Exploring the Patent Landscape and Regulatory Prospective on Pharmaceutical Cocrystals
Home >
2023,
Vol. 11 No. 01 > Exploring the Patent Landscape and Regulatory Prospective on Pharmaceutical Cocrystals
Published: April 15, 2023
Authors
Ritu Rathi, Yukta Guggal, Twinkle, Varneet Sandhu, Inderbir Singh
Keywords
Pharmaceutical Cocrystals, USFDA, EMA, Patent, Regulatory Consideration paper in rows
Abstract
Background: Cocrystals are not new, they have sparked considerable interest among scientists and the pharmaceutical business in the last decade. Cocrystals are multiphase formations composed of at least two particles that are held together by noncovalent bonds. Cocrystal offers unmatched physio-engineered attributes (like stability, melting point, taste concealment, dissolvability, purity, bioavailability, etc.) without changing the pharmacological capabilities of the drug. Recently, as pharmaceutical cocrystal development has increased, we have given more attention to the absurd state of cocrystals.
Purpose: The purpose of the current review is to explore the patent perspective on pharmaceutical cocrystals. And to discuss the new regulations that came up from the U.S. Food and Drug Administration (USFDA) and European Medicines Agency (EMA).
Methods: In order to accomplish the said objectives, literature was surveyed from GOOGLE PATENTS, GOOGLE SCHOLAR, PUBMED, EBSCO, etc. type for search engines for a detailed overview of the patentability and regulatory status of pharmaceutical cocrystals.
Conclusions: The journey of pharmaceutical cocrystals is bit challenging and still going on. In addition, if attention is drawn on some challenging aspects such as scalability, reproducibility, herbal bioactives cocrystals and 3D printed cocrystals related preparation and stability challenges, it can prove to be a paradigm shift in drug discovery processes.
References
- Alvani, A., & Shayanfar, A. (2022). Solution Stability of Pharmaceutical Cocrystals. Crystal Growth & Design, 22(10), 6323-6337. https://doi.org/10.1021/acs.cgd.2c00787
- Annete bak, Drazen Ostovic. Sorbic Acid Analogue Cocrystals Patent, 2009-05-13. EP 2056798 A2.
- Bandi Parthasaradhi Reddy, Hyderabad (IN); Kura Rathnakar Reddy, Hyderabad (IN); Rapolu Raji Reddy, Hyderabad (IN); Dasari Muralidhara, Hyderabad (IN); Matta Ramakrishna, Hyderabad. May 3, 2007, Crystalline alfuzosin base. US 2007/0100143 A1.
- Benjamin S. Lane, Lynnfield, MA (US); Chong – Hui Gu, Waban, MA (US). Nov. 17, 2022. Cocrystals, pharmaceutical compositions thereof, and methods of treatment involving same. US 2022/0363661 A1.
- Bolla, G., Sarma, B., & Nangia, A. K. (2022). Crystal engineering of pharmaceutical cocrystals in the discovery and development of improved drugs. Chemical Reviews, 122(13), 11514-11603. https://doi.org/10.1021/acs.chemrev.1c00987
- Brittain, Harry G, felice, Phillip v, 2015-08-13. Intravenous Formulation with water soluble cocrystals of Acetylsalicylic Acid and theanine. AU2013201664 B2.
- Buschmann, Helmut Heinrich 52076 Aachen (Walheim) (DE), Solá Carandell, Lluis 43893 Altafulla (Tarragona) (ES). 21.04.2010. Cocrystals of tramadol and NSAIDs. EP 2 177 215 A1.
- Chavan, R. B., Thipparaboina, R., Yadav, B., & Shastri, N. R. (2018). Continuous manufacturing of cocrystals: challenges and prospects. Drug delivery and translational research, 8, 1726-1739. https://doi.org/10.1007/s13346-018-0479-7
- Comely, Alexander Christian, Tesson, Nicolas. 14-12-2017. Chiral Resolution Of An Intermediate of Suvorexant And Cocrystals Thereof. WO2017/211733 A1.
- Ekaterina Albert, West Lafayette, IN (US); Patricia Andres, West Lafayette, IN (US); Melanie Janelle Bevill, West Lafayette, IN (US); Jared Smit, Lafayette, IN (US); Jennifer Nelson, Kokomo, IN (US). Aug.21, 2014. Cocrystals of PROGESTERONE. US20140235595A1.
