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Intranasal Composition Of Methylcobalamin

Abstract: The present invention relates to an intranasal composition particularly once weekly intranasal composition comprising methylcobalamin and at least one gelling agent and a process for preparation thereof.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
31 July 2019
Publication Number
32/2019
Publication Type
INA
Invention Field
BIO-CHEMISTRY
Status
Email
Info@khuranaandkhurana.com
Parent Application
Patent Number
Legal Status
Grant Date
2022-04-20
Renewal Date

Applicants

TORRENT PHARMACEUTICALS LTD.
Torrent House, Off Ashram Road Near Dinesh Hall, Ahmedabad Gujarat 380 009

Inventors

1. ABRAHAM, Jaya
Torrent Pharmaceuticals Limited, Torrent Research Centre P.O. Bhat, Dist. Gandhinagar Gujarat 382 428
2. MISHRA, Vivek
Torrent Pharmaceuticals Limited, Torrent Research Centre P.O. Bhat, Dist. Gandhinagar Gujarat 382 428
3. CHAUDHARI, Kiran
Torrent Pharmaceuticals Limited, Torrent Research Centre P.O. Bhat, Dist. Gandhinagar Gujarat 382 428
4. MITTAL, Vipul
Torrent Pharmaceuticals Limited, Torrent Research Centre P.O. Bhat, Dist. Gandhinagar Gujarat 382 428

Specification

1. An intranasal composition comprising methylcobalamin, atleast one gelling agent and optionally a permeation enhancer selected from lecithin and di-ethylene glycol monoethyl ether, wherein the composition forms in-situ gel after intranasal administration.
2. The intranasal composition according to claim 1, wherein the composition comprises methylcobalamin, at least one gelling agent and a permeation enhancer selected from lecithin and di-ethylene glycol monoethyl ether.
3. The intranasal composition according to any of the preceding claims, wherein the composition comprises about 0.01 to about 0.45% w/v of methyl cobalamin.
4. The intranasal composition according to any of the preceding claims, wherein the composition comprises about 0.1-1% w/v of gelling agent.
5. The intranasal composition according to any of the preceding claims, wherein the composition comprises about 0.1-1% w/v of permeation enhancer.
6. The intranasal composition according to claim 4, wherein the gelling agent is gellan gum.
7. The intranasal composition according to any of the preceding claims, wherein the composition further comprises excipients selected from thickening agent, humectant, preservative, flavoring agent and vehicle.
8. The intranasal composition according to claim 7, wherein the amount of thickening agent present is about 0.1% to about 1% w/v of the composition.

9. The intranasal composition according to claim 7, wherein the amount of
humectant present is about 1% to about 5% w/v of the composition.
10. The intranasal composition according to claim 7, wherein the amount of preservative present is about 0.01 to about 1% w/v of the composition.
11. The intranasal composition according to any of the preceding claims, wherein pH of the composition ranges from 4 to 5.5.
12. The intranasal composition according to any of the preceding claims, wherein composition is administered once weekly.
13. The intranasal composition according to any of the preceding claims, wherein the composition comprises about 2500 microgram/ml of methylcobalamin.
14. The intranasal composition according to claim 13, wherein an intranasal administration of 100 microliters of the composition to each nostril of human, provides and maintains mean plasma concentration of cobalamin of about 200pg/mL or more for at least 7 days.
15. A method of treating vitamin B12 deficiency by intranasally administering composition comprising methylcobalamin, atleast one gelling agent and optionally a permeation enhancer selected from lecithin and di-ethylene glycol monoethyl ether, wherein composition forms in-situ gel after intranasal administration.
16. Use of intranasal composition comprising methylcobalamin, atleast one gelling agent and optionally a permeation enhancer selected from lecithin and di-ethylene glycol monoethyl ether, for the treatment of Vitamin B12 deficiency wherein, wherein composition forms in-situ gel after intranasal administration.

