Formulation and Evaluation of Ocusert Embeded with Ciprofloxacin Loaded Nanoparticles
Abstract
Ophthalmic drug delivery is very challenging. Upon the application of conventional topical ophthalmic formulations, a significant portion of the administered dose goes to waste due to the existence of various ophthalmic barriers. There is a swift elimination of the applied solution from the anterior part of the eyes through the nasolacrimal duct to the nasal cavity. The aim of this study was to develop an ocusert embedded with ciprofloxacin-loaded nanoparticles to increase patient compliance by improving local delivery of the drug. Ciprofloxacin-loaded Eudragit RL PO polymeric nanoparticles were prepared and evaluated for particle properties. These drug-loaded polymeric nanoparticles were embedded in an ocusert made of carboxymethylcellulose. Various properties of ocuserts, like film endurance, surface pH, disintegration time, and sterility, were studied. A drug-loaded nanoparticle-embedded ocusert was found to be a suitable system to improve ophthalmic drug delivery. The nanoparticles' particle size, polydispersity index (PDI), entrapment efficiency, and in vitro drug release were all assessed. The generated ocuserts underwent screening for sterility, drug content, weight variability, folding durability, thickness, surface pH, and disintegration time. In order to gain insight into the process by which drugs release from the formulations, the in vitro drug release from the preparations was examined using a standard Abron Visking semipermeable membrane.
Keywords:
Ciprofloxacin, Carboxymethyl cellulose, CMC, Eudragit Polymeric nanoparticles, Ocular insert, Ocusert
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References
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Baig, M. S. and S. A. (2020). Cationic nanostructured lipid carriers: optimization of zeta potential and evaluation. International Journal of Applied Pharmaceutics, 12(4), 77–84. https://doi.org/10.22159%2Fijap.2020v12i4.37531
Baig, M. S., Owida, H., Njoroge, W., Siddiqui, A.-R., & Yang, Y. (2020a). Development and evaluation of cationic nanostructured lipid carriers for ophthalmic drug delivery of besifloxacin. Journal of Drug Delivery Science and Technology, 55(July 2019), 101496. https://doi.org/10.1016/j.jddst.2019.101496
Baig, M. S., Owida, H., Njoroge, W., Siddiqui, A. ur R., & Yang, Y. (2020b). Development and evaluation of cationic nanostructured lipid carriers for ophthalmic drug delivery of besifloxacin. Journal of Drug Delivery Science and Technology, 55(December 2019), 101496. https://doi.org/10.1016/j.jddst.2019.101496
Chandana, M., Venkata Ramana, M., & Rama Rao, N. (2021). Formulation and Evaluation of Valsartan Solid Lipid Nanoparticles. Journal of Drug Delivery and Therapeutics, 11(2-S), 103–108. https://doi.org/10.22270/jddt.v11i2-S.4694
Dave, V., Paliwal, S., & Yadav, S. (2013). Formulation and evaluation of controlled delivery of aceclofenac through ocular insert. Turkish Journal of Pharmaceutical Sciences, 10(2), 205–219.
Dillen, K., Vandervoort, J., Van den Mooter, G., & Ludwig, A. (2006). Evaluation of ciprofloxacin-loaded Eudragit® RS100 or RL100/PLGA nanoparticles. International Journal of Pharmaceutics, 314(1), 72–82. https://doi.org/10.1016/j.ijpharm.2006.01.041
Gajanan, G. V., Pravin, P., & Adhikrao, Y. (2017). Methods for Evaluation of Ocular Insert with Classification and Uses in Various Eye Diseases-A Review. Asian Journal of Pharmacy and Technology, 7(4), 261. https://doi.org/10.5958/2231-5713.2017.00038.1
Hajwani, A., Khan, A., Ansari, N., Zerdi, N., & Baig, M. S. (2023). Fabrication of Transdermal Gel Embedded with Solid Lipid Nanoparticles of Indomethacin. International Journal of Drug Delivery Technology, 13(1), 414–417. https://doi.org/10.25258/ijddt.13.1.66
Hardainiyan, S., Kumar, K., Nandy, B. C., & Saxena, R. (2017). Design, Formulation and in Vitro Drug Release From Transdermal Patches Containing Imipramine Hydrochloride As Model Drug. International Journal of Pharmacy and Pharmaceutical Sciences, 9(6), 220. https://doi.org/10.22159/ijpps.2017v9i6.16851
Jiao, G., Lou, G., Mo, Y., Pan, Y., Zhang, Z., Guo, R., & Li, Z. (2017). A combination of GDNF and hUCMSC transplantation loaded on SF/AGs composite scaffolds for spinal cord injury repair. Materials Science and Engineering: C, 74, 230–237. https://doi.org/10.1016/j.msec.2016.12.017
Kalyanwat, R., Shrivastava, B., & Pathak, K. (2016). Preparation and evaluation of bioadhesive ocular inserts of aceclofenac. International Journal of Pharmaceutical Sciences Review and Research, 41(2), 207–213.
