Anand Babu K, Ram Narayanan R
Anand Babu K1*, Ram Narayanan R2
1Department of Pharmaceutical Chemistry, College of Pharmacy, Kannur Medical College, Anjarakandy, Kannur -670612, Kerala.
2Department of Pharmaceutics, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 116, Tamil Nadu.
Volume - 14,
Issue - 6,
Year - 2021
Objective: The research is about the stability of ophthalmic products as they start to produce irritancy effects during their shelf life. The aim of the present study is to assess the stability of certain ophthalmic products by the HET-CAM (Hen’s Egg Test-Chorioallatonic membrane) Method. Method: Incubated Eggs were utilized for performing the HET-CAM assay according to the protocol prescribed by ICCVAM (The Inter agency Coordinating Committee on the Validation of Alternative Methods). Results: Calculation of various irritancy factors like hemorrhage time, vascular lysis time and coagulation time and to calculate HET-CAM score. Statistical interpretation of the data obtained by one-way ANOVA. Conclusion: Results have shown that the few ophthalmic products are slight and moderate irritants. None of the products are strong irritants. However further studies to be conducted to confirm the potential and safety of the products.
Cite this article:
Anand Babu K, Ram Narayanan R. Determination of Ocular Irritancy Potential of Ophthalmic products using HET-CAM Method. Research Journal of Pharmacy and Technology. 2021; 14(6):3063-6. doi: 10.52711/0974-360X.2021.00535
Anand Babu K, Ram Narayanan R. Determination of Ocular Irritancy Potential of Ophthalmic products using HET-CAM Method. Research Journal of Pharmacy and Technology. 2021; 14(6):3063-6. doi: 10.52711/0974-360X.2021.00535 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-6-25
1. Drazie JH, Woodard G, Clavery OH. Methods for the study of irritation and toxicity of substances applied tropically to the skin and mucous membranes. J Pharmacol Exp Ther.1944; 83: 377-390.
2. Wilhelmus KR. Therapeutic reviews: The Draize eye test. Surv ophthalmol.2001; 45(6): 493-515.
3. Princen MK. The Draize eye test and In vitro alternatives; a left – handed marriage. Toxicol invitro.2006; 20: 78,81.
4. Vinardell MP, Mitjans M. Alternative methods for eye and skin irritation tests: an over view. J Pharma Sci.2008;97(1): 46-59.
5. Scott L et al. A proposed eye irritation testing strategy to reduce and replace in vivo studies using bottom – up and top – down approches. toxicol in vitro 2010; 24:1,9.
6. OECD. Guideline for the testing of the chemicals No. 437; bovine corneal opacity and permeablity testing method for identifying ocular corrosives and severe irritants. Paris.2009.18.
7. Vishnu Vardhana Rao. G, V. Srinivasa Rao, K. Ramakrishna. Quality by Design Approach for the Development and Validation of LC method for the Estimation of in-Vitro release of Raloxifene hydrochloride in Dosage Formulation. Research J. Pharm. and Tech. 8(11): Nov., 2015; Page 1487-1494.
8. V.V.S. Ashritha et al., Development of Validated Q-absorbance Ratio, Derivative Spectrophotometric and Stability indicating RP-HPLC methods for the simultaneous estimation of Losartan Potassium & Hydrochlorothiazide in Pharmaceutical Dosage Form and comparison of the results by ANOVA. Research J. Pharm. and Tech. 2019; 12(6): 2687-2694.
9. Yenduri Suvarna, S K. Abdul Rahaman. In Vitro – In Vivo Evaluation of Antiurolithiatic activity of piperine from Piper nigrum. Research J. Pharm. and Tech. 2020; 13(1): 63-68.
10. Fares Hezam Al-Ostoot et al., Statistical Analysis of Antimicrobial Data of 2-[2-(Aroyl) aroyloxy]methyl-1,3,4 Oxadiazoles analogues Using ANOVA. Asian J. Research Chem. 2018; 11(2): 293-297.
11. D. Anuradha D. Kalpanapriya. Intuitionistic Fuzzy ANOVA and its Application in Medical Diagnosis. Research J. Pharm. and Tech 2018; 11(2): 653-656.
12. Salem H, Katz SA. Alternative toxicological methods. Boca Raton: CRC Press; 2003.
13. Barile FA. Validating and troubleshooting ocular In vitro toxicology tests. J Pharmacol Toxicol Methods. 2010; 61: 136–145.
14. Scott L et al. A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicol In vitro. 2010; 24: 1-9.