Safety and toxicological evaluation of Aflapin^®: A novel Boswellia-derived anti-inflammatory product

Abstract

Boswellia serrata gum resin has been used for treatment of various ailments in different cultures for thousands of years. Aflapin^® is a novel synergistic composition derived from B. serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. To assess the safety of Aflapin, a battery of acute and sub-acute toxicity studies were conducted in various animal models according to the OECD test guidelines. The acute oral LD50 of Aflapin was greater than 5000 mg/kg in female Sprague Dawley (SD) rats. Acute dermal LD50 of Aflapin was greater than 2000 mg/kg in SD rats. A primary dermal irritation study conducted using New Zealand White rabbits indicated that Aflapin is non-irritating to skin. Aflapin caused minimal ocular irritation in a primary eye irritation test conducted on New Zealand Albino rabbits. A repeat dose 28-day sub-acute oral toxicity study in SD rats demonstrated no significant signs of toxicity. Various evaluations including hematology, clinical chemistry, gross necropsy, and histopathology did not show any significant adverse changes. The NOAEL of Aflapin was found to be greater than 2500 mg/kg body weight. These studies demonstrate broad spectrum safety of Aflapin in animal models.

Keywords::

• Acute oral toxicity
• acute dermal toxicity
• Aflapin
• anti-inflammatory
• Boswellia serrata
• New Zealand albino rabbit
• primary eye irritation
• primary skin irritation
• Sprague-Dawley rat
• sub-acute toxicity

Acknowledgements

The Authors thank Sri G. Ganga Raju, Chairman, Mr G. Rama Raju, Director Laila Group, and Mr B. Kiran, CEO, Laila Nutraceuticals for encouragement and support.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.