Karmakar, S., Manna, S., Kabiraj, S., & Jana, S. (2022). Recent progress in alginate-based carriers for ocular targeting of therapeutics. Food Hydrocolloids for Health, 2, 100071. https://doi.org/10.1016/j.fhfh.2022.100071
Kulhari, H., Pooja, D., Narayan, H., Meena, L., & Prajapati, S. K. (2011). Design and evaluation of ocusert for controlled delivery of flurbiprofen sodium. Current Eye Research, 36(5), 436–441. https://doi.org/10.3109/02713683.2010.542866
Kumar, N., & Sharma, S. (2013). Design, formulation and evaluation of sustained ophthalmic delivery of ciprofloxacin from ocular inserts. Research Journal of Pharmacy and Technology, 6(3), 285–286.
Liu, Z., Zhang, X., Wu, H., Li, J., Shu, L., Liu, R., Li, L., & Li, N. (2011). Preparation and evaluation of solid lipid nanoparticles of baicalin for ocular drug delivery system in vitro and in vivo. Drug Development and Industrial Pharmacy, 37(4), 475–481. https://doi.org/10.3109/03639045.2010.522193
Maheswara Reddy, D., Krishna Reddy, Y., Rajasekhar Reddy, D., Vinay Kumar, N., Suresh, M., Althaff, M., & Valaparla, N. K. (2011). Formulation and evaluation of ciprofloxacin ocuserts. Research Journal of Pharmacy and Technology, 4(11), 1663–1665.
Mandal, A., Gote, V., Pal, D., Ogundele, A., & Mitra, A. K. (2019). Ocular Pharmacokinetics of a Topical Ophthalmic Nanomicellar Solution of Cyclosporine (Cequa®) for Dry Eye Disease. Pharmaceutical Research, 36(2), 36. https://doi.org/10.1007/s11095-018-2556-5
Mandal, S., Shiva, K., Gupta, P., Singh, A., Ahmad, A., Shankar Ahirwar, R., & Ray, P. (2022). Ocular inserts: A Changing Trend in Targeted Drug Delivery. November. https://doi.org/10.14704/nq.2022.20.10.NQ55773
Mujoriya, R. Z., & Kshirsagar, M. D. (2016). Evaluation Study of Sustained Release Ocular Insert of Brimonidine Tartrate and Timolol. Research Journal of Pharmaceutical Dosage Forms and Technology, 8(4), 231. https://doi.org/10.5958/0975-4377.2016.00032.x
Nautiyal, D., Singh, V., & Ali, S. (2012). Formulation and evaluation of sustained release of Ofloxacin ocular inserts. Research Journal of Pharmacy and Technology, 5(12), 1497–1499.
Onugwu, A. L., Nwagwu, C. S., Onugwu, O. S., Echezona, A. C., Agbo, C. P., Ihim, S. A., Emeh, P., Nnamani, P. O., Attama, A. A., & Khutoryanskiy, V. V. (2023). Nanotechnology based drug delivery systems for the treatment of anterior segment eye diseases. Journal of Controlled Release, 354, 465–488. https://doi.org/10.1016/j.jconrel.2023.01.018
Parveen, N., & Joshi, H. (2020). Ocuserts: A Novel Formulation Approach in Drug Delivery System. Saudi Journal of Medical and Pharmaceutical Sciences, 06(05), 420–425. https://doi.org/10.36348/sjmps.2020.v06i05.005
Patel, A., Patel, D., Patel, N., Patel, J., Patel, M., & Patel, A. (2012). Novel ophthalmic drug delivery approach: An ophthalmic inserts. Research Journal of Pharmacy and Technology, 5(6), 729–735.
