Exantema intertriginosoflexural y simétrico (SDRIFE) por piroxicam: a propósito de un caso clínico / Symmetrical drug related intertriginous and flexural exanthema secondary to piroxicam: a case report

Resumen El exantema intertriginoso y flexural simétrico por fármacos (SDRIFE) es una toxicodermia que se presenta con exantema limitado a pliegues, sobretodo en región glútea y genital, y representa una reacción a la exposición sistémica a un medicamento sin sensibilización previa. Presentamos el caso de una paciente mujer adulta previamente sana, que consulta por este tipo de reacción medicamentosa asociada al uso de piroxicam intramuscular, manejada de forma exitosa con antihistamínicos, esteroides tópicos y sistémicos.

Abstract Symmetrical drug related intertriginous and flexural exanthema is a cutaneous drug eruption that is characterized by exanthema limited to creases, buttocks and the upper inner thighs. It represents a reaction to systemic exposure to a drug, without previous sensitization. We present the case of a woman, previously healthy, who consulted due to this drug reaction after being injected with piroxicam, who was successfully treated with antihistamines, topical and systemic corticosteroids.

Study of intermolecular interactions of piroxicam polymorphs / 药学学报

Piroxicam has polymorphism. Different crystalline forms can exhibit different physicochemical properties and biological activities. Analysis of the intermolecular interactions is essential to reveal the formation mechanism and differences of polymorphs. In this paper, Hirshfeld surface analysis and semi-empirical methods were used to calculate and analyze the intermolecular interactions in seven polymorphic forms of piroxicam. The results show that the Hirshfeld surface analysis method can clearly and intuitively reveal the intermolecular interactions, among which H…H, O…H/H…O and N…H/H…N interactions account for 95% of the total energy. There are differences in the proportion and distribution of the forces of different crystal forms. The energy calculation shows that the lattice energy of the hydrate is significantly lower than that of the anhydrous forms, and in the specific energy distribution, the contribution of the dispersion force is the most prominent. Further interaction energy analysis was found that within the distance of 3.8 Å from the center of the piroxicam molecule, different crystalline forms of piroxicam molecule have different interaction energies with surrounding molecules.

Synthesis and electrochemical properties of environmental free L-glutathione grafted graphene oxide/ZnO nanocomposite for highly selective piroxicam sensing / 药物分析学报

A simple and reliable strategy was proposed to engineer the glutathione grafted graphene oxide/ZnO nanocomposite(glutathione-GO/ZnO)as electrode material for the high-performance piroxicam sensor.The prepared glutathione-GO/ZnO nanocomposite was well characterized by X-ray diffraction(XRD),Fourier transform infrared spectrum(FTIR),X-ray photoelectron spectroscopy(XPS),field emission scanning electron microscopy(FE-SEM),cyclic voltammetry(CV),electrochemical impedance spectros-copy(EIS)and differential pulse voltammetry(DPV).The novel nanocomposite modified electrode showed the highest electrocatalytic activity towards piroxicam(oxidation potential is 0.52 V).Under controlled experimental parameters,the proposed sensor exhibited good linear responses to piroxicam concentrations ranging from 0.1 to 500 μM.The detection limit and sensitivity were calculated as 1.8 nM and 0.2 μA/μM·cm2,respectively.Moreover,it offered excellent selectivity,reproducibility,and long-term stability and can effectively ignore the interfering candidates commonly existing in the pharmaceutical tablets and human fluids even at a higher concentration.Finally,the reported sensor was successfully employed to the direct determination of piroxicam in practical samples.

Fabrication of Non-Ionic Surfactant Vesicular Gel for Effective Treatment of Rheumatoid Arthritis.

