Formulation And Evaluation Of Solid Dispersion Incorporated Fast Disintegrating Tablets Of Tenoxicam Using Design Of Experiment

The aim of the present work is to develop fast dissolving tablets from the solid dispersion of Tenoxicam for enhancement of solubility. The solid dispersions of Tenoxicam were prepared with Kollidon CL, PVP K30 and Poloxamer 127, in 1:1:1, 1:2:1 and 1:3:1 by using solvent evaporation method. The prepared solid dispersions were analyzed for all the physical parameters, drug: carrier interactions like FTIR, SEM, XRD. Solid dispersions showed a better dissolution compared to the pure drugs and among all the other formulations SD9 shows high percentage drug release i.e. 99.11 ± 5.17% for 90 min and selected as an optimized formulation for the preparation of fast disintegrating tablets of Tenoxicam. Gellan Gum, Fenugreek Seed Mucilage and L-HPC (low, middle and high concentrations) used in the preparation of fast disintegrating tablets prepared by direct compression method using 33 Response surface method. The post compression parameters of all the prepared tablets were within the limits. TF13 was selected as optimized formulation based on its highest disintegration time 36 sec and drug release 99.68 ± 1.52% for 10 min. Drug-excipients characterization also revealed that there is no interaction. Hence it concluded that solid dispersions incorporated fast disintegrating tablets is very useful approach for immediate release of Tenoxicam in the efficient management of inflammation and pain.

Comparison of the effectivity of oral and intra-articular administration of tenoxicam in patients with knee osteoarthritis / Comparação da eficácia de tenoxicam administrado por via oral e intra-articular a pacientes com osteoartrite de joelhos

ABSTRACTBACKGROUND AND OBJECTIVES:Tenoxicam is widely used in osteoarthritis treatment and we aimedto compare the effectivity of oral and intra-articular administration of tenoxicam in osteoarthri-tis treatment.METHODS: This study was performed between 2011 and 2012 by retrospectively analyzing andcomparing the findings of 60 patients who were clinically and radiologically diagnosed with kneedegenerative osteoarthritis in Bünyan state hospital pain policlinic. 60 patients included in thestudy were divided into two groups. The first group (tenoxicam IA, n = 30) included patientfindings of those subjected to intra-articular injection of 20 mg tenoxicam to the knee oncea week for three weeks and the second group (oral tenoxicam, n = 30) included patients whowere administered 20 mg oral tenoxicam once a day for three weeks. All patients were clini-cally evaluated pre-treatment and in the 1st week, 1st month and 3rd month post-treatmentaccording to specified criteria.RESULTS AND CONCLUSIONS: Twenty two of 60 patients included in the study were male and 38were female. In both groups significant improvements were detected in all of the observedparameters: visual analog scale, Western Ontario McMaster Osteoarthritis Index (pain, physicalactivity, knee stiffness) and Lequesne index scores and in the evaluations performed in 1st week,1st month and 3rd month with respect to pre-treatment values. Besides, a better complianceto treatment and gastrointestinal system tolerability in tenoxicam IA group was also observed.Intra-articular tenoxicam administration could be thought as an alternative treatment methodin patients with knee osteoarthritis who cannot use oral tenoxicam especially due to systemicgastrointestinal system side effects and those who have difficulties in adapting to treatment.

RESUMOJUSTIFICATIVA E OBJETIVOS: Tenoxicam é amplamente usado no tratamento da osteoartrite (OA)e o nosso objetivo foi comparar a eficácia de tenoxicam administrado por via oral (VO) e intra-articular (IA) no tratamento da OA.MÉTODOS: Este estudo foi conduzido entre 2011 e 2012 por meio de análise retrospectiva ecomparação dos resultados de 60 pacientes que foram clínica e radiologicamente diagnosticadoscom OA degenerativa de joelhos na Policlínica de Tratamento da Dor do Hospital Estadual deBünyan. Os 60 pacientes incluídos no estudo foram alocados em dois grupos. O primeiro grupo(tenoxicam IA, n = 30) incluiu resultados de pacientes submetidos à injeção nos joelhos porvia IA de 20 mg de tenoxicam uma vez por semana durante três semanas e o segundo grupo(tenoxicam VO, n = 30) incluiu pacientes que receberam 20 mg de tenoxicam por VO uma vezpor dia durante três semanas. Todos os pacientes foram avaliados clinicamente na fase basalpré-tratamento e em uma semana, um mês e três meses pós-tratamento, de acordo com oscritérios especificados.RESULTADOS E CONCLUSÕES: Dos 60 pacientes, 22 eram do sexo masculino e 38 do sexo feminino.Em ambos os grupos, melhorias significativas foram detectadas em todos os parâmetros da escalavisual analógica, do índice Western Ontario and MacMaster (Womac --- dor, atividade física erigidez dos joelhos) e do índice de Lequesne nas avaliações feitas em uma semana, um mês etrês meses e comparadas aos valores basais. Além disso, uma melhor adesão ao tratamento etolerabilidade ao sistema gastrointestinal no grupo tenoxicam IA também foram observadas. Aadministração de tenoxicam IA pode ser considerada como um método opcional de tratamentoem pacientes com OA de joelhos que não podem usar tenoxicam por VO, especialmente porcausa dos efeitos colaterais sobre o sistema gastrintestinal, e naqueles com dificuldades de adaptação ao tratamento.

