Wet-milling is the most common approach to formulate nano-crystalline suspensions. The effect of high intensity wet-milling on the physical and chemical stability of a poorly soluble drug was investigated. Naproxen (1%, w/v) was suspended in two different stabilizers (i.e. HPMC E15 and Tween 80) and stabilizer concentrations (0.2% or 0.6%, w/v) in distilled water. Wet-milling was performed at two different speeds (i.e. 3,400 rpm and 2,000 rpm) for four continuous hours. The milled samples were analyzed for physical and chemical instabilities. Wet-milling of naproxen-HPMC E15 at high milling intensity caused both physical and chemical instabilities as observed by particle size measurement and chemical analysis, respectively. The naproxen-Tween 80 formulations were stable regardless of milling intensity. Naproxen-HPMC E15 wet-milled samples, showed an IR peak shift suggesting strong bond formation or molecular interaction (i.e. amorphous phase). In addition, naproxen has a strong interaction with HPMC E15 as determined by MTDSC (i.e. melting point depression). The generation of amorphous phase at the naproxen-HPMC E15 crystal surface may be responsible for both aggregation and degradation during wet milling. Decarboxylated naproxen was identified as a degradation product. Milling intensity and/or selection of stabilizer/s are crucial for the stability of nano-crystalline suspensions.
A randomized endoscopic double-blind double-dummy study.
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Candida rugosa lipase (CRL) was immobilized on glutaraldehyde-activated aminopropyl glass beads by using covalent binding method or sol-gel encapsulation procedure and improved considerably by fluoride-catalyzed hydrolysis of mixtures of RSi(OCH3)3 and Si(OCH3)4. The catalytic properties of the immobilized lipases were evaluated into model reactions, i.e. the hydrolysis of p-nitrophenylpalmitate (p-NPP). It has been observed that the percent activity yield of the encapsulated lipase was 166.9, which is 5.5 times higher than that of the covalently immobilized lipase. The enantioselective hydrolysis of racemic Naproxen methyl ester by immobilized lipase was studied in aqueous buffer solution/isooctane reaction system and it was noticed that particularly, the glass beads based encapsulated lipases had higher conversion and enantioselectivity compared to covalently immobilized lipase. In short, the study confirms an excellent enantioselectivity (E>400) for the encapsulated lipase with an ee value of 98% for S-Naproxen.
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Heterotopic ossification is a common complication following total hip arthroplasty and surgery following acetabular trauma. It is associated with pain and a decreased range of movement. Prophylaxis is achieved by either non-steroidal anti-inflammatory drug treatment or localised irradiation therapy. The objective of this study was to evaluate the evidence for pharmacological agents used for the prophylaxis of heterotopic ossification following hip and acetabular surgery. The study used a comprehensive literature search to identify all major clinical studies investigating the pharmacological agents used in the prophylaxis of heterotopic ossification following hip and acetabular surgery. It was concluded that indometacin remains the 'gold standard' for heterotopic ossification prophylaxis following total hip arthroplasty and is the only drug proven to be effective against heterotopic ossification following acetabular surgery. Following total hip arthroplasty, other non-steroidal anti-inflammatory drugs, including naproxen and diclofenac, are equally as effective as indometacin and can be considered as alternative first-line treatments. Celecoxib is also of equal efficacy to indometacin and is associated with significantly fewer gastrointestinal side effects. However, serious concerns were raised over the safety of selective cyclooxygenase-2 inhibitors for the cardiovascular system and these should be used cautiously.
