IP Library › Granted Patent US 12,514,818
Granted Patent B2
US 12,514,818 · App. 16/955,373 · Granted Jan 6, 2026

Pharmaceutical compositions comprising a floating interpenetrating polymer network forming system

Inventors: Paras Rameshlal Jain (Dayton, NJ); Sachin Vasant Chaudhari (Monmouth Junction, NJ)
Assignee: TRIS PHARMA, INC.
A61K9/0065A61K9/1617A61K9/1652A61K9/1664A61K9/5146A61K31/197A61K47/585
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Quick Facts
Patent No.
US 12,514,818
App. No.
16/955,373
Granted
Jan 6, 2026
Kind
B2
Abstract

Drug delivery systems comprising a floating interpenetrating network (IPN) are provided. The pharmaceutical compositions contain at least one IPN forming system, at least one drug, and at least one gas generating agent, such that upon oral ingestion of the compositions, a floating IPN is formed in situ. These floating IPN provide extended release of the drug entrapped therein for at least about 3 hours.

Claims (65)

1 . An orally administrable extended release composition which comprises a floating inter-penetrating network (IPN) forming system comprising:

(a) at least one drug in a drug-ion exchange resin complex;

(b) an inter-penetrating network (IPN) forming blend, which comprises:

(i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;

(ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan (i) to form an IPN; and

(iii) at least one non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,

wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN which further comprises the IPN-forming polymers individually cross-linked to cross-linking agent(s),

further wherein the at least two IPN-forming polymers are not cross-linked to each other,

provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof.

2 . The orally administrable drug composition according to claim 1 , wherein the self-assembling IPN forming blend comprises the at least one non-toxic gas generating agent and:

(a) at least two anionic polymers and at least one cross linking agent;

(b) at least one anionic polymer, at least one galactomannan, and at least two cross linking agents;

(c) at least one galactomannan, at least one anionic polymer, at least one non-ionic polymer and at least two cross linking agents;

(d) at least one galactomannan, at least two anionic polymers, at least one non-ionic polymer and at least two cross linking agents;

(e) at least two galactomannan polymers, at least one anionic polymer and at least two cross linking agents;

(f) at least two galactomannan polymers, at least one anionic polymer, at least one non-ionic polymer and at least two cross linking agents;

(g) at least one anionic polymer, at least one galactomannan, and at least two cross linking agents;

(h) at least one anionic polymer, at least one galactomannan, and at least two cross linking agents at least one of which is pH dependent cross-linking agent;

(i) at least one galactomannan, at least one anionic polymer, at least one non-ionic polymer and at least two cross linking agents;

(j) at least one galactomannan polysaccharide, at least two anionic polymers, at least one non-ionic polymer and at least two cross linking agents;

(k) at least two galactomannan polymers, at least one anionic polymer and at least two cross linking agents, at least one of which is a pH-dependent cross-linking agent; or

(l) at least two galactomannan polymers, at least one anionic polymer, at least one non-ionic polymer and at least two cross linking agents, at least one of which is a pH-dependent cross-linking agent.

3 . An orally administrable drug composition comprising a floating inter-penetrating network (IPN) forming system comprising:

(a) at least one drug in a drug-ion exchange resin complex;

(b) an inter-penetrating network (IPN) forming blend, which comprises:

(i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;

(ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan (i) to form an IPN; and

(iii) a non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,

wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN which further comprises the IPN-forming polymers individually cross-linked to the cross-linking agent(s),

wherein the IPN forming blend comprises at least one anionic polymer selected from sodium alginate, carrageenan I, pectin, gellan gum, alginic acid, carrageenan k, sodium carboxymethylcellulose, xanthan gum, or combinations thereof and at least a second polymer which are at least partially crosslinked with a crosslinking agent,

further wherein the at least two IPN-forming polymers are not cross-linked to each other,

provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof.

4 . The orally administrable drug composition according to claim 1 , wherein the IPN forming blend comprises at least one galactomannan polysaccharide which is at least partially cross-linked with borax, glutaraldehyde, or zirconium, divalent and trivalent metal salts, or combinations thereof.

5 . The orally administrable drug composition according to claim 4 , wherein the galactomannan is selected from guar gum, fenugreek gum, locust bean gum, or combinations thereof.

