A systematic literature review was performed using the Cochrane Library, Medline, Embase, and conference proceedings for the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) for 2008-2009. The search aimed to identify studies describing adverse events (AE) with the concurrent use of paracetamol and/or NSAID in people taking MTX for IA. Articles fulfilling our predefined inclusion criteria were systematically reviewed and quality appraised.
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Droxicam acts by inhibition of PGE2 varies. Although it belongs to the oxicam family, it is characterised by being a pro-drug of piroxicam, the molecule undergoing conversion by hydrolysis once dissolved in the digestive tract. This allows us to suppose in principle that, there being less contact between the active drug (piroxicam) and the gastric mucosa, the side effects in the said mucosa would be slight. The studies which have already been performed in healthy volunteers and in patients with osteoarthritis and rheumatoid arthritis, to evaluate the efficacy and the tolerance of droxicam in patients suffering from such clearly inflammatory processes demonstrate an analgesic potential and anti-inflammatory effects which become noticeable after two weeks of treatment, and the drug is well-tolerated.
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The crystalline states of cimetidine and piroxicam, when coprecipitated from solvents containing 1:1 mole ratio, were transformed to amorphous states as observed using powder X-ray diffraction (PXRD). Amorphous forms of drugs generally exhibit higher water solubility than crystalline forms. It is therefore interesting to investigate the interactions that cause the transformation of both the crystalline drugs. Intermolecular interactions between the drugs were determined using Fourier-transform infrared spectroscopy (FTIR) and solid-state (13)C CP/MAS NMR. Molecular dynamic (MD) simulation was performed for the first time for this type of study to indicate the specific groups involved in the interactions based on radial distribution function (RDF) analyses. RDF is a useful tool to describe the average density of atoms at a distance from a specified atom. FTIR spectra revealed a shift of the C identical withN stretching band of cimetidine. The (13)C CP/MAS NMR spectra indicated downfield shifts of C(11), C(15) and C(7) of piroxicam. RDF analyses indicated that intermolecular interactions occurred between the amide oxygen atom as well as the pyridyl nitrogen of piroxicam and H-N(3) of cimetidine. The hydrogen atom (O-H) at C(7) interacts with the N(1) of cimetidine. Since the MD simulation results are consistent with, and complementary to the experimental analyses, such simulations could provide a novel strategy for investigating specific interacting groups of drugs in coprecipitates, or in amorphous mixtures.
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This study aims to investigate the solid lipid nanoparticle (SLN) as a novel vehicle for the sustained release and transdermal delivery of piroxicam, as well as to determine the anti-inflammation effect of piroxicam-loaded SLN. SLN formulation was optimized and the particle size, polydispersity index, zeta potential (ZP), encapsulation efficiency, drug release, and morphological properties were characterized. The transdermal efficiency and mechanism of the piroxicam-loaded SLNs were investigated in vitro. With the inflammation induced edema model in rat, the anti-inflammatory efficiency of piroxicam-enriched SLNs (Pir-SLNs) was evaluated. The SLN formulation was optimized as: lecithin 100 mg, glycerin monostearate 200 mg, and Tween (1%, w/w). The particle size is around 102 ± 5.2 nm with a PDI of 0.262. The ZP is 30.21 ± 2.05 mV. The prepared SLNs showed high entrapment efficiency of 87.5% for piroxicam. There is no interaction between piroxicam and the vehicle components. The presence of polymorphic form of lipid with higher drug content in the optimized Pir-SLNs enables the Pir-SLNs to release the drug with a sustained manner. Pir-SLNs with oleic acid as enhancer can radically diffuse into both the stratum corneum and dermal layer, as well as penetrate through the hair follicles and sebaceous glands with significantly higher density than the other control groups. Pir-SLNs promptly inhibited the inflammation since the 3rd hour after the treatment by decreasing the PGE2 level. SLN was demonstrated to be a promising carrier for encapsulation and sustained release of piroxicam. Pir-SLN is a novel topical preparation with great potential for anti-inflammation application.
