A REVIEW ON HOW TO CHARACTERIZE AND EVALUATE THE OPHTHALMIC IN SITU GEL PREPARATIONS

Authors

  • INSAN SUNAN KURNIAWANSYAH Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia https://orcid.org/0000-0001-9093-789X
  • TAOFIK RUSDIANA Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia https://orcid.org/0000-0002-3321-2179
  • SRIWIDODO Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
  • IYAN SOPYAN Center of Dosage Form Development Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia https://orcid.org/0000-0001-7616-5176

DOI:

https://doi.org/10.22159/ijap.2022v14i5.45248

Keywords:

in situ gel; controlled release; isotonicity; gelation temperature; gelling capacity; ocular irritability; ocular tolerability; hemolysis activity; bovine corneal opacity and permeability test; preservative efficacy test.

Abstract

In situ gelling systems are becoming one of the most popular and well-known, with many potential benefits from delivery systems, such as ease of use and ease of manufacture, improve adherence and patient comfort by minimizing the frequency of drug administration. In this review, we will describe the characterization and evaluation of the ophthalmic in situ gel preparation. Among them are physical evaluation (appearance and clarity, pH, isotonicity, gelation temperature, gelling capacity, viscosity, and stability), chemical evaluation (determining drug content, drug release), microbiological evaluation (sterility, ocular irritability, ocular tolerability, antimicrobial activity, hemolysis activity, bovine corneal opacity and permeability (BCOP) test, preservative efficacy test (PET), microtetrazolium (MTT) reduction cytotoxicity test), and in vivo evaluation such as pharmacokinetic and pharmacodynamic evaluation. Characterizing the chemical, physical, microbiological, and miscellaneous properties of ophthalmic in situ gel formulations can meet the ideal requirements and help determine the best formulation of ophthalmic in situ gel to achieve higher bioavailability values, longer contact times, minimize side effects, not causing irritation or liquid tear production, and providing maximum therapeutic effect. In situ gels offer the primary requirement of a successful controlled release product that is increasing patient compliance.

Downloads

Download data is not yet available.

References

Garala K, Joshi P, Shah M, Ramkishan A, Patel J. (2013). Formulation and evaluation of periodontal in situ gel. Int J Pharma Investig 3(1): 29–41.

Shubhrica. (2013). Effect of environment on eyes: A review. Indian Journal of Clinical Practice 24(4): 381–4.

Mandal S, Prabhushankar G, Thimmasetty M, Geetha M. (2012). Formulation and evaluation of an in situ gel-forming ophthalmic formulation of moxifloxacin hydrochloride. Int J Pharm Investig 2(2): 78.

Chand PP, Gnanarajan G, Kothiyal P. (2016). In situ gel: a review. Indian J Pharm Biol Res 4(2): 11–9.

Mohanty D, Bakshi V, Simharaju N, Haque MA, Sahool CK. (2018). A review on in situ gel: a novel drug delivery system, Int J Pharm Sci Rev Res 50(1): 175-81.

Soliman KA, Ullah K, Shah A, Jones DS, Singh TRR. (2019). Poloxamer-based in situ gelling thermoresponsive systems for ocular drug delivery applications. Drug Discovery Today 24(8): 1575–86.

Patel A. (2013). Ocular drug delivery systems: an overview. World J Pharmacol 2(2): 47.

Reddy MC, Kumar AC. (2011). Design and evaluation of chloramphenicol thermoreversible insitu gels for occular drug delivery. Int J Innov Pharm Res 2(2): 131–8.

Venkatesh MP, Purohit Kamlesh L, Pramod Kumar TM. (2013). Development and evaluation of chitosan based thermosensitive in situ gels of pilocarpine. Int J Pharm Pharm Sci 5(1): 164–9.

Sonawane SD. (2014). Formulation and evaluation of polyox/hpmc based in situ gel formulation for levofloxacin hemihydrate ophthalmic delivery. Int J Pharm Sci Invent 4(6): 38–43.

