RESUMO
OBJECTIVE: This research aimed to formulate fast-dissolving sublingual films of Ketorolac tromethamine to improve therapeutic efficacy, patient compliance and overcome the drug's gastrointestinal side effects by avoiding direct contact with the gastric mucosa. METHODS: This research produced Ketorolac tromethamine sublingual film by solvent casting method using a variable ratio of polymer and plasticizer but a fixed quantity of other excipients and solvent ratio to evaluate the effect of these components on the overall formulation. Total 9 (F1 to F9) formulations were prepared where the ratio of Kollicoat®IR as polymer and Polyethylene glycol 400 as plasticizer were 2.0:1, 3.0:1, 4.0:1, 4.0:1, 4.8:1, 5.6:1, 5.33:1, 6.0:1, 6.66:1 respectively. The prepared films were evaluated through morphological and organoleptic properties, weight uniformity, folding endurance, surface pH, thickness, percentage of moisture loss, dispersion, dissolution, and drug content uniformity. Also, API-excipients compatibility was evaluated by FTIR spectroscopy. RESULTS: Formulation-2 (F2) demonstrated better film with optimum folding endurance where the ratio of Kollicoat®IR and Polyethylene glycol 400 was 3.0:1. The film's surface and distribution of polymers and drugs were examined by trinocular microscopic imaging where drug molecule showed uniform distribution which was supported by the assay (100.1%) and content uniformity (100.1 ± 1.97%). Performed dissolution studies showed 99.3% of drug dissolution occurred in just 3 min at pH 6.8. CONCLUSION: Prepared films were found to have thin, fast dispersion and dissolution properties. Therefore, the patients can use the sublingual film to get rapid relief of pain with minimal side effects in the gastrointestinal tract.
