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.
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.
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| # | 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 |
| 1 | 201847045507_10-12-2019.pdf |