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Novel Omega 3 Carrier Preparations For Inhalation Drug Delivery For Treating Lung Inflammation

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.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
04 August 2021
Publication Number
12/2023
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
kcs@leiutis.com
Parent Application
Patent Number
Legal Status
Grant Date
2024-05-21
Renewal Date

Applicants

LEIUTIS PHARMACEUTICALS LLP
Plot No 23, TIE 1st Phase, Balanagar, Hyderabad.
LEIUTIS PHARMACEUTICALS LLP
Plot No 23, TIE 1st Phase, Balanagar, Hyderabad.
LEIUTIS PHARMACEUTICALS LLP
Plot No 23, TIE 1st Phase, Balanagar, Hyderabad.

Inventors

1. JAMES THOMAS BRENNA
210 Lavaca St, Apt 2204, Austin, TX 78701.
2. JAMES THOMAS BRENNA
210 Lavaca St, Apt 2204, Austin, TX 78701.
3. JAMES THOMAS BRENNA
210 Lavaca St, Apt 2204, Austin, TX 78701.
4. BANDA NAGARAJU
Flat 301, Kamalakar Rao Classic, Saplhagii Colony, Kukatpaly, Hyderbad.
5. BANDA NAGARAJU
Flat 301, Kamalakar Rao Classic, Saplhagii Colony, Kukatpaly, Hyderbad.
6. BANDA NAGARAJU
Flat 301, Kamalakar Rao Classic, Saplhagii Colony, Kukatpaly, Hyderbad.
7. AKULA SRINATH
H.No: 18-2-8a0003; Plot No:94; Sita Avenue, Balapur, Hyderabad,500005.
8. AKULA SRINATH
H.No: 18-2-8a0003; Plot No:94; Sita Avenue, Balapur, Hyderabad,500005.
9. AKULA SRINATH
H.No: 18-2-8a0003; Plot No:94; Sita Avenue, Balapur, Hyderabad,500005.
10. KOCHERLAKOTA CHANDRASHEKHAR
Plot-13, Sonal Cooperatille Housing Society, Bhavana Enclave, Bowenpaly, Tarbund, Secunderabad, 500009.
11. KOCHERLAKOTA CHANDRASHEKHAR
Plot-13, Sonal Cooperatille Housing Society, Bhavana Enclave, Bowenpaly, Tarbund, Secunderabad, 500009.
12. KOCHERLAKOTA CHANDRASHEKHAR
Plot-13, Sonal Cooperatille Housing Society, Bhavana Enclave, Bowenpaly, Tarbund, Secunderabad, 500009.
13. NARALA ARJUN
H.No: 4-7-40, kumarpally, hanarnkonda, warangal, Telangana.
14. NARALA ARJUN
H.No: 4-7-40, kumarpally, hanarnkonda, warangal, Telangana.
15. NARALA ARJUN
H.No: 4-7-40, kumarpally, hanarnkonda, warangal, Telangana.
16. KOTHAPALLI SESHA DURGA KUMAR
16530 Avaranche Wa,, Round Rock, Texas- 78681.
17. KOTHAPALLI SESHA DURGA KUMAR
16530 Avaranche Wa,, Round Rock, Texas- 78681.
18. KOTHAPALLI SESHA DURGA KUMAR
16530 Avaranche Wa,, Round Rock, Texas- 78681.

Specification

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.

Documents

Application Documents

# 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

Search Strategy

1 202141035170E_14-08-2023.pdf

ERegister / Renewals

3rd: 02 Jul 2024

From 04/08/2023 - To 04/08/2024

4th: 02 Jul 2024

From 04/08/2024 - To 04/08/2025

5th: 02 Jul 2024

From 04/08/2025 - To 04/08/2026

6th: 02 Jul 2024

From 04/08/2026 - To 04/08/2027