Formulation And Evaluation Of Liquisolid Compacts Of Lornoxicam

Objective: Objective of the present investigation was to enhance the solubility and dissolution rate of poorly water-soluble drug lornoxicam using liquisolid technique with comparative determination of in vitro release profile of liquisolid compacts and conventional formulation of lornoxicam. Methods: Formulation was prepared by a liquisolid technique using different drug concentration in a liquid vehicle and different carrier/coating ratio. Prepared liquisolid compact was evaluated for Fourier transform infrared (FTIR) spectra analysis, differential scanning calorimetry (DSC), X-ray diffraction (P-XRD), scanning electron microscopy (SEM) and in vitro dissolution study. Results: The result showed that liquisolid compacts of lornoxicam displayed significantly higher drug release rate as compared to pure drug and conventional tablet prepared. The results of both DSC and X-ray crystallography indicated loss of crystallinity of the drug upon formulated into the liquisolid compact. Conclusion: Dissolution rate of the drug from liquisolid compacts was affected by changing the drug concentration and excipient ratio. The liquisolid technique appeared to be a promising approach for improving the dissolution of poorly soluble drug lornoxicam.

Comparative study of effectiveness and safety of nonsteroidal anti-inflammatory drugs in patients of knee joint osteoarthritis of knee, tertiary care hospital, Bidar, India

Background: Osteoarthritis (OA) is a joint failure and OA is the most frequent chronic joint disease causing pain and disability. Where all the structures of joints have undergone pathological changes and they are hyaline articular cartilage loss which may be focal or non-uniform, initially it will be focal then spread all over non-uniformly. Non-Steroidal Anti Inflammatory Drugs (NSAID) are the mainstay of medical management of OA. Increased in reports suggests that GIT adverse effect with old NSAID’s and cardiovascular effects with selective cyclooxygenase-2 (COX2) inhibitors had precipitated to chase for better NSAID’s with minimal adverse effects. The current study compares the clinical effectiveness and safety of newer NSAID’s, etoricoxib, lornoxicam, to diclofenac which has been standard therapy in patients of OA of the knee joint.Methods: The current study is randomized, prospective, open-label, parallel group study conducted in 120 patients with OA of the knee joint diagnosed using American College of Rheumatology criteria. After getting the informed consent, they were randomized in three groups of 40 patients each who received tablet etoricoxib 120mg BID, tablet Lornoxicam 16mg BID, tablet diclofenac 50mg TID respectively. The duration of the study is 12 weeks. Data are calculated, tabulated and analyzed using analysis of variance (ANOVA) test, and level of significance was determined by its P value.Results: After 12weeks of treatment, the severity of pain and functional indices using visual analog scale and Western Ontario and McMaster Universities Osteoarthritis score were significantly better (P <0.05) in etoricoxib group as compared to lornoxicam or diclofenac group along with a lesser rate of adverse effects.Conclusions: It is concluded that etoricoxib is more effective and tolerated NSAID than lornoxicam and diclofenac in the treatment of knee joint OA.

Lornoxicam,clinical observation and peptide drugs in the treatment of osteoarthritis / 中国生化药物杂志

Objective To investigate the combined use of osteoarthritis treatment effect of lornoxicam and peptide drugs.Methods 260 patients with osteoarthritis treated in our hospital from May 2014 to June 2016 were selected, were randomly divided into study group and control group, each group of 130 cases.The patients in the control group were treated with sodium hyaluronate and lornoxicam, the study group was given bone peptide on the basis of the control group. The pain scores, knee function and adverse reactions were compared between the two groups.Results There was no significant difference in VAS and WOMAC scores between the two groups before treatment; after treatment, the improvement of VAS and WOMAC score in the study group was better than that in the control group (P<0.05). There was no significant difference in the incidence of adverse drug reactions between the two groups. Conclusion Sodium hyaluronate, bone peptide, lornoxicam and other drugs in the treatment of patients with osteoarthritis clinical efficacy is obvious, and fewer adverse reactions.