Rheumatoid Arthritis (RA) is a chronic, inflammatory auto immune disorder with unknown aetiology. Though various efficacious treatment options are currently available to treat RA, failure to cure is unpredictable. Hence the present study aimed to evaluate Piroxicam (PC) loaded non-ionic surfactant vesicular carrier as transdermal patches. MethodsTransdermal patches of PC- niosomes were formulated by solvent casting method using different polymers. The prepared formulation was examined for physico - chemical and morphological characteristics and drug release studies were performed by Franz diffusion cell method. ResultsThe results of physico-chemical characterizations show that all formulations were with optimum range and morphological characterization shows that the prepared niosomes are spherical in shape. Drug release characteristic of all formulations was performed and the result exhibits that formulation TN4 (PC encapsulated niosomal gel transdermal patch) shows highest % drug release (95.13%) when compared to other formulation. The release data was fitted with release kinetics and results shows zero order with non Fickian diffusion mechanism. ConclusionsPC encapsulated vesicular carrier as transdermal patches is a promising drug delivery system to enhance the solubility of poorly soluble drugs. It also enhances the residence time of drug at absorption site. Hence this approach could be beneficial for the effective management of RA.

Stability-indicating HPLC-DAD method for the simultaneous determination of fluoroquinolone in combination with a non-steroidal anti-inflammatory drug in pharmaceutical formulation

We developed and validated a stability-indicating assay method for the simultaneous determination of enrofloxacin and piroxicam in combination and in the presence of degradation products. Reverse-phase high-performance liquid chromatography analyses were carried out on a Vertisep C18 column and acetonitrile-water (48:52 v/v, pH 3.0) mobile phase with a 1.00 mL min−1 flow rate. The efficient chromatographic separation of these drugs and their forced degradation products was achieved in less than 5min with a peak purity match factor higher than 950. The method used showed linearity in the concentration ranges of 0.25 to 16.0 µg mL−1 for enrofloxacin (r = 0.9997) and 0.125 to 8.0 µg mL−1 for piroxicam (r = 0.9999) as well as precision (relative standard deviation lower than 2%), accuracy (mean recovery 100 ± 2%), and robustness, according to ICH (International Conference on Harmonization) and AOAC (Association of Official Analytical Chemists) guidelines. This method can simultaneously determine the combination of these drugs in a veterinary formulation and separate the drug peaks from their forced degradation products. Additionally, its optimized chromatographic conditions can contribute to the quality control of this formulation in pharmaceutical manufacturing plants and minimize waste from the organic solvent.

Piroxicam voltammetric determination by ultra low cost pencil graphite electrode

Piroxicam (PRX) was determined in pharmaceutical capsules with differential pulse voltammetry (DPV) in a three electrode system consisting of a pencil graphite electrode (PGE) as working electrode, a Pt wire and a reference electrode of Ag/AgCl/KCl 3 M. An irreversible oxidation peak was observed in Epa c.a. 0.6 V, which correlates to the oxidation of PRX. The coefficient of linear correlation obtained was 0.9946, with limit of detection of 2.1 µM and limit of quantification of 4.7 µM. PGE assays showed good analytical performance compared to high performance liquid chromatography and spectrophotometry, showing the potential to be further developed and employed in quick and simple analyses.

Formulation and investigation of crushed puffed rice-chitosan-HPMC based polymeric blends as carrier for sustained stomach specific drug delivery of piroxicam using 3(2) Taguchi mathematical design studies

In the present experimental investigation an attempt has been made to assess the utility of Crushed Puffed Rice (CPR)-High Molecular Weight Chitosan (HMWCH)-Hydroxypropyl Methylcellulose K15M (HPMC K15M) as a polymeric carrier for the sustained stomach delivery of Piroxicam (PRX). A total of nine formulations were prepared by using 3 (2) Taguchi factorial design, physically blending drug and polymer(s) followed by encapsulation into hard gelatin capsules size 1. The prepared capsules were evaluated for various performance such as weight variation, drug contents, in vitro buoyancy and drug release in 0.1 M HCl. The effect of drug loading on in vitro performance of the formulations was also determined. Crushed puffed rice (CPR) remained buoyant for up to average time span of 06 hr as an unwetted irregular mass in 0.1 M HCl. However, when combined with HMWCH or HPMC K15M or HPMC K15M + HMWCH a low -density cylindrical raft type hydrogel was formed which remained buoyant for up to 12 hr and released up to 99% drug in a sustained manner from 8 to 12 hr following zero order release kinetics. It was also observed that drug release from drug + CPR matrices followed Fickian mechanism. Combination of CPR + HMWCH or HMWCH + HPMC K15M also follows Fickian mechanism. Obtained data from the research work suggests that CPR in combination with HMWCH or HPMC K15M or HPMC has sufficient potential to be used as a carrier for stomach specific delivery of gastric irritant drug like PRX

Quality Analysis of Piroxicam Tablets / 中国药师

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.