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Pharmaceutically active compounds (PhACs) are commonly found in wastewater influent. However, little research has focused on determining their impact on fundamental processes in wastewater treatment such as nitrogen removal. In this study, focus was placed on 4 commonly occurring PhACs (ketoprofen, naproxen, carbamazepine and gemfibrozil). Their effect was ascertained in the ammonia oxidizing bacterium (AOB), Nitrosomonas europaea in terms of membrane integrity and nitrite production. These PhACs were shown to inhibit nitrite production at concentrations of 1 and 10 μM while no effect was observed at 0.1 μM. The maximum observed nitrification inhibition was 25%, 29%, 22% and 26% for ketoprofen, naproxen, carbamazepine and gemfibrozil, respectively. A decrease in the live/dead ratio ranging from 10% to 16% suggests that these PhACs affect membrane integrity in N.europaea. The difference in nitrite production between PhACs treated cells and non PhAC treated controls was still significant following washing suggesting that inhibition is irreversible. Finally, nitrite production when adjusted to the live fraction of cells was also found to decrease suggesting that PhACs inhibited the activity of surviving cells. These results suggest that the presence of PhACs may affect AOB activity and may impact nitrogen removal, a key function in wastewater treatment. Follow up studies with additional AOB and in mixed culture are needed to further confirm these results.
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Previous studies by this research team proved that vasodilating prostaglandins (PGs) E1, E2 and I2 inhibit carbonic anhydrase (CA) in vitro and in vivo, which suggested involvement of CA in gastric acid secretion inhibition and the increase of gastric mucosa blood flow produced by this group of PGs. Relying on these findings, as well as on our clinical observations, we studied in vitro and in vivo the effects of nonsteroidal anti-inflammatory drugs (NSAIDs) on CA I and CA II. We also followed in vitro the effects on these isozymes of NSAIDs associated to histamine, Ca, PGE2 and acetazolamide. The results show that the NSAIDs used here, which reduce the activity of cyclooxygenase and PG production, activated CA I and CA II in a dose-dependent manner by a mechanism of the noncompetitive type. Histamine and Ca added to NSAIDs amplified the activating effect of the latter on CA II. Association of PGE2 or acetazolamide to NSAIDs reduced NSAID-induced activation of CA I and CA II. Indomethacin abolished the inhibitory effect of acetazolamide on CA I and CA II. Our data imply that between CA and cyclooxygenase there is an inverse relationship, CA activation being accompanied by reduction of cyclooxygenase activity, a reduction achieved by the pH modifications induced by CA activation. In this way, cyclooxygenase, inhibition occurs "via CA," with the pH variations it brings about.
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The importance of cyclooxygenase and lipoxygenase pathways in the determination of collagen abnormalities in diabetes was investigated. Pharmacological agents with antiprostaglandin activity, such as indomethacin, naproxen, and aspirin, were able to prevent the rise in thermal rupture time of tail collagen in diabetic rats. Paracetamol was without effect. The action of indomethacin on diabetic collagen was abolished by concurrent administration of sodium benoxaprofen, an inhibitor of lipoxygenase, to the diabetic rats. Collagen abnormalities in diabetes may be regulated by a balance of the cyclooxygenase and lipoxygenase pathways. Antiprostaglandin agents may have a role in the prevention of some diabetic complications.
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Naproxen, ibuprofen, mefenamic acid and aspirin are all effective in primary dysmenorrhoea. Ibuprofen appears to have the most favourable risk-benefit ratio. Acetaminophen appears to be less effective than nonsteroidal anti-inflammatory drugs, but there was only one trial meeting our inclusion criteria and further studies are required.
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From Health Care Financing Administration inpatient claims, we identified the first hospitalization for GI perforation, ulcer, or hemorrhage that occurred during the year of follow up (ICD9-CM discharge codes: 531-534, 578). Cox proportional hazards models provided adjusted estimates of rate ratios.
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Two multi-centre studies were carried out in general practice comparing tiaprofenic acid ('Surgam') with five other non-steroidal anti-inflammatory agents (ibuprofen, indomethacin, naproxen, piroxicam and benoxaprofen), one in rheumatoid arthritis and one in osteoarthritis. Two hundred and seventy-seven general practitioners provided completed case records for 856 patients, 373 with rheumatoid arthritis and 483 with osteoarthritis. Approximately half of the patients received tiaprofenic acid and the remainder one of the other drugs. Results showed that tiaprofenic acid was at least as effective as the other drugs. The incidence of side-effects was similar for each group except in the osteoarthritis trial where there was a higher incidence in the patients receiving indomethacin. The overall withdrawal rate from each trial was 4.6% and 5.2% in rheumatoid arthritis and osteoarthritis, respectively.