Documents

Orders

Section Controller Decision Date

Application Documents

# Name Date
1 201947031000-Annexure [20-04-2022(online)].pdf 2022-04-20
1 201947031000.pdf 2019-07-31
2 201947031000-IntimationOfGrant20-04-2022.pdf 2022-04-20
2 201947031000-STATEMENT OF UNDERTAKING (FORM 3) [31-07-2019(online)].pdf 2019-07-31
3 201947031000-PatentCertificate20-04-2022.pdf 2022-04-20
3 201947031000-FORM 1 [31-07-2019(online)].pdf 2019-07-31
4 201947031000-Written submissions and relevant documents [20-04-2022(online)].pdf 2022-04-20
4 201947031000-DRAWINGS [31-07-2019(online)].pdf 2019-07-31
5 201947031000-DECLARATION OF INVENTORSHIP (FORM 5) [31-07-2019(online)].pdf 2019-07-31
5 201947031000-Correspondence to notify the Controller [05-04-2022(online)].pdf 2022-04-05
6 201947031000-FORM-26 [05-04-2022(online)].pdf 2022-04-05
6 201947031000-COMPLETE SPECIFICATION [31-07-2019(online)].pdf 2019-07-31
7 201947031000-US(14)-HearingNotice-(HearingDate-07-04-2022).pdf 2022-03-09
7 201947031000-Proof of Right (MANDATORY) [18-09-2019(online)].pdf 2019-09-18
8 Correspondence by Agent_Form1-Power of Attorney_26-09-2019.pdf 2019-09-26
8 201947031000-CLAIMS [29-10-2021(online)].pdf 2021-10-29
9 201947031000-COMPLETE SPECIFICATION [29-10-2021(online)].pdf 2021-10-29
9 201947031000-FORM 3 [22-01-2020(online)].pdf 2020-01-22
10 201947031000-CORRESPONDENCE [29-10-2021(online)].pdf 2021-10-29
10 201947031000-FORM 18 [30-07-2020(online)].pdf 2020-07-30
11 201947031000-FER.pdf 2021-10-18
11 201947031000-FER_SER_REPLY [29-10-2021(online)].pdf 2021-10-29
12 201947031000-FORM 3 [29-10-2021(online)].pdf 2021-10-29
12 201947031000-OTHERS [29-10-2021(online)].pdf 2021-10-29
13 201947031000-Information under section 8(2) [29-10-2021(online)].pdf 2021-10-29
14 201947031000-FORM 3 [29-10-2021(online)].pdf 2021-10-29
14 201947031000-OTHERS [29-10-2021(online)].pdf 2021-10-29
15 201947031000-FER.pdf 2021-10-18
15 201947031000-FER_SER_REPLY [29-10-2021(online)].pdf 2021-10-29
16 201947031000-CORRESPONDENCE [29-10-2021(online)].pdf 2021-10-29
16 201947031000-FORM 18 [30-07-2020(online)].pdf 2020-07-30
17 201947031000-FORM 3 [22-01-2020(online)].pdf 2020-01-22
17 201947031000-COMPLETE SPECIFICATION [29-10-2021(online)].pdf 2021-10-29
18 201947031000-CLAIMS [29-10-2021(online)].pdf 2021-10-29
18 Correspondence by Agent_Form1-Power of Attorney_26-09-2019.pdf 2019-09-26
19 201947031000-US(14)-HearingNotice-(HearingDate-07-04-2022).pdf 2022-03-09
19 201947031000-Proof of Right (MANDATORY) [18-09-2019(online)].pdf 2019-09-18
20 201947031000-FORM-26 [05-04-2022(online)].pdf 2022-04-05
20 201947031000-COMPLETE SPECIFICATION [31-07-2019(online)].pdf 2019-07-31
21 201947031000-DECLARATION OF INVENTORSHIP (FORM 5) [31-07-2019(online)].pdf 2019-07-31
21 201947031000-Correspondence to notify the Controller [05-04-2022(online)].pdf 2022-04-05
22 201947031000-Written submissions and relevant documents [20-04-2022(online)].pdf 2022-04-20
22 201947031000-DRAWINGS [31-07-2019(online)].pdf 2019-07-31
23 201947031000-PatentCertificate20-04-2022.pdf 2022-04-20
23 201947031000-FORM 1 [31-07-2019(online)].pdf 2019-07-31
24 201947031000-STATEMENT OF UNDERTAKING (FORM 3) [31-07-2019(online)].pdf 2019-07-31
24 201947031000-IntimationOfGrant20-04-2022.pdf 2022-04-20
25 201947031000-Annexure [20-04-2022(online)].pdf 2022-04-20
25 201947031000.pdf 2019-07-31

Search Strategy

1 2021-04-29E_29-04-2021.pdf

ERegister / Renewals

3rd: 03 Jun 2022

From 05/02/2020 - To 05/02/2021

4th: 03 Jun 2022

From 05/02/2021 - To 05/02/2022

5th: 03 Jun 2022

From 05/02/2022 - To 05/02/2023

6th: 03 Jun 2022

From 05/02/2023 - To 05/02/2024

7th: 02 Feb 2024

From 05/02/2024 - To 05/02/2025

8th: 27 Jan 2025

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