Formulation and evaluation of ocular drops containing solid dispersion of tobramycin
DOI:
https://doi.org/10.25081/rip.2022.v12.7557Keywords:
Solid dispersion, Tobramycin, HPMC, PVP-K30, beta cyclodextrinAbstract
Tobramycin is a potent antimicrobial aminoglycoside that can be used to treat ocular infections. Its solubility and bioavailability are limited, so its solid dispersion was prepared using PVP-K30, HPMC and Beta cyclodextrin by solvent evaporation technique. This solid dispersion was formulated as an eye drop using sodium chloride, EDTA and benzalkonium chloride. Totally 9 formulations were prepared. The in-vitro dissolution profile of optimised formulation (F6) showed 85.1% drug release at the end of 2nd hour. The optimized formula was evaluated which showed no microbial growth, and drug content uniformity was 80.12% to 85%. The optimized formulation was evaluated for clarity, pH, isotonicity, microbial growth, stability and in vitro diffusion studies and all these showed acceptable results.
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Allawadi, D., Singh, N., Singh, S., & Arora, S. (2013). Solid Dispersions: A Review on Drug Delivery System and Solubility Enhancement. International Journal of Pharmaceutical Sciences and Research, 4(6), 2094-2105. https://doi.org/10.13040/IJPSR.0975-8232.4(6).2094-05
Baranowski, P., Karolewicz, B., Gajda, M., & Pluta, J. (2014). Ophthalmic Drug Dosage Forms: Characterisation and Research Methods. The Scientific World Journal, 2014, 861904. https://doi.org/10.1155/2014/861904
Curti, C., Lamy, E., Primas, N., Fersing, C., Jean, C., Bertault-Peres, P., & Vanelle, P. (2017). Stability studies of five anti-infectious eye drops under exhaustive storage conditions. Die Pharmazie – An International Journal of Pharmaceutical Sciences, 72(12), 741-746. https://doi.org/10.1691/ph.2017.7089
Dash, A. K., & Suryanarayan, R. (1991). Solid-State properties of Tobramycin. Pharmaceutical Research, 8, 1159-1165. https://doi.org/10.1023/a:1015858503031
Deshpande, J., Shah, P. B., & Bhandari, A. (2013). Design and Development of pH-monitered in situ Gel of Lomefloxacin. Journal of Pharmaceutical Science and Bioscientific Research, 3(1), 10-15.
Dhondikubeer, R., Bera, S., Zhanel, G. G. & Schweizer, F. (2012). Antibacterial activity of amphiphilic tobramycin. The Journal of Antibiotics, 65, 495-498. https://doi.org/10.1038/ja.2012.59
Gupta, N. V., & Reddy, G. V. (2015). A Comparative study of quality control tests for eye preparations as per IP, BP and USP. International Journal of Drug Development and Research, 7(1), 61-68.
Hill, M., Cunningham, R. N., Hathout, R. M., Johnston, C., Hardy, J. G., & Migaud, M. E. (2019). Formulation of antimicrobial tobramycin loaded PLGA nanoparticles via complexation with AOT. Journal of Functional Biomaterials, 10(2), 26. https://doi.org/10.3390/jfb10020026
Kamal, D., Kavita, P., Sharma,V. K., Singh, U. V., & Ramana M. V. (2009). Applications of solid dispersion & determination of Solid dispersion technology. Retrieved from www.pharmabiz.com
Kim, K. H., Frank, M. J., & Henderson, N. L. (1985). Applications of differential scanning Calorimetry to the study of the solid drug dispersions. Journal of Pharmaceutical Sciences, 74(3), 283-289. https://doi.org/10.1002/jps.2600740312
Kumar, A., & Kumar, K. (2017). Solid Dispersion- Strategy to Enhance Solubility and Dissolution of Poorly Water-Soluble Drugs. Universal Journal of Pharmaceutical Research, 2(5), 54-59. https://doi.org/10.22270/ujpr.v2i5.RW4
Kumar, B. (2017). Solid Dispersion- A Review. Pharma Tutor, 5(2), 24-29.
Kumar, P., & Singh, P. (2018). Formulation and Evaluation of Eye Drop for Dry Eye Syndrome. International Journal of Pharma Research and Health Sciences, 6(2), 2410-2412.