Clinical Observation of Lornoxicam in the Treatment of Knee Osteoarthritis / 中国药房

OBJECTIVE:To investigate the therapeutic efficacy of celecoxib in the treatment of knee osteoarthritis and its ef-fects on patin degree. METHODS:One hundred and twenty cases of knee osteoarthritis were selected from our hospital during Jan. 2014 to Jan. 2016,and then divided into control group and observation group according to therapy plan,with 60 cases in each group. Control group was given Ibuprofen sustained-release capsule 0.3 g,bid;observation group was additionally given lornoxi-cam 8 mg,bid,on the basis of control group. Both groups were treated for 4 weeks. VAS score was compared between 2 groups before and after treatment,and clinical efficacy and the occurrence of ADR were observed in 2 groups. RESULTS:There was no statistical significance in VAS score between 2 groups before treatment(P>0.05). After treatment,VAS score of 2 groups were de-creased significantly,and the observation group was significantly lower than the control group,with statistical significance (P<0.05). Clinical response rate of observation group was 95.0%,which was significantly higher than 75.0% of control group,with statistical significance (P<0.05). The incidence of ADR was 3.33% in observation group,which was significantly lower than 11.67% of control group,with statistical significance(P<0.05). CONCLUSIONS:Lornoxicam is effective for knee osteoarthritis and can significantly improve pain with good safety.

Formulation Optimization of Nanostructured Lipid Carriers Loaded with Lornoxicam by Central Compos-ite Design-response Surface Method / 中国药房

OBJECTIVE:To optimize the formulation of nanostructured lipid carriers loaded with lornoxicam (LN-NLC). METHODS:Emulsification-solvent evaporation method was used to prepare the LN-NLC. Using drug-lipid ratio,dosage of soy lec-ithin,liquid-lipid ratio (proportion of liquid lipid to total lipid) and dosage of emulsifier as factors,the overall normalized value was calculated by particle size,Zeta potential and entrapment efficiency as indexes was used as comprehensive index. Central com-posite design-response surface method was used to optimize the formulation and investigate the appearance and stability of prepared LN-NLC. RESULTS:The optimal formulation were as follows as drug-lipid ratio of 1:50,dosage of soy lecithin of 162.5 mg,liq-uid-lipid ratio of 25% and emulsifier dosage of 958.2 mg. The particle size of prepared LN-NLC was(96.9±3.3)nm,Zeta poten-tial was(-16.1±0.3)mV,entrapment efficiency was(60.1±0.9)%(n=3),which showed relative error of 2.47%,-4.55%,-0.17%with predicted value,respectively. The prepared LN-NLC was spherical. It had no obvious changes in particle size and Ze-ta potential in sealed storage for 30 d in 4 ℃,and the entrapment efficiency only declined 1.2%. CONCLUSIONS:The LN-NLC formulation is successfully optimized,and the LN-NLC has good stability.

Formulation Optimization of Nanostructured Lipid Carriers Loaded with Lornoxicam by Central Compos-ite Design-response Surface Method / 中国药房

OBJECTIVE:To optimize the formulation of nanostructured lipid carriers loaded with lornoxicam (LN-NLC). METHODS:Emulsification-solvent evaporation method was used to prepare the LN-NLC. Using drug-lipid ratio,dosage of soy lec-ithin,liquid-lipid ratio (proportion of liquid lipid to total lipid) and dosage of emulsifier as factors,the overall normalized value was calculated by particle size,Zeta potential and entrapment efficiency as indexes was used as comprehensive index. Central com-posite design-response surface method was used to optimize the formulation and investigate the appearance and stability of prepared LN-NLC. RESULTS:The optimal formulation were as follows as drug-lipid ratio of 1:50,dosage of soy lecithin of 162.5 mg,liq-uid-lipid ratio of 25% and emulsifier dosage of 958.2 mg. The particle size of prepared LN-NLC was(96.9±3.3)nm,Zeta poten-tial was(-16.1±0.3)mV,entrapment efficiency was(60.1±0.9)%(n=3),which showed relative error of 2.47%,-4.55%,-0.17%with predicted value,respectively. The prepared LN-NLC was spherical. It had no obvious changes in particle size and Ze-ta potential in sealed storage for 30 d in 4 ℃,and the entrapment efficiency only declined 1.2%. CONCLUSIONS:The LN-NLC formulation is successfully optimized,and the LN-NLC has good stability.