Patil, R., Dehari, D., Chaudhuri, A., Kumar, D. N., Kumar, D., Singh, S., Nath, G., & Agrawal, A. K. (2023). Recent advancements in nanotechnology-based bacteriophage delivery strategies against bacterial ocular infections. Microbiological Research, 273, 127413. https://doi.org/10.1016/j.micres.2023.127413
Jadhav, R., Vaidya, V., Mahajan, M., Farande, P., Bhagde, S., & Galgate, A. (2023). Formulation, Optimization and Evaluation of Ocular Inserts Containing Anti-Fungal Drug. Journal of Coastal Life Medicine, 11(2), 252–259. Retrieved from https://www.jclmm.com/index.php/journal/article/view/959
Said, M., Elsayed, I., Aboelwafa, A. A., Elshafeey, A. H., & Hassan, M. (2023). Ocular Mucoadhesive and Biodegradable Sponge-Like Inserts for the Sustained and Controlled Delivery of Voriconazole; Preparation, D-optimal Factorial Optimization and in-vivo Evaluation. Journal of Pharmaceutical Sciences. https://doi.org/10.1016/j.xphs.2023.09.026
Shah, M. R., Imran, M., & Ullah, S. (2022). Chapter 10 - Overcoming ocular barriers through nanocarrier-based drug delivery systems. In M. R. Shah, M. Imran, & S. Ullah (Eds.), Nanocarriers for Organ-Specific and Localized Drug Delivery (pp. 225–244). Elsevier. https://doi.org/10.1016/B978-0-12-821093-2.00009-8
Shanmugam, S., Valarmathi, S., Kumar, S. S., Shanmugasundaram, P., & Senthilkumar, M. (2016). Formulation development and evaluation of opthalmic ocusert containing aciclovir. Research Journal of Pharmacy and Technology, 9(11), 1858–1862. https://doi.org/10.5958/0974-360X.2016.00379.6
Shanmugam, S., Valarmathi, S., & Kumars, S. (2017). Sterility testing procedure of ophthalmic ocusert aciclovir used for treating herpes simplex virus. Asian Journal of Pharmaceutical and Clinical Research, 10(10), 344–346. https://doi.org/10.22159/ajpcr.2017.v10i10.19216
Uncu, L., Donici, E., Valica, V., Vislouh, O., Gonciar, V., & Parii, S. (2019). DEVELOPMENT and validation of an assay method for ciprofloxacin hydrochloride determination in combination ear drops. Chemistry Journal of Moldova, 14(2), 56–61. https://doi.org/10.19261/cjm.2019.607
Valarmathi, S., Shanmugam, S., Satheesh Kumar, S., & Shanmugasundaram, P. (2017). In vivo studies of ophthalmic ocular insert containing aciclovir. Research Journal of Pharmacy and Technology, 10(7), 2139–2142. https://doi.org/10.5958/0974-360X.2017.00376.6
Virmani, T., Kumar, G., Sharma, A., & Pathak, K. (2023). Chapter 2 - An overview of ocular drug delivery systems—conventional and novel drug delivery systems. In M. Rai, M. L. Occhiutto, & S. Talegaonkar (Eds.), Nanotechnology in Ophthalmology (pp. 23–48). Academic Press. https://doi.org/10.1016/B978-0-443-15264-1.00007-5
Watson, S., Cabrera-Aguas, M., & Khoo, P. (2018). Common eye infections. Australian Prescriber, 41(3), 67–72. https://doi.org/10.18773/austprescr.2018.016
Wu, W., Panduro Vela, D. H., Bück, A., & Fröba, A. P. (2023). Characterization of nanofluids in evaporating droplets by dynamic light scattering. Measurement, 220, 113321. https://doi.org/10.1016/j.measurement.2023.113321
Youssef, A. A. A., Cai, C., Dudhipala, N., & Majumdar, S. (2021). Design of topical ocular ciprofloxacin nanoemulsion for the management of bacterial keratitis. Pharmaceuticals, 14(3), 1–19. https://doi.org/10.3390/ph14030210