This paper proposes a multi-particulate drug delivery system produced by prilling technique in combination with an enteric coating. Optimization of process parameters, such as feed viscosity at nozzle, selection of cross-linker, pH of the gelling solution and cross-linking time, allows to obtain beads with strong gelled matrix. Results showed that dextran/piroxicam beads demonstrated high encapsulation efficiency, very narrow dimensional distribution and high sphericity. Coated beads retained shape and narrow size distribution of the uncoated particles. Moreover, the strength of the produced Zn(2+)-pectinate beads allows to reduce Eudragit coating thickness. Piroxicam loaded multi-particulate systems show an interesting prolonged drug release in intestinal fluids. Hence, such platforms could be proposed for the treatment of inflammatory bowel diseases.
Most of the efficacy parameters showed no significant differences between the NSAIDs, although diclofenac SR was significantly better than nabumetone in one of 18 efficacy parameters. Nabumetone-treated patients experienced significantly fewer ulcer and bleeding events compared to patients treated with the comparator NSAIDs [1.1% (4/348) vs. 4.3% (15/346), P = 0.01]. Bleeding events, including outright upper or lower GI bleeding or a significant decline in haemoglobin, occurred in significantly fewer patients treated with nabumetone than with the comparator NSAIDs [1.1% (4/348) vs. 3.5% (12/346), P < 0.05]. More importantly, complications associated with either ulcers (perforation) or bleeding (leading to hospitalization or withdrawal) occurred in significantly fewer patients receiving nabumetone [0% (0/348)] than with comparator NSAIDs [1.4% (5/346), (P < 0.05)].
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Terahertz pulsed spectroscopy was used to distinguish between different hydrate systems. In the example of four pharmaceutical materials lactose, carbamazepine, piroxicam and theophylline it was demonstrated that all different hydrate and anhydrate forms exhibit distinct spectra in the far infrared. Furthermore the dehydration of theophylline monohydrate was characterised in situ. Here, a phase transition from the monohydrate to the anhydrous form was observed, followed by evaporation of the hydrate water in a second step. The rotational spectrum of water vapour is very characteristic in the far infrared and can easily be discerned from the terahertz spectrum of the solid state form.
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The importance of piroxicam, a therapeutic anti-inflammatory drug, is well known. Because of gastrointestinal disorders, dermatological dosage forms are recommended most. In our first studies, oil-in-water (O/W) creams of piroxicam (1% concentration) were prepared using glyceryl monostearate (GMS), stearic acid, and triethanolamine as additive ingredients. In our second studies, hydroalcoholic transparent gel formulations of this drug in a 0.5% concentration were prepared using hydroxypropylcellulose (HPC) as the gelling agent. The release of piroxicam from all formulations via dialysis through a cellulose membrane into phosphate buffer pH 6.8 at 37 degrees C was studied. The effects of additives such as propylene glycol and 2-propanol on the drug release were also investigated. The release profiles from the standpoint of diffusion-controlled processes, as well as zero-order and first-order kinetics, were evaluated, and relevant parameters, such as diffusion coefficient, permeability coefficient, and partition coefficient, were calculated. The release obeys both the diffusion mechanism and first-order kinetics. The drug release from gel formulations containing 10%, 20%, and 30% propylene glycol was decreased due to the enhancement of viscosity. However, the limpidity of these formulations was improved. Moreover, the release of drug from gel formulations containing 15% and 20% of 2-propanol was increased. These results show that a hydroalcoholic gel formulation with HPC is a more suitable preparation of piroxicam when compared with an O/W cream formulation.
