Optimizing chemically stable chloramphenicol in-situ gel formulations using poloxamer 407 and HPMC through full-factorial design.
In-situ gel
Desirability
Full-factorial design
HPMC
Ophthalmic
Poloxamer 407
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
25 Oct 2024
25 Oct 2024
Historique:
received:
14
07
2024
accepted:
30
09
2024
medline:
26
10
2024
pubmed:
26
10
2024
entrez:
25
10
2024
Statut:
epublish
Résumé
The primary goal was to enhance the stability and bioavailability of chloramphenicol for ophthalmic use without compromising patient comfort, such as causing blurry vision. This study employed a 2-level full factorial design to optimize the formulation, exploring different concentrations of poloxamer 407 and HPMC to achieve this objective.
Identifiants
pubmed: 39455653
doi: 10.1038/s41598-024-74945-w
pii: 10.1038/s41598-024-74945-w
doi:
Substances chimiques
Chloramphenicol
66974FR9Q1
Poloxamer
106392-12-5
Hypromellose Derivatives
3NXW29V3WO
Gels
0
Anti-Bacterial Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
25344Subventions
Organisme : Universitas Padjadjaran
ID : 1549/UN6.3.1/PT.00/2023
Informations de copyright
© 2024. The Author(s).
Références
Majeed, A. & Khan, N. A. Ocular in situ gel: An overview. J. Drug Deliv. Ther. 9(1), 337–347. https://doi.org/10.22270/jddt.v9i1.2231 (2019).
doi: 10.22270/jddt.v9i1.2231
Wu, Y. et al. Research progress of in-situ gelling ophthalmic drug delivery system. Asian J. Pharm. Sci. 14(1), 1–15. https://doi.org/10.1016/j.ajps.2018.04.008 (2019).
doi: 10.1016/j.ajps.2018.04.008
pubmed: 32104434
Kurniawansyah, I. S., Sopyan, I., Wathoni, N., Fillah, D. L. & Praditya, R. U. Application and characterization of in situ gel. Int. J. Appl. Pharm. https://doi.org/10.22159/ijap.2018v10i6 (2018).
doi: 10.22159/ijap.2018v10i6
Almeida, H., Amaral, M. H., Lobão, P. & Sousa Lobo, J. M. Applications of poloxamers in ophthalmic pharmaceutical formulations: An overview. Expert Opin. Drug Deliv. 10(9), 1223–1237. https://doi.org/10.1517/17425247.2013.796360 (2013).
doi: 10.1517/17425247.2013.796360
pubmed: 23688342
Kurniawansyah, I. S., Rusdiana, T., Sopyan, I. & Subarnas, A. A review on poloxamer and hydroxy propyl methyl cellulose combination as thermoresponsive polymers in novel ophthalmic in situ gel formulation and their characterization. Int. J. Appl. Pharm. 13(1), 27–31. https://doi.org/10.22159/ijap.2021v13i1.39697 (2021).
doi: 10.22159/ijap.2021v13i1.39697
Popa, L., Ghica, M. V., Popescu, R., Irimia, T. & Dinu-pîrvu, C. E. Development and optimization of chitosan-hydroxypropyl methylcellulose in situ gelling systems for ophthalmic delivery of bupivacaine hydrochloride. Processes https://doi.org/10.3390/pr9101694 (2021).
doi: 10.3390/pr9101694
Patel, P. B., Shastri, D. H., Shelat, P. K. & Shukla, A. K. Ophthalmic drug delivery system: Challenges and approaches. Syst. Rev. Pharm. 1(2), 113–120. https://doi.org/10.4103/0975-8453.75042 (2010).
doi: 10.4103/0975-8453.75042
Lanier, O. L. et al. Review of approaches for increasing ophthalmic bioavailability for eye drop formulations. AAPS Pharm. Sci. Tech. https://doi.org/10.1208/s12249-021-01977-0 (2021).
doi: 10.1208/s12249-021-01977-0
pubmed: 33719019
Xu, H. et al. Preparation and characterization of ion-sensitive brimonidine tartrate in situ gel for ocular delivery. Pharmaceuticals. 16(1), 1–20. https://doi.org/10.3390/ph16010090 (2023).
doi: 10.3390/ph16010090
Soliman, K. A., Ullah, K., Shah, A., Jones, D. S. & Singh, T. R. R. Poloxamer-based in situ gelling thermoresponsive systems for ocular drug delivery applications. Drug Discov. Today https://doi.org/10.1016/j.drudis.2019.05.036 (2019).
doi: 10.1016/j.drudis.2019.05.036
pubmed: 31175956
Minami, M. et al. Balance of drug residence and diffusion in lacrimal fluid determine ocular bioavailability in in situ gels incorporating tranilast nanoparticles. Pharmaceutics 13(9), 6–8. https://doi.org/10.3390/pharmaceutics13091425 (2021).
doi: 10.3390/pharmaceutics13091425
Chen, L. C. et al. Poloxamer sols endowed with in-situ gelability and mucoadhesion by adding hypromellose and hyaluronan for prolonging corneal retention and drug delivery. Drug Deliv. https://doi.org/10.1080/10717544.2022.2158964 (2023).
