Aceclofenac-Induced Drug Reaction with Eosinophilia and Systemic Symptoms Syndrome

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a rare but severe and potentially life-threatening systemic clinical condition. We report a case of a 44-year-old female, who developed DRESS syndrome after taking two doses of aceclofenac, paracetamol, and thiocolchicoside fixed-dose combination. The patient presented with maculopapular rashes, itching, fever, pedal edema, swelling of the face and lips, difficulty in swallowing, loose stools, and vomiting for 4 days following drug intake. Laboratory and histopathological investigations supported the diagnosis following RegiSCAR criteria. The DRESS syndrome in this patient was definite as per Naranjo’s adverse drug reaction probability scale. The patient was adequately managed using systemic corticosteroids, antibiotics, and intravenous fluids. Aceclofenac is the most likely causative agent of DRESS syndrome in this patient. Early detection and withdrawal of the suspected drug along with adequate supportive treatment are the mainstay of management.

A comparative study to assess the safety and efficacy of etoricoxib versus aceclofenac in osteoarthritis

Background: Osteoarthritis (OA) is most common form of arthritis; also referred as degenerative joint disease or “wear and tear” arthritis. Cyclooxygenase-2 (COX-2) inhibitors are effective for pain and inflammation in OA and gained importance over conventional non-steroidal anti-inflammatory agents (NSAIDs), as causes significantly less toxicity, particularly, in gastrointestinal tract. The objective of the present research was to study the short-term comparative clinical efficacy of aceclofenac and etoricoxib in patients with osteoarthritis and to compare the safety profile of the two drugs i.e. aceclofenac and etoricoxib.Methods: The present study was a prospective, open label, parallel, intention to treat 80 patients out of 102 screened for osteoarthritis in the Department of Orthopaedics, Guru Nanak Dev Hospital attached to the Government Medical College, Amritsar. Patients were randomly divided in two groups with 40 patients each. Group A patients received Tab etoricoxib 60mg once daily and Group B patients received Tab. Aceclofenac 100mg twice daily. Patients were followed up after three weeks and at six weeks for clinical efficacy and safety.Results: Both the groups found to have significant improvement in signs and symptoms of osteoarthritis. However, aceclofenac was superior to etoricoxib in terms of change in visual analogue scale score, osteoarthritic severity index, patients’ and physicians’ global assessment while, etoricoxib was superior in terms of WOMAC osteoarthritic index and safety parameters in terms of ADR.Conclusions: Etoricoxib was better than conventional NSAIDs for the symptomatic management of osteoarthritis in terms of safety profile and clinical efficacy.

Effect of aceclofenac on pharmacokinetics of phenytoin sodium in epileptic patients

Background: Epilepsy is a chronic disorder characterised by recurrent seizures/convulsions that affects people of all ages. Phenytoin sodium is an effective, cheaper, most commonly used first line drug for the treatment of epilepsy. As a result of sure encounter with various painful inflammatory conditions like chronic arthritis at some point of time the co administration of analgesics becomes inevitable in epileptic patients. Aceclofenac is a commonly prescribed, moderately COX-2 selective congener of Diclofenac. Because of similarity in some pharmacokinetic properties between Phenytoin sodium and Aceclofenac; the possibility of drug interaction between them is postulated.Methods: In this prospective randomized observational study diagnosed and stabilized patients of epilepsy of either sex of more than 18 years of age were included. Patient taking Phenytoin sodium 100mg BD and prescribed tab Aceclofenac 100mg bd for 7 days. Serum Phenytoin sodium levels were measured before and after administering Aceclofenac. Graph pad Prism software Version 6 used for statistical analysis.Results: At the end of the study, we found statistically significant effect (p = 0.0104) on serum Phenytoin sodium level. However, no statistical difference was found in any of the other parameters i.e., epilepsy outcome parameters and lab parameters - Urine routine microscopy, CBC, LFT, KFT and RBG.Conclusions: Findings in this study forms a platform for future researchers to explore this field of research by designing an interventional study with well scrutinised study population considering all pharmacokinetic parameters.

