Abstract: ABSTRACT Inflammatory disorders of the lung are induced by COVID-19 disease, asthma, and numerous other disorders. Omega-3 fatty acids (03FA ), particularly docosahexaenoic acid (DHA), docosapentaenoic acid (DPA) or eicosapentaenoic acid (EPA), have known anti-inflammatory and pro-resolving properties. Redúction of lung pathology and inflammation will be accomplished by a mixture incorporating 03FA that is suitable for nebulization using formulas and nebulization apparatus known in the art. The 03FA may be delivered in the form of ethyl esters (EE) or free fatty acid (FFA) oils or non- phosphate-containing glycerolipids or as phospholipids (PL) or as any other form known in the art. The mixture can also be delivered in any of the other forms of inhaled droplet or solids for inhalation known in the art. The patient will inhale for a therapeutically effective period of time to reduce inflammation and improve breathing.
WE CLAIM:
Claim 1: A novel inhalation formulation of omega 3 fatty acids, comprising therapeutically effective dose of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) or a combination of any two or all the three of DHA, DPA, and EPA.
Claim 2: The formulation of claim 1, wherein the fatty acids are present as free fatty acids (FFA) or ethyl esters (EE) or phospholipids (PL) or non- phosphate-containing glycerolipids selected from the group comprising triacylglycerol, diacylglycerol, and/or monoacylglycerol.
Claim 3: The formulation of claim 1, wherein the formulation is suitable for nebulization or inhalation by any method known in the art.
Claim 4: The formulation of claim 1, wherein the formulation additionally comprises phospholipid.
Claim 5: The formulation of claim 1, wherein the formulation is a suspension or emulsion.
Claim 6: The formulation of claim 1, wherein the formulation additionally comprises a therapeutically active ingredient selected from the group comprising pirfenidone, apremilast, roflumilast, tiotropium bromide, nintedanib, isoniazid, streptomycin, montelukast, tetrahydrocannabinol and thereof.
Claim 7: The formulation of claim 1 used for treatment of COVID-19 and other lung disorders.
Claim 8: The formulation of claim 1 used for reducing pathological levels of IL-6 in the lung.
Claim 9: The formulation of claim 1 used for reducing pathological levels of TNF-alpha in the lung.
Claim 10: The formulation of claim 1 used for reducing pathological levels of IL-10 in the lung.
Claim 11: The formulation of claim 1 used for reducing pathological levels of TGF-beta in the lung.
Claim 12: The formulation of claim 1 used for treatment of disorders selected from the group comprising bronchiolitis, asthma, cystic fibrosis, COPD, pneumonia, tuberculosis, emphysema, pulmonary edema, lung cancer, acute respiratory distress syndrome (ARDS), asbestosis, bronchiectasis, interstitial lung disease (ILD) including sarcoidosis, idiopathic pulmonary fibrosis and CNS disorders.
Claim 13: The formulation of claim 1 further comprising a therapeutically effective dose of melatonin.
Claim 14: The formulation of claim 1 further comprising a therapeutically effective dose of budesonide.
Claim 15: The formulation of claim 1 further comprising a therapeutically effective dose of cannabidiol.
Claim 16: The formulation of claims 13, 14 and 15 is administered to patients for whom NSAIDs are contraindicated.
Claim 17: The formulation of claims 13, 14 and 15 is administered to patients to prevent or treat conditions selected from the group comprising acute pulmonary thrombosis, acute or chronic pulmonary inflammation, inflammatory conditions of the heart and its blood vessels or to alleviate bronchoconstriction optionally in combination with a fast acting bronchodilator.
Claim 18: A formulation comprising a therapeutically effective dose of phospholipid in which the phospholipid delivers docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) or any combination of two or all three of DHA, DPA, and EPA.
Claim 19: The formulation of claim 18, further comprising a therapeutically effective dose of melatonin.
Claim 20: The formulation of claim 18, further comprising a therapeutically effective dose of budesonide.
Claim 21: The formulation of claim 18, further comprising a therapeutically effective dose of cannabidiol.
Claim 22: A formulation containing a therapeutically effective dose of glycerolipid in which the glycerolipid delivers docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) or any combination of two or all three of DHA, DPA, and EPA.
Claim 23: The formulation of claim 22, further comprising a therapeutically effective dose of melatonin.
Claim 24: The formulation of claim 22, further comprising a therapeutically effective dose of budesonide.
Claim 25: The formulation of claim 22, further comprising a therapeutically effective dose of cannabidiol.