6 . The orally administrable drug composition according to claim 1 , wherein the gas-generating agent is selected from carbonates or bicarbonates of an alkali or alkaline earth metal, sulfites, or combinations thereof, or combinations thereof with an acid source which create a gas-generating couple.

7 . The orally administrable drug composition according to claim 6 , wherein the carbonate or bicarbonate of an alkali or alkaline earth metal are selected from potassium carbonate, potassium bicarbonate, sodium carbonate, sodium bicarbonate, calcium carbonate, sodium glycine carbonate, magnesium carbonate, or aluminum carbonate.

8 . The composition according to claim 1 , wherein the floating IPN provides extended release for at least about 3 hours to about 24 hours.

9 . The composition according to claim 1 , wherein the composition further comprises the at least one drug in the drug-ion exchange resin complex in more than one form.

10 . The composition according to claim 1 , wherein the drug-ion exchange resin complex is coated with at least one modified release coating, which is selected from an enteric coat, a reverse enteric coat, or a pH-independent barrier coating.

11 . The composition according to claim 9 , wherein the composition comprises an immediate release and a controlled release form of the same drug.

12 . The composition according to claim 1 , wherein the composition comprises two or more different drugs.

13 . The composition according to claim 1 formulated as a tablet, capsule, suspension, powder, paste, or pudding.

14 . The composition according to claim 1 which is a modified release composition.

15 . The composition according to claim 14 which further comprises an immediate release component.

16 . A product comprising a reconstituted orally administrable extended release powder composition which comprises a floating inter-penetrating network (IPN) forming system comprising:

(a) at least one drug in a drug-ion exchange resin complex;

(b) an IPN forming powder blend, which comprises:

(i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;

(ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan; and

(iii) a non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,

wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN comprising the IPN-forming polymers individually cross-linked to the cross-linking agent(s),

further wherein the at least two IPN-forming polymers are not cross-linked to each other,

provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof; and

(c) water,

wherein the ratio, by weight, of the composition to water is 1:0.1 to 1:15, or 1:0.5 to 1:10, or 1:2 to 1:7.

17 . An orally administrable extended release drug composition, which comprises a floating inter-penetrating network (IPN) forming system comprising:

(a) at least one drug in a drug-ion exchange resin complex;

(b) an inter-penetrating network (IPN) forming blend, which comprises:

(i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;

(ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan (i) to form an IPN; and

(iii) at least one non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,

wherein the at least one IPN forming anionic polymer is gellan gum, and wherein the at least second, different, IPN forming anionic polymer, is carrageenan and/or xanthan gum;

or the at least one IPN forming galactomannan is fenugreek gum or guar gum, wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN which further comprises the IPN-forming polymers individually cross-linked to cross-linking agent(s),

further wherein the at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer is calcium carbonate or calcium chloride, and further wherein the at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan is calcium carbonate or calcium chloride,

provided that the composition does not include a gamma hydroxybutyrate, its salts, hydrates, tautomers, or solvates, or complexes thereof.