Aceclofenac induced morbilliform eruptions: a case report

Maculopapular or morbilliform eruptions may be the most common of all cutaneous drug reactions. Antimicrobials, NSAIDS, barbiturates, anticonvulsants, oral hypoglycemics etc. have been commonly implicated in these adverse reactions (ADR). Here, authors are presenting a case of a 38-year-old female with morbilliform eruptions due to aceclofenac for the treatment of joint pain. The patient was treated with antihistaminics, steroids, antimicrobials and local application of GV paint. She was discharged after eleven days with good recovery.

A prospective study comparing the safety and efficacy of combination of aceclofenac and thiocolchicoside against aceclofenac alone in low back pain

Background: Aceclofenac is a non steroidal anti-inflammatory drug commonly prescribed in patients with acute low back pain. Thiocolchicoside is a skeletal muscle relaxant which is used in combination with NSAIDs. The efficacy of a combination of aceclofenac and thiocolchicoside has to be proved over aceclofenac alone in patients with acute low back pain. Objective of this study was to compare the safety and efficacy of a combination of aceclofenac and thiocolchicoside against aceclofenac alone in patients with acute low back pain.Methods: This study was undertaken as a prospective comparative study. Patients with acute low back pain receiving either aceclofenac 100 mg or a combination of aceclofenac 100 mg and thiocolchicoside 4 mg twice daily were enrolled in the study and were divided into two groups of 50 each. The primary efficacy parameter was pain intensity measured on a visual analogue scale. Adverse effects if any were monitored at the follow up visit.Results: At the start of the study, pain intensity, measured on visual analogue scale was comparable in both the groups. At the end point, there was a reduction in pain intensity in both the groups and the reduction was more significant in the combination group (p <0.001). Adverse effects reported in both the groups were found to be comparable.Conclusions: Combination of aceclofenac and thiocolchicoside is superior to aceclofenac alone in patients with acute low back pain.

Aceclofenac Induced Stevens Johnson Syndrome: A Rare Case Report

Aceclofenac is commonly used Non Steroidal Anti-Inflammatory Drugs (NSAIDs) for musculoskeletal pain. Though mostly it is a safe drug but there were some spurious reports of Adverse Drug Reaction (ADR) by this drug. Here we report a rare occurrence of Stevens-Johnson syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) after the use of Aceclofenac. An elderly female presented to dermatology OPD with complaints of eye discharge, blackish disclouration and oedema around both the eyes and lips and a rapidly evolving rash over face and bullaes and blisters all over the body. On taking history patient stated that she is taking Tab. Aceclofenac 100 mg BD since 2 days for sprain in her Right Foot. It was diagnosed as a case of drug induced SJS and Naranjo score for this adverse drug event was six, thereby making it a

Comparison of pharmacokinetics and safety of fixed-dose combination of SKI306X and aceclofenac versus separate tablets in healthy subjects

JOINS (SKI306X) is an herbal anti-arthritic medicine that is widely used with aceclofenac for treating osteoarthritis in Korea. A fixed-dose combination (FDC) tablet containing SKI306X and aceclofenac was developed to improve patient compliance. This study aimed to compare the pharmacokinetics (PK) and safety of the FDC tablet with those of co-administered SKI306X and aceclofenac in healthy subjects. In this randomized, open-label, two-way crossover, single-dose study, the FDC tablet (SKI306X 300 mg/aceclofenac 100 mg) (test) was given or co-administration of 300 mg of SKI306X and 100 mg of aceclofenac (reference) was performed followed by a 7-day wash-out period. Blood samples were collected before and after drug administration to evaluate aceclofenac PK parameters, and safety was assessed throughout the study. A total of 54 healthy male subjects were enrolled in and completed the study. T(max) and t(1/2) of aceclofenac of the FDC tablet were similar to those of aceclofenac co-administered with SKI306X (T(max): test 2.96 h and reference 2.14 h; t(1/2): test 3.46 h and reference 4.04 h). The geometric mean ratios (90% confidence intervals) of C(max) and AUC(last) (T/R) were 0.85 (0.81 to 0.91) and 1.03 (1.01 to 1.06) respectively; these results were within the predefined range (0.8 to 1.25). There was only one drug-related adverse event (dizziness) occurred after administration of the FDC tablet; however, it was mild in severity and resolved without any complications. The FDC tablet was well tolerated and exhibited an absorption rate and extent comparable to those of SKI306X and aceclofenac administered simultaneously.

Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials

PURPOSE: Nonsteroidal anti-inflammatory drugs are a mainstay for medical treatment of chronic lower back pain (CLBP). Increased dose intervals for medication have been associated with increased patient adherence to prescriptions. The purpose of this clinical trial was to compare the efficacy and safety of a once daily dose of aceclofenac controlled release (CR) and a twice daily dose of aceclofenac for CLBP management. MATERIALS AND METHODS: A prospective, randomized, single center, open-label clinical trial was performed to compare the efficacy and safety of aceclofenac CR (200 mg once daily) to aceclofenac dose (100 mg twice daily). Fifty patients in each group were enrolled for the study. The primary end point was Visual Analogue Scale (VAS) change at baseline to that at 2 weeks after medication and safety profiles. Also, change in quality of life measured by EuroQoL 5D (EQ-5D) and Oswestry Disability Index (ODI) functional score for the lumbar spine were also assessed. RESULTS: Within groups at pre- and post-treatment, there were significant VAS reductions for aceclofenac CR and aceclofenac (p=0.028). EQ-5D increased significantly in both groups (p=0.037). ODI scores decreased significantly in both groups (p=0.012). However, there were no significant differences between aceclofenac CR and aceclofenac at pre- and post-treatment. Patients with aceclofenac CR showed significant increases in heartburn and indigestion and adverse gastrointestinal effects, compared to aceclofenac. CONCLUSION: In patients with CLBP, aceclofenac CR and aceclofenac demonstrated significant symptomatic pain relief, improvement in quality of life and functional scores. Aceclofenac CR slightly increased gastrointestinal adverse effects, such as heartburn and indigestion.

Effects of JOINS® on the pharmacokinetic profiles of aceclofenac in healthy Korean volunteers: an open-label, multiple-dose, one sequence, two-period study

JOINS, an herbal anti-arthritic drug, was developed for the treatment and pain relief of knee osteoarthritis. It was approved for use in Korea by the Ministry of Food and Drug Safety in 2001. The aim of this study was to investigate the effect of JOINS on the pharmacokinetic (PK) profiles of aceclofenac in healthy adults. A PK drug-drug interaction study was conducted in 61 healthy subjects by using an open-label, multiple-dose, one sequence, two-period design. Blood samples were collected for plasma concentrations of aceclofenac during the reference period (aceclofenac 100 mg alone) and interaction period (aceclofenac 100 mg + JOINS 300 mg). The area under the curve within a dosing interval (τ) at steady state (AUC(τ,ss)) and the C(max) at steady state (C(max,ss)) of aceclofenac were analyzed by a non-compartment model using the Phoenix® WinNonlin® software version 6.3 (Pharsight, Mountain View, CA, USA). The 90% CIs of the geometric mean ratios (GMRs) of the AUC(τ,ss) of aceclofenac with JOINS to without JOINS (D4/D3 and D11/D3) were 0.9593–1.0130 and 0.9745–1.0291, respectively, and the corresponding values for the C(max,ss) of aceclofenac with JOINS to without JOINS (D4/D3 and D11/D3) were 0.8578–0.9795 and 0.8510–0.9717. Aceclofenac alone or co-administered with JOINS was safe and well tolerated with no serious adverse drug reactions or significant differences in the severity of adverse events (AEs) between the two treatment groups. We conclude that co-administration of aceclofenac with JOINS does not influence the PK and safety profiles of aceclofenac.

Comparison of efficacy and tolerability of aceclofenac and diclofenac in osteoarthritis of knee joint.

