Efficacy and Safety of Naproxen for Acute Pain.

Acute pain often is treated with over-the-counter (OTC) therapeutics, including non-steroidal anti-inflammatory drugs (NSAIDs). However, not all NSAIDs are equally effective for treating different types of acute pain. In this article, we review the data supporting the use of OTC naproxen to effectively treat a variety of types of acute pain, including dysmenorrhea, headache, and dental pain, as well as review adverse effects. This information can be used to provide appropriate treatment for patients experiencing acute pain and help prevent progression to chronic pain.

Application of quality by design (QbD) to formulation and processing of naproxen pellets by extrusion-spheronization.

The aim of this research was to apply quality by design (QbD) to the development of naproxen loaded core pellets which can be used as the potential core for colon-specific pellets. In the early stages of this study, prior knowledge and preliminary studies were systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA) and fishbone diagram. Then Plackett-Burman design was used to screen eight potential high risk factors (spheronization speed, spheronization time, extrusion speed, drying method, CCMC-Na concentration, lactose concentration, water concentration and Tween 80 concentration) obtained from the above risk assessment. It was discovered that out of the eight potential high risk factors only three factors (spheronization speed, extrusion speed and CCMC-Na concentration) had significant effects on the quality of the pellets. This allowed the use of Box-Behnken design (BBD) to fully elucidate the relationship between the variables and critical quality attribute (CQA). Finally, the final control space was established within which the quality of the pellets can meet the requirement of colon-specific drug delivery system. This study demonstrated that naproxen loaded core pellets were successfully designed using QbD principle.

Determination of non-steroidal anti-inflammatory drugs in pharmaceuticals and human serum by dual-mode gradient HPLC and fluorescence detection.

Non-steroidal anti-inflammatory drugs (NSAIDs) such as piroxicam and mefenamic acid are commonly prescribed to treat inflammation, pain and fever. Similarly acetylsalicylic acid is used to prevent strokes and heart attacks. A rapid and selective method was developed for the simultaneous assay of three NSAIDs and salicylic acid via HPLC with fluorescence detection. The separation was performed using a "dual-mode" gradient (acetonitrile-0.1% aqueous orthophosphoric acid) and the analysis was completed within 7 min using an ACE column C18, 5 microm, 150 mm x 4.6 mm. Naproxen was used as internal standard. The proposed method is simple, selective as well as with a good sensitivity reaching LOD lower than 2 pmol (0.05 microM) and was applied for quantitative analysis in pharmaceuticals and in human serum samples. The mean recovery was more than 95% and the within-day and between-days precisions were found to be satisfactory having RSD within the acceptable limits (<10%).

Development of a HPLC method for the determination of cyclosporin-A in rat blood and plasma using naproxen as an internal standard.

An isocratic reversed phase high-performance liquid chromatographic (HPLC) method with ultraviolet detection at 205 nm has been developed for the determination of cyclosporin-A (CyA) in rat blood and plasma. Naproxen was successfully used as an internal standard. Blood or plasma samples were pretreated by liquid-liquid extraction with diethyl ether. The ether extract was evaporated and the residue was reconstituted in acetonitrile-0.04 M monobasic potassium phosphate buffer (pH 2.5) solvent mixture. After washing with n-hexane, 30 microl of the reconstituted solution was injected into HPLC system. Good chromatographic separation between CyA and internal standard peaks was achieved by using a stainless steel analytical column packed with 4 microm Nova-Pak Phenyl material. The system was operated at 75 degrees C using a mobile phase consisting of acetonitrile-0.04 M monobasic potassium phosphate (pH 2.5) (65:35 v/v) at a flow rate of 1 ml/min. The calibration curve for CyA in rat blood was linear over the tested concentration range of 0.0033-0.0166 M with a correlation coefficient of 0.989. For rat plasma, the range of the concentrations tested were between 0.002 and 0.0166 M and showed linearity with a correlation coefficient of 0.953. The intra- and inter-run precision and accuracy results were 1.24-21.87 and 3.1-12.23%, respectively. The low volume of blood or plasma needed (200 microl), simplicity of the extraction process, short run time (5 min) and low injection volume (30 microl) make this method suitable for quick and routine analysis.

Worldwide experience with etodolac (Lodine) 300 mg b.i.d. in the treatment of osteoarthritis.

Worldwide experience with the conventional formulation of etodolac (300 mg b.i.d.) was reviewed in 12 randomized, double-blind, parallel-group studies in patients with osteoarthritis (OA) of the hip or knee. The studies were conducted in 13 countries at 59 sites, and 1289 patients were enrolled. The results of 9 comparative and 3 placebo-controlled clinical studies were examined to compare the efficacy and safety of etodolac versus piroxicam, naproxen, indomethacin, indomethacin sustained-release (SR), and diclofenac SR. Efficacy assessments were made at pretreatment screening, baseline, and every 2 weeks thereafter during treatment until study completion up to 4, 6, or 8 weeks. The primary efficacy assessments were the patient's and physician's global evaluations, pain intensity and night pain, or joint tenderness and walking pain. Safety was assessed with reference to study events, reports of laboratory results, and vital signs measurements. Patients in all active treatment groups showed prompt response to therapy. According to the physicians' global evaluation, at least 64% of all etodolac-treated patients and 62% of all active-reference preparation-treated patients had improved by the end of the study. Similar results were seen in the patients' global evaluation. All of the study drugs were well tolerated. Eight (8%) percent of the etodolac-treated patients withdrew because of study events. The proportions of patients treated with active reference preparations and placebos who withdrew because of study events ranged from 3% to 18%.(ABSTRACT TRUNCATED AT 250 WORDS)

Development of preliminary criteria for response to treatment in fibromyalgia syndrome.

We developed a set of preliminary response criteria for use in future clinical trials in fibromyalgia syndrome. We determined outcome measures from a previously reported clinical trial which best distinguished patients treated with effective medication from those treated with placebo or ineffective medication, using stepwise logistic regression analysis. Several combinations of outcome measures were identified and plotted in the form of receiver operating characteristic (ROC) curves. The combination of variables possessing the greatest area under the ROC curve included (1) physician global assessment score less than or equal to 4 (0 = extremely well, 10 = extremely poorly), (2) patient sleep score less than or equal to 6 (0 = sleeping extremely well, 10 = sleeping extremely poorly), and (3) tender point score less than or equal to 14 (maximum possible tender point score equalled 20). These criteria accurately distinguished those treated with effective drug from those treated with placebo when tested in an unreported therapeutic trial of cyclobenzaprine. The criteria identified 11 of 14 patients in the amitriptyline trial and 4 of 6 patients in the cyclobenzaprine trial who attained improvement measured independently. The methodology used to define these preliminary criteria may be applied to refine the criteria as additional sensitive and clinically relevant outcomes are developed.