Assignments (4)
CORRECTIVE ASSIGNMENT TO CORRECT THE THE ASSIGNMENT PREVIOUSLY RECORDED PREVIOUSLY RECORDED AT REEL: 068713 FRAME: 0499. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Oct 24, 2024
From: TRIS PHARMA, INC.; PARK THERAPEUTICS, INC.
To: PROVIDENT BANK
Reel/Frame 070760/0864 →
SECURITY INTEREST Recorded Sep 26, 2024
From: TRIS PHARMA, INC.; PARK THERAPEUTICS, INC.
To: PROVIDENT BANK
Reel/Frame 068713/0499 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 18, 2023
From: JAIN, PARAS R; CHAUDHARI, SACHIN V
To: TRIS PHARMA, INC.
Reel/Frame 064941/0231 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2020
From: JAIN, PARAS RAMESHLAL; CHAUDHARI, SACHIN VASANT
To: TRIS PHARMA, INC.
Reel/Frame 054676/0153 →
Continuity (2)
Provisional Application 62607129 · Dec 18, 2017
Related Publication 20210015744A1 · Jan 21, 2021
References Cited (193)
US 3138525A · Koff · 1964 [cited by applicant]
US 3499960A · Macek et al. · 1970 [cited by applicant]
US 3901232A · Michaels et al. · 1975 [cited by applicant]
US 4221778A · Raghunathan · 1980 [cited by applicant]
US 4352891A · Quinlan · 1982 [cited by applicant]
US 4393236A · Klosa · 1983 [cited by applicant]
US 4575539A · DeCrosta et al. · 1986 [cited by applicant]
US 4844905A · Ichikawa et al. · 1989 [cited by applicant]
US 4847077A · Raghunathan · 1989 [cited by applicant]
US 4996047A · Kelleher et al. · 1991 [cited by applicant]
US 5368852A · Umemoto et al. · 1994 [cited by applicant]
US 5604927A · Moore · 1997 [cited by applicant]
US 5780057A · Conte et al. · 1998 [cited by applicant]
US 5808107A · Hollingsworth · 1998 [cited by applicant]
US 5908631A · Arnaud et al. · 1999 [cited by applicant]
US 5972389A · Shell et al. · 1999 [cited by applicant]
US 5980882A · Eichman · 1999 [cited by applicant]
US 5990162A · Scharf · 1999 [cited by applicant]
US 6022562A · Autant et al. · 2000 [cited by applicant]
US 6120803A · Wong et al. · 2000 [cited by applicant]
US 6187323B1 · Aiache et al. · 2001 [cited by applicant]
US 6340475B2 · Shell et al. · 2002 [cited by applicant]
US 6488962B1 · Barner et al. · 2002 [cited by applicant]
US 6713639B1 · Gurjar et al. · 2004 [cited by applicant]
US 7294347B2 · Menjoge et al. · 2007 [cited by applicant]
US 7405238B2 · Markey et al. · 2008 [cited by applicant]
US 7413751B2 · Devane et al. · 2008 [cited by applicant]
US 7682629B1 · Besse · 2010 [cited by applicant]
US 7906145B2 · Castan et al. · 2011 [cited by applicant]
US 7910133B2 · Castan et al. · 2011 [cited by applicant]
US 7976870B2 · Berner et al. · 2011 [cited by applicant]
US 8062667B2 · Mehta et al. · 2011 [cited by applicant]
US 8193211B2 · Liang et al. · 2012 [cited by applicant]
US 8202542B1 · Mehta et al. · 2012 [cited by applicant]
US 8263650B2 · Cook et al. · 2012 [cited by applicant]
US 8277843B2 · Singh et al. · 2012 [cited by applicant]
US 8287848B2 · Mehta et al. · 2012 [cited by applicant]
US 8313770B2 · Pathak et al. · 2012 [cited by applicant]
US 8318210B2 · Tengler et al. · 2012 [cited by applicant]
US 8324275B2 · Cook et al. · 2012 [cited by applicant]
US 8470375B1 · McMahen et al. · 2013 [cited by applicant]
US 8512759B1 · McMahen et al. · 2013 [cited by applicant]
US 8586083B2 · Mohammad · 2013 [cited by applicant]
US 8591922B1 · Allphin et al. · 2013 [cited by applicant]
US 8592481B2 · Berner et al. · 2013 [cited by applicant]
US 8668929B2 · Han et al. · 2014 [cited by applicant]
US 8747902B2 · Mehta et al. · 2014 [cited by applicant]
US 8778396B2 · Pillay et al. · 2014 [cited by applicant]
US 8790700B2 · Mehta et al. · 2014 [cited by applicant]
US 8802157B2 · Berner et al. · 2014 [cited by applicant]
US 8859619B2 · Cook et al. · 2014 [cited by applicant]
US 8901173B2 · Allphin et al. · 2014 [cited by applicant]
US 9000046B2 · Berner et al. · 2015 [cited by applicant]
US 9132107B2 · Allphin et al. · 2015 [cited by applicant]
US 9161911B2 · Hou · 2015 [cited by applicant]