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Nonsteroidal anti-inflammatory drugs (NSAIDs) have been demonstrated to reduce cancer rates in oesophagus, stomach and colon of humans and animals. Earlier, we showed that high human gastrointestinal tissue levels of glutathione S-transferase (GST), a family of detoxification enzymes consisting of class alpha, mu, pi and theta isoforms, were inversely correlated with cancer risk. We investigated whether the NSAIDs indomethacin, ibuprofen, piroxicam, acetyl salicylic acid (ASA), and sulindac, supplemented in the diet for 2 weeks at 25, 400, 400, 400, and 320 ppm, respectively, influenced gastrointestinal GSTs in male Wistar rats. In cytosolic fractions of oesophagus, stomach, intestine and liver, GST activity towards 1-chloro-2,4-dinitrobenzene was measured, GST isozyme levels were determined by densitometrical analysis of Western blots after immunodetection with monoclonal antibodies, and glutathione levels were determined by HPLC. GST activity and GST mu levels were increased (1.2-1.8 x) in oesophagus and small intestine by indomethacin, ibuprofen, piroxicam and sulindac. GST alpha levels were induced (1.2-2.8 x) in stomach by piroxicam, in small intestine by indomethacin, ibuprofen, piroxicam and sulindac, and in liver by piroxicam. GST pi levels were raised (1.9-3.6 x) in stomach by ibuprofen, ASA, and sulindac, and in small intestine by indomethacin, piroxicam, ASA, and sulindac. Glutathione levels were raised (1.2-2.3 x) by indomethacin and ASA in small intestine and by piroxicam in oesophagus. Enhancement of GSTs in the upper part of the digestive tract, resulting in a more efficient detoxification, may explain in part the anticarcinogenic properties of NSAIDs.
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Cyclooxygenase (COX) enzymes are expressed in the brain; however, their role in hippocampus-dependent and cortex-dependent cognitive functions remains to be fully elucidated. The aim of the present study was to comparatively investigate the effects of piroxicam, a selective COX-I inhibitor, and celecoxib, a selective COX‑II inhibitor, on cognitive functions in an AlCl3‑induced neurotoxicity mouse model to understand the specific role of each COX enzyme in the hippocampus and cortex. The AlCl3 (250 mg/kg) was administered to the mice in drinking water and the drugs were administered in feed for 30 days. Assessments of memory, including a Morris water maze, social behavior and nesting behavior were performed in control and treated mice. The RNA expression of the COX enzymes were analyzed using reverse transcription‑quantitative polymerase chain reaction analysis. An ex‑vivo 2,2‑Diphenyl‑1‑picrylhydrazyl assay was performed in the hippocampus and cortex. Following 30 days of treatment with thedrugs, the mice in the celecoxib‑ and piroxicam‑treated groups exhibited enhanced learning (6.84 ± 0.76 and 9.20 ± 1.08, respectively), compared with the AlCl3‑induced neurotoxicity group (21.14 ± 0.76) on the fifth day of the Morris water maze test. Celecoxib treatment improved social affiliation in the AlCl3‑induced neurotoxicity group, the results of which were superior to piroxicam. Piroxicam led to better improvement in nesting score in the AlCl3‑induced neurotoxicity group. Both drugs decreased the expression levels of COX‑I and COX‑II in the hippocampus and cortex, and rescued oxidative stress levels. These findings suggested that each drug distinctly affected cognitive functions, highlighting the distinctive roles of COX-I and COX-II in learning and memory.
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This study was carried out in a randomized, double-blind fashion with 66 patients divided into three groups undergoing gynecological operations. Group I was administered 8 mg of lornoxicam i.v. preoperatively followed by an 8-mg bolus every 8 h for a total dose of 24 mg in the first 24 h. Group II was administered 8 mg of lornoxicam i.v. bolus before the end of the operation followed by 8 mg every 8 h for a total dose of 24 mg in the first 24 h. Group III was administered placebo before and after the operation and for the first 24 h. The effectiveness was assessed postoperatively using the visual analogue scale (at rest, on exertion) and by calculating the total analgesic consumption of morphine hydrochloride in the first 24 h following operation. Vital signs and side effects were documented.
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The pharmacokinetic profile of total and free methotrexate (MTX) and the effect of piroxicam on MTX pharmacokinetics was studied in 20 rheumatoid arthritis patients receiving a stable dosage of MTX (10 mg/week). Plasma protein binding ranged from 25 to 55%. To describe the variations with time of the unbound fractions a mathematical characterization relationship between the total and free MTX was used. Total and free MTX were correlated with the sigmoid maximum effect model. The slope factor (gamma) was proportional to the number of binding sites. The free fraction for a given patient can be evaluated from this relationship. Total clearance of MTX was not statistically different with piroxicam (8.0 l/h for total MTX, 13.7 l/h for free MTX) vs without piroxicam. Likewise, there were no significant difference in tmax, area under the plasma concentration vs time curve, distribution and elimination half-lives, mean resonance time, and volumes of distribution. Although the highest observed total MTX concentration was significantly lower with piroxicam, there were no significant pharmacokinetic interactions between low-dose MTX and piroxicam.
