FORMULATION DEVELOPMENT OF KETOROLAC TABLETS COMPARED TO INNOVATOR FORMULATION AND EVALUATION VIA IN-VITRO BIO-EQUIVALENCE STUDY FOR PRODUCT INTERCHANGEABILITY

*Farzana Hasin, Md. Ataur Rahman, Md. Sohanoor Rahman, Nasrin Akter and Nayeema Afrin Habib

ABSTRACT

Ketorolac Tromethamine (KT) is a non-steroidal anti-inflammatory drug that belongs to the class of Heteroaryl acetic acid derivatives. It is a non-selective cyclooxygenase (COX) inhibitor, being marketed in the racemate form. Most of its analgesic and COX inhibitory activity is retained in the S-isomer. Ketorolac is administered as its Tromethamine salt orally. Side by side there is a common psychology that high cost drug product manufactured by top pharmaceutical companies are better in comparison with the low cost products manufactured by small scale companies. These facts directed our interest to develop interchangeable product having same quality as innovator product. Assess the quality of developed formulation with special emphasis on physicochemical and dissolution study due to their enormous prominence in predicting bioavailability and product quality. In the present study Ketorolac Tablet 10 mg were prepared by using direct compression method with the excipients that are used in innovator formulation (Microcrystalline Cellulose, Lactose Monohydrade, Magnesium Stearate, Hypromellose, Titanium dioxide etc) by adjusting concentration of Microcrystalline Cellulose, Lactose Monohydrade & Magnesium Stearate. Formula number BF3 containing Microcrystalline Cellulose 58.25 %, Lactose Monohydrade 33.50% & Magnesium Stearate 0.5% was found to be the best formulation shows good physicochemical behavior and dissolution profile.

Keywords: Ketorolac, Formulation, Direct Compression Method, Physicochemical, Dissolution profile.