US 9301934B2 · Berner et al. · 2016 [cited by applicant]
US 9439851B2 · Dharmadhkari et al. · 2016 [cited by applicant]
US 9555017B2 · Allphin et al. · 2017 [cited by applicant]
US 9566258B2 · Hou · 2017 [cited by applicant]
US 10092511B2 · Castan et al. · 2018 [cited by applicant]
US 10398662B1 · Allphin et al. · 2019 [cited by applicant]
US 11337919B2 · Jain et al. · 2022 [cited by applicant]
US 11337920B2 · Jain et al. · 2022 [cited by applicant]
US 11666546B2 · Jain et al. · 2023 [cited by applicant]
US 20020034541A1 · Valducci et al. · 2002 [cited by applicant]
US 20020037941A1 · Lau · 2002 [cited by examiner]
US 20030099711A1 · Meadows et al. · 2003 [cited by applicant]
US 20040092455A1 · Mamelak et al. · 2004 [cited by applicant]
US 20040219186A1 · Ayres · 2004 [cited by applicant]
US 20050136114A1 · Kulkarni et al. · 2005 [cited by applicant]
US 20060062844A1 · Chenevier et al. · 2006 [cited by applicant]
US 20060210630A1 · Liang et al. · 2006 [cited by applicant]
US 20070036843A1 · Hirsh et al. · 2007 [cited by applicant]
US 20070148239A1 · Hall et al. · 2007 [cited by applicant]
US 20070215511A1 · Mehta et al. · 2007 [cited by applicant]
US 20090275530A1 · Tester et al. · 2009 [cited by applicant]
US 20120076865A1 · Allphin et al. · 2012 [cited by applicant]
US 20130142846A1 · Lee · 2013 [cited by examiner]
US 20160128981A1 · Chen · 2016 [cited by examiner]
US 20160228379A1 · Kumar et al. · 2016 [cited by applicant]
US 20160317388A1 · Bhargava et al. · 2016 [cited by applicant]
US 20210069136A1 · Jain et al. · 2021 [cited by applicant]
US 20220241189A1 · Jain et al. · 2022 [cited by applicant]
US 20220241190A1 · Jain et al. · 2022 [cited by applicant]
US 20250099376A1 · Jain et al. · 2025 [cited by applicant]
US 20250108005A1 · Patil et al. · 2025 [cited by applicant]
JP 2008174511A · 2008 [cited by applicant]
WO WO2007001300A1 · 2007 [cited by applicant]
WO WO2007010400 · 2007 [cited by applicant]
WO WO2007109104A3 · 2007 [cited by applicant]
WO WO2011018582 · 2011 [cited by applicant]
WO WO2011119839A1 · 2011 [cited by applicant]
WO WO2012107652A1 · 2012 [cited by applicant]
WO WO2013188413A1 · 2013 [cited by applicant]
WO WO2015166473A1 · 2015 [cited by applicant]
WO WO2015186108A1 · 2015 [cited by applicant]
WO WO2016066256A1 · 2016 [cited by applicant]
WO WO2016087952A1 · 2016 [cited by examiner]
WO WO2019126214A1 · 2019 [cited by applicant]
WO WO2019126215A1 · 2019 [cited by applicant]
WO WO2019126218A1 · 2019 [cited by applicant]
Patil, Digest Journal of Nanomaterials and Biostructures, 5, 1, 2010 (Year: 2010). [cited by examiner]
Guar, International Journal of Pharmacology and Pharmaceutical Sciences, 1, 2014 (Year: 2014). [cited by examiner]
Banerjee S et al., Investigation on crosslinking density for development of novel interpenetrating polymer network (IPN) based formulation, Journal of Scientific and Industrial Research, 2010, 69(10):777-784. [cited by applicant]
Bhardwaj V et al., Interpenetrating Polymer Network (IPN): Novel approach in Drug delivery, Int. J. Drug Dev. Res., 4(3), Jul.-Sep. 2012. [cited by applicant]
Bhardwaj L et al., A Short Review on Gastro Retentive Formulations for Stomach Specific Drug Delivery: Special Emphasis on Floating In situ Gel Systems, African J of Basic & Applied Sciences, 2011, 3(6):300-312. [cited by applicant]
Hanninen K et al., Mechanistic evaluation of factors affecting compound loading into ion-exchange fibers, Eur. J. Pharm. Sci., 2007, 31(5): 306-317. [cited by applicant]
Koul V et al., Interpenetrating polymer network (IPN) nanogels based on gelatin and poly(acrylic acid) by inverse mini-emulsion technique: synthesis and characterization, Colloids Surf. B. Biointerfaces, 2011, 83(2):201… [cited by applicant]
Koshmala JD et al., Preparation of interpenetrating networks of gelatin and dextran as degradable biomaterials, Biomaterials, 2000, 21(20) :2019-2023. [cited by applicant]