Comparison of tramadol and lornoxicam in intravenous regional anesthesia: a randomized controlled trial / Comparação de tramadol e lornoxicam em anestesia regional por via intravenosa, um estudo randomizado e controlado

BACKGROUND AND OBJECTIVES: Tourniquet pain is one of the major obstacles for intravenous regional anesthesia. We aimed to compare tramadol and lornoxicam used in intravenous regional anesthesia as regards their effects on the quality of anesthesia, tourniquet pain and postoperative pain as well. METHODS: After the ethics committee approval 51 patients of ASA physical status I-II aged 18-65 years were enrolled. The patients were divided into three groups. Group P (n = 17) received 3 mg/kg 0.5% prilocaine; group PT (n = 17) 3 mg/kg 0.5% prilocaine + 2 mL (100 mg) tramadol and group PL (n = 17) 3 mg/kg 0.5% prilocaine + 2 mL (8 mg) lornoxicam for intravenous regional anesthesia. Sensory and motor block onset and recovery times were noted, as well as tourniquet pains and postoperative analgesic consumptions. RESULTS: Sensory block onset times in the groups PT and PL were shorter, whereas the corresponding recovery times were longer than those in the group P. Motor block onset times in the groups PT and PL were shorter than that in the group P, whereas recovery time in the group PL was longer than those in the groups P and PT. Tourniquet pain onset time was shortest in the group P and longest in the group PL. There was no difference regarding tourniquet pain among the groups. Group PL displayed the lowest analgesic consumption postoperatively. CONCLUSION: Adding tramadol and lornoxicam to prilocaine for intravenous regional anesthesia produces favorable effects on sensory and motor blockade. Postoperative analgesic consumption can be decreased by adding tramadol and lornoxicam to prilocaine in intravenous regional anesthesia.

JUSTIFICATIVA E OBJETIVOS: A dor relacionada ao torniquete é um dos maiores obstáculos para a anestesia regional intravenosa (ARIV). Nosso objetivo foi comparar tramadol e lornoxicam usados em ARIV em relação aos seus efeitos sobre a qualidade da anestesia, dor relacionada ao torniquete e dor no pós-operatório. MÉTODOS: Após a aprovação do Comitê de Ética, 51 pacientes com estado físico ASA I-II entre 18-65 anos foram inscritos. Os pacientes foram divididos em três grupos. Grupo P (n = 17) recebeu 3 mg/kg de prilocaína a 0,5%; Grupo PT (n = 17) 3 mg/kg de prilocaína a 0,5% + 2 mL (100 mg) de tramadol e Grupo PL (n = 17) de 3 mg/kg de prilocaína a 0,5% + 2 mL (8 mg) de lornoxicam para ARIV. O início do bloqueio sensorial e motor e os tempos de recuperação foram registrados, bem como a dor relacionada ao torniquete e o consumo de analgésico no pós-operatório. RESULTADOS: Os tempos de início do bloqueio sensorial foram mais curtos nos grupos PT e PL, enquanto que os tempos de recuperação correspondentes foram mais longos do que os do Grupo P. Os tempos de início do bloqueio motor nos grupos PT e PL foram menores do que no Grupo P, enquanto que o tempo de recuperação do grupo PL foi maior do que os dos grupos P e PT. O tempo para início da dor relacionada ao torniquete foi menor no Grupo P e maior no Grupo PL. Não houve diferença em relação à dor relacionada ao torniquete entre os grupos. O Grupo PL apresentou o menor consumo de analgésicos no pós-operatório. CONCLUSÃO: A adição de tramadol e lornoxicam à prilocaína para ARIV produz efeitos favoráveis sobre o bloqueio sensorial e motor. O consumo de analgésicos no pós-operatório pode ser reduzido com a adição de tramadol e lornoxicam à prilocaína em ARIV.

Effect of HPMC and ethyl cellulose polymeric granules and its combinations in press coated tablets of lornoxicam: fabrication and in vitro characterization.