Claim 26: A novel inhalation formulation of omega 3 fatty acids, comprising therapeutically effective dose of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), or eicosapentaenoic acid (EPA) or a combination of any two or all the three of DHA, DP A, and EPA, wherein the formulation is suspension or emulsion.
| # | Name | Date |
|---|---|---|
| 1 | 202141035170-STATEMENT OF UNDERTAKING (FORM 3) [04-08-2021(online)].pdf | 2021-08-04 |
| 2 | 202141035170-PROVISIONAL SPECIFICATION [04-08-2021(online)].pdf | 2021-08-04 |
| 3 | 202141035170-FORM FOR SMALL ENTITY(FORM-28) [04-08-2021(online)].pdf | 2021-08-04 |
| 4 | 202141035170-FORM FOR SMALL ENTITY [04-08-2021(online)].pdf | 2021-08-04 |
| 5 | 202141035170-FORM 1 [04-08-2021(online)].pdf | 2021-08-04 |
| 6 | 202141035170-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [04-08-2021(online)].pdf | 2021-08-04 |
| 7 | 202141035170-EVIDENCE FOR REGISTRATION UNDER SSI [04-08-2021(online)].pdf | 2021-08-04 |
| 8 | 202141035170-DRAWINGS [04-08-2021(online)].pdf | 2021-08-04 |
| 9 | 202141035170-FORM FOR SMALL ENTITY [03-08-2022(online)].pdf | 2022-08-03 |
| 10 | 202141035170-FORM 3 [03-08-2022(online)].pdf | 2022-08-03 |
| 11 | 202141035170-EVIDENCE FOR REGISTRATION UNDER SSI [03-08-2022(online)].pdf | 2022-08-03 |
| 12 | 202141035170-ENDORSEMENT BY INVENTORS [03-08-2022(online)].pdf | 2022-08-03 |
| 13 | 202141035170-DRAWING [03-08-2022(online)].pdf | 2022-08-03 |
| 14 | 202141035170-COMPLETE SPECIFICATION [03-08-2022(online)].pdf | 2022-08-03 |
| 15 | 202141035170-Request Letter-Correspondence [22-09-2022(online)].pdf | 2022-09-22 |
| 16 | 202141035170-Request Letter-Correspondence [22-09-2022(online)]-1.pdf | 2022-09-22 |
| 17 | 202141035170-FORM28 [22-09-2022(online)].pdf | 2022-09-22 |
| 18 | 202141035170-FORM28 [22-09-2022(online)]-1.pdf | 2022-09-22 |
| 19 | 202141035170-Form 1 (Submitted on date of filing) [22-09-2022(online)].pdf | 2022-09-22 |
| 20 | 202141035170-Form 1 (Submitted on date of filing) [22-09-2022(online)]-1.pdf | 2022-09-22 |
| 21 | 202141035170-Covering Letter [22-09-2022(online)].pdf | 2022-09-22 |
| 22 | 202141035170-Covering Letter [22-09-2022(online)]-1.pdf | 2022-09-22 |
| 23 | 202141035170-Response to office action [23-09-2022(online)].pdf | 2022-09-23 |
| 24 | 202141035170-MSME CERTIFICATE [22-02-2023(online)].pdf | 2023-02-22 |
| 25 | 202141035170-FORM28 [22-02-2023(online)].pdf | 2023-02-22 |
| 26 | 202141035170-FORM 18A [22-02-2023(online)].pdf | 2023-02-22 |
| 27 | 202141035170-FORM 3 [26-06-2023(online)].pdf | 2023-06-26 |
| 28 | 202141035170-FER.pdf | 2023-09-08 |
| 29 | 202141035170-RELEVANT DOCUMENTS [02-03-2024(online)].pdf | 2024-03-02 |
| 30 | 202141035170-POA [02-03-2024(online)].pdf | 2024-03-02 |
| 31 | 202141035170-FORM-26 [02-03-2024(online)].pdf | 2024-03-02 |
| 32 | 202141035170-FORM FOR SMALL ENTITY [02-03-2024(online)].pdf | 2024-03-02 |
| 33 | 202141035170-FORM 13 [02-03-2024(online)].pdf | 2024-03-02 |
| 34 | 202141035170-EVIDENCE FOR REGISTRATION UNDER SSI [02-03-2024(online)].pdf | 2024-03-02 |
| 35 | 202141035170-AMENDED DOCUMENTS [02-03-2024(online)].pdf | 2024-03-02 |
| 36 | 202141035170-Information under section 8(2) [08-03-2024(online)].pdf | 2024-03-08 |
| 37 | 202141035170-FORM 3 [08-03-2024(online)].pdf | 2024-03-08 |
| 38 | 202141035170-FER_SER_REPLY [08-03-2024(online)].pdf | 2024-03-08 |
| 39 | 202141035170-DRAWING [08-03-2024(online)].pdf | 2024-03-08 |
| 40 | 202141035170-CORRESPONDENCE [08-03-2024(online)].pdf | 2024-03-08 |
| 41 | 202141035170-CLAIMS [08-03-2024(online)].pdf | 2024-03-08 |
| 42 | 202141035170-US(14)-HearingNotice-(HearingDate-15-04-2024).pdf | 2024-03-15 |
| 43 | 202141035170-FORM-26 [15-04-2024(online)].pdf | 2024-04-15 |
| 44 | 202141035170-Correspondence to notify the Controller [15-04-2024(online)].pdf | 2024-04-15 |
| 45 | 202141035170-Written submissions and relevant documents [27-04-2024(online)].pdf | 2024-04-27 |
| 46 | 202141035170-PatentCertificate21-05-2024.pdf | 2024-05-21 |
| 47 | 202141035170-IntimationOfGrant21-05-2024.pdf | 2024-05-21 |
| 1 | 202141035170E_14-08-2023.pdf |