Preparation and Transdermal Absorption in vitro of Piroxicam Nanostructured Lipid Carrier / 中国药师

Objective: To prepare piroxicam nanostructured lipid carrier and investigate its transdermal absorption behavior in vitro. Methods:Piroxicam nanostructured lipid carrier was prepared by a melt-emulsion ultrasonication and low temperature-solidifica-tion method. The physicochemical properties such as appearance, morphology, particle size distribution, PdI and zeta potential of pi-roxicam nanostructured lipid carrier were evaluated. The transdermal absorption in vitro was investigated using Franz diffusion cells. Results:Piroxicam nanostructured lipid carrier was clear and transparent with small spherical shape as seen under a transmission elec-tron microscope. The particle size distribution, PdI and zeta potential was (106. 4 ± 31. 6) nm, (0. 217 ± 0. 07) and ( -31. 6 ± 2. 5) mV, respectively. Piroxicam nanostructured lipid carrier had higher cumulative transdermal amount in 12 h than piroxicam solution. Conclusion:The nanostructured lipid carrier can remarkably improve piroxicam permeation into skin, which provides reference for the new dosage form for the topical use of piroxicam.

Efecto gastroprotector de la miel de abeja en ratas Holtzman con úlceras gástricas inducidas por piroxicam

Objetivo: Determinar el efecto de la miel de abeja sobre úlceras gástricas inducidas por piroxicam en ratas Holtzman. Material y método: Se trabajó con 48 ratas hembra Holtzman de ocho semanas de edad con pesos entre 100 y 200 g, divididas en 6 grupos, con las siguientes intervenciones: Grupo A: agua; Grupo B: piroxicam (30 mg/kg); Grupo C: omeprazol (5 mg/kg) y piroxicam (30 mg/kg); Grupo D: miel (2,5 g/kg) y piroxicam (30 mg/kg); Grupo E: miel (5 g/kg) y piroxicam (30 mg/kg); Grupo F: miel (7,5 g/kg) y piroxicam (30 mg/kg). Luego de las intervenciones se realizaron estudios macroscópicos de las lesiones de la mucosa gástrica mediante el paquete Scion Image® y microscópicos, por estudio histológico. Resultados: El estudio macroscópico determinó que la miel a dosis de 5 g/kg y 7,5 g/kg se asoció a úlceras gástricas significativamente menores que el piroxicam (p=0,016 y p=0,001 respectivamente); por otro lado, el efecto gastroprotector de ambas dosis fue similar al omeprazol (p>0,05). En el estudio microscópico, se halló que solo la miel a dosis de 7,5 g/kg tuvo lesiones significativamente menores al piroxicam (p=0,0018), además que el efecto gastroprotector fue similar al omeprazol (p=1). Conclusiones: La miel a dosis 7,5 g/kg mostró un efecto gastroprotector similar al del omeprazol tanto a nivel macroscópico y microscópico. La miel a dosis de 5 g/kg tuvo un efecto gastroprotector similar al omeprazol, solo a nivel macroscópico.

