Sign In to Follow Application
View All Documents & Correspondence

Oral Composition Of Celecoxib For Treatment Of Pain

Abstract: The present invention relates to a stable oral liquid pharmaceutical composition of celecoxib or pharmaceutically acceptable salts thereof. The celecoxib present in the compositions as described herein do not show any precipitation when subjected in Fasted- State Simulated Gastric Fluid (FaSSGF) at pH 2.0 temperature of 37°C ± 0.5°C and under stirring at a speed of 50 rpm at least for 60 minutes. It also relates to the process of preparing and method of using said composition of celecoxib.

Get Free WhatsApp Updates!
Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
03 December 2018
Publication Number
08/2019
Publication Type
INA
Invention Field
PHARMACEUTICALS
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2021-04-23
Renewal Date

Applicants

DR. REDDY'S LABORATORIES LTD.
8-2-337, Road No. 3, Banjara Hills Hyderabad - 500034

Inventors

1. MUNJAL, Sagar
11 Hunters Path, Skillman, NJ 08558
2. BAHETI, Ankit
170, Brijeshwari Extension Near Chouhan Nagar Pipliyahana Chouraha, Indore Madhya Pradesh-452 016
3. PADHI, Bijay, Kumar
Kaniapally, Post-dhunkapada Dist. Ganjam (orissa) PIN-761 118
4. VAKADA, Supritha
H. No. 24-88/43/8 Lalwani Nagar, East Anandbagh, Malkajgiri Hyderabad, Telangana 500047
5. RAGHUVANSHI, Rajeev, Singh
#605 Ivory Towers South City-1, Gurgaon-122 001

Specification

We Claim:
1. A method for providing pain freedom in a human subject suffering from
pain, said method comprising administering to the subject a stable oral liquid
pharmaceutical composition comprising a therapeutically effective amount of
celecoxib and at least one pharmaceutically acceptable excipient, whereby the
subject is provided with pain freedom at 2 hours following administration, wherein
said composition upon oral administration to a human subject under fasting
conditions, provides at least one of the following pharmacokinetic parameters:
a. AUC (0-15 min) from about 10 ngh/mL to about 80 ngh/mL;
b. AUC (0-30 min) from about 80 ngh/mL to about 400 ngh/mL;
c. AUQo-i hr) from about 400 ngh/mL to about 1500 ngh/mL;
d. AUC(o-2hr) from about 1000 ngh/mL to about 4000 ngh/mL;
e. AUC(o-t) at least about 2000 ngh/mL;
f AUC(o-oo) of at least about 2000 ngh/mL; and g. Tiag of not more than 8 minutes.
2. The method of claim 1, wherein said pain is acute pain, migraine pain, cluster headache, neuropathic pain, post-operative pain, chronic lower back pain, herpes neuralgia pain, phantom limb pain, central pain, dental pain, neuropathic pain, opioid-resistant pain, visceral pain, surgical pain, bone injury pain, pain during labor and delivery, pain resulting from burns, sunburn pain, post-partum pain, angina pain, genitourinary tract-related pain, cystitis pain, arthritis pain, inflammation pain, osteoarthritis pain, juvenile rheumatoid arthritis pain, ankylosing spondylitis pain, primary dysmenorrhea pain, breakthrough pain, or any kind of cancer pain.
3. The method of claim 2, wherein said pain is associated with migraine.
4. The method of claim 2, wherein said pain freedom is maintained for at least about 2 hours to about 24 hours.
5. The method of claim 1, wherein said therapeutically effective amount of celecoxib is about 120 mg to about 240 mg.

6. The method of claim 1, wherein said composition further comprises of at
least one solubilizer and at least one medium chain glyceride.
7. The method of claim 1, wherein said composition further comprises of at least one polar solvent.
8. The method of claim 1, wherein said composition is in the form of a solution, suspension, emulsion or liquid mixture.
9. The method of claim 1, wherein said composition has a pH of from about 3 to about 7.
10. The method of claim 6, where in the composition comprises weight ratio of the solubilizer to celecoxib from about 4.0:1.0 to about 20:1.0.
-93-