Alzahrani, A., Youssef, A. A. A., Nyavanandi, D., Tripathi, S., Bandari, S., Majumdar, S., & Repka, M. A. (2023). Design and optimization of ciprofloxacin hydrochloride biodegradable 3D printed ocular inserts: Full factorial design and in-vitro and ex-vivo evaluations: Part II. International Journal of Pharmaceutics, 631, 122533. https://doi.org/10.1016/j.ijpharm.2022.122533
Baig, M. S. and S. A. (2020). Cationic nanostructured lipid carriers: optimization of zeta potential and evaluation. International Journal of Applied Pharmaceutics, 12(4), 77–84. https://doi.org/10.22159%2Fijap.2020v12i4.37531
Baig, M. S., Owida, H., Njoroge, W., Siddiqui, A.-R., & Yang, Y. (2020a). Development and evaluation of cationic nanostructured lipid carriers for ophthalmic drug delivery of besifloxacin. Journal of Drug Delivery Science and Technology, 55(July 2019), 101496. https://doi.org/10.1016/j.jddst.2019.101496
Baig, M. S., Owida, H., Njoroge, W., Siddiqui, A. ur R., & Yang, Y. (2020b). Development and evaluation of cationic nanostructured lipid carriers for ophthalmic drug delivery of besifloxacin. Journal of Drug Delivery Science and Technology, 55(December 2019), 101496. https://doi.org/10.1016/j.jddst.2019.101496
Chandana, M., Venkata Ramana, M., & Rama Rao, N. (2021). Formulation and Evaluation of Valsartan Solid Lipid Nanoparticles. Journal of Drug Delivery and Therapeutics, 11(2-S), 103–108. https://doi.org/10.22270/jddt.v11i2-S.4694
Dave, V., Paliwal, S., & Yadav, S. (2013). Formulation and evaluation of controlled delivery of aceclofenac through ocular insert. Turkish Journal of Pharmaceutical Sciences, 10(2), 205–219.
Dillen, K., Vandervoort, J., Van den Mooter, G., & Ludwig, A. (2006). Evaluation of ciprofloxacin-loaded Eudragit® RS100 or RL100/PLGA nanoparticles. International Journal of Pharmaceutics, 314(1), 72–82. https://doi.org/10.1016/j.ijpharm.2006.01.041
Gajanan, G. V., Pravin, P., & Adhikrao, Y. (2017). Methods for Evaluation of Ocular Insert with Classification and Uses in Various Eye Diseases-A Review. Asian Journal of Pharmacy and Technology, 7(4), 261. https://doi.org/10.5958/2231-5713.2017.00038.1
Hajwani, A., Khan, A., Ansari, N., Zerdi, N., & Baig, M. S. (2023). Fabrication of Transdermal Gel Embedded with Solid Lipid Nanoparticles of Indomethacin. International Journal of Drug Delivery Technology, 13(1), 414–417. https://doi.org/10.25258/ijddt.13.1.66
Hardainiyan, S., Kumar, K., Nandy, B. C., & Saxena, R. (2017). Design, Formulation and in Vitro Drug Release From Transdermal Patches Containing Imipramine Hydrochloride As Model Drug. International Journal of Pharmacy and Pharmaceutical Sciences, 9(6), 220. https://doi.org/10.22159/ijpps.2017v9i6.16851
Jiao, G., Lou, G., Mo, Y., Pan, Y., Zhang, Z., Guo, R., & Li, Z. (2017). A combination of GDNF and hUCMSC transplantation loaded on SF/AGs composite scaffolds for spinal cord injury repair. Materials Science and Engineering: C, 74, 230–237. https://doi.org/10.1016/j.msec.2016.12.017
Kalyanwat, R., Shrivastava, B., & Pathak, K. (2016). Preparation and evaluation of bioadhesive ocular inserts of aceclofenac. International Journal of Pharmaceutical Sciences Review and Research, 41(2), 207–213.
