Granted Patent
B2
US 12,491,179 · App. 18/665,824 · Granted Dec 9, 2025
Oral pharmaceutical composition comprising zonisamide and process of preparation thereof
Inventors:
Swati Nagar (Amreli, IN); Sandip P. Mehta (Ahmedabad, IN); Manish Umrethia (Ahmedabad, IN); Jayanta Kumar Mandal (Ahmedabad, IN); Sandeep Pal (Ahmedabad, IN)
Assignee:
AZURITY PHARMACEUTICALS, INC.
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Abstract
The present invention relates to the pharmaceutical composition comprising Zonisamide and one or more pharmaceutically acceptable excipients and also relates to the process for the preparation of the pharmaceutical composition comprising Zonisamide.
Claims (12)
1 . A stable liquid oral pharmaceutical suspension comprising:
zonisamide in an amount of about 20 mg/mL;
about 2 mg/mL to about 3.5 mg/ml of xanthan gum or 20 mg/ml of a combination of microcrystalline cellulose and sodium carboxymethyl cellulose;
buffering agents, wherein the buffering agents comprise citric acid monohydrate and trisodium citrate dihydrate;
one or more preservatives, wherein the one or more preservatives comprise sodium benzoate present at a concentration of about 1 mg/mL or about 2 mg/mL; sucralose; strawberry flavor; and
purified water;
wherein zonisamide is the only active ingredient in the suspension;
wherein the liquid oral pharmaceutical suspension has a pH of 3.5 to 5.0;
wherein the liquid oral suspension has no more than 0.1% total impurities when stored at 40° C. and 25% relative humidity for at least 1 month.
2 . The pharmaceutical suspension of claim 1 , wherein the citric acid monohydrate is present at about 3.7 mg/mL.
3 . The pharmaceutical suspension of claim 1 , wherein the trisodium citrate dihydrate is present at about 3.6 mg/mL.
4 . The pharmaceutical suspension of claim 1 , wherein the liquid oral pharmaceutical suspension has a pH of 4.2, 4.3, 4.4, or 4.5.
Assignments (9)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: MANDAL, JAYANTA KUMAR
To: FTF PHARMA PRIVATE LIMITED
Reel/Frame 072807/0541 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: FTF PHARMA PRIVATE LIMITED
To: LIQMEDS WORLDWIDE LIMITED
Reel/Frame 072807/0576 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: LIQMEDS WORLDWIDE LIMITED
To: ETON PHARMACEUTICALS, INC.
Reel/Frame 072807/0590 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: ETON PHARMACEUTICALS, INC.
To: AZURITY PHARMACEUTICALS, INC.
Reel/Frame 072807/0640 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: PAL, SANDEEPKUMAR
To: FTF PHARMA PRIVATE LIMITED
Reel/Frame 073481/0882 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: NAGAR, SWATI
To: FTF PHARMA PRIVATE LIMITED
Reel/Frame 073481/0943 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: UMRETHIA, MANISH
To: FTF PHARMA PRIVATE LIMITED
Reel/Frame 073481/0964 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2025
From: MEHTA, SANDIP P.
To: FTF PHARMA PRIVATE LIMITED
Reel/Frame 073814/0812 →
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS
Recorded Mar 17, 2025
From: ARBOR PHARMACEUTICALS, LLC; AZURITY PHARMACEUTICALS, INC.; AZURITY PHARMACEUTICALS IRELAND LIMITED; SILVERGATE PHARMACEUTICALS, INC.
To: HPS INVESTMENT PARTNERS, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 070531/0487 →
Priority Claims (1)
IN 201721029415
· Aug 19, 2017
· national
Continuity (6)
Continuation
PCTIB2018000901
· Aug 18, 2018
References Cited (67)
US 4788220A
· Mody et al.
· 1988
[cited by applicant]
US 5272137A
· Blase et al.
· 1993
[cited by applicant]
US 20070208069A1
· Krishnan et al.
· 2007
[cited by applicant]
US 20080260837A1
· Namburi et al.