- European Medicine Agency Science Medicine Health, European Union (2018). https://www.ema.europa.eu/en/homepage
- Fang, X., Gao, R., Yang, Y., & Yan, D. (2019). A cocrystal precursor strategy for carbon-rich graphitic carbon nitride toward high-efficiency photocatalytic overall water Retrieved from splitting. Iscience, 16, 22-30. https://doi.org/10.1016/ j.isci.2019.05.015
- United States Food and Drug Administration (US FDA), Government of United States (2018), Retrieved from https://www.fda.gov/
- G· M. Dahl, A. Carl, E. Sharp, Nicotine Salts, 2022-04-26 Cocrystals and salt cocrystal complexes. CN 108495563B.
- Gadade, D. D., & Pekamwar, S. S. (2016). Pharmaceutical cocrystals: regulatory and strategic aspects, design and development. Advanced pharmaceutical bulletin, 6(4), 479.
- Gaggero, A., Dukovski, B. J., Radić, I., Šagud, I., Škorić, I., Cinčić, D., & Jug, M. (2020). Co-grinding with surfactants as a new approach to enhance in vitro dissolution of praziquantel. Journal of Pharmaceutical and Biomedical Analysis, 189, 113494. https://doi.org/10.1016/j.jpba.2020.113494
- Gary D. Glick, Ann Arbor, MI (US); Luigi Franchi, Ann Arbor, MI (US); Giancarlo Santus, Milan (IT). May 21, 2019. Methods and compositions for treating conditions associated with an abnormal inflammatory response. US10292951 B2.
- Gary M. Dull, Lewisville, NC (US); Susana del Rio Gancedo, Cambridge (GB); Judit Galcera Julia, Sant Just Desvern (ES). Dec. 17, 2019. Nicotine salts, co – crystals, and salt co – crystal complexes. US 10,508,096 B2.
- Goldman, David, 2007-06-21. Methods for preparing mixed phase cocrystals with activator, JP2007516259A.
- Isabel Kalofonos, Cambridge, MA (US); Patrick G. Stahly, West Lafayette, IN (US); William Martin-Doyle, Cambridge, MA (US); Dimitris Kalofonos, Cambridge, MA (US); Travis L. Houston, Lafayette, IN (US); Jeffrey S. Stults, West Lafayette, IN (US). Nov. 10, 2011. Novel choline cocrystal of epalrestat. US 2011/0275682 A1.
- Kavanagh, O. N., Croker, D. M., Walker, G. M., & Zaworotko, M. J. (2019). Pharmaceutical cocrystals: from serendipity to design to application. Drug Discovery Today, 24(3), 796-804. https://doi.org/10.1016/j.drudis.2018.11.023
- Khan, S., Zahoor, M., Rahman, M. U., & Gul, Z. (2023). Cocrystals; basic concepts, properties and formation strategies. Zeitschrift für Physikalische Chemie, 237(3), 273-332. https://doi.org/10.1515/zpch-2022-0175
- Koya KIMOTO, Mitsuo Yamamoto, Masato Kitayama, Yasuhiro Sawai, Miyuki Hohokabe, Kentaro IWATA. 2017-06-29. Cocrystals, production method thereof, and medicament containing cocrystals, WO2017111179A1.
- Kshirsagar, S. M., Chatale, B. C., & Amin, P. D. (2022). Comparative evaluation of ibuprofen cocrystals prepared by solvent evaporation and hot melt extrusion technology. Journal of Drug Delivery Science and Technology, 67, 103003. https://doi.org/10.1016/j.jddst.2021.103003
- Kumar, A., Kumar, S., & Nanda, A. (2018). A review about regulatory status and recent patents of pharmaceutical cocrystals. Advanced pharmaceutical bulletin, 8(3), 355. 10.15171/apb.2018.042
- Kumar, S., & Nanda, A. (2017). Pharmaceutical Cocrystals: An Overview. Indian Journal of Pharmaceutical Sciences, 79(6). 10.4172/PHARMACEUTICAL-SCIENCES.1000302
- Kumar, S., & Nanda, A. (2018). Approaches to design of pharmaceutical cocrystals: A review. Molecular Crystals and Liquid Crystals, 667(1), 54-77. https://doi.org/10.1080/15421406.2019.1577462
- Leonard R. MacGillivray, Iowa City, IA (US). Jan. 2, 2014 Cocrystals and Salts of Contrast Agents and Imaging. US 2014/0004051A1.
- Michael Zaworotko, Heather Clarke, Arora Kapildev, Padmini Kavuru, Roland Douglas Shytle, Twarita Pujari, Lissette Marshall, Tien Teng Ong. 2013-05-01. Neutraceuticals Co-crystrals Compositions.EP2167043 A4.
- Mkrtchyan, Gnel;2872 Meadows Lake Drives, Watkinesville, Georgia, 3067 (US). Hoerner Joshua K. Couch Ricky W,Bis Joanna A, Carino Stephen A.R. 08-07-2021. Cocrystals of cannabinoids. WO2021/138610 A1.