Landfester K et al., Synthesis of colloidal particles in miniemulsions, Annual Review of Materials Research, 2006, 36:231-279. [cited by applicant]
Lohani A et al., Interpenetrating Polymer Networks as Innovative Drug Delivery Systems, Journal of Drug Delivery, 2014, 2014:1-11. [cited by applicant]
Lu J et al., One-step synthesis of interpenetrating network hydrogels: Environment sensitivities and drug delivery properties, Saudi J. Biol. Sci. 2016, 2016(3):S22-S31. [cited by applicant]
Nirmal HB et al., In-Situ gel: New trends in Controlled and Sustained Drug Delivery System, Int. J. of PharmTech Research, 2010, 2(2):1398-1408. [cited by applicant]
Yashwantrao PA et al., A Raft Forming System: An Novel Approach for Gastroretention, Int. J. Pure App. Biosci., 2015, 3(4):178-192. [cited by applicant]
Shailaja P et al., A Review on Gastroretentive Drug Delivery System, International Journal of Research and Development in Pharmacy and Life Sciences, 2016, 5(4):2178-2187. [cited by applicant]
Sharma AR and Khan A, Gastroretentive Drug Delivery System: An Approach to Enhance Gastric Retention for Prolonged Drug Release, International Journal of Pharmaceutical Sciences and Research, 2014, 5(4):1095-1106. [cited by applicant]
Subrahmanyam PJ, Design and development of guar gum and borax crosslinked guar gum matrix tablets of theophylline for colon specific drug, Journal of Chemical and Pharmaceutical Research, 2012, 4(2):1052-1060. [cited by applicant]
Rajesh AM et al, Taste masking of ciprofloxacin by ion-exchange resin and sustain release at gastric-intestinal through interpenetrating polymer network, Asian Journal of Pharmaceutical Sciences, 2015, 10(2015):331-340. [cited by applicant]
Rajesh AM et al, Taste masking of ofloxacin and formation of interpenetrating polymer network beads for sustained release, Journal of Pharmaceutical Analysis, 2017, 7(2017):244-251. [cited by applicant]
El Nabarawi MA et al., Formulation, release characteristics, and bioavailability study of gastroretentive floating matrix tablet and floating raft system of Mebeverine HCI, Drug Design, Development and Therapy, 2017, 11… [cited by applicant]
Shah SH et al, Stomach Specific Floating Drug Delivery System: A Review, International Journal of PharmTech Research, 2009, 1(3):623-633. [cited by applicant]
Gupta KC and Ravi Kumar Mnv, Semi-interpenetrating polymer network beads of crosslinked chitosan-glycine for controlled release of chlorophenramine maleate, Journal of Applied Polymer Science, 2000, 76(5):672-683. [cited by applicant]
Qadri MF et al, Biomedical Applications of Interpenetrating Polymer Network System, Open Pharmaceutical Sciences Journal, 2015, 2: 21-30. [cited by applicant]
Sperling LH and Hu R, Interpenetrating Polymer Networks, Polymer Blends Handbook, 2003, 417-447. [cited by applicant]
Klempner et al, Interpenetrating Polymer Networks, Advances in Chemistry; American Chemical Society, 1994, 21-38. [cited by applicant]
Dolas RT et al, Raft Technology for Gatsro Retentive Drug Delivery, Human Journal, 2015, 3(1):232-252. [cited by applicant]
Prajapati VD et al, Raft forming system—An upcoming approach of gastroretentive drug delivery system, Journal of Controlled Release, 2013, 168(2):151-165. [cited by applicant]
Davis SS et al., Transit of Pharmaceutical Dosage Forms Through the Small Intestine, Gut, 1986, 27(8):886-892. [cited by applicant]
Broughton et al., Gamma-hydroxy-butyrate in the treatment of narcolepsy: a preliminary report, In: Guilleminault et al. (Eds.). Narcolepsy (Advances in sleep research. vol. 3.). Holliswood, NY: Spectrum Publications, pp… [cited by applicant]
Flamel Technologies Announces Positive Results of a Second Clinical Trial with Micropump® Sodium Oxybate, Dec. 19, 2014, which reports achieving the objective of one single dose before bedtime. [cited by applicant]