· 2008
[cited by applicant]
US 20080274196A1
· Jayanthi et al.
· 2008
[cited by applicant]
US 20110166225A1
· Verma et al.
· 2011
[cited by applicant]
US 20160089437A1
· Hsiao
· 2016
[cited by applicant]
US 20160287594A1
· Gupta et al.
· 2016
[cited by applicant]
US 20230046943A1
· Nagar et al.
· 2023
[cited by applicant]
US 20230218586A1
· Nagar et al.
· 2023
[cited by applicant]
US 20230241036A1
· Nagar et al.
· 2023
[cited by applicant]
CA 2999414A1
· 2017
[cited by applicant]
CA 2912345C
· 2020
[cited by applicant]
EP 1040830A1
· 2000
[cited by applicant]
EP 1411931A1
· 2004
[cited by applicant]
EP 1503755A1
· 2005
[cited by applicant]
EP 1505967A1
· 2005
[cited by applicant]
EP 1656094A2
· 2006
[cited by applicant]
EP 1682522A1
· 2006
[cited by applicant]
EP 1683516A2
· 2006
[cited by applicant]
EP 1913935A1
· 2008
[cited by applicant]
EP 1954241A1
· 2008
[cited by applicant]
EP 2164487A1
· 2010
[cited by applicant]
EP 2222296A2
· 2010
[cited by applicant]
EP 2285374A1
· 2011
[cited by applicant]
EP 2301537A1
· 2011
[cited by applicant]
EP 2497467A1
· 2012
[cited by applicant]
IN 201621039392A
· 2018
[cited by applicant]
WO WO02094220A1
· 2002
[cited by applicant]
WO WO2007084331A2
· 2007
[cited by examiner]
WO WO2009082038A2
· 2009
[cited by applicant]
WO WO2011075691A1
· 2011
[cited by examiner]
WO WO2011107855A2
· 2011
[cited by examiner]
WO WO2014184973A1
· 2014
[cited by applicant]
WO WO2017057562A1
· 2017
[cited by applicant]
WO WO2018067401A1
· 2018
[cited by applicant]
WO WO2019038584A1
· 2019
[cited by applicant]
WO WO2020039263A3
· 2020
[cited by applicant]
Rowe et al., Sodium Benzoate, Handbook of Pharmaceutical Excipients, 2009, Sixth Edition, Pharmacuetical Press, 627-629.
[cited by examiner]
Winfield, Pharmaceutical Practice, Formulation of Solutions—Preservation of solutions, Churchill Livingstone, 2004, pp. 184-186.
[cited by examiner]
www.mystrica.com (0.1M Citric acid-Sodium citrate buffer buffer—pH range 3.0-6.2, Jul. 25, 2016, printed from https://web.archive.org/web/20160725015105/http:/Awww. mystrica.com/Pages/Applications/citratebuffer. pdf, 1 …
[cited by examiner]
Rowe et al., Citric Acid Monohydrate, Handbook of Pharmaceutical Excipients, 2009, Sixth Edition, Pharmaceutical Press, p. 181-183.
[cited by examiner]
Rowe et al., Sodium Citrate Dihydrate, Handbook of Pharmaceutical Excipients, 2009, Sixth Edition, Pharmaceutical Press, pp. 640-642.
[cited by examiner]
Abobo et al.: Stability of zonisamide in extemporaneously compounded oral suspensions. Database Medline US National Library of Medicine (NLM), Bethesda, MD (2009).
[cited by applicant]
Allen et al.: Zonisamide 10-mg/ml oral suspension. International Journal of Pharmaceutical Compounding, US 13(5):437 (2009).
[cited by applicant]
Allen: Monthly Compounding Update, www.uspharmacist.com, Nov. 13, 2015, printed from https://uspharmacist.com/monthly_compounding_undate/nl/57830/, 2 pages.
[cited by applicant]
Dainippon Sumitomo Pharma, Notice of launching of a new Parkinson's disease drug “TRERIEF®”. https://www.ds-pharma.com, Mar. 13, 2009, printed from https://www.ds-pharma.com/ir/news/pdf/ene20090313.pdf, 2 pages.