Bachhav HD, Savkare A, Karmarkar R, Derle D. (2015). Development of poloxamer based thermosensitive in situ ocular gel of betaxolol hydrochloride. Int J Pharm Pharm Sci 7(6): 287–91.

Barse RK, Tagalpallewar AA, Kokare CR, Sharma JP, Sharma PK. (2018). Formulation and ex vivo–in vivo evaluation of pH-triggered brimonidine tartrate in situ gel for the glaucoma treatment using application of 32 factorial design. Drug Dev Ind Pharm 44(5): 800–7.

Zhu L, Ao J, Li P. (2015). A novel in situ gel base of deacetylase gellan gum for sustained ophthalmic drug delivery of ketotifen: In vitro and in vivo evaluation. Drug Des Dev Ther 9: 3943–49.

Lou J, Hu W, Tian R, Zhang H, Jia Y, Zhang J, Zhang L. (2014). Optimization and evaluation of a thermoresponsive ophthalmic in situ gel containing curcumin-loaded albumin nanoparticles. Int J Nanomed 9(1): 2517–25.

Pandurangan D, Bodagala P, Palanirajan V, Govindaraj S. (2016). Formulation and evaluation of voriconazole ophthalmic solid lipid nanoparticles in situ gel. Int J Pharm Investig 6(1): 56.

Bhoyar BS, Patil AT. (2015). Formulation and evaluation of ophthalmic gel based on drug-polymer-polymer ternary interaction. Asian J Pharm Clin Res 8(3): 283–8.

Patel N, Thakkar V, Metalia V, Baldaniya L, Gandhi T, Gohel M. (2016). Formulation and development of ophthalmic in situ gel for the treatment ocular inflammation and infection using application of quality by design concept. Drug Dev Ind Pharm 42(9): 1406–23.

Gupta A, Manocha N. (2012). Formulation and evaluation of in situ ophthalmic drug delivery system. Int J Pharm Bio Arch 3: 715-8.

Sethuraman N, Balu A, Selvaraj R, Johnson T, Seetharaman S. (2018). Formulation and characterization of pH based stimuli sensitive based hydrogels for the treatment of ocular infection. J Young Pharm 10(1): 32–6.

Dasankoppa FS, Solankiy P, Sholapur HN, Jamakandi VG, Sajjanar VM, Walvekar PM. (2017). Design, formulation, and evaluation of in situ gelling ophthalmic drug delivery system comprising anionic and nonionic polymers. Indian Journal of Health Sciences and Biomedical Research KLEU 10(3): 323–30.

Dawood BY, Kassab HJ. (2019). Preparation and in vitro evaluation of naproxen as a pH sensitive ocular insitu gel. Int J Appl Pharm 11(2): 37–44.

Chaudhari PD, Desai US. (2019). Formulation and evaluation of niosomal in situ gel of prednisolonesodium phosphate for ocular drug delivery. Int J Appl Pharm 11(2): 97–116.

Kurniawansyah IS, Rusdiana T, Sopyan I, Ramoko H, Wahab HA, Subarnas A. (2020). 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 6(11): e05365.

Kurniawansyah IS, Rusdiana T, Abnaz ZD, Sopyan I, Subarnas A. (2021). Study of isotonicity and ocular irritation of chloramphenicol in situ gel. Int J Appl Pharm 13(1): 103–7.

Shetty GN, Charyulu RN. (2013). A study on stability and in vivo drug release of naphazoline and antazoline in situ gelling systems for ocular delivery. Int J Pharma Bio Sci 4(1): 161–71.

Kumar D, Jain N, Gulati N, Nagaich U. (2013). Nanoparticles laden in situ gelling system for ocular drug targeting. J Adv Pharm Technol Res 4(1): 9–17.

Nagalakshmi S, Anbarasan B, Ramesh S, Shanmuganathan S, Thanka J. (2015). An overview – stimuli sensitive hydrogels in ocular drug delivery system. J Pharm Sci Res7(10): 818–22.

Kadam AT, Jadhav RL, Salunke PB, Kadam SS. (2017). Design and evaluation of modified chitosan based in situ gel for ocular drug delivery. Int J Pharm Pharm Sci 9(10): 87.