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We assessed the effects of equipotent analgesic doses of celecoxib, rofecoxib, valdecoxib, etoricoxib and lumiracoxib and of the NSAIDs, diclofenac and naproxen, on postpartum kidney development in mice, from postnatal day 1 (P1) to P21.
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The Intestinal Protective Drug Absorption System (IPDAS) is a new oral drug delivery approach that is applicable to gastrointestinal (GI) irritant drugs, including the nonsteroidal anti-inflammatory drug (NSAID) class. Although naproxen, as the free acid or the sodium salt, has pharmacokinetic characteristics that are consistent with once-daily dosing, the GI irritant and ulcerogenic potential associated with a large bolus dose of naproxen precludes safe use of an immediate-release form. In addition, the desired pharmacodynamic activity of a once-daily dosage form of naproxen requires rapidly available naproxen for a prompt onset of analgesic activity, as well as a prolonged phase of absorption to provide 24-hour analgesic/anti-inflammatory activity. Naprelan (naproxen sodium; Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania) controlled-release tablets are a unique dosage form designed to achieve the desired features of such a once-daily presentation. Through a series of in vivo studies, the pharmaceutical design features of the product have been confirmed in humans using a combination of imaging and pharmacokinetic characterization. In addition, the potential for limiting any undesirable GI adverse events has been supported by evaluation of the GI toxicity of Naprelan in specialized animal toxicity studies. Naprelan exhibited in vivo performance characteristics that support the hypothesis that, as a once-daily dosage form, it may demonstrate safety and efficacy advantages in clinical evaluation.
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According to our review, AMDs safe during breastfeeding are as follows: low-dose acetylsalicylic acid (ASA), ibuprofen, sumatriptan, metoprolol, propranolol, verapamil, amitriptyline, escitalopram, paroxetine, sertraline, acetaminophen, caffeine, and metoclopramide. AMDs compatible with breastfeeding but warranting caution are as follows: diclofenac, ketoprofen, naproxen, most new triptans, topiramate, valproate, venlafaxine, and cyproheptadine. Finally, high-dose ASA, atenolol, nadolol, cinnarizine, flunarizine, ergotamine, methysergide, and pizotifen are contraindicated.
To provide a view on how the clinician can select appropriate treatment when managing individual patients with endometriosis.
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Thirty-one patients with osteoarthritis of the knee were treated with either diflunisal (n = 17) or naproxen (n = 14) in a 12-week open-label study. Treatment was begun with 500 mg BID of diflunisal or 375 mg BID of naproxen. Patients not showing an adequate response to these dosages were given increases to 750 mg BID of diflunisal (n = 7) or 500 mg BID of naproxen (n = 8). Both drugs achieved statistically significant improvements in pain indices, tenderness, swelling, morning stiffness, functional capacity, knee flexion, and 50-foot walking time, and no significant difference was found between the two drugs. At the end of the study, all patients taking diflunisal and 11/14 patients taking naproxen felt that they had improved with treatment. Drug safety and tolerability were assessed in 21 patients given diflunisal and 16 given naproxen (including patients not part of the efficacy evaluation). Six (29%) patients in the diflunisal group and four (25%) in the naproxen group experienced side effects; three were withdrawn from the diflunisal group and one from the naproxen group because of adverse effects. In general, both drugs were well tolerated.
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The aim of this study was to evaluate the effect of nonsteroidal anti-inflammatory drugs (NSAIDs) and other operative variables on the development of HO.