Kurniawansyah, I. S., Rusdiana, T., Abnaz, Z. D., Sopyan, I., & Subarnas, A. (2021). Study of Isotonicity and Ocular Irritation of Chloramphenicol in-situ Gel. International Journal Applied Pharmaceutics, 13(1), 103- 107. https://doi.org/10.22159/ijap.2021v13i1.39925
Kurniawansyah, I. S., Sopyan, I., Wardhana, Y. W., & Gunasekaran, M. (2018). Formulation and Evaluation of Chloramphenicol Hydrogel Ophthalmic Preparation. Journal of Young Pharmacist, 10(2S), S73-S78. https://doi.org/10.5530/jyp.2018.2s.14
Miller, D. P., Tan, T., Nakamura, J., Malcolmson, R. J., Tarara, T. E., & Weers, J. G. (2017). Physical Characterization of Tobramycin Inhalation Powder: II. State Diagram of an Amorphous Engineered Particle Formulation. Molecular Pharmaceutics, 14(6), 1950-1960. https://doi.org/10.1021/acs.molpharmaceut.7b00036
Mingeot-Leclercq, M.-P., Glupczynski, Y., & Tulkens, P. M. (1999). Aminoglycosides: activity and resistance. Antimicrobial Agents and Chemotherapy, 43(4), 727-737. https://doi.org/10.1128/aac.43.4.727
Nikghalb, L. A., Singh, G., Singh, G., & Kahkeshan, K. F. (2012). Solid Dispersion: Methods and Polymers to increase the solubility of poorly soluble drugs. Journal of Applied Pharmaceutical Science, 2(10), 170-175.
Patere, S., Newman, B., Wang, Y., Choi, S., Mekjaruskul, C., Jay, M., & Lu, X. (2020). Influence of in vitro release methods on assessment of tobramycin ophthalmic ointments. International Journal of Pharmaceutics, 590, 119938. https://doi.org/10.1016/j. ijpharm.2020.119938
Patil, M., Waydande, S., & Pravin, P. (2019). Design and evaluation of topical solid dispersion composite of voriconazole for the treatment of ocular keratitis. Therapeutic Delivery, 10(8), 481-492. https://doi.org/10.4155/tde-2019-0021
Pooja, Lal, V. K., & Verma, A. (2016). Development and Evaluation of Ophthalmic Drop and In-situ Gel from Roots of Boerhaavia diffusa. Journal of Pharmaceutical Research International, 11(1), 1-20. https://doi.org/10.9734/BJPR/2016/24395
Raj, A. L., & Kumar, Y. S. (2018). Preparation and Evaluation of Solid Dispersion of Nebivolol Using Solvent Evaporation Method. International Journal of Pharmaceutical Sciences and Drug Research, 10(4), 322-328. https://doi.org/10.25004/IJPSDR.2018.100418
Rajia, S., Hasan, I., Ahmmed. B., & Islam, A. U. (2020). Development and Validation of a Microbiological Assay for the Quantification of Marketed Chloramphenicol Eye Drops. IOSR Journal of Pharmacy and Biological Sciences, 15(3), 13-19.
Rosasco, M. A., Bonafede, S. L., Faudone, S. N., & Segall, A. I. (2018). Compatibility study of tobramycin and pharmaceutical excipients using differential scanning calorimetry, FTIR, DRX, and HPLC. Journal of Thermal Analysis and Calorimetry, 134, 1929-1941. https://doi.org/10.1007/s10973-018-7282-z
Saha, R. N., Sanjeev, C., Priya, K. P., Sreekhar, C., & Shashikanth, G. (2002). Solubility enhancement of Nimesulide and Ibuprofen by solid dispersion technique. Indian Journal of Pharmaceutical Sciences, 64(6), 529-534.
Schwartz, G. F., Hollander, D. A., & Williams, J. M. (2013). Evaluation of eye drop administration technique in patients with glaucoma or ocular hypertension. Current Medical Research and Opinion, 29(11), 1515-1522. https://doi.org/10.1185/03007995.2013.83 3898
Sebastian-Morello, M., Alambiaga-Caravaca, A. M., Calatayud-Pascual, M. A., Rodilla, V., Balaguer-Fernández, C., Miranda, M., & López-Castellano, A. (2020). Ex-Vivo Trans-Corneal and Trans-Scleral Diffusion Studies with Ocular Formulations of Glutathione as an Antioxidant Treatment for Ocular Diseases. Pharmaceutics, 12(9), 861. https://doi.org/10.3390/pharmaceutics12090861
Shantier S. W., Gadkariem, E. A., Ibrahim, K. E., & Hagga, M. E. (2012). Kinetic Determination of Tobramycin in Drug Formulations. Research Journal of pharmaceutical, Biological and Chemical Sciences, 3(1), 566-573.
Sharma, A., & Jain, C. P. (2010). Preparation and characterization of solid dispersions of carvedilol with PVP K30. Research in Pharmaceutical Sciences, 5(1), 49-56.
Vyas, M. B., Patel, D., & Shah, S. K. (2015). Formulation & Evaluation of Eye Care Solution of Vasoconstrictor and Antihistaminic Drug for Conjunctivitis. Global Journal of Medical Research, 15(2), 19-34.
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