The main objective of the present exploration was to formulate and evaluate chronomodulated press-coated tablets to deliver the NSAID lornoxicam, when a pain in the joints, functional disability persist in the early morning time is typically observed in most Rheumatoid arthritis (RA) patients. Pre formulation studies and drug excipient compatibility studies were carried out for lornoxicam and excipients. Core tablets containing lornoxicam was prepared by direct compression method and the tablets were subjected to various pre-compression and post-compression parameters (C1-C4 formula) based on the above result best core tablet batch was selected and used for press coating processes. HPMC and EC granules were used as controlled release polymers in the outer layer. These tablets were subjected to pre and post compression parameters, finally the tablets were evaluated for lag time and in vitro dissolution. Results of preformulation studies were acceptable limits. No interaction was observed between lornoxicam and excipients by FTIR. The results of pre and post compression studies were within limits. Formulation code CC3 was identified as best formulation that extends a release profile with 6 h lag time followed by complete lornoxicam release after 8 h. From the graphical representation it can be well perceive that this is perfectly fit in to Korsemeyer which had a Regression coefficient (R2) of 0.9431. The results of the in-vitro release data of this layer were fitted to the Korsemeyer-Peppas equation to examine the release pattern of the drug from the polymeric system. The drug release was identified as super case II transport as the “n” value found to be more than 0.89.

Analysis of 48 Cases of Lornoxicam-induced ADR in Beijing / 中国药房

OBJECTIVE:To investigate the characteristics and regularity of lornoxicam related ADR,and to provide reference for rational and safe use of lornoxicam. METHODS:From Jan. 1,2006 to Dec. 31,2013,lornoxicam related ADR reports collect-ed by National ADR Monitoring System in Beijing were analyzed retrospectively about their characteristics and related factors. RE-SULTS:In the statistical period,there were 48 ADR reports related to lornoxicam. The people over 40 years age accounted for 62.5%. 38 patients used lornoxicam by intravenous infusion or intramuscular injection ,accounting for 79.17%. The clinical mani-festations were diverse and complex,in which skin(32.96%)and gastrointestinal damage(25.00%)were more common ADR oc-curred within 30 min,accounting for 35.42%,and it would be better after stopping drug or 1-3 days symptomatic treatment. CON-CLUSIONS:The rational use of lornoxicam can reduce the occurrence of ADR. Suggestion on the use of the drug,is that the pa-tient should be monitored for security,in order to reduce the risk of ADR.

Effect of HPMC and ethyl cellulose polymeric granules and its combinations in press coated tablets of lornoxicam: fabrication and in vitro characterization.

The main objective of the present exploration was to formulate and evaluate chronomodulated press-coated tablets to deliver the NSAID lornoxicam, when a pain in the joints, functional disability persist in the early morning time is typically observed in most Rheumatoid arthritis (RA) patients. Pre formulation studies and drug excipient compatibility studies were carried out for lornox-icam and excipients. Core tablets containing lornoxicam was prepared by direct compression method and the tablets were subjected to various pre-compression and post-compression parameters (C1-C4 formula) based on the above result best core tablet batch was selected and used for press coating processes. HPMC and EC granules were used as controlled release polymers in the outer layer. These tablets were subjected to pre and post compression parameters, finally the tablets were evaluated for lag time and in vitro dissolution. Results of preformulation studies were acceptable limits. No interaction was observed between lornoxicam and excipients by FTIR. The results of pre and post compression studies were within limits. Formulation code CC3 was identified as best formulation that extends a release profile with 6 h lag time followed by complete lornoxicam release after 8 h. From the graphical representation it can be well perceive that this is perfectly fit in to Korsemeyer which had a Regression coefficient (R2) of 0.9431. The results of the in-vitro release data of this layer were fitted to the Korsemeyer-Peppas equation to examine the release pattern of the drug from the polymeric system. The drug release was identified as super case II transport as the “n” value found to be more than 0.89.

Formulation and Evaluation of Microemulsion Based Topical Hydrogel Containing Lornoxicam.