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Piroxicam FDDF is as effective as parenteral diclofenac in emergency renal colic treatment. Furthermore, its ease of self-administration increases patient compliance and potential use in general practice.
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We searched the Cochrane Renal Group's Specialised Register (to 27 November 2014) through contact with the Trials' Search Co-ordinator using search terms relevant to this review.
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The innovative vehicle was capable of enhancing the transdermal absorption of active pharmaceutical ingredients from the manipulated formulations, thus, demonstrating the capability thereof to improve the permeability of active pharmaceutical ingredients by transdermal use.
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The place of cyclo-oxygenase (COX)-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) in the peri-operative period remains under discussion. Due to the absence of COX-2 in platelets, the risk of bleeding in patients who use selective NSAIDs is thought to be decreased. We studied the influence of aspirin, diclofenac, lornoxicam and rofecoxib on the in vitro bleeding time using the platelet function analyser (PFA-100). The PFA-100 simulates the process of platelet adhesion and aggregation after vascular injury in vitro. Measurements in 43 volunteers were performed at three time points: before, 3 h, and 12 h after oral ingestion of one of the randomly assigned study medications. Aspirin, diclofenac and lornoxicam had a significant effect on the in vitro closure time, while rofecoxib did not show this effect. This supports the use of COX-2 selective drugs in the peri-operative period to minimise the risk of bleeding.
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Light and temperature have considerable effect on the degradation of piroxicam in aqueous solutions. The pH and acetate buffer ions also affect the degradation process. The apparent first-order rate constants for the photochemical and thermal degradation of piroxicam have been determined as 2.04-10.01 and 0.86-3.06×10(-3) min(-1), respectively. The first-order plots for the degradation of piroxicam showed good linearity within a range of 20-50% loss of piroxicam at pH 2.0-12.0. The rate-pH profile for the photodegradation of piroxicam is a U-shaped curve and for the thermal degradation a bell-shaped curve in the pH range of 2.0-12.0. The thermal degradation of piroxicam was maximum around pH 6.0. It is increased in the presence of acetate ions but was not affected by citrate and phosphate ions.
The analysis suggested a difference in pain reduction favoring IV APAP over morphine. IV APAP had a significant effect in pain reduction than IV morphine (difference in mean pain score reduction = 7.5 in a 100-point visual analog scale (VAS); 95% confidence interval [CI], 1.99-13.00; P = 0.008). There was mild-to-moderate study heterogeneity (I = 42%). No difference was observed when IV APAP was compared with intramuscular piroxicam for pain reduction (difference in mean pain score reduction = 0.17 in a VAS reduction ≥50% VAS; 95% CI, -0.22 to 0.57) and to intramuscular diclofenac (difference in mean pain score reduction = 0.00 in a numeric rating scale reduction ≥50%; 95% CI, -0.12 to 0.12). The analysis for nonsteroidal anti-inflammatory drugs versus IV APAP revealed no difference (difference in mean pain score reduction = 0.01 in a 100-point VAS; 95% CI, -0.10 to 0.13; P = 0.80).
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In this small study in healthy Mexican adult subjects, a single 20-mg dose of the test formulation of orally administered piroxicam met the regulatory requirements to assume bioequivalence, based on the rate and extent of absorption. Both formulations were well tolerated. Mexican national registry code: CE-PEC.0875.
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We prospectively investigated 60 patients in a single-centre double-blind study. The group was divided into two groups (M1 fluvoxamine; M2 placebo) each containing 30 patients, age ranging from 30 to 80 years. During treatment results were evaluated using several scales once at the beginning (V1) followed by weekly evaluations (V1-V8) and one final investigation at the end of treatment (V9). The investigated medication consisted of 50-150 mg fluvoxamine. In addition other drugs such as NSAID were administered (diclofenac, piroxicam, ibuprofen).