Karmakar, S., Manna, S., Kabiraj, S., & Jana, S. (2022). Recent progress in alginate-based carriers for ocular targeting of therapeutics. Food Hydrocolloids for Health, 2, 100071. https://doi.org/10.1016/j.fhfh.2022.100071
Kulhari, H., Pooja, D., Narayan, H., Meena, L., & Prajapati, S. K. (2011). Design and evaluation of ocusert for controlled delivery of flurbiprofen sodium. Current Eye Research, 36(5), 436–441. https://doi.org/10.3109/02713683.2010.542866
Kumar, N., & Sharma, S. (2013). Design, formulation and evaluation of sustained ophthalmic delivery of ciprofloxacin from ocular inserts. Research Journal of Pharmacy and Technology, 6(3), 285–286.
Liu, Z., Zhang, X., Wu, H., Li, J., Shu, L., Liu, R., Li, L., & Li, N. (2011). Preparation and evaluation of solid lipid nanoparticles of baicalin for ocular drug delivery system in vitro and in vivo. Drug Development and Industrial Pharmacy, 37(4), 475–481. https://doi.org/10.3109/03639045.2010.522193
Maheswara Reddy, D., Krishna Reddy, Y., Rajasekhar Reddy, D., Vinay Kumar, N., Suresh, M., Althaff, M., & Valaparla, N. K. (2011). Formulation and evaluation of ciprofloxacin ocuserts. Research Journal of Pharmacy and Technology, 4(11), 1663–1665.
Mandal, A., Gote, V., Pal, D., Ogundele, A., & Mitra, A. K. (2019). Ocular Pharmacokinetics of a Topical Ophthalmic Nanomicellar Solution of Cyclosporine (Cequa®) for Dry Eye Disease. Pharmaceutical Research, 36(2), 36. https://doi.org/10.1007/s11095-018-2556-5
Mandal, S., Shiva, K., Gupta, P., Singh, A., Ahmad, A., Shankar Ahirwar, R., & Ray, P. (2022). Ocular inserts: A Changing Trend in Targeted Drug Delivery. November. https://doi.org/10.14704/nq.2022.20.10.NQ55773
Mujoriya, R. Z., & Kshirsagar, M. D. (2016). Evaluation Study of Sustained Release Ocular Insert of Brimonidine Tartrate and Timolol. Research Journal of Pharmaceutical Dosage Forms and Technology, 8(4), 231. https://doi.org/10.5958/0975-4377.2016.00032.x
Nautiyal, D., Singh, V., & Ali, S. (2012). Formulation and evaluation of sustained release of Ofloxacin ocular inserts. Research Journal of Pharmacy and Technology, 5(12), 1497–1499.
Onugwu, A. L., Nwagwu, C. S., Onugwu, O. S., Echezona, A. C., Agbo, C. P., Ihim, S. A., Emeh, P., Nnamani, P. O., Attama, A. A., & Khutoryanskiy, V. V. (2023). Nanotechnology based drug delivery systems for the treatment of anterior segment eye diseases. Journal of Controlled Release, 354, 465–488. https://doi.org/10.1016/j.jconrel.2023.01.018
Parveen, N., & Joshi, H. (2020). Ocuserts: A Novel Formulation Approach in Drug Delivery System. Saudi Journal of Medical and Pharmaceutical Sciences, 06(05), 420–425. https://doi.org/10.36348/sjmps.2020.v06i05.005
Patel, A., Patel, D., Patel, N., Patel, J., Patel, M., & Patel, A. (2012). Novel ophthalmic drug delivery approach: An ophthalmic inserts. Research Journal of Pharmacy and Technology, 5(6), 729–735.