The objective of present study was to formulate hydrogel thickened Lornoxicam transdermal formulation. Eutectic mixture of camphor and menthol was chosen as oily phase (maximum 10%), solvent for Lornoxicam and powerful penetration enhancer. Tween 80, ethanol and Carbopol 934p, HPMC K-15M and Xanthan gum were selected as surfactant, co-surfactant and hydrogel thickening agent respectively. Ternary phase diagrams were constructed to obtain the concentration range of oil phase, surfactant and co-surfactant for microemulsion formulation. Hydrogel thickened microemulsions were characterized for pH, viscosity, spreadability, in vitro drug transport study with excised rat skins and invivo anti inflammatory activity. The average drug transport rate of optimized hydrogel thickened microemulsion containing 1 % w/w Lornoxicam, 10 % w/w oily phase of camphor and menthol, 30 % w/w tween 80, ethanol (2:1), 57 % w/w water, 1.5 % w/w Carbopol 934p and 0.5 % w/w Triethanolamine through rat skin was 2.02 μg/cm2/h . The percentage in vitro drug release of optimized hydrogel thickened microemulsion was 78.91 %. pH, viscosity and spreadability of optimizes batch was 6.4, 5291 cps and 5.98 gcm/sec.

Fabrication and Optimization of Novel Lornoxicam Matrix Tablets Using 3-Factor 3-Level Box-Behnken Statistical Design: Invitro and Invivo Evaluation.

In the present study efforts have been made to prepare sustained release matrix tablets of Lornoxicam. Matrix tablets were prepared by direct compression method by using Hydroxypropyl methyl cellulose K15 (HPMC- K15), Ethyl cellulose (EC) and Sodium carboxy methyl cellulose (Na-CMC) as polymers in different concentrations. A 3-factor 3- level Box-Behnken statistical design was used as an optimization tool having total of 17 experimental runs with 5 central points. All three polymers were selected as independent variables while %age drug release at various time intervals and hardness were used as dependant variables. In vivo studies were conducted on human plasma using Tenoxicam as internal standered. All the detections were made on SYKNM HPLC. Foriour Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetery (DSC) studies were conducted and no chemical interaction was found between drug and polymers. The drug release mechanism was mainly governed by non-fickian (anomalous) diffusion and zero-order (case II) transport diffusion. Regression analysis was performed on dissolution data obtained with the selected response variables and polynomial models were constructed. Polynomial models were further validated using one way ANOVA and results indicated that all the polymers used have significant effect on selected response (p>0.05). Contour plots and three dimensional response surface curves were drawn. In- vivo studies were conducted on two tablet formulation indicating slow and sustained release of the drug from matrix. From Behnken design it is possible to successfully formulate and optimize Lornoxicam sustained release matrix tablets with three polymers (HPMC- K15, EC and Na-CMC) in combination.

Implementation of time release technology in formulation development and evaluation of sustained release tablet of Lornoxicam.

In present study, the attempts have been made to formulate sustained release tablets of lornoxicam by direct compression method. Based on viscosity grades different proportions of hydrophilic polymers (HPMC K4M, HPMC K15M, HPMC K100M) are used for preparation of lornoxicam sustained release matrix tablet. The drug excipient mixtures were subjected to preformulation studies comprising of micromeritic properties. The tablets were subjected to various studies like as physicochemical studies, in vitro drug release, kinetic studies, etc. FTIR studies shown there was no interaction between drug and polymers. The physicochemical properties of tablets were found within the limits. Lornoxicam is a first generation analgesic, inflammatory & antipyretic agent used in relieving symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute sciatica and low back pain. From developed formulations batch F1 have shown zero order drug release behavior and prolong drug release over a period of 12 h which was deemed as suitable and optimum formulation for sustained drug delivery. Results of the present study indicated the suitability of the low viscous polymer in the proportion of (drug:polymer) 1:1 in the preparation of sustained release formulation of lornoxicam.