Objective: To determine the effect of treatment with honey in piroxicam-induced gastric ulcer in Holtzman rats. Materials and methods: 48 eight-week old female Holtzman rats, weights between 100 and 200 grams, were divided into 6 treatment groups as follow: Group A: water; Group B: piroxicam (30 mg/kg); Group C: omeprazole (5 mg/kg) and piroxicam (30 mg/kg); Group D: honey (2.5 g/kg) and piroxicam (30 mg/kg); Group E: honey (5 g/kg) and piroxicam (30 mg/kg); Group F: honey (7.5 g/kg) and piroxicam (30 mg/kg). Macroscopic studies, using Scion Image, and microscopic histological section of gastric mucosa were performed after the interventions. Results: The results of the macroscopic studies showed statistically significant differences for both doses of honey at 6 g/kg and 7.5 g/kg when compared to piroxicam (p=0.016 and p=0.001 respectively) and the gastroprotective effect was similar when compared to omeprazole (p>0.05). Microscopic studies showed statistically significant differences only for dose at 7.5 g/kg when compared to piroxicam (p=0.0018) and the gastroprotective effect was similar to omeprazole (p=1). Conclusion: Dose of honey at 7.5 g/kg showed gastroprotective effect at microscopic and macroscopic studies when compared to omeprazole.

Effective method for the detection of piroxicam in human plasma using HPLC

Abstract Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used by the general population to alleviate inflammation and pain after oral surgeries. Piroxicam is among the most commonly used NSAIDs and excels in controlling pain, swelling, trismus and other common symptoms of inflammation. This study aimed to evaluate different concentrations of piroxicam and its major metabolite, 5'-hydroxypiroxicam, in human plasma samples over time using high performance liquid chromatography (HPLC) after liquid-liquid extraction. Briefly, 10 volunteers participated in this study after approval by the Ethics Committee of Bauru School of Dentistry, Universidade de São Paulo - USP, Brazil. Volunteers received a single dose oral of piroxicam (20 mg) and had blood collected at various times following an established protocol. The methodology of liquid-liquid extraction was effective for determining concentrations of piroxicam in plasma using HPLC in 10 out of 10 volunteers while 5'-hydroxypiroxicam was only detected in 2 out of 10 volunteers.

Effects of non-selective (piroxicam) and selective (meloxicam) cyclo-oxygenase inhibitors on the intestinal contractility of rabbits.

Background: To shed some light on full characterization and utilization of nonsteroidal anti-inflammatory drugs (NSAIDs) in veterinary medicine, this study, therefore, was designed to clarify the pharmacological effects of two NSAIDs (one selective, that is meloxicam, and the other is non-selective, that is piroxicam) on intestinal contractility of rabbit as a farm animal species. Methods: Rabbits were humanely slaughtered, and segments from different parts of intestinal tracts were dissected out and an intestinal segment of about 2 cm long was fixed in an organ bath containing warm oxygenated Tyrode’s solution at 37°C. The tissue was subjected to a resting tension of 2 g and allowed to equilibrate for 30 min and then the effects of graded increased concentrations of piroxicam and meloxicam were demonstrated on the normal rhythmic motility of the isolated intestinal segments. The sites of action of piroxicam and meloxicam were tried. Results: Piroxicam and meloxicam exhibited concentration-dependent relaxations of intestinal smooth muscle segments with minimal and maximal effects of more potency by prioxicam than meloxicam. Calculated inhibitory concentration 50% were 15.45 and 23.10 μg/ml bath for piroxicam and meloxicam, respectively. Effects of either piroxicam or meloxicam did not involve cholinergic, adrenergic, histaminergic, nitrergic, or purinergic pathways as the application of the corresponding agonists/ antagonists did not affect the inhibitory response of piroxicam and meloxicam. It was assumed that the effects of the drugs were attributed to the direct effects of the drugs on the intestines in addition to inhibiting endogenous prostaglandin synthesis activity via their cyclo-oxygenase inhibiting properties. Conclusions: Data of the present study may indicate that piroxicam and meloxicam could be used effectively and safely in rabbits for their anti-inflammatory actions in small therapeutic doses. However, in large doses, they (particularly, piroxicam) may produce depressant effects on gastrointestinal tract motility that should be taken in consideration in the case of introducing these drugs in therapy with larger doses.

A comparative study of efficacy and safety of flupirtine versus piroxicamin patients with low back pain.