Patil, R., Dehari, D., Chaudhuri, A., Kumar, D. N., Kumar, D., Singh, S., Nath, G., & Agrawal, A. K. (2023). Recent advancements in nanotechnology-based bacteriophage delivery strategies against bacterial ocular infections. Microbiological Research, 273, 127413. https://doi.org/10.1016/j.micres.2023.127413
Jadhav, R., Vaidya, V., Mahajan, M., Farande, P., Bhagde, S., & Galgate, A. (2023). Formulation, Optimization and Evaluation of Ocular Inserts Containing Anti-Fungal Drug. Journal of Coastal Life Medicine, 11(2), 252–259. Retrieved from https://www.jclmm.com/index.php/journal/article/view/959
Said, M., Elsayed, I., Aboelwafa, A. A., Elshafeey, A. H., & Hassan, M. (2023). Ocular Mucoadhesive and Biodegradable Sponge-Like Inserts for the Sustained and Controlled Delivery of Voriconazole; Preparation, D-optimal Factorial Optimization and in-vivo Evaluation. Journal of Pharmaceutical Sciences. https://doi.org/10.1016/j.xphs.2023.09.026
Shah, M. R., Imran, M., & Ullah, S. (2022). Chapter 10 - Overcoming ocular barriers through nanocarrier-based drug delivery systems. In M. R. Shah, M. Imran, & S. Ullah (Eds.), Nanocarriers for Organ-Specific and Localized Drug Delivery (pp. 225–244). Elsevier. https://doi.org/10.1016/B978-0-12-821093-2.00009-8
Shanmugam, S., Valarmathi, S., Kumar, S. S., Shanmugasundaram, P., & Senthilkumar, M. (2016). Formulation development and evaluation of opthalmic ocusert containing aciclovir. Research Journal of Pharmacy and Technology, 9(11), 1858–1862. https://doi.org/10.5958/0974-360X.2016.00379.6
Shanmugam, S., Valarmathi, S., & Kumars, S. (2017). Sterility testing procedure of ophthalmic ocusert aciclovir used for treating herpes simplex virus. Asian Journal of Pharmaceutical and Clinical Research, 10(10), 344–346. https://doi.org/10.22159/ajpcr.2017.v10i10.19216
Uncu, L., Donici, E., Valica, V., Vislouh, O., Gonciar, V., & Parii, S. (2019). DEVELOPMENT and validation of an assay method for ciprofloxacin hydrochloride determination in combination ear drops. Chemistry Journal of Moldova, 14(2), 56–61. https://doi.org/10.19261/cjm.2019.607
Valarmathi, S., Shanmugam, S., Satheesh Kumar, S., & Shanmugasundaram, P. (2017). In vivo studies of ophthalmic ocular insert containing aciclovir. Research Journal of Pharmacy and Technology, 10(7), 2139–2142. https://doi.org/10.5958/0974-360X.2017.00376.6
Virmani, T., Kumar, G., Sharma, A., & Pathak, K. (2023). Chapter 2 - An overview of ocular drug delivery systems—conventional and novel drug delivery systems. In M. Rai, M. L. Occhiutto, & S. Talegaonkar (Eds.), Nanotechnology in Ophthalmology (pp. 23–48). Academic Press. https://doi.org/10.1016/B978-0-443-15264-1.00007-5
Watson, S., Cabrera-Aguas, M., & Khoo, P. (2018). Common eye infections. Australian Prescriber, 41(3), 67–72. https://doi.org/10.18773/austprescr.2018.016
Wu, W., Panduro Vela, D. H., Bück, A., & Fröba, A. P. (2023). Characterization of nanofluids in evaporating droplets by dynamic light scattering. Measurement, 220, 113321. https://doi.org/10.1016/j.measurement.2023.113321
Youssef, A. A. A., Cai, C., Dudhipala, N., & Majumdar, S. (2021). Design of topical ocular ciprofloxacin nanoemulsion for the management of bacterial keratitis. Pharmaceuticals, 14(3), 1–19. https://doi.org/10.3390/ph14030210
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Shaikh, F., Khan, S., Shaikh, A., Shivsharan, S., Lal, M., Sheikh, I., & Baig, M. (2024). Formulation and Evaluation of Ocusert Embeded with Ciprofloxacin Loaded Nanoparticles. International Journal of Advancement in Life Sciences Research, 7(1), 130-138. https://doi.org/https://doi.org/10.31632/ijalsr.2024.v07i01.014
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