STUDY OF ISOTONICITY AND OCULAR IRRITATION OF CHLORAMPHENICOL IN SITU GEL

Authors

  • INSAN SUNAN KURNIAWANSYAH Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
  • TAOFIK RUSDIANA Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
  • ZAHRA DZAKIRAH ABNAZ Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
  • IYAN SOPYAN PUSDI Drug Delivery and Drug Disposition Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
  • ANAS SUBARNAS Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia

DOI:

https://doi.org/10.22159/ijap.2021v13i1.39925

Keywords:

Chloramphenicol, HPMC, In situ gel, Poloxamer 407, Isotonicity, Ocular irritation, draize test

Abstract

Objective: The objective of this study was to find out the isotonicity of chloramphenicol ophthalmic in situ gel and to know the irritating effect of its in the eyes of test animals, so it can be to maximize absorption of the drug in the eye, minimize drug loss before corneal penetration and safe to used.

Methods: This study were started by making four aseptic formulations of in situ gel preparations with a comparison of the baseline concentrations of different Poloxamer 407 and HPMC, F1 (5: 0.45), F2 (10: 0.45), F3 (5: 1) and F4 (10: 1). Four aseptic of in situ gel preparations, followed by a qualitative isotonicity test using blood cells to see the comparison between control and test preparations, and ocular irritation test using the draize test method to determine the presence or absence of the irritation.

Results: The results obtained from the isotonicity test showed that the four preparations have normal blood cells that similar with isotonic control solution; therefore, it can be said that the preparations have been made isotonic.

The results of the ocular irritation test using the draize test method showed for each category, such as cornea, iris, conjunctiva and edema were zero. A zero value on the cornea indicates no ulceration or opacity, and the iris, conjunctiva and edema were normal. Conclusion: Chloramphenicol in situ gel are isotonic and do not cause irritation to the rabbit's eyes, so they are safe to use and the formulation can be used for further research until the final goal is obtained.

Downloads

Download data is not yet available.

References

Thamizhvanan K, Himabindu R, Sarada K, Hyndavi N, Roopa KL. Current status and advanced approaches in ocular drug delivery systems. Int J Curr Pharm Clin Res 2012;2:77-86.

Sonawane SD, Patil RY, Lad M. A review on polymers used in novel in situ gel formulation for ocular drug delivery and their evaluation. J Biol Sci Opin 2013;1:132-7.

Nagaich U, Jain N, Kumar D, Gulati N. Controlled ocular drug delivery of ofloxacin using temperature modulated in situ gelling system. J Sci Soc 2013;40:90-4.

Kurniawansyah IS, Sopyan I, Wathoni N, Fillah DL, Praditya RU. Application and characterization of in situ gel. Int J Appl Pharm 2018;10:34-7.

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

Dasankoppa FS, Kujur S, Ahmed Sholapur HP, Jamakandi VG. Design, formulation and evaluation of carboxy methyl tamarind based in situ gelling ophthalmic drug delivery system of dorzolamide hydrochloride. Indian J Health Sci 2016;9:56-66.

Champalal KD, Poddar SS. Current status of ophthalmic in situ forming hydrogel. Int J Pharm Bio Sci 2012;3:372-88.

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

Montgomery DC. Design and analysis of experiments. 8th ed. Hoboken: John Wiley and Sons Inc; 2013.

Giuliano E, Paolino D, Fresta M, Cosco D. Mucosal applications of poloxamer 407-based hydrogels: an overview. Pharmaceutics 2018;10:1-26.

Dasankoppa FS, Hiremath SP, Nadaf A. Formulation and evaluation of a novel in situ gum based ophthalmic drug delivery system of linezolid. Sci Pharm 2008;76:515‑32.

Remington. The science and practice of pharmacy. 21st ed. Vol. II. Philadelphia, PA Lippincott Williams and Wilkins; 2005.

Saini R, Seema S, Singh G, Banerjee A. In situ gels–a new trends in ophthalmic drug delivery systems. Int J Pharm Sci Res 2015;6:886-90.

Dasankoppa FS, Swamy NG. Design, development and evaluation of cationic guar and hydroxypropyl guar based in situ gels for ophthalmic drug delivery. Indian Drugs 2013;50:30‑40.

Rajas NJ, Kavitha K. Sustained ophthalmic delivery of levofloxacin hemihydrate from an ion activated in situ gelling system. Int J Pharm Tech Res 2011;3:702 6.

Wilhelmus KR. The draize eye test. Surv Ophthalmol 2001;45:493 515.

Kepala Badan Pengawas Obat Dan Makanan Republik Indonesia. Peraturan Kepala Badan Pengawas Obat Dan Makanan Republik Indonesia Nomor 7 Tahun 2014 Tentang Pedoman Uji Toksisitas Nonklinik Secara In vivo; 2014.

OECD/OCDE. OECD guideline for the testing of chemicals: acute eye irritation/Corrosion; 2012.

Nayak NS, Bharani SS, Thakur RS. Formulation and evaluation of pH triggered in situ ophthalmic gel of moxifloxacin hydrochloride. Int J Pharm Pharm Sci 2012;4:452-9.

Champalal KD, Poddar SS. Current status of an ophthalmic in situ forming hydrogel. Int J Pharm Bio Sci 2012;3:372-88.

Azita H, Talasaz H, Ali AG, Shadi HM, Mazda RM, Atyabi F, et al. In situ gel forming systems of poloxamer 407 and hydroxypropyl cellulose or hydroxypropyl methyl cellulose mixtures for controlled delivery of vancomycin. J Appl Polym Sci 2008:2369-74. https://doi.org/10.1002/app.28163

Makwana SB, Patel VA, Parmar. Development and characterization of in situ gel for ophthalmic formulation containing ciprofloxacin hydrochloride. Results Pharma Sci 2016;6:1–6.

Barse R, Kokare C, Tagalpallewar A. Influence of hydroxypropylmethylcellulose and poloxamer composite on developed ophthalmic in situ gel: ex vivo and in vivo characterization. J Drug Delivery Sci Technol 2016;33:1-29.

Published

07-01-2021

How to Cite

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 of Applied Pharmaceutics, 13(1), 103–107. https://doi.org/10.22159/ijap.2021v13i1.39925

Issue

Section

Original Article(s)

Most read articles by the same author(s)

1 2 3 4 > >>