Background: Low back pain is a common musculoskeletal symptom caused by a variety of disorders that affect the lumbar spine. The most frustrating aspect in the treatment of low back pain is that there is “no magic bullets”. The objective of the study was to compare the efficacy and safety of flupirtine versus piroxicam in patients with back pain. Methods: This was prospective, open labeled, randomized, comparative clinical study conducted by the Departments Orthopedics and Pharmacology, BMC&H, Chitradurga. Study was conducted on 60 patients of either sex, aged above 18 years with low back pain. Assessments were done for Finger-to-Floor Distance (FFD), lumbar pain, Lasegue’s sign, tenderness of vertebral muscles, pain & sensory disturbance in lower limbs and response to therapy for efficacy. Parametric data was analyzed by t-test and proportions were compared using Chi-square test. Results: 74 patients were randomized to 2 groups of 37 each. Group I patients received flupirtine maleate 100 mg twice daily and Group II patients received piroxicam 20 mg twice daily for 14 days. 30 patients in each group completed the study and were analysed. On intergroup comparison, there was no statistical difference (p>0.05) in the efficacy parameters of finger-to-floor distance (FFD), lumbar pain, Lasegue’s sign, tenderness of vertebral muscles, sensory disturbance in lower limbs, VAS scores & global assessment of response to therapy. 13.3% in flupirtine group and 16.6% in piroxicam group reported adverse events. Conclusions: Both flupiritine and piroxicam were equally effective but flupirtine was better tolerated than piroxicam.

Cirurgia reconstrutiva com retalho cutâneo de avanço como técnica alternativa para tratamento de carcinoma de células escamosas em cães: relato de caso / Reconstructive surgery with skin flap advance as alternative technique for treating squamous cell carcinoma in dog: case report

O carcinoma de células escamosas (CCE) é uma das neoplasias mais frequentemente observadas no trato genital de cães. O tratamento de eleição para o CCE é a exérese com ampla margem cirúrgica (1 a 3 cm), porém quando a região prepucial está comprometida, se torna difícil obter margem adequada, tanto pela anatomia da região quanto pelas características agressivas dessa neoplasia. A penectomia com uretrostomia pré-escrotal seria a técnica mais indicada nesses casos, entretanto, complicações pós-cirúrgicas podem reduzir a qualidade e a expectativa de vida do animal. O objetivo deste relato foi demonstrar uma técnica cirúrgica conservativa, com base em plásticas reconstrutivas com retalhos cutâneos, como tratamento para CCE em prepúcio e região inguinal, associada ao uso do piroxicam como terapia adjuvante. O animal não apresentou recidiva do tumor ou complicações secundárias ao tratamento até a última avaliação, um ano após o término do tratamento.

Squamous cell carcinoma (SCC) is one of the most frequently neoplasms observed in genital tract in dogs. The treatment of choice for the CCE is the excision with wide surgical margin (1-3 cm), but when the foreskin region is committed becomes difficult to obtain adequate margin, due both the anatomy of the region and the aggressive characteristics of this neoplasm. The penectomy with pre-scrotal urethrostomy would be the most suitable technique in such cases, however, postoperative complications may reduce the quality and expectancy of life. The objective of this report was to present a conservative surgical technique, based on reconstructive plastic with skin flap as a treatment for SCC in prepuce and inguinal region, associated with the use of piroxicam as adjuvant therapy. The dog was evaluated during one year after the end of treatment and haven't showed any tumor recurrence or secondary complications to treatment.

Capillary electrophoresis to determine entrapment efficiency of a nanostructured lipid carrier loaded with piroxicam / 药物分析学报

A simple and fast capillary electrophoresis method has been developed to determine the amount of piroxicam loaded in a drug delivery system based on nanostructured lipid carriers (NLCs). The entrapment efficiency of the nanostructured lipid carrier was estimated by measuring the concentration of drug not entrapped in a suspension of NLC. The influence of different parameters on migration times, peak symmetry, efficiency and resolution was studied; these parameters included the pH of the electrophoretic buffer solution and the applied voltage. The piroxicam peak was obtained with a satisfactory resolution. The separation was carried out using a running buffer composed of 50 mM ammonium acetate and 13.75 mM ammonia at pH 9. The optimal voltage was 20 kV and the cartridge temperature was 20 1C. The corresponding calibration curve was linear over the range of 2.7–5.4 mg/mL of NLC suspension. The reproducibility of migration time and peak area were investigated, and the obtained RSD% values (n ? 5) were 0.99 and 2.13, respectively.