Frucht et al., A Pilot Tolerability and Efficacy Trial of Sodium Oxybate in Ethanol-Responsive Movement Disorders, Movement Disorders, vol. 20(10):1330-1337, Jun. 2005. [cited by applicant]
Mamelak et al., The effects of [gamma]-hydroxybutyrate on sleep, Biol Psychiatry, vol. 12(2):273-288, Aug. 1976 (published 1977). [cited by applicant]
Arora S et al., Floating Drug Delivery Systems: A Review, AAPS PharmScieTech, 2005, 6(3):E372-E390. [cited by applicant]
Chen Y et al., Cubic and Hexagonal Liquid Crystals as Drug Delivery Systems, BioMed Research International, 2014:1-12. [cited by applicant]
Jain D et al., Recent technologies in pulsatile drug delivery systems, Biomatter, 2011, 1(1):57-65. [cited by applicant]
Kumar KK et al., Formulation and evaluation of floating in situ gelling system of losartan potassium, Der Pharmacia Lettre, 2015, 7(1):98-112. [cited by applicant]
Lam WK et al., Monocarboxylate Transporter-Mediated Transport of Gamma-Hydroxybutyric Acid in Human Intestinal Caco-2 Cells, Drug Metabolism and Disposition, 2010, 38(3):441-447. [cited by applicant]
Liechti ME et al., Pharmacokinetics and pharmacodynamics of gamma- hydroxybutyrate in healthy subjects, British Journal of Clinical Pharmacology, 2016, 81:980-988. [cited by applicant]
Madan JR et al., Development and evaluation of in situ gel of pregabalin, International Journal of Pharmaceutical Investigation, 2015, 5(4):226-233. [cited by applicant]
Patel DM et al., Formulation and Evaluation of Floating Oral In Situ Gelling System of Amoxicillin, ISRN Pharmaceutics, 2011. [cited by applicant]
Sajan J et al., Chromotherapeutics and Chronotherapeutic Drug Delivery Systems, Tropical Journal of Pharmaceutical Research, 2009, 8(5):467-475. [cited by applicant]
Vijaya C and Goud KS, Ion-activated In Situ Gelling Ophthalmic Delivery Systems of Azithromyin, Indian Journal of Pharmaceutical Sciences, 2011, 73(6):615-620. [cited by applicant]
Saito S et al., Combination of borane-dimehtyl sulfide complex with catalytic sodium tetrahydroborate as a selective reducing agent for alpha-hydroxy esters, versatile chiral building block from (s)-(-)-malic acid, Chem… [cited by applicant]
Jain, U.S. Appl. No. 16/955,377, filed Jun. 18, 2020. [cited by applicant]
Jain, U.S. Appl. No. 16/955,389, filed Jun. 18, 2020. [cited by applicant]
Jain, U.S. Appl. No. 16/955,392, filed Jun. 18, 2020. [cited by applicant]
International Search Report and Written Opinion issued Apr. 3, 2019 in International Patent Application No. PCT/US2018/066301. [cited by applicant]
International Search Report and Written Opinion issued Apr. 3, 2019 in International Patent Application No. PCT/US2018/066303. [cited by applicant]
International Search Report and Written Opinion issued Apr. 15, 2019 in International Patent Application No. PCT/US2018/066300. [cited by applicant]
International Search Report and Written Opinion issued Apr. 2, 2019 in International Patent Application No. PCT/US2018/066299. [cited by applicant]
Thakral, S et al. Eudragit®: a technology evaluation [cited by applicant]
Sing, I. et al. Ion Exchange Resins: Drug Delivery and Therapeutic Applications [cited by applicant]
Non-Final Office Action, dated Jun. 30, 2021, issued in U.S. Appl. No. 16/955,392, and response. [cited by applicant]
Non-Final Office Action, dated Jul. 7, 2021, issued in U.S. Appl. No. 16/955,377, and response. [cited by applicant]
Notice of Allowance, dated Feb. 3, 2022, issued in U.S. Appl. No. 16/955,377. [cited by applicant]
Notice of Allowance, dated Jan. 26, 2022, issued in U.S. Appl. No. 16/955,392. [cited by applicant]
Office Action issued in European Patent Application No. 18834152.3, dated May 14, 2021, and response. [cited by applicant]
Office Action issued in European Patent Application No. 18834153.1, dated May 14, 2021. [cited by applicant]