- Nascimento, A. L., Fernandes, R. P., Charpentier, M. D., ter Horst, J. H., Caires, F. J., & Chorilli, M. (2021). Cocrystals of non-steroidal anti-inflammatory drugs (NSAIDs): Insight toward formation, methods, and drug enhancement. Particuology, 58, 227-241. https://doi.org/10.1016/j.partic.2021.03.015
- ORACZ, Monika 97-360 Kamiensk (PL), SKOCZEN, Przemyslaw 83-010 Straszyn (PL), 27.06.2018 Bulletin 2018/26. Cocrystals of apremilast, EP 3 339 292 A1.
- O’Sullivan, A., Long, B., Verma, V., Ryan, K. M., & Padrela, L. (2022). Solid-state and particle size control of pharmaceutical cocrystals using atomization-based techniques. International Journal of Pharmaceutics, 621, 121798. https://doi.org/10.1016/j.ijpharm.2022.121798
- Pawar, N., Saha, A., Nandan, N., & Parambil, J. V. (2021). Solution cocrystallization: A scalable approach for cocrystal production. Crystals, 11(3), 303. https://doi.org/10.3390/cryst11030303
- Plata Salaman, Carlos Ramon 08950 Esplugues de Llobregat, (Barcelona) (ES). 2011 Bulletin 2011/27. Cocrystals of venlafaxine and celecoxib. EP 2 340 818 A1.
- Prohens lopen, Rafel. Barbas Canero Rafael, Bofill Herrera, Lidia. De Sande Lopez, Dafne. 29 august 2019. Cocrystals Of Ubiquinol And Composition Comprise Them. WO2019/162429 A1.
- Ringle, S. (2018). Regulatory implications using API cocrystals for generic medicinal products within the EU and US. Heinische Friedrich-Wilhelms University: Hamburg, Germany.
- Rathi, R., Kaur, S., & Singh, I. (2022). A review on co-crystals of Herbal Bioactives for solubility enhancement: preparation methods and characterization techniques. Crystal Growth & Design, 22(3), 2023-2042.. https://doi.org/10.1021/acs.cgd.1c01408
- Rathi, R., Kushwaha, R., Goyal, A., & Singh, I. (2022). Oxaliplatin-flavone pharmaceutical co-crystal-CN111205332A: patent spotlight. Pharmaceutical Patent Analyst, 11(5), 147-154. https://doi.org/10.4155/ppa-2022-0011
- Rathi, R., & Singh, I. (2022). Multicomponent crystal compromising dasatinib and selected co-crystals formers: a patent evaluation of EP2861589B1. Pharmaceutical Patent Analyst, 11(1), 15-21. https://doi.org/10.4155/ppa-2021-0024
- Rodriguez-Hornedo, Nair; kuminek, gislaine, Cavanagh Katie, L. 04-02-2021. Cocrystals of Posaconazole, Method of Making and Using Same. WO2021/022103 A1.
- Ruksanna Ahmad, Redcar Cleveland (GB); Jeremy Cooper, Redcar Cleveland (GB) ; Isaac Odiase , Merseyside ( GB ). May 7, 2019. Methods for making active crystalline materials. US 10280124 B2.
- Samineni, R., Chimakurthy, J., Sumalatha, K., Dharani, G., Rachana, J., Manasa, K., & Anitha, P. (2019). Cocrystals: A review of recent trends in co crystallization of BCS class II drugs. Research Journal of Pharmacy and Technology, 12(7), 3117-3124. 10.5958/0974-360X.2019.00527.4 .
- Samue, R., Kunjal, K. K., Thayyil, A. R., & Shabaraya, R. A. (2022). FDA regulatory implications for cocrystals and recent cocrystal patents. International Journal Of Drug Regulatory Affairs, 10(3), 10-18. 10.22270/ijdra.v10i3.541.
- Savio, Guilherme. 30-12-2021. Cocrystals derivatives of apixaban. WO2021/260519 A1.
- Scott L. Childs, Atlanta, GA (US); Patricia M. Mougin-Andres, West Lafayette, IN (US); Barbara C. Stahly, West Lafayette, IN (US). Dec. 30, 2014. Screening for solid forms by ultrasound crystallization and cocrystallization using ultrasound. US 8,920,559 B2.
- Shanghai tehua pharmaceutical technology co., ltd. 2016-07-06. The salt of a kind of pyrazolo pyrimidinone compound, polymorph and pharmaceutical composition, preparation method and application. CN102952138B.
