Abstract
Formulation and pharmacopoeial quality evaluation of ketorolac tromethamine IR tablet and comparison with marketed product
Highlights
Ketorolac tromethamine is a non-steroidal antiinflammatory drug having potent analgesic activity chemically which is 2-amino-2-(hydroxymethyl) propane-1,3-diol; 5-benzoyl2,3-dihydro-1H-pyrrolizine-1-carboxylic acid (Fig. 1)
This study describes the formulation of immediate release Ketorolac tromethamine (KT) 10-mg tablet by direct compression method; evaluation of their compliance to various Pharmacopoeial quality parameters, i.e., weight variation, friability, hardness, thickness, moisture content, disintegration, assay, and dissolution; and their comparison with marketed brands for determination of pharmaceutical equivalency
KT 10-mg tablet was prepared by using direct compression method with the excipients tabulated in Table 1 by adjusting the concentration of super disintegrants, such as Crosscarmellose sodium, Crospovidone, Maize starch, and other ingredients
Summary
Ketorolac tromethamine is a non-steroidal antiinflammatory drug having potent analgesic activity chemically which is 2-amino-2-(hydroxymethyl) propane-1,3-diol; 5-benzoyl2,3-dihydro-1H-pyrrolizine-1-carboxylic acid (Fig. 1). It is a nonselective Cyclooxygenase (COX) inhibitor acting through the inhibition of prostaglandin synthesis by competitively blocking the enzyme COX (Banker and Anderson, 2009). Ketorolac tromethamine (KT) has a short plasma half-life of 4–6 hours requiring its frequent administration rate. Direct compression is one of the processes of choice for its advantages over the other manufacturing methods for tablets, such as wet granulation for its high efficiency, reduced cycle time, less contact of moisture for thermolabile and moisture sensitive product, etc.
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