Topical formulations of serratiopeptidase: development and pharmacodynamic evaluation.

Serratiopeptidase, an enzyme derived from Serratia marcescences strain E-15 (ATCC 21074), present in the gut wall of the silk worm possesses anti-inflammatory properties, and can prove to be a suitable alternative to commonly used non steroidal antiinflammatory agents. Being sensitive to gastric degradation, serratiopeptidase is conventionally given orally in the form of enteric coated tablet formulations. Topical formulations of serratiopeptidase would be useful to treat local inflammations and may prove to be more effective compared to non steroidal antiinflammatory agents. The present study investigates the feasibility of developing topical preparations of serratiopeptidase in the form of ointments and gels. Excipient compatibility of serratiopeptidase with various excipients and polymers, formulation development, characterization and stability studies have been carried out. Stable formulation was evaluated for anti-inflammatory activity by oxazolone induced ear edema method in mice and allergenic potential by passive cutaneous anaphylaxis.