Prasanth V, Parambi DGT, Ranjan S. (2017). Formulation and evaluation of in situ ocular gel of levofloxacin. J Drug Deliv Ther 7(5): 68–73.

Sayed EG, Hussein AK, Khaled KA, Ahmed OAA. (2015). Improved corneal bioavailability of ofloxacin: biodegradable microsphere-loaded ion-activated in situ gel delivery system. Drug Des Dev Ther 9: 1427–35.

Reddy JS, Ahmed MG. (2013). Sustained ocular delivery of sparfloxacin from pH triggered in situ gelling system. RGUHS J Pharm Sci 40(3): 103–9.

Yassir Al-Bazzaz F, Al-Kotaji M. (2018). Ophthalmic in-situ sustained gel of ciprofloxacin, preparation and evaluation study. Int J Appl Pharm 10(4): 153–61.

Kataria P, Katara R, Sahoo PK, Sachdeva S. (20178). Dorzolamide in situ gel forming system: characterization and evaluation for glaucoma treatment. Madridge Journal of Pharmaceutical Research 1(1): 13–21.

Dasankoppa FS, Kujur S, Sholapur HPNA, Jamakandi VG. (2016). Design, formulation and evaluation of carboxy methyl tamarind based in situ gelling ophthalmic drug delivery system of dorzolamide hydrochloride. Indian J Health Sci 9(1): 56.

Jethava J, Jethava G. (2014). Design, formulation, and evaluation of novel sustain release bioadhesive in-situ gelling ocular inserts of ketorolac tromethamine. Int J Pharm Investig 4(4): 226.

Pujitha C, Sai Jyothi J, Sucharitha J, Lakshmi G, Rao AL. (2017). Formulation and characterization of ofloxacin opthalmic gel. Indian J Pharm Pharmacol 4(2): 105–9.

Kadam S, Kondawar M, Kamble K. (2010). Formulation and evaluation of in situ gelling system of ketorolac tromethamine for opthalmic drug delivery. IJPT 1(2): 64–71.

Kannan SK, Duraisamy D, Sudhakar Y. (2018). Full factorial design based norfloxacin nanoparticles embedded thermo sensitive droppable gel for ocular drug delivery. World J Pharm Res 6(10): 1793–821.

MA Fathalla Z, Vangala A, Longman M, Khaled KA, Hussein AK, El-Garhy OH, Alany RG. (2017). Poloxamer-based thermoresponsive ketorolac tromethamine in situ gel preparations: design, characterisation, toxicity and transcorneal permeation studies. Eur J Pharm Biopharm 114: 119–34.

Rasagna M, Prasuna Sundari PJ, Srinivas P. (2015). Formulation and evaluation of ion sensitive ocular insitu gels for sustained release of balofloxacin. Int J Pharm Technol 7(2): 9105–15.

Rao JV, Pradesh A. (2011). Formulation and evaluation of in situ mucoadhesive ophthalmic hydrogel for sustained delivery of pefloxacin mesylate. Int J Pharm Pharm Sci 1(1), 30–4.

El-Laithy HM, Nesseem DI, Shoukry M. (2011). Evaluation of two in situ gelling systems for ocular delivery of moxifloxacin: in vitro and in vivo studies. J Chem Pharm Res 3(2), 66–79.

Sun J, Zhou Z. (2018). A novel ocular delivery of brinzolamide based on gellan gum: in vitro and in vivo evaluation. Drug Des Dev Ther 12: 383–9.

Published

04-07-2022

How to Cite

KURNIAWANSYAH, I. S., RUSDIANA, T., SRIWIDODO, & SOPYAN, I. (2022). A REVIEW ON HOW TO CHARACTERIZE AND EVALUATE THE OPHTHALMIC IN SITU GEL PREPARATIONS. International Journal of Applied Pharmaceutics, 14(5). https://doi.org/10.22159/ijap.2022v14i5.45248

Issue

Section

Review Article(s)

Most read articles by the same author(s)

1 2 3 > >>