doi: 10.1080/10717544.2022.2158964
pubmed: 38130151
pmcid: 10763865
Kurniawansyah, I. S. et al. In situ ophthalmic gel forming systems of poloxamer 407 and hydroxypropyl methyl cellulose mixtures for sustained ocular delivery of chloramphenicole: Optimization study by factorial design. Heliyon https://doi.org/10.1016/j.heliyon.2020.e05365 (2020).
doi: 10.1016/j.heliyon.2020.e05365
pubmed: 33251348
pmcid: 7677690
Kurniawansyah, I. S., Gozali, D., Sopyan, I., Iqbal, M. & Subarnas, A. Physical study of chloramphenicol in situ gel with base hydroxypropyl methylcellulose and poloxamer 188. J. Pharm. Bioallied Sci. https://doi.org/10.4103/jpbs.JPBS_201_19 (2019).
doi: 10.4103/jpbs.JPBS_201_19
pubmed: 32148375
pmcid: 7020836
Kurniawansyah, I. S. et al. in vitro drug release study of chloramphenicol in situ gel with bases mixture of poloxamer 407 and HPMC by optimization with factorial design. Int. J. Appl. Pharm. https://doi.org/10.22159/IJAP.2021.V13S4.43829 (2021).
doi: 10.22159/IJAP.2021.V13S4.43829
Fukuda, I. M., Pinto, C. F. F., Moreira, C. D. S., Saviano, A. M. & Lourenço, F. R. Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD). Brazilian J. Pharm. Sci. https://doi.org/10.1590/s2175 (2018).
doi: 10.1590/s2175
Irshad Alam, M., Alam, I., Khanam, N., Shaikh, J.K., Ganguly, S. Quality by design - a recent trend in pharmaceutical industries. Alam al World J Pharm Res. 2018;5.
Deore, A. B., Dhumane, J. R., Wagh, H. V. & Sonawane, R. B. Review on pharmaceutical quality by design (QbD). Asian J. Pharm. Res. Dev. 7(6), 62–67 (2019).
doi: 10.22270/ajprd.v7i6.616
Savitha, S. & Devi, K. Quality by design: A review. J. Drug Deliv. Ther. https://doi.org/10.22270/jddt.v12i2-s.5451 (2022).
doi: 10.22270/jddt.v12i2-s.5451
Politis, S. N., Colombo, P., Colombo, G. & Rekkas, D. M. Design of experiments (DoE) in pharmaceutical development. Drug Dev. Ind. Pharm. 43(6), 889–901. https://doi.org/10.1080/03639045.2017.1291672 (2017).
doi: 10.1080/03639045.2017.1291672
Barad, M. Design of experiments ( DOE ) - A valuable multi-purpose methodology. Appl. Math. https://doi.org/10.4236/am.2014.514206 (2014).
doi: 10.4236/am.2014.514206
Ranga, S., Jaimini, M., Sharma, S. K., Chauhan, B. S. & Kumar, A. Review Article : A review on design of experiments ( DOE ). Int. J. Pharm. Chem. Sci. 3(1), 216–224 (2014).
Conto López, R. A., Correa Espinal, A. A. & Úsuga Manco, O. C. Run orders in factorial designs: A literature review. Commun Stat. Theory Methods https://doi.org/10.1080/03610926.2023.2185472 (2023).
doi: 10.1080/03610926.2023.2185472
Shravani, Y. et al. Past decade work done on cubosomes and its factorial design: A fast track information for researchers. Int. J. Life Sci. Pharma Res. 11(1), 124–135 (2022).
Giuliano, E., Paolino, D., Fresta, M. & Cosco, D. Mucosal applications of poloxamer 407- based hydrogels: An overview. Pharmaceutics 10(3), 1–26. https://doi.org/10.3390/pharmaceutics10030159 (2018).
doi: 10.3390/pharmaceutics10030159
Viswanath, V. et al. Synthesis and characterization of chloramphenicol silver nanoshells for targeting diverse bacterial infections. Int. J. Pharm. Sci. Res. 10(4), 120–132 (2019).
Dangre, P. V., Kattekar, K. R. & Shirolkar, S. V. Development and evaluation of in situ gelling otic formulations of chloramphenicol using poloxamer 407. Indo Am. J. Pharm. Res. 3(10), 8000–8007 (2013).
Kurniawansyah, I. S., Rusdiana, T., Abnaz, Z. D., Sopyan, I. & Subarnas, A. Study of isotonicity and ocular irritation of chloramphenicol in situ gel. Int. J. Appl. Pharm. 13(1), 103–107. https://doi.org/10.22159/ijap.2021v13i1.39925 (2021).
doi: 10.22159/ijap.2021v13i1.39925
Bahçecitapar, M. K., Karadağ, Ö. & Aktaş, S. Estimation of sample size and power for general full factorial designs. J. Stat. Actuarial Sci. 9(2), 79–86 (2016).
Montgomery, D.C. Design and Analysis of Experiments (Ninth Edition).; 2017.
Taam, B.W. Half-normal plot - Some examples. Published online 2014:1–7.
Raissi, S. & Farsani, R. E. Statistical process optimization through multi-response surface methodology. World Acad. Sci. Eng. Technol. 2009(39), 280–284 (2017).