nationality-Address For Service [05-09-2018(online)].pdf | 2018-09-05 |
| 27 | 201747031123-PETITION UNDER RULE 137 [13-04-2020(online)].pdf | 2020-04-13 |
| 27 | 201747031123-RELEVANT DOCUMENTS [05-09-2018(online)].pdf | 2018-09-05 |
| 28 | 201747031123-Response to office action [12-09-2020(online)].pdf | 2020-09-12 |
| 28 | Correspondence by Agent_Proof Of Right_06-12-2017.pdf | 2017-12-06 |
| 29 | 201747031123-Annexure [12-09-2020(online)].pdf | 2020-09-12 |
| 29 | 201747031123-Proof of Right (MANDATORY) [04-12-2017(online)].pdf | 2017-12-04 |
| 30 | 201747031123-PatentCertificate16-09-2020.pdf | 2020-09-16 |
| 30 | Correspondence by Agent_Power of Attorney_03-10-2017.pdf | 2017-10-03 |
| 31 | 201747031123-Marked up Claims_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 31 | 201747031123-FORM-26 [22-09-2017(online)].pdf | 2017-09-22 |
| 32 | 201747031123.pdf | 2017-09-07 |
| 32 | 201747031123-IntimationOfGrant16-09-2020.pdf | 2020-09-16 |
| 33 | 201747031123-Drawings_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 33 | 201747031123-COMPLETE SPECIFICATION [01-09-2017(online)].pdf | 2017-09-01 |
| 34 | 201747031123-Description_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 34 | 201747031123-DECLARATION OF INVENTORSHIP (FORM 5) [01-09-2017(online)].pdf | 2017-09-01 |
| 35 | 201747031123-DRAWINGS [01-09-2017(online)].pdf | 2017-09-01 |
| 35 | 201747031123-Claims_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 36 | 201747031123-FIGURE OF ABSTRACT [01-09-2017(online)].pdf | 2017-09-01 |
| 36 | 201747031123-Abstract_Granted 346878_16-09-2020.pdf | 2020-09-16 |
| 37 | 201747031123-FORM 1 [01-09-2017(online)].pdf | 2017-09-01 |
| 37 | 201747031123-RELEVANT DOCUMENTS [06-05-2022(online)].pdf | 2022-05-06 |
| 38 | 201747031123-RELEVANT DOCUMENTS [29-08-2022(online)].pdf | 2022-08-29 |
| 38 | 201747031123-STATEMENT OF UNDERTAKING (FORM 3) [01-09-2017(online)].pdf | 2017-09-01 |
| 1 | 2019-11-1314-55-08_13-11-2019.pdf |
| 1 | SearchStrategyMatrix_13-11-2019.pdf |
| 2 | 2019-11-1314-55-08_13-11-2019.pdf |
| 2 | SearchStrategyMatrix_13-11-2019.pdf |