Extended Release Niosomal Hydrogel for Ocular Targeting of Piroxicam: In vitro and Ex vivo Evaluation.

This study aimed at the investigation of piroxicam-niosomal hydrogel for ocular targeting to prolong and enhance its local analgesic activity. Various formulations were prepared, characterized and evaluated ex vivo for their transocular permeation using excised cow cornea. The prepared niosomes had distinct spherical multi-lamellar shape and mean vesicle size between 1.25±0.81μm and 7.47±0.85μm. Relevant increase in drug EE% was obtained with increase of cholesterol content and surfactant’s hydrophobicity. Drug retention in vesicles was significantly (p<0.05) higher at refrigerated condition than that at the room temperature. Prolonged drug release was achieved with high niosomal cholesterol content and the mechanism of drug release can be described as Fickian diffusion. The niosomal hydrogel showed 3.7 Permeability Improvement Ratio comparing to piroxicam aqueous suspension. The optimized niosomal gel showed prolonged drug release and enhanced piroxicam ocular bioavailability due to the formation of an amorphous drug form within the gel.

Engineering Spherical Beads as an Approach to Improve the Physico-Mechanical Properties of Poorly Soluble Drugs.

Improving oral bioavailability of drugs given as solid dosage forms remains a challenge for the formulation scientists due to solubility problems. To address this encumbrance, ionotropic gelation technique has attracted considerable interest of improving the dissolution rate of highly lipophilic drugs thereby improving their bioavailability by engineering spherical agglomerates. Spherical beads of poorly water soluble drug, piroxicam, were formulated by dispersing the drug in solutions of ionic polysaccharide sodium alginate and then dropping these dispersions into a solution of the counterion calcium chloride. The droplets rapidly created gelled spheres by ionotropic gelation. Strong spherical beads could be engineered with high yield and a drug content approaching 100%. The flow characteristics of micronized rods like crystals were significantly enhanced by this agglomeration technique when compared to the non-agglomerated drug crystals. Furthermore, scanning electron microscopy, size, image analysis, dissolution profiles and compression properties of piroxicam beads were evaluated. Beads engineered by using 1% sodium alginate and 3% calcium chloride gave the most desirable results as compared to other compositions.

Comparison of Piroxicam Pharmacokinetics and Anti-Inflammatory Effect in Rats after Intra-Articular and Intramuscular Administration

This study evaluated the pharmacokinetic profile and therapeutic efficacy of piroxicam (PX), a long acting non-steroidal anti-inflammatory drug for the treatment of arthritis, following intra-articular (IA) injection in comparison to the pharmacokinetic profile and therapeutic efficacy of PX after intramuscular (IM) injection. In the pharmacokinetic study in rats, systemic exposure and pharmacokinetic parameters of PX after a single IA dose were compared with systemic exposure and pharmacokinetic parameters of PX after administration of the same dose IM (0.6 mg/kg). The anti-inflammatory and analgesic effects of IA PX were evaluated simultaneously in a monoiodoacetate-induced osteoarthritis rat model. The plasma PX concentration rapidly rose following IA injection, and it was comparable to the plasma PX concentration following IM injection, suggesting the rapid efflux of the drug molecule from the joint cavity. However, in the efficacy study, the IA PX administration significantly reduced the knee swelling by reducing the level of prostaglandin E2 in the joint, compared to that following administration of IA vehicle and after administration of the IM PX dose. In addition, we found that the anti-inflammatory and anti-nociceptive efficacies of IA PX were synergistically increased upon co-treatment with hyaluronic acid (HA), a potent agent for the treatment of osteoarthritis, at the weight ratio of 1:1 or 1:2, and these effects were more pronounced than those following administration of HA or PX alone. In conclusion, this study demonstrated the efficacy of the IA use of PX alone and/or in combination with HA in osteoarthritis.