Aspirin induced asthma in adults is more prevalent than previously suggested. When there is a clinical necessity to use aspirin or a non-steroidal anti-inflammatory drug and there is uncertainty about safety, oral provocation testing should be performed.
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The aim of this research has been to determine the biperiden hydrochloride permeability in Caco-2 model, in order to classify it based on the Biopharmaceutics Classification System (BCS). The World Health Organization (WHO) as well as many other authors have provisionally assigned the drug as BCS class I (high solubility-high permeability) or III (high solubility-low permeability), based on different methods. We determined biperiden BCS class by comparing its permeability to 5 pre-defined compounds: atenolol and ranitidine hydrochloride (low permeability group) and metoprolol tartrate, sodium naproxen and theophylline (high permeability group). Since biperiden permeability was higher than those obtained for high permeability drugs, we classified it as a BCS class I compound. On the other hand, as no differences were obtained for permeability values when apical to basolateral and basolateral to apical fluxes were studied, this drug cannot act as a substrate of efflux transporters. As a consequence of our results, we suggest that the widely used antiparkinsonian drug, biperiden, should be candidate for a waiver of in vivo bioequivalence studies.
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To determine the role of medication toxicity in the discontinuation of antirheumatic treatment among patients with ankylosing spondylitis (AS), and to compare the toxicity of different medications.
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Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate risk ratios and numbers needed to treat (NNT) or harm (NNH) compared with placebo or a different active treatment.
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Non-steroidal anti-inflammatory drugs (NSAIDs) that act as cyclo-oxygenase (COX) inhibitors are commonly used in the treatment of a range of headache disorders, although their mechanism of action is unclear. Indomethacin is of particular interest given its very special effect in some primary headaches. Here the in vivo technique of intravital microscopy in rats has been utilised as a model of trigeminovascular nociception to study the potential mechanism of action of indomethacin. Dural vascular changes were produced using electrical (neurogenic) dural vasodilation (NDV), calcitonin gene-related peptide (CGRP) induced dural vasodilation and nitric oxide (NO) induced dural vasodilation using NO donors. In each of these settings the effect of intravenously administered indomethacin (5 mg kg(-1)), naproxen (30 mg kg(-1)) and ibuprofen (30 mg kg(-1)) was tested. All of the tested drugs significantly inhibited NDV (between 30 and 52%). Whilst none of them was able to inhibit CGRP-induced dural vasodilation, only indomethacin reduced NO induced dural vasodilation (35 ± 7%, 10 min post administration). We conclude NSAIDs inhibit release of CGRP after NDV without an effect on CGRP directly. Further we describe a differentiating effect of indomethacin inhibiting nitric oxide induced dural vasodilation that is potentially relevant to understanding its unique action in disorders such as paroxysmal hemicrania and hemicrania continua.
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The pharmacological activity of ketoprofen enantiomers was investigated in humans by an in vitro method. The antiplatelet effect of ketoprofen was assessed by measuring the inhibition of platelet thromboxane B2 (TXB2) generation during the controlled clotting of whole blood obtained from each of four healthy volunteers. Ketoprofen was added separately to whole blood as a range of concentrations of (1) predominantly (S)-ketoprofen, (2) racemic ketoprofen, and (3) predominantly (R)-ketoprofen. (S)-Ketoprofen was found to be solely active at inhibiting human platelet TXB2 production; (R)-ketoprofen was devoid of such activity and did not modify the potency of its optical antipode. A relationship between the percentage inhibition of TXB2 generation and the unbound concentration of (S)-ketoprofen in serum was modelled according to a sigmoidal Emax equation. The mean (+/- SD) serum unbound concentration of (S)-ketoprofen required to inhibit platelet TXB2 generation by 50% (EC50) was 0.320 (+/- 0.062) ng/ml. This value for ketoprofen is considerably lower than previously reported values for (S)-ibuprofen and (S)-naproxen.
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Various animal models of non-steroidal anti-inflammatory drug (NSAID)-induced gastric ulceration exist. These models have limitations, which make them less relevant to the human situation.