Background: Osteoarthritis is a slowly progressive disorder associated with a hyaline cartilage loss. Non-steroidal antiinflammatory drugs play a pertinent role in management of osteoarthritis. Objectives: The study was carried out for the comparison of efficacy and tolerability of Aceclofenac and Diclofenac in patients of osteoarthritis of knee joint. Material and Methods: It is a randomised parallel group double blinded study. The study included 60 patients of confirmed osteoarthritis of knee joint, 30 patients were given Aceclofenac and 30 patients were given Diclofenac after food for 8 weeks and the patients were evaluated and compared statistically for pain intensity by VAS Score, Joint tenderness, Swelling, Erythema, Pain on movement, Functional capacity and Overall Assessment on LIKERT Scale. Results: Both the drugs caused marked improvements in the parameters of - Pain intensity, Joint tenderness, Swelling, Erythema, Pain on movement of OA knee joint but there was increased improvement in all the parameters with aceclofenac. Conclusion: Aceclofenac is the NSAID of choice in the osteoarthritis of knee joint as compare to Diclofenac.

Oral udenafil and aceclofenac for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a randomized multicenter study

BACKGROUND/AIMS: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Combination therapy w ith ora l udenafil and aceclofenac may reduce the occurrence of post-ERCP pancreatitis by targeting different pathophysiological mechanisms. We investigated whether combining udenafil and aceclofenac reduced the rates of post-ERCP pancreatitis. METHODS: A prospective, randomized, double-blind, placebo-controlled, multicenter study was conducted in four academic medical centers. Between January 2012 and June 2013, a total of 216 patients who underwent ERCP were analyzed for the occurrence of post-ERCP pancreatitis. Patients were determined to be at high risk for pancreatitis based on validated patient and procedure-related risk factors. RESULTS: Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. There were no significant differences in the rate (15.8% [17/107] vs. 16.5% [18/109], p = 0.901) and severity of post-ERCP pancreatitis between the udenafil/aceclofenac and placebo groups. One patient in each group developed severe pancreatitis. Multivariate analyses indicated that suspected dysfunction of the sphincter of Oddi and endoscopic papillary balloon dilation without sphincterotomy were associated with post-ERCP pancreatitis. CONCLUSIONS: Combination therapy with udenafil and aceclofenac is not effective for the prevention of post-ERCP pancreatitis.

Development and validation of stability-indicating RP-UPLC method for simul-taneous estimation of thiocolchicoside and aceclofenac in combined dosage form.

A stability indicating RP-UPLC method was developed and validated for the simultaneous determination of Thiocolchicoside (TCC) and Aceclofenac (ACF) in tablet dosage form. The chromatographic separation was carried out by Thermo Scientific UPLC Instrument, Accela 1250 Pump, auto sampler with PDA detector, using column Thermo Scientific hypersil gold C18, (50 x 2.1mm) particle size 1.9μm using 5% ammonium acetate buffer and methanol in the ratio of 40:60, pH was adjusted to 5 with ortho phosphoric acid as mobile phase at a flow rate of 250 μl/min with the detection at 276nm. The run times of the TCC and ACF were about 0.697 and 1.125 minutes, respectively. The detector response is linear from 4.8 μg/ml to 7.2 μg/ml and 63.8 μg/ml to 96 μg/ml concentrations for TCC and ACF respectively. The linear regression equation was found to be y = 20620x-677.68 (r2 = 0.9996) for TCC and y= 50931x-319.3 (r2 = 0.9997) for ACF. The detection limit and quantification limit was 0.076μg and 0.23μg for TCC and 0.27μg and 0.71μg for ACF. The percentage of assay of TCC and ACF were about 99.50% and 99.96% respectively. The stability indicating capability was established by forced degradation experiments. The method was satisfactorily validated as per the ICH guidelines.

UPLC-MS/MS Determination of Aceclofenac and Diclofenac in Bulk, Dosage forms and in At-line Monitoring of Aceclofenac Synthesis.