Comparação de lornoxicam e fentanil adicionados à lidocaína em anestesia regional intravenosa / Comparison of lornoxicam and fentanyl when added to lidocaine in intravenous regional anesthesia / Comparación de lornoxicam y fentanilo adicionados a la lidocaína en la anestesia regional intravenosa

JUSTIFICATIVA E OBJETIVO: Comparar os efeitos analgésicos nos períodos intra e pós-operatório de lornoxicam e fentanil adicionados à lidocaína para anestesia regional intravenosa (ARIV) em um grupo de pacientes submetidos à cirurgia de mão. MÉTODOS: Estudo randômico, duplo-cego e controlado. Foram incluídos e randomizados 45 pacientes em três grupos: o Grupo I recebeu 3 mg.kg-1 de lidocaína a 2% (40 mL); o Grupo II recebeu 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de lornoxicam; o Grupo III recebeu 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de fentanil. O desfecho primário avaliado foi o tempo até a primeira necessidade de analgésicos no pós-operatório. RESULTADOS: Lornoxicam adicionado à lidocaína em ARIV aumentou o tempo de recuperação do bloqueio sensorial sem aumentar os efeitos colaterais, e o tempo até a primeira necessidade de analgésicos no pós-operatório em comparação com lidocaína sozinha (p < 0,001, p < 0,001, respectivamente) e fentanil adicionado à lidocaína (p < 0,001, p < 0,001, respectivamente). Além disso, também descobrimos que fentanil diminuiu a dor ocasionada pelo torniquete (p < 0,01) em comparação com lidocaína, mas mostrou efeito analgésico similar ao de lornoxicam (p > 0,05), embora os escores da escala visual analógica (EVA) relacionados à dor ocasionada pelo torniquete tenham sido menores no grupo fentanil. Lornoxicam adicionado à lidocaína em ARIV não foi superior à lidocaína sozinha para diminuir a dor ocasionada pelo torniquete. CONCLUSÃO: A adição de fentanil à lidocaína em ARIV parece ser superior à lidocaína sozinha e ao lornoxicam adicionado à lidocaína para diminuir a dor ocasionada pelo torniquete, apesar de aumentar os efeitos secundários. No entanto, lornoxicam não aumentou os efeitos secundários e proporcionou analgesia nos períodos tanto intraoperatório quanto pós-operatório. Portanto, lornoxicam pode ser mais adequado para o uso clínico.

BACKGROUND AND OBJECTIVES: In this study, our goal was to compare intraoperative and postoperative analgesic effects of lornoxicam and fentanyl when added to lidocaine Intravenous Regional Anesthesia (IVRA) in a group of outpatients who underwent hand surgery. METHODS: This is a double blind randomized study. A total of 45 patients were included, randomized into three groups. Patients in Group I (L) received 3 mg.kg-1 of 2% lidocaine 40 mL; patients in Group II (LL) received 3 mg.kg-1 lidocaine 38 mL + 2 mL lornoxicam; patients in Group III (LF) received 3 mg.kg-1 lidocaine 38 mL + 2 mL fentanyl. Our primary outcome was first analgesic requirement time at postoperative period. RESULTS: Lornoxicam added to lidocaine IVRA increased the sensory block recovery time without increasing side effects and increased first analgesic requirement time at the postoperative period when compared to lidocaine IVRA (p < 0.001, p < 0.001 respectively) and fentanyl added to lidocaine IVRA (p < 0.001, p < 0.001 respectively). In addition, we also found that fentanyl decreased tourniquet pain (p < 0.01) when compared to lidocaine but showed similar analgesic effect with lornoxicam (p > 0.05) although VAS scores related to tourniquet pain were lower in fentanyl group. Lornoxicam added to lidocaine IVRA was not superior to lidocaine IVRA in decreasing tourniquet pain. CONCLUSIONS: Addition of fentanyl to lidocaine IVRA seems to be superior to lidocaine IVRA and lornoxicam added to lidocaine IVRA groups in decreasing tourniquet pain at the expense of increasing side effects. However, lornoxicam did not increase side effects while providing intraoperative and postoperative analgesia. Therefore, lornoxicam could be more appropriate for clinical use.