- Stephan D Parent, Nathan Carl Schultheiss, Yiduo Wu, Melanie Janelle bevill ,travis L Houston ,Petinka Vlahova. 2017-02-24. New form of rifaximin and uses thereof. NZ710780A.
- Teófilo Cardoso de Vasconcelos, Perafita (PT). Jan. 20, 2011, Pharmaceutical composition for poorly soluble drugs. US 2011/0014282 A1.
- Tesson Nicolas, Gordo Campon, Esther. 31.08.2017. Cocrystals of Lorcaserin. WO2017/144598 A1.
- Tesson, Nicolas 08028 Barcelona (ES) Jiménez González, Carmen 08028 Barcelona (ES) Nienaltowski, Tomasz 18-400 Lomza (PL) Pogoda, Dorota 51-649 Wroclaw (PL) Krzyzanowski, Mariusz 83-220 Skórcz (PL) Pawlowska, Jolanta 83-200 Starogard Gdanski (PL). 01.07.2020 Bulletin 2020/27. Cocrystals of (r)-baclofen. EP 3 674 287 A1.
- Tesson, Nicolas 08902 L’Hospitalet de Llobregat (ES), Segade Rodriguez, Antonio 08017 Barcelona (ES). , 28.10.2015 Bulletin 2015/44. Cocrystals of lapatinib. EP 2 937 346 A1.
- Tesson, Nicolas, Trilla Castano, Montserrat, Comely, Alexander Cristian. 07 May 2020. Solid Compositions of Cocrystals of Cannabinoids. WO 2020/089424A1
- Thakor, P., Yadav, B., Modani, S., & Shastri, N. R. (2020). Preparation and optimization of nano-sized cocrystals using a quality by design approach. CrystEngComm, 22(13), 2304-2314. DOI https://doi.org/10.1039/C9CE01930H
- Tharik, A. A., & Meyyanathan, S. N. (2023). Recent Patents of Pharmaceutical Cocrystals: Product Development on Anti-Cancer Drugs and Beyond. Recent Patents on Anti-Cancer Drug Discovery, 18(3), 246-267.
- Thayyil, A. R., Juturu, T., Nayak, S., & Kamath, S. (2020). Pharmaceutical cocrystallization: Regulatory aspects, design, characterization, and applications. Advanced Pharmaceutical Bulletin, 10(2), 203. 10.34172/apb.2020.024
- Thompson, A. J., Price, J. R., McMurtrie, J. C., & Clegg, J. K. (2021). The mechanism of bending in cocrystals of caffeine and 4-chloro-3-nitrobenzoic acid. Nature Communications, 12(1), 5983. https://doi.org/10.1021/acs.cgd.1c01408
- Tom Leyssens, Richard alan couch,Michael Paul Rene Guillot, Bram Harmsen, Thomas R. bailey, martin appelmans. Mar.21.2023 Solid forms of fasoracetam. US011608324 B2.
- Tu Lee, Pu-Yun Wang, 2011-09-16. A cocrystal compound of optical devices. TW201131192A.
- Vemuri, V. D., & Lankalapalli, S. (2019). Insight into concept and progress on pharmaceutical cocrystals: an overview. Indian J. Pharm. Educ. Res, 53(4), s522-38. https://doi.org/10.5530/ijper.53.4s.147
- Xiao, Y., Wu, C., Hu, X., Chen, K., Qi, L., Cui, P., … & Yin, Q. (2023). Mechanochemical Synthesis of Cocrystal: From Mechanism to Application. Crystal Growth & Design. https://doi.org/10.1021/acs.cgd.3c00183
- Yadav, B. K., Khursheed, A. T. I. F., & Singh, R. D. (2019). Cocrystals: A complete review on conventional and novel methods of its formation and its evaluation. Asian J. Pharm. Clin. Res, 12(7), 68-74. http://dx.doi.org/10.22159/ajpcr.2019.v12i7.33648
- Zaworotko, Michael J. Tampa Florida 33620 (US), Shytle, Roland D. Tampa Florida 33620 (US), ONG, Tien Teng Tampa Florida 33620 (US), Kavuru, Padmini Tampa Florida 33620 (US), Cantwell, Ryan N. Tampa Florida 33620 (US), NGUYEN, Tranhha Tampa Florida 33620 (US), Smith, Adam John Tampa Florida 33620 (US). 23.03.2016 Bulletin 2016/12. Lithium compositions. EP 2 688 575 B1.
How to Cite
Ritu Rathi, Yukta Guggal, Twinkle, Varneet Sandhu, Inderbir Singh. Exploring the Patent Landscape and Regulatory Prospective on Pharmaceutical Cocrystals.
J. Pharm. Technol. Res. Manag.. 2023, 11, 49-60
