RESUMO
Objective: To evaluate the quality status of piroxicam tablets. Methods: The samples were examined by the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results: Totally 138 batches were exam-ined according to the statutory standard, and among them, 135 batches were qualified with the qualified rate of 97. 8% . The unquali-fied item of 3 unqualified batches was dissolution. The exploratory studies showed that there were two crystal forms of piroxicam used in the tablets, and the dissolution of the two crystal forms was different with form 1 less than form 2. An inspection method for the relative substance was established. Totally 14 impurities were detected out and the structures of 8 impurities were identified. The impurities were mainly derived from the raw materials, and many batches of samples were with single largest impurity content exceeding 0. 5% , and the total of impurity content above 1. 0% . A class I solvent 1,2-dichloroethane was detected out in 13 batches of tablets by GC and confirmed by GC-MS. Through the dissolution consistency test, it was found that there was a great difference in the dissolution behavior among the products from different manufacturers. Conclusion: The overall quality of piroxicam tablets is not ideal, and the production process of some manufacturers needs to be improved.
RESUMO
Introduction: Surgical removal of impacted mandibular third molar is one of the most commonly performed procedures in oral and maxillofacial surgical practice. The role of preoperative and postoperative medications for management of postoperative complications has been extensively evaluated. Aim: To assess the therapeutic effect of a single dose of 40 mg sublingual piroxicam (study group) vs 150 mg oral diclofenac (50 mg thrice a day) (control group) in patients undergoing surgical removal of impacted mandibular third molar. Materials and Methods: A total of 100 patients with asymptomatic impacted mandibular third molars were randomized into two groups. One group received two 20-mg tablets of piroxicam once daily on the first and second postoperative days, followed by one 20-mg tablet on the third post-operative day. The other group received one tablet of diclofenac 50 mg orally thrice daily on the first, second, and third post-operative days. Repeated extraoral examinations were done for continuous assessment of swelling, trismus, and reduction in pain. Ovearall impression of the treating physician and the patient regarding efficacy of study drugs were recorded at the end of the study. Results: In the piroxicam group there was >50% reduction in pain on all three days postoperatively. The incidence of swelling and trismus was found to be higher in the control group as compared to the study group. Adverse events, such as gastrointestinal (GI) disturbances, were significantly higher in the diclofenac group (11%) as compared to the piroxicam group (0%). Conclusion: Two sublingual piroxicam 20 mg tablets once daily has better efficacy and tolerability profile than diclofenac 50 mg one tablet thrice daily in the management of pain after surgical removal of impacted mandibular third molar. Study Title: A Comparative Study to Evaluate Clinical Efficacy and Safety of Sublingual Piroxicam and Diclofenac in the Management of Pain after Surgical Removal of Impacted Mandibular Third Molar.