Study on preparation and transdermal permeation of lornoxicam ethosomal gel in vitro / 中国药学杂志

OBJECTIVE: To prepare lornoxicam (LN) ethosomal gel and to study its transdermal permeation in vitro. METHODS: The LN ethosomes were prepared by ethanol injection method. The formulation and the preparation method of ethosomes were optimized by orthogonal experiment using encapsulation efficiency as index. The morphology, particle size, Zeta potential and entrapment efficiency were evaluated, and the carbomer was added as the base for the preparation of the ethosomal gel. The penetration experiments of LN ethosomal gel through mouse skin were performed by Franz's cell. The concentration of LN was determined by HPLC. The cumulative penetration amount, steady penetration rate and the skin deposition of the drug were calculated. RESULTS: The obtained ethosomes were spherical, the mean size and Zeta potential were (385.6 ± 59.2) nm and (-23.49 ± 2.38) mV, respective-ly. The mean entrapment efficiency of LN in ethosomes was (73.44 ± 1.35)%. The LN ethosomal gel had a translucent yellow viscous colloidal appearance. The steady penetration rate of LN from ethosomal gel (2.81 μg · cm-2 · h-1) was 12.77, 3.51 and 2.60 times higher than that from suspensions, gel and hydroethanolic suspensions of LN, respectively. The skin deposition of the drug at the end of the experiment was statistically greater from the ethosomal gel than from other control groups. CONCLUSION: The gel is feasible in preparation technique, stable and controllable in quality and can improve transdermal penetration and increased the LN amount retain in the skin significantly.

Formulation and Evaluation of Oral Disintegrating Tablets of Lornoxicam by 3² Factorial Design.

Oral disintegrating dosage form provides an opportunity to manufacturers to extend product life cycle and to expand market. Oral disintegrating tablets (ODT) have this opportunity over conventional tablets. Lornoxicam is non steroidal anti-inflammatory drug and used in treatment of post traumatic pains, muscular and skeletal pains, joint disorder and rheumatic arthritis. Fast onset of action is required in these indications. Therefore it was thought to prepare ODT of Lornoxicam which would help to avoid first pass metabolism and to improve bioavailability as well. ODT were prepared by direct compression method by using crospovidone as superdisintegrating agent and optimized by 32 factorial design. Independent variables were concentration of crospovidone (X1) and hydroxypropyl cellulose (X2) while dependent variables were disintegration time and percent drug released. Optimised formulation, F4, showed drug content (97.90±0.37%), disintegration time (20.33±0.317 sec), percent drug released (101.5±0.59%), water absorption ratio (113.5±1.26%). This formulation was stable at 400C ±20C and RH 75%±5% for three months. Present study demonstrated potential for rapid absorption, improved bioavailability, effective therapy and patient compliance.

Development and Evaluation of self Emulsifying Drug Delivery System for Lornoxicam.

Aim of the present work was to develop and evaluate a solid self-emulsifying drug delivery system (SEDDS) for oral poorly water-soluble drug lornoxicam. The liquid (SEDDS) consisted of capmul MCM as oil phase, tween 20 as surfactant and PEG 400 as co-surfactant. Oil, surfactant and co-surfactant were selected on the basis of solubilisation capacity of drug and emulsification ability of surfactant and co-surfactants. The formulations were optimized by constructing the pseudo-ternary phase diagram. The liquid formulation was solidified by laboratory scale spray dryer, using Aerosil 200 as solid carrier. The solid SEDDS shows greater drug release thus, solid SEDDS improves the oral bioavailability and may provide the useful solid dosage form for oral poorly water soluble drugs.

Lornoxicam versus diclofenac sodium in acute renal colic: a prospective randomized trial.

Background: Acute renal colic is excruciatingly painful event, opioid analgesics and nonsteroidal anti-inflammatory drugs remain the mainstay of treatment for acute renal colic. This study compares diclofenac and lornoxicam in their efficacy to relieve pain of renal origin. Methods: Prospective, randomized, double blind clinical study including eighty patients with renal pain admitted in emergency department of a tertiary care teaching hospital. Parameters were observed at baseline and after 15, 30, 60, 180 minutes and 5hrs of drug treatment. The efficacy of the drug was measured by observing: Pain score, onset & duration of action, rescue drug use, global patient and physician impression. Results: Both drugs are effective in relieving pain of renal origin (p<0.05) and maintaining it over time as well. When decrease in value of pain score compared between two groups at various interval there was statistically significant (p<0.05) decrease in pain score only at 15 minutes in lornoxicam group showing this slightly more effective in early phase compared to diclofenac. In either group there is no statistically significant difference regarding onset of action, duration of action and side effect profile. Conclusions: Both the drugs are equally effective and safe in renal colicky pain with added advantage of lornoxicam being more effective in early period.