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We analysed the whole consumption of NSAIDs from ATC class M01 in Slovakia during 1996-2007.
One or more of the four nonsteroidal anti-inflammatory drugs (NSAIDs) were used by 6511 pregnant women (7.2%). No effect on rates of infant survival, congenital malformation, or structural heart defects was found. The use of ibuprofen in the second trimester was significantly associated with low birthweight (adjusted OR 1.7, 95% CI 1.3-2.3), and ibuprofen use in the second and third trimesters was significantly associated with asthma in 18-month-old children (adjusted OR 1.5, 95% CI 1.2-1.9; adjusted OR 1.5, 95% CI 1.1-2.1). The use of diclofenac in the second trimester was significantly associated with low birthweight (adjusted OR 3.1, 95% CI 1.1-9.0), whereas diclofenac use in the third trimester was significantly associated with maternal vaginal bleeding (adjusted OR 1.8, 95% CI 1.1-3.0). No associations with other neonatal complications were found.
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Ibuprofen showed the lowest odds ratio (OR = 1.7; 95% confidence interval 1.1, 2.5), followed by diclofenac (4.9; 3.3, 7.1), indomethacin (6.0; 3.6, 10.0), naproxen (9.1; 6.0-13.7), piroxicam (13.1; 7.9-21.8) and ketoprofen (34.9; 12.7, 96.5). Striking dose-response relationships were seen with four to eight-fold increases in risk within conventionally used dose ranges for all except ketoprofen, where numbers were too few to allow dose analysis. Across the class, risk was highest during the first week of use (11.7; 6.5, 21.0), decreased thereafter with continuing use (5.6; 4.6, 7.0), and fell to 3.2 (2.1, 5.1) 1 week after discontinuing use. Concurrent use of more than one NANSAID substantially increased risk.
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Lornoxicam-QR and lornoxicam-IM did not differ with respect to AUCinfinity, Cmax and tmax, but both lornoxicam-QR and lornoxicam-IM showed significantly shorter tmax and significantly higher Cmax values than lornoxicam-ST.
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9 NSAID were studied at 5 concentrations. Thromboxane B2 (TxB2) was assayed as a measure of COX-1 activity in clotted blood. Prostaglandin E2 (PGE2) was assayed as a measure of COX-2 activity in heparinized, lipopolysaccharide (LPS)-stimulated blood. All assays were competitive ELISA tests. Cyclooxygenase selectivity was expressed as a ratio of the concentration of an NSAID that inhibited 50% of the activity (IC50) of COX-1 to the IC50 of COX-2. A separate ratio of the concentration that inhibited 80% of COX activity (IC80) was also determined. A ratio of < 1.0 indicated selectivity for COX-1, whereas a ratio of > 1.0 indicated COX-2 selectivity.
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A rapid spectrodensitometric method for the determination of Piroxicam and its impurities is described. The procedure involves a HPTLC separation on Silica Gel F254 plates. Quantitative determinations are carried out using a spectrodensitometer at 310 nm. The proposed method is sensitive and the minimum amount detectable of Piroxicam impurities is around 10 ng.
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We tested whether the addition of phloroglucinol to piroxicam could improve pain relief in patients with acute renal colic visiting the emergency department.
In a 2-week, double-blind, parallel, multicenter study, piroxicam (20 mg once-daily) and indomethacin (25 mg three times daily) were compared in the treatment of painful lumbar disorders. A total of 230 patients were evaluated, 116 who received piroxicam and 114 who received indomethacin. While both drugs were highly effective in relieving symptoms, numerical superiority was evident for piroxicam in most efficacy parameters. The difference between treatments was most obvious at the end of the first week, when a greater percentage of patients receiving piroxicam was rated as 'very much improved'. No serious adverse reactions or clinical laboratory abnormalities were noted for either drug, although fewer gastrointestinal side effects were observed with piroxicam.