Vol.:(0123456789) 1 3 Journal of Pharmaceutical Investigation DOI 10.1007/s40005-017-0366-0 ORIGINAL ARTICLE Formulation evaluation and optimization of fast disintegrating tablets of ketorolac tromethamine Binu Raina 1  · Abhimanyu Sharma 1  · Prabhjot Singh Bajwa 1   Received: 24 May 2017 / Accepted: 30 October 2017 © The Korean Society of Pharmaceutical Sciences and Technology 2017 systems (Mohapatra et al. 2008). The major problem faced by many patients with conventional tablet dosage form is dif- fculty in swallowing. This problem is more apparent when drinking water is not easily available to the patient taking medicine. Hence, patient may not comply with the prescrip- tion, which results in high incidence of inefective therapy. Literature search revealed that there are various tech- nologies for preparation of fast disintegrating tablets (FDT) including conventional and patented technologies (Badgujar and Mundada 2011; Fu et al. 2004), but depending upon ease of access and availability, present research work was planned to include direct compression method. Direct com- pression is the simplest and most cost-efective manufactur- ing technique for FDT. Furthermore, only a few excipients are required and it involves less number of processing steps. Ketorolac tromethamine (KT) a nonsteroidal anti-infam- matory drug (NSAID) with potent analgesic, anti-infamma- tory, and antipyretic efects was chosen to develop as FDT. It is administered orally, intramuscularly, intravenously and as ocular formulation. In view of its pharmacological potency, it ofers promise as an alternative to opioid and to other NSAIDs in postsurgical pain, renal colic, migraine head- ache, acute musculoskeletal and other pain states. KT is 36 times more potent than phenylbutazone, approximately twice as potent as indomethacin and three times more potent than naproxen in systemic anti-infammatory activity. Its anal- gesic activity is stronger than aspirin. Clinical studies indi- cated that single-dose efcacy of KT is greater than that of morphine, pethidine and pentazocine in moderate to severe post-operative pains (Genc and Jalvand 2008). For this rea- son, KT was used in our study. KT has short half-life (3–6 h) (Mofat et al. 2011; Tripathi 2003), low dose (10–20 mg) (Tripathi 2003) high physicochemical stability and feasible analytical method for in vitro studies (UV Spectrophotom- eter) again makes it fulfll the criteria of being formulated Abstract In this study, we aimed to design fast disintegrat- ing tablets (FDT) of ketorolac tromethamine (KT) to reduce gastric side efects of KT by physically associating it with phospholipon 80H (PL) by wet granulation. First prelimi- nary batches were formulated to determine the efect of PL on tablet characteristics and to select best superdisintegrant among sodium starch glycolate and crospovidone. The efect of PL and maltodextrin (MD) concentrations on hardness, disintegration time and % drug release at 4 min was studied for the optimization of FDT. Optimization of FDT was done by employing 3 2 full factorial design using Design expert 10.1 software. The optimized batch of FDT showed disinte- gration time and percent release value of 37.33 ± 1.47 s and 42.74 ± 1.53% respectively. It was also found that 91.87% of drug was released within 10 min. Thus, by an appropriate combination of excipients, it was possible to formulate FDT capable of undergoing fast disintegration and having opti- mum hardness using simple and conventional techniques. Keywords Fast disintegrating tablet · Ketorolac tromethamine · Phospholipon 80H · Maltodextrin · 3 2 Full factorial design Introduction Convenience of administration and patient compliance are gaining signifcant importance in the design of dosage forms. Recently more stress is laid down on the development of organoleptically elegant and patient friendly drug delivery Online ISSN 2093-6214 Print ISSN 2093-5552 * Prabhjot Singh Bajwa prabhjot.bajwa1@gmail.com 1 Ch. Devi Lal College of pharmacy, Jagadhri, Haryana, India