JUSTIFICATIVA Y OBJETIVO: Comparar los efectos analgésicos en los períodos intra y postoperatorio del lornoxicam y del fentanilo adicionados a la lidocaína para la anestesia regional intravenosa (ARIV), en un grupo de pacientes sometidos a la cirugía de mano. MÉTODOS: Estudio aleatorio, doble ciego y controlado. Fueron incluidos y aleatorizados por el equipo de investigación 45 pacientes en tres grupos: el Grupo I recibió 3 mg.kg-1 de lidocaína al 2% (40 mL); el Grupo II recibió 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de lornoxicam; el Grupo III recibió 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de fentanilo. El resultado primario evaluado fue el tiempo hasta la primera necesidad de analgésicos en el postoperatorio. RESULTADOS: El Lornoxicam adicionado a la lidocaína en ARIV aumentó el tiempo de recuperación del bloqueo sensorial, sin aumentar los efectos colaterales y el tiempo hasta la primera necesidad de analgésicos en el postoperatorio en comparación con la lidocaína sola (p < 0,001, p < 0,001, respectivamente) y el fentanilo adicionado a la lidocaína (p < 0,001, p < 0,001, respectivamente). Además de eso, también descubrimos que el fentanilo redujo el dolor ocasionado por el torniquete (p < 0,01) en comparación con la lidocaína, pero mostró un efecto analgésico parecido con el del lornoxicam (p > 0,05), aunque las puntuaciones de la escala visual analógica (EVA) relacionadas con el efecto ocasionado por el torniquete, hayan sido menores en el grupo fentanilo. El Lornoxicam adicionado a la lidocaína en ARIV no fue superior a la lidocaína sola para reducir el dolor ocasionado por el torniquete. CONCLUSIÓN: Podemos decir que la adición del fentanilo a la lidocaína en ARIV parece ser superior a la lidocaína sola y al lornoxicam adicionado a la lidocaína para disminuir el dolor ocasionado por el torniquete, a pesar de aumentar los efectos secundarios. Sin embargo, el lornoxicam no aumentó los efectos secundarios, proporcionando una analgesia en los períodos tanto intraoperatorio como postoperatorio. Por tanto, el lornoxicam puede ser más adecuado para el uso clínico.

Characterization and Optimization of Natural Maltodextrin-based Niosome.

Natural maltodextrin, due to their outstanding merits, have received more and more attention in the field of drug delivery systems. In particular, maltodextrin seem to be the most promising materials in the preparation of niosome carriers. This study aimed to optimize and characterize the formulation of natural maltodextrin-based niosome. The natural maltodextrin was made from cilembu sweet potato starch which used partial starch hydrolysis method by α-amylase enzyme. Proniosome and niosome formulations used three various concentration of surfactant (sorbitan monostearat) which about 5 mmol, 7.5 mmol, and 10 mmol for formula 1 (F1), formula 2 (F2), and Formula 3 (F3) respectively. In addition, physical and chemical characterizations had been done to characterize maltodextrin, proniosome, and niosome. The Dextrose Equivalent (DE) value of natural maltodextrin was 7.99+0.11. Furthermore, the vesicle size of proniosome was in the range of 5μ to 13μ. The entrapment percentages of piroxicam in niosome formulations were 72.5+1.1%,, 76+1.7 %, and 77.5+1.9 % for FI, F2 and F3 respectively. It can be concluded that the result provided an indication of natural maltodextrin from Cilembu sweet potato starch are potentialy carrier in the proniosome preparation which can be used for producing niosomes.