Safety and Skin Irritation Study of Topical Analgesic Preparations Using Draize Assessment
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Abstract
Introduction: A cream is defined as a semisolid dosage form containing one or more medicinal substances dissolved or dispersed in a suitable base. Cream preparations require an irritation test to detect skin reactions such as erythema and edema that may be caused by potentially irritating ingredients.
Objective: This study aimed to determine the safety and skin irritation effects of the raw materials or final product of an analgesic cream preparation using the draize method.
Methods: Seven male New Zealand rabbits were divided into two groups. Group I was the control group, with two rabbits using a commercially available cream containing camphor and menthol as active ingredients. Group II was the treatment group, with five rabbits using an analgesic cream containing camphor and menthol as active ingredients. Erythema and edema were observed at 24, 48, and 72 hours.
Results: No erythema or edema was observed in either the treatment or control groups. The irritation index calculation showed a value of 0 (zero), which can be categorized as non-irritating. These results indicate that the analgesic cream composition is safe and does not cause skin irritation.
Conclusion: The analgesic cream preparation has a primary irritation index that is included in the category of not causing primary irritation to rabbit skin topically.
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