[cited by applicant]
Ferreira et al.: Ferreira et al.: Feasibility of amlodipine besylate, chloroquine phosphate, dapsone, phenytoin, pyridoxine hydrochloride, sulfadiazine, sulfasalazine, tetracycline hydrochloride, trimethoprim and zonisa…
[cited by applicant]
Kitano et al.: Anticonvulsant and neuroprotective effects of the novel nootropic agent nefiracetam on kainic acid-induced seizures in rats. Brain Research, Elsevier, Amsterdam, NL. 1057(1-2):168-176 (2005).
[cited by applicant]
Medisca. Suggested Flavoring Reference Chart, www.medisca.com, Apr. 17, 2016, printed from https://web.archive.org/web/20160417002400/https://www.medisca.com/Files/ReferenceCharts/Suggested%20Flavoring20Reference%20Char…
[cited by applicant]
Nahata, Milap C.: Long-term Stability of Zonisamide, Amitriptyline, and Glycopyrrolate in Extemporaneously Prepared Liquid-dosage Forms at Two Temperatures. International Journal of Pharmaceutical Compounding 20:2 (2016…
[cited by applicant]
PCT/IB2018/000901 International Search Report and Written Opinion dated Jan. 18, 2019.
[cited by applicant]
Rowe et al.: Carboxymethylcellulose sodium Handbook of Pharmaceutical Excipients, Sixth Edition, Pharmaceutical Press, (2009), 118-121.
[cited by applicant]
Shayoub et al.: Evaluation of Guar Gum as Suspension Agent in Comparison with Xanthan Gum Using Metronidazole Benzoate as Model of Drug to Estimate the Effects of Temperatures and Storage on its Suspension Ability. Jour…
[cited by applicant]
Winfield, Pharmaceutical Practice, Ophthalmic products, Churchill Livingstone, (2004), pp. 264-269.
[cited by applicant]
www.mystrica.com, 0.1M Citric acid-Sodium citrate buffer buffer-pH range 3.0-6.2, Jul. 25, 2016, print from https://web.archive.org/web/20160417002400/https://www.mystrica/Pages/Applications/citratebuffer.pdf, 1 page.
[cited by applicant]
Banzel Oral Suspension Instructions for Use, Eisai Co. Ltd. 2011, https://www.fda.gov/drugsatfda.
[cited by applicant]
Elan Pharma, NDA 20-789; Zonegran (zonisamide) Capsules 100mg: Zonegran™ (zonisamide) capsules, FDA Approved Labeling Text dated Mar. 27, 2000, https://www.fda.gov/drugsatfda.
[cited by applicant]
Epilepsy—World Health Organization, published Feb. 7, 2024 (downloaded Aug. 21, 2025), https://www.who.int/news-room/fact-sheets/detail/epilepsy.
[cited by applicant]
Hakami, Tahir et al.: Neuropharmacology of Antiseizure Drugs. Neuropsychopharmacology Reports 41:336-351 (2021). DOI: 10.1002/npr2.12196.
[cited by applicant]
JRS Pharma GMBH & Co. KG, Dispersible Cellulose Navigator, Vivapur MCG, downloaded from Internet Apr. 5, 2025, https://www.jrspharma.com/pharma_en/media-library/data/dispersible-cellulose-navigator.php.
[cited by applicant]
Trileptal (oxcarbaxepine) USFDA Pack Insert, Novartis Pharmaceuticals Corporation 2000, https://www.fda.gov/drugsatfda.
[cited by applicant]
Vivapur MCG, Dispersible Cellulose Navigator. JRS Pharma,2025. Available at URL: https://www.jrspharma.com/pharma-wAssets/docs/technical-information/ti-leaflet-vapur-mcg-cell.pdf.
[cited by applicant]
What Is Epilepsy?—sage Epilepsy Foundation—your AI epilepsy assistant, Epilepsy Foundation (downloaded online Aug. 21, 2025), https://www.epilepsy.com/what-is-epilepsy.
[cited by applicant]
Cited By (1)