Aim: The derivatization product of diclofenac (DCL), aceclofenac (ACL), is a non-steroidal anti-inflammatory drug (NSAID) which causes faster and extended action with reduced gastrointestinal (GI) inflammation. The detection of DCL in ACL bulk and pharmaceutical products indicates incomplete synthesis and hydrolysis. In this article we have developed a UPLC-MS/MS method for analysis of ACL and DCL. The method was designed as an at-line monitoring tool for process analytical technology (PAT) application to ACL synthesis. The method was also applied for analysis of ACL and DCL in bulk and tablets. Methodology: Isocratic elution was performed on a UPLC C18 column (2.1 x 50 mm, 1.7 μm) using a mobile phase consisting of acetonitrile, water and formic acid (80:20:0.5, v/v/v). Flow rate was 0.2 mL/min and total run time was 1 min. Auto-sampler temperature was maintained at 5ºC to prevent any further degradation of ACL. Electrospray positive ionization (ESI +Ve) in multiple-reaction monitoring mode (MRM) was used for the simultaneous determination of ACL and DCL. Monitoring was performed at [M+H]+ 354.23: 250.09 and 296.13:250.1 m/z; respectively. The method was validated according to ICH guidelines Q2(R1). Results: The linearity range was 20 – 3000 ng/mL for both drugs. The developed method was accurate and precise (RSD<2%) for the determination of ACL and DCL in single solution (99.65±1.33 and 100.37±1.02 for ACL and DCL; respectively) and laboratory prepared mixtures (101.01±1.07 and 100.45±1.54 for ACL and DCL; respectively). The method was applied to Bristaflam® and Cataflam® tablets and the recovery was 100.95±0.18 and 99.15±0.62; respectively. The average recovery from reaction mixture was101.21±0.06 and 98.89±0.64 for ACL and DCL; respectively. Conclusion: The proposed UPLC-MS/MS method is valid for at-line monitoring of ACL and DCL during PAT application to ACL synthesis and drug determination in bulk and tablets.

Efficacy and Safety of Aceclofenac Controlled Release in Patients with Knee Osteoarthritis: A 4-week, Multicenter, Randomized, Comparative Clinical Study

PURPOSE: To evaluate the analgesic effect, efficacy and safety of aceclofenac controlled release (CR) in patients with chronic knee osteoarthritis (OA). MATERIALS AND METHODS: A total of 125 subjects with chronic knee OA were randomly divided into two groups: one group (n=62) was administered aceclofenac CR once daily and the other (n=63), aceclofenac immediate release (IR) twice a day for 4 weeks. A 100-mm visual analogue scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS) and range of motoin (ROM) were evaluated as the outcome measures. To evaluate the safety of the drug, adverse events, vital signs, physical examination findings, clinical laboratory values and electrocardiographic findings were evaluated. RESULTS: The VAS, KOOS and ROM were improved after 4 weeks of administration in both groups, but the differences between the two groups were not statistically significant. Significant differences between the two groups were not shown in the evaluation of the adverse events, vital sign, physical examination results, clinical laboratory values, and electrocardiography. CONCLUSIONS: The aceclofenac CR and aceclofenac IR were equally effective in patients with chronic knee OA and the clinical trial results didn't show any significant difference in safety. The new aceclofenac CR formulation was found to be effective and safe with the practical advantage of once daily administration.

The influence of aceclofenac to cartilage cell proliferation and substrate metabolism in osteoarthritis / 中国生化药物杂志