Documents

Application Documents

# Name Date
1 201847045507.pdf 2018-12-03
2 201847045507-STATEMENT OF UNDERTAKING (FORM 3) [03-12-2018(online)].pdf 2018-12-03
3 201847045507-FORM 1 [03-12-2018(online)].pdf 2018-12-03
4 201847045507-DRAWINGS [03-12-2018(online)].pdf 2018-12-03
5 201847045507-DECLARATION OF INVENTORSHIP (FORM 5) [03-12-2018(online)].pdf 2018-12-03
6 201847045507-COMPLETE SPECIFICATION [03-12-2018(online)].pdf 2018-12-03
7 201847045507-FORM 3 [20-03-2019(online)].pdf 2019-03-20
8 201847045507-MARKED COPIES OF AMENDEMENTS [26-03-2019(online)].pdf 2019-03-26
9 201847045507-FORM 18 [26-03-2019(online)].pdf 2019-03-26
10 201847045507-FORM 13 [26-03-2019(online)].pdf 2019-03-26
11 201847045507-Annexure [26-03-2019(online)].pdf 2019-03-26
12 201847045507-AMMENDED DOCUMENTS [26-03-2019(online)].pdf 2019-03-26
13 Form 1_After Filling_01-04-2019.pdf 2019-04-01
14 Correspondence by Applicant_Form 1_01-04-2019.pdf 2019-04-01
15 201847045507-FER.pdf 2019-12-10
16 201847045507-FORM 3 [16-03-2020(online)].pdf 2020-03-16
17 201847045507-FORM 4(ii) [03-06-2020(online)].pdf 2020-06-03
18 201847045507-RELEVANT DOCUMENTS [04-06-2020(online)].pdf 2020-06-04
19 201847045507-FORM-26 [04-06-2020(online)].pdf 2020-06-04
20 201847045507-FORM 13 [04-06-2020(online)].pdf 2020-06-04
21 201847045507-RELEVANT DOCUMENTS [10-09-2020(online)].pdf 2020-09-10
22 201847045507-PETITION UNDER RULE 137 [10-09-2020(online)].pdf 2020-09-10
23 201847045507-OTHERS [10-09-2020(online)].pdf 2020-09-10
24 201847045507-FORM 3 [10-09-2020(online)].pdf 2020-09-10
25 201847045507-FER_SER_REPLY [10-09-2020(online)].pdf 2020-09-10
26 201847045507-DRAWING [10-09-2020(online)].pdf 2020-09-10
27 201847045507-CLAIMS [10-09-2020(online)].pdf 2020-09-10
28 201847045507-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [02-12-2020(online)].pdf 2020-12-02
29 201847045507-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [04-01-2021(online)].pdf 2021-01-04
30 201847045507-Written submissions and relevant documents [22-03-2021(online)].pdf 2021-03-22
31 201847045507-RELEVANT DOCUMENTS [22-03-2021(online)].pdf 2021-03-22
32 201847045507-PETITION UNDER RULE 137 [22-03-2021(online)].pdf 2021-03-22
33 201847045507-MARKED COPIES OF AMENDEMENTS [22-03-2021(online)].pdf 2021-03-22
34 201847045507-FORM 13 [22-03-2021(online)].pdf 2021-03-22
35 201847045507-Annexure [22-03-2021(online)].pdf 2021-03-22
36 201847045507-AMMENDED DOCUMENTS [22-03-2021(online)].pdf 2021-03-22
37 201847045507-PatentCertificate23-04-2021.pdf 2021-04-23
38 201847045507-IntimationOfGrant23-04-2021.pdf 2021-04-23
39 201847045507-RELEVANT DOCUMENTS [29-09-2021(online)].pdf 2021-09-29
40 201847045507-US(14)-HearingNotice-(HearingDate-07-12-2020).pdf 2021-10-17
41 201847045507-US(14)-ExtendedHearingNotice-(HearingDate-08-03-2021).pdf 2021-10-17
42 201847045507-US(14)-ExtendedHearingNotice-(HearingDate-07-01-2021).pdf 2021-10-17
43 201847045507-RELEVANT DOCUMENTS [03-10-2022(online)].pdf 2022-10-03
44 201847045507-RELEVANT DOCUMENTS [29-08-2023(online)].pdf 2023-08-29
45 201847045507-FORM-27 [27-09-2024(online)].pdf 2024-09-27

Search Strategy

1 201847045507_10-12-2019.pdf

ERegister / Renewals

3rd: 19 Jul 2021

From 26/05/2019 - To 26/05/2020

4th: 19 Jul 2021

From 26/05/2020 - To 26/05/2021

5th: 19 Jul 2021

From 26/05/2021 - To 26/05/2022

6th: 16 May 2022

From 26/05/2022 - To 26/05/2023

7th: 19 May 2023

From 26/05/2023 - To 26/05/2024

8th: 27 May 2024

From 26/05/2024 - To 26/05/2025

9th: 23 May 2025

From 26/05/2025 - To 26/05/2026