Azeotropic mixture used for development and validation of Lornoxicam in bulk and its tablet dosage form by spectrophotometric method / 药物分析学报

A novel,safe,economic and sensitive method of spectrophotometric estimation has been developed using Azeoptropic mixture (water∶methanol:60∶40,v/v) for the quantitative determination of Lornoxicam,a practically water-insoluble drug.Hence,Lornoxicam stock solution was prepared in Azeoptropic mixture.Lornoxicam showed maximum absorbance at 383 nm.Beer's law was obeyed in the concentration range 4-24 μg/mL with regression coefficient of 0.999.The method was validated in terms of linearity (R2=0.999),precision (CV for intra-day and inter-day was 0.28 0.68 and 0.12-0.92,respectively),accuracy (98.03-100.59％ w/w) and specificity.This method is simple,precise,accurate,sensitive and reproducible and can be used for the routine quality control testing of the marketed formulations.

Design and evaluation of lornoxicam bilayered tablets for biphasic release

The objective of the present investigation was to develop bilayered tablets of lornoxicam to achieve biphasic release pattern. A bilayered tablet, consisting of an immediate and controlled release layer, was prepared by direct compression technique. The controlled release effect was achieved by using various hydrophilic natural, semi synthetic and synthetic controlled release polymers such as xanthan gum, hydroxypropyl methylcellulose (HPMC) and polyethylene oxide (PEO) to modulate the release of the drug. The in vitro drug release profiles showed the biphasic release behavior in which the immediate release (IR) layer containing the lornoxicam was released within 15 minutes, whereas the controlled release (CR) layer controlled the drug release for up to 24 h. All the bilayered tablets formulated have followed the zero order release with non-Fickian diffusion controlled release mechanism after the initial burst release. FTIR studies revealed that there was no interaction between the drug and polymers used in the study. Statistical analysis (ANOVA) showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p < 0.05) in the amount of drug released after 24 h from optimized formulations was observed. Based on the release kinetic parameters obtained, it can be concluded that xanthan gum polymer was suitable for providing a biphasic release of lornoxicam.

O objetivo do presente trabalho foi desenvolver comprimidos bicamada de lornoxicam para atingir padrão de liberação bifásica. Preparou-se, por compressão direta, comprimido bicamada, consistindo de uma camada de liberação imediata e uma de liberação controlada. A liberação controlada foi obtida pelo uso de vários polímeros naturais hidrofílicos, semi-sintéticos e sintéticos, tais como goma xantana, hidroxipropilmetil celulose (HPMC) e óxido de polietileno (PEO) para modular a liberação do fármaco. Os perfis de liberação in vitro mostraram comportamento bifásico em que a camada de liberação imediata (IR) contendo lornoxicam foi liberada em 15 minutos, enquanto a camada de liberação controlada (CR) liberou o fármaco em mais de 24 horas, Todos os comprimidos bicamada formulados seguiram a liberação de ordem zero com mecanismo de liberação controlada por difusão não fickiana após a liberação inicial por erupção. Os estudos de FTIR revelaram que não há interação entre o fármaco e os polímeros utilizados no estudo. A análise estatística (ANOVA) não mostrou diferença significativa na quantidade acumulada de fármaco após 15 minutos de liberação, mas observou-se diferença significativa (p<0,05) na quantidade de fármaco liberado após 24 h nas formulações otimizadas. Com base nos parâmetros de cinética de liberação obtidos, pode-se concluir que a goma xantana foi adequada para se atingir liberação bifásica de lornoxicam.

New spectrophotometric methods for the determination of lornoxicam in pharmaceutical dosage forms.

Two simple and sensitive visible spectrophotometric methods (A & B) for the determination of Lornoxicam (LOC) in bulk and pharmaceutical dosage forms are described. Method A is based on oxidation of drug with Ferric Chloride and subsequent complexation of Fe(II) with 2, 2' Bipyridine to form a blood red colored species ( λmax :520 nm). Method B is based on oxidation of LOC with Ferric Chloride and chelation of Fe (II) with Bathophenanthroline to produce a blue colored chromogen (λmax: 610 nm). These methods were extended to the analysis of pharmaceutical formulations and results compared with the reference method.