Objective To invesgate the influence of aceclofenac to cartilage cell proliferation and substrate metabolism in osteoarthritis.Methods Select 65 cases of patients with osteoarthritis who were treated in Department of Rheumatism and Hematology of Affiliated Hospital of Qinghai University from September 2011 to September 2013.Patients were divided into observation group(n=35)and control group(n=30).The observation group were treated with aceclofenac,while control group were treated with ibuprofen,Compare the efficacy of patients in two group.Compare human articular cartilage cells of 5-bromodeoxyuridine(BrdU)positive rate,the content of glycogen protein(PG)and collagen type Ⅱ in two groups. Results The effective rate of observation group and control group was 74.29%and 73.33% respectively.There was significant difference between the two groups. Compared with control group,the joints pain,joints tenderness,15 meters walking time,daily activity ability(P<0.05).The incidence of adverse reactions of observation group(1 1.43%)was significantly lower than that of control group(P<0.05 ).The difference of BrdU positive rate in two groups had no statistical significance. Ⅱ type collagen content of observation group was significantly higher than that of control group (P <0.05 ).PG of observation group was significantly lower than that of control group(P<0.05).Conclusion The efficacy of aceclofenac is good and the incidence of adverse reactions is low in treatment of osteoarthritis.Aceclofenac can alleviate clinical symptoms of patients by increasing collagen type Ⅱ and decreasing PG.

Repeated Administration of Newly Synthesized Aceclofenac Sustained Release Form Causes Agranulocytosis: Case Report of an Unforeseen Adverse Event during the Phase 1 Trial

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAIDs) for inflammatory diseases. In this report, we report a serious adverse event (AE) occurred during the phase I clinical trial for a new sustained-release (SR) formulation of aceclofenac. There was a serious adverse event (AE), agranulocytosis, induced by aceclofenac SR form. An open-labeled, repeated-doses, randomized, crossover study was conducted at Kyung Hee University Hospital and 26 Korean healthy male volunteers were enrolled. All subjects received both aceclofenac SR 200 mg once daily and aceclofenac IR 100 mg twice daily for 4 days with 11 days washout period. After 11 days washout period, one subject showed a serious decrease in the segment neutrophil (267/mm3) on a laboratory test prior to the reference drug administration in period 2. We first report a case of agranulocytosis, during a phase I clinical trial.

Development and validation of stability-indicating RP-UPLC method for simul-taneous estimation of thiocolchicoside and aceclofenac in combined dosage form.

A stability indicating RP-UPLC method was developed and validated for the simultaneous determination of Thiocolchicoside (TCC) and Aceclofenac (ACF) in tablet dosage form. The chromatographic separation was carried out by Thermo Scientific UPLC Instrument, Accela 1250 Pump, auto sampler with PDA detector, using column Thermo Scientific hypersil gold C18, (50 x 2.1mm) particle size 1.9μm using 5% ammonium acetate buffer and methanol in the ratio of 40:60, pH was adjusted to 5 with ortho phosphoric acid as mobile phase at a flow rate of 250 μl/min with the detection at 276nm. The run times of the TCC and ACF were about 0.697 and 1.125 minutes, respectively. The detector response is linear from 4.8 μg/ml to 7.2 μg/ml and 63.8 μg/ml to 96 μg/ml concentrations for TCC and ACF respectively. The linear regression equation was found to be y = 20620x-677.68 (r2 = 0.9996) for TCC and y= 50931x-319.3 (r2 = 0.9997) for ACF. The detection limit and quantification limit was 0.076μg and 0.23μg for TCC and 0.27μg and 0.71μg for ACF. The percentage of assay of TCC and ACF were about 99.50% and 99.96% respectively. The stability indicating capability was established by forced degradation experiments. The method was satisfactorily validated as per the ICH guidelines.

Bioequivalence of HCP1104, a New Fixed Dose Combination Drug and Co-administration of Eperisone 50 mg and Aceclofenac 100 mg: A Partial Replicated Crossover Study Design to Estimate the Pharmacokinetics of Highly Variable Drugs