Office Action issued in European Patent Application No. 18840118.6, dated May 31, 2021, and response. [cited by applicant]
Non-Final Office Action, dated Mar. 21, 2022, issued in U.S. Appl. No. 16/955,389, and response. [cited by applicant]
Final Office Action, dated Sep. 16, 2022, issued in U.S. Appl. No. 16/955,389, and response. [cited by applicant]
Office Action issued in European Patent Application 18834152.3, dated Nov. 10, 2022, and response. [cited by applicant]
Office Action issued in Israeli Patent Application 275312, dated Dec. 1, 2022, and response. [cited by applicant]
Office Action issued in European Patent Application 18840118.6, dated Nov. 10, 2022, and response. [cited by applicant]
Office Action issued in Chinese Patent Application 201880089838.9, dated Feb. 28, 2023. [cited by applicant]
Office Action issued in Israeli Patent Application 275444, dated Dec. 11, 2022, and response. [cited by applicant]
Office Action issued in European Patent Application 18834153.1, dated Nov. 10, 2022, and response. [cited by applicant]
Office Action issued in Japanese Patent Application 2020-554387, dated Oct. 12, 2022. [cited by applicant]
Non-Final Office Action, dated Oct. 24, 2023, issued in U.S. Appl. No. 17/725,677. [cited by applicant]
Office Action issued in Canadian Patent Application 3,097,737, issued Sep. 27, 2023, and response. [cited by applicant]
Office Action issued in European Patent Application 18834152.3, dated Nov. 11, 2023. [cited by applicant]
Office Action issued in Canadian Patent Application 3,085,941, issued Sep. 27, 2023, and response. [cited by applicant]
Office Action issued in European Patent Application 18840118.6, dated Dec. 5, 2023. [cited by applicant]
Non-Final Office Action, dated Nov. 7, 2023, issued in U.S. Appl. No. 17/725,673. [cited by applicant]
Office Action issued in Israeli Patent Application 275444, dated Jan. 30, 2024. [cited by applicant]
Final Rejection issued in Japanese Patent Application 2020-554387, dated Jun. 2, 2023. [cited by applicant]
Office Action issued in European Patent Application 18834153.1, dated Nov. 24, 2023. [cited by applicant]
Office Action issued in Canadian Patent Application 3,086,153, issued Sep. 27, 2023, and response. [cited by applicant]
Examination Report issued in Australian Patent Application 2018388577, issued Nov. 8, 2023. [cited by applicant]
Office Action issued in Chinese Patent Application 201880089838.9, dated Aug. 23, 2023. [cited by applicant]
Office Action issued in Chinese Patent Application 201880089838.9, dated Jan. 10, 2024. [cited by applicant]
Notice of Allowance issued in Israeli Patent Application No. 275444, dated May 19, 2024. [cited by applicant]
Notice of Allowance issued in U.S. Appl. No. 17/725,677, dated Sep. 10, 2024. [cited by applicant]
Notice of Acceptance issued in Australian Patent Application No. 2018388577, dated May 22, 2024. [cited by applicant]
Notice to Grant Patent Right issued in Chinese Patent Application No. 201880089838.9, dated Jun. 3, 2024. [cited by applicant]
Office Action issued in Canadian Patent Application 3,086,153, issued Jun. 3, 2024. [cited by applicant]
Office Action issued in Canadian Patent Application 3,097,737, issued May 29, 2024, and response. [cited by applicant]
Office Action issued in Canadian Patent Application 3,085,941, issued May 28, 2024, and response. [cited by applicant]
Office Action issued in European Patent Application 18834152.3, dated Feb. 27, 2025. [cited by applicant]
Office Action issued in European Patent Application 18840118.6, dated Apr. 17, 2025. [cited by applicant]
Restriction Requirement, dated Jun. 18, 2025, issued in U.S. Appl. No. 18/302,525. [cited by applicant]
Non-Final Office Action, dated Feb. 14, 2025, issued in related U.S. Appl. No. 17/725,673. [cited by applicant]
Office Action issued in European Patent Application 18834153.1, dated Feb. 27, 2025. [cited by applicant]