Comparative study on two rapid and sensitive methods for quantitative determination of tenoxicam in tablets

Tenoxicam, a piroxicam analogue, is an NSAID (Non-Steroid Antinflamatory Drug). It is used in the symptomatic management of musculoskeletal and joint disorders such as osteoarthritis and rheumatoid arthritis, and also in the short-term management of soft-tissue injury. Its quantitative determination in pharmaceutical formulations is important to guarantee the desired therapeutic effects. The objective of this research was to develop, validate and compare spectrophotometric and chromatographic methods in the quantitative determination of tenoxicam in tablet preparations. In this work, tablets containing 20.0 mg of tenoxicam from different origins were analyzed. The spectrophotometric method was validated using 0.1 mol/L NaOH as solvent and a signal at 368 nm was taken. The HPLC method was validated using Synergi Hydro-RP® C18 column (250x4.6 mm, 4 µm). The mobile phase was constituted of methanol-water (61:39 v/v) with pH adjusted to 2.5 with formic acid, at a flow rate of 1.0 mL/min. UV detection was made at 375 nm. All analyses were performed with a column temperature of 25 ºC ± 1. The calibration curves were linear over a concentration range from 4.0-24.0 µg/mL with a correlation coefficient better than 0.9999. The detection limit (DL) and quantitation limit (QL) were 0.25 µg/mL and 0.90 µg/mL for UV method and 0.35 µg/mL and 1.20 µg/mL for HPLC method respectively. The intra-day and inter-day precision expressed as RSD were below 2 percent for both methods. The mean recovery of tenoxicam was found to be in the range of 98.5-101.25 percent for UV method and 99.01-101.93 percent for HPLC method. The UV and HPLC methods were found to be rapid, precise and accurate. Statistically there was no significant difference between proposed UV spectrophotometric and HPLC methods.

Tenoxicam, um análogo de piroxicam, é um AINE (Antiinflamatório Não-Esteróide). ë usado no tratamento sintomático de doenças musculoesqueléticas das juntas, tais como osteoartrite e artrite reumatóide, e, também, no tratamento de danos dos tecidos moles. Sua determinação quantitativa em formulações farmacêuticas é importante para garantir os efeitos terapêuticos desejados. O objetivo dessa pesquisa foi desenvolver, validar e comparar métodos espectrofotométrico e cromatográfico na determinação quantitativa de tenoxicam em comprimidos. Neste trabalho, comprimidos contendo 20,0 mg de tenoxicam de diferentes procedências foram analisados. O método espectrofotométrico foi validado utilizando-se 0,1 mol/L de NaOH como solvente e se obteve sinal a 368 nm. O método por CLAE foi validado utilizando-se coluna Synergi Hydri-RP® C18 (250x4,6 nm, 4µm). A fase móvel constitui-se de metanol-água (61:39 v/v), com pH ajustado para 2,5 com ácido fórmico, e velocidade de fluxo de 1,0 mL/minuto. A detecção por UV foi efetuada a 375 nm. Todas as análises foram realizadas com temperatura de coluna a 25 ºC ± 1. As curvas de calibração foram lineares na faixa de concentração de 4,0 a 24,0 µg/mL, comcoeficiente de correlação melhor que 0,9999. O limite de detecção (LD) e o limite de quantificação (LQ) foram 0,25 µg/mL e 0,90 µg/mL e 1,20 µg/mL por CLAE, respectivamente. A precisão intra e inter-dia, expressa como RSD, foi abaixo de 2 por cento para ambos os métodos. A média de recuperação do tenoxicam ficou na faixa de 98,5 a 101,25 por cento para o método de UV, e 99,01 a 101,93, para a CLAE. Os métodos de UV e de CLAE mostraram-se rápidos, precisos e exatos. Estatisticamente, não se observou diferença significativa entre os métodos espectrofotométricos (UV) e CLAE.

Incomplete Preemptive Analgesic Effects of Tenoxicam on Continuous Intravenous Analgesia with Morphine after Cesarean Section / 대한마취과학회지

BACKGROUND: The analgesic properties of the nonsteroidal antiinflammatory drugs (NSAIDs) have been attributed to their effects on the peripheral synthesis of prostaglandins. Although the preoperative use of NSAIDs has been increasing because of concerns regarding the side effects of opioid analgesics but results of clinical preemptive analgesia studies remain inconclusive. So, we studied the efficacy of preemptive analgesic effects of tenoxicam, new NSAID, on postoperative continuous intravenous analgesia with morphine. METHODS: We studied 40 parturients, undergoing cesarean section, ASA class I or II, randomly divided into two groups. Tenoxicam group were injected tenoxicam 0.3 mg/kg and control group were injected normal saline 3 ml at ten min. before induction. For both groups morphine 0.1 mg/kg was administered as loading dose and 0.015 mg/kg/hr as maintenance dose. We examined verbal quantitative score (VQS) at postoperative 30 min, 1, 6, 12, 24 and 48 hr. Maternal satisfaction, side effects, hepatic and renal function also evaluated after pain control. RESULTS: The values of VQS showed no significant differences between two groups 30 min, 1 and 6hr after start of morphine infusion, but there was significant decrease in tenoxicam group compared to control group 12, 24 and 48 hr after start of morphine infusion (p<0.05). There was no significant difference in maternal satisfaction between two groups and also there were no significant differences in the overall incidences of side effects between two groups. CONCLUSIONS: Preoperative single injection of tenoxicam showed incomplete preemptive analgesic effects on postoperative pain control after cesarean section.