BACKGROUND: This clinical study was conducted to compare pharmacokinetics of eperisone and aceclofenac of HCP1104, a new fixed dose combination drug with those in co-administration of eperisone 50 mg and aceclofenac 100 mg. The study used a partial replicated study design to characterize intra-subject variability of eperisone when co-administrated with aceclofenac. METHODS: A partial replicated crossover design was employed in 30 subjects. Each subject received a single dose of co-administration of eperisone 50 mg and aceclofenac 100 mg on two occasions and a single dose of 1 capsule of HCP1104. Blood samples were obtained for 24 hrs after dosing, and plasma was assayed for eperisone and aceclofenac by Liquid chromatography-electrospray ionization-mass spectrometry. RESULTS: Using an average bioequivalence criterion, the 90 % confidence limits for Ln-transformed Cmax and AUClast for aceclofenac fell wihin the acceptable range of 80 - 125 %. Point estimates of eperisone AUClast and Cmax were 1.0152 and 1.0490, respectively and the 90 % confidence interval for Cmax was 0.8499 - 1.3025. The within-subject coefficient of variation of Cmax for the reference was 50.198 %. Acceptance range for eperisone Cmax based on new bioequivalence guidance for highly variable drugs was extended to 0.6984 - 1.4319. CONCLUSION: The extent of exposure and rate of absorption of both eperisone and aceclofenac with a single dose of HCP1104 capsule were equivalent to those with co-administration of a marketed eperisone 50 mg tablet and a marketed aceclofenac 100 mg tablet under fasting conditions in healthy adult males.

Comparison The Safety and The Efficacy between the Group of using Pelubiprofen Tab. and the Group of using Aceclofenac Tab. on Back Pain Patients: Multi Institution, Double Blind, Random Sample

STUDY DESIGN: Multi institution, double blind, random sample. OBJECTIVES: We conducted a comparative study with Aceclofenac Tab, which is widely used in the clinical field in order to observe the Pelubiprofen Tab's clinical efficiency in patients with back pain. SUMMARY OF LITERATURE REVIEW: Among the numerous literatures regarding the chronic back pain, there is are few studies with Pelubiprofen Tab's clinical efficiency. MATERIALS AND METHODS: We computed an experimental model through a case control study, practiced from January, 2010 to January, 2011, and thereby, 298 back pain patients were selected. This study was conducted through a multi institution, double blind, and random sample. We compared the experimental and control groups' clinical efficiency that was estimated by VAS after 28 days of medication. Also, we compared the treatment efficiency of both drugs by using a variation of Oswestry Disability Index (ODI) and Physician's Global assessment, with a total usage of relief medicine. Also, the side effect and clinical pathologic result were tested. Statistical analysis was done with three different methods, Safety method, ITT (Intent-To-Treat), and PP (Per Protocol). Logistic regression model was used, and this result was compared by a Chi-square or Fisher's Exact test. RESULTS: Comparing the VAS of both groups, VAS decreased with statistical significance. Both groups didn't show a significant difference in VAS (p=0.6764). As the decrement of the total dosage of relief medicine, the decrease in the control group was rather higher, but the difference didn't show any statistical significance (p=0.9955). The experimental group was not inferior than that of the control group in ODI and PGA variation. Analyzing the side effect, both groups didn't show any significant difference (p=0.9843). CONCLUSIONS: As a result of the clinical trial, Pelubiprofen Tab. applied to back pain patients was not inferior to that of aceclofenac Tab., in terms of efficiency, and didn't show any significant difference in safety.

Comparative in vitro dissolution study of Aceclofenac Marketed Tablets in Two Different Dissolution Media by Validated Analytical Method.

In this study five marketed brands of aceclofenac 100 mg tablets have been evaluated using dissolution test in two different media with the aim to assess bioequivalence and to select a proper dissolution medium. Other general quality parameters of these tablets like weight variation, hardness, friability, disintegration time were also determined according to established protocols. All the brands complied with the official specification for friability, uniformity of weight, disintegration time and drug content. UV spectroscopic and RP-HPLC methods were validated for the parameters like linearity, accuracy, precision and robustness. Potency was determined by using these two methods. Potency obtained from UV method and HPLC methods were found similar with paired t test. Dissolution test results were subjected to further analysis by difference factor (f1), similarity factor (f2) and dissolution efficiency (% DE). Higher drug release was found in phosphate buffer pH 6.8 than in 0.05% sodium lauryl sulphate solution. All brands were found similar in respect of drug release in phosphate buffer pH 6.8 but they differ in respect of drug release in 0.5% sodium lauryl sulphate. So phosphate buffer pH 6.8 may be a suitable media for dissolution study of aceclofenac tablets.