Four patients, ages 3.5 to 19 years.
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This multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and upper gastrointestinal tract safety of valdecoxib at dosages of 5, 10, and 20 mg once daily with placebo and naproxen at the dosage of 500 mg twice daily.
Three drugs containing the naphthalene (NP) chromophore, namely, naproxen (NPX), propranolol (PPN), and cinacalcet (CIN), but with different affinities toward serum albumins (SAs) and α-1-acid glycoproteins (AAGs) have been employed for the assessment of drug distribution in binary SA/AAG systems. These three drugs represent an appropriate choice for checking whether a methodology based on transient absorption spectroscopy of a given reporter can be employed for discrimination between different distribution patterns in multicompartmental biological media. Thus, upon laser flash photolysis (LFP) of NPX, PPN, and CIN in the presence or absence of proteins, the NP triplet excited state ((3)NP*) at ∼420 nm was always detected, although the kinetics of the decay traces was structure- and medium-dependent. In aerated PBS, only a very short triplet lifetime (τ(T)) was found (1-2 μs). By contrast, in the presence of SAs, two longer triplet lifetimes (5-76 μs) were observed, ascribed to (3)NP* within site I and site II. Upon binding to AAGs, only a long τ(T) (15-47 μs) was found. When the two proteins were present simultaneously in the same media, fitting of the decay traces was clearly consistent with a distribution of the drug between the different biological compartments and the bulk solution, which correlates well with the known protein affinities of every drug. Experiments were performed in both human (HSA/HAAG) and bovine protein media (BSA/BAAG). The results showed that SAs are the major carriers for NPX; by contrast, PPN binds preferentially to AAGs. An intermediate situation was found for CIN, which presents comparable affinity for both proteins. The results obtained for the two enantiomers of each drug were very similar, although a small stereodifferentiation was observed between the triplet lifetimes in the protein binding sites.
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NSAIDs are first line drug in the treatment of juvenile chronic arthritis (JCA), mainly in pauciarticular onset. New agents such as naproxen and ibuprofen are frequently preferred because of equivalent efficacy, lower toxicity and longer half-life than salicilates. Antimalarics, sulphasalazine and penicilamine are good options in seronegative JCA, specially with limited articular involvement and in pauciarticular JCA that become polyarticular. However, in the absence of a response with these drugs and insevere polyarticular disease, seropositive JCA and in polyarticular involvement associated to systemic manifestations, low-dose methotrexate is our first choice. Steroids are important in specific life-threatening disease, severe fever and iritis, and should be discontinued as soon as possible. Cytotoxics and immunomodulators should be reserved for active disease unresponsive to conventional therapy.
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Although nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used, their main limitation is gastrointestinal (GI) injury. Two double-blind, randomized, outcomes trials were conducted to determine the incidence of clinical GI events with the coxibs, rofecoxib and celecoxib, compared with nonselective NSAIDs. The VIGOR study (VIOXX Gastrointestinal Outcomes Research) compared rofecoxib with naproxen, and the CLASS study (Celecoxib Long-term Arthritis Safety Study) compared celecoxib with ibuprofen and diclofenac. The VIGOR trial revealed a relative risk reduction for clinical upper GI events of 50% with rofecoxib, and a 60% reduction in complicated events. In the CLASS study, the 23% reduction in complicated ulcers with celecoxib did not reach statistical significance (P = 0.45), although when all clinical events were examined, the 34% reduction was significant (P = 0.04). However, low-dose aspirin use, which was allowed in the CLASS study, may have influenced the results. A subgroup analysis in the patients who did not take aspirin revealed a nonsignificant 45% reduction in complicated events with celecoxib (P = 0.19), and a 47% reduction in complicated and symptomatic ulcers (P = 0.02).
Extensive use of rofecoxib, celecoxib, and diclofenac increases the risk of acute myocardial infarction, but similar use of ibuprofen and naproxen does not.