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Formulation and in Vitro Evaluation of Once Daily Sustained Release Formulation of Aceclofenac
S Ghosh, B.B Barik
Tropical Journal of Pharmaceutical Research , 2010,
Abstract: Purpose: The objective of the study was to develop matrix tablets for oral controlled release of aceclofenac using ethyl cellulose, guar gum and various grades of cellulose polymers. Methods: Possible drug-excipient interaction was evaluated by high performance liquid chromatography (HPLC) and Fourier infrared spectroscopy (FTIR). The tablets prepared were assessed for their physicochemical, in vitro drug release at pH1.2, 4.5, 6.8 and 7.5 and stability characteristics. Comparison with a ‘once daily’ commercial aceclofenac product was made in the in vitro studies. Results: There was no interaction between aceclofenac and the polymers used as excipients. Furthermore, the physicochemical properties of the tablets were satisfactory. The release profile of one of the formulated aceclofenac tablets (F7), which contained hydroxypropyl methyl cellulose (HPMC K4M), was statistically similar (p < 0.05) to that of the commercial aceclofenac brand in all the dissolution media. The formulated products ware stable and showed no changes in physical appearance, drug content, or dissolution pattern after storage at 40 oC /75 %RH for 6 months. Conclusion: The results indicate that it is feasible to achieve a stable ‘once daily’ sustained release aceclofenac tablet formulation by using HPMC K4M of 4000cps viscosity grade as matrix material.
Parasuram Rajam Radhika,Pankaj R. Kharkate,Thangavel Sivakumar
International Journal of Research in Ayurveda and Pharmacy , 2011,
Abstract: In order to reduce production costs, a simple, direct compression sustained release formulation consisting of drug Aceclofenac and by using hydrophilic polymer guar gum and tamarind gum as the release modifier was investigated. No interaction between drug and polymer was confirmed by FTIR, which shows the suitability of all excipients with the drug to formulate the sustained release matrix tablets. Five batches of sustained release matrix tablets of Aceclofenac with both guar gum and tamarind gum were prepared by using different drug: polymer ratio i.e. 1; 2, 1:2.5, 1:3, 1:3.5, and 1:4 by direct compression method. The tablets were analyzed for their various parameters such as hardness, friability, weight variation. In- vitro release was performed with the phosphate buffer of pH 7.4 for 24 hrs. Swelling index study was carried out to study the dispersibility of gums at different concentration. The results of in vitro drug release shows that as the concentration of gum increases, swelling index also increases proportionately. Batch F2 and F7 shows maximum drug release with sustained release rate and when compared F7 was more sustained. It is clear through the dissolution study and the kinetic release study of the Aceclofenac matrix tablets prepared using tamarind gum, retarded up to 24 hrs and tamarind gum is best suitable for sustained release formulation by direct compression method.
A Comparative Study of the Pharmacokinetics of Conventional and Sustained-release Tablet Formulations of Aceclofenac in Healthy Male Subjects
S Ghosh, B.B Barik
Tropical Journal of Pharmaceutical Research , 2010,
Abstract: Purpose: To examine the pharmacokinetics of a formulated aceclofenac sustained release tablet formulation and determine if it is bioequivalent to a commercial brand of aceclofenac immediate release tablet (Zerodol 100 mg). Methods: Each of two groups of twelve fasting volunteers received either the reference standard (Zerodol 100 mg tablets) or the test formulation (200 mg aceclofenac) orally once, using a cross-over design with a one week wash-out period. Their blood samples were obtained at regular time intervals over 24 h and analyzed by high performance liquid chromatography (HPLC). Using the noncompartmental approach, plasma levels of aceclofenac were employed to compute their individual disposition kinetics, including peak plasma concentration (Cmax), peak time (Tmax), area under the plasma level-time curve (AUC 0-t), elimination rate constant (Kel) and elimination half life ( t1/2). Results: The Cmax values of 11043 ± 3073 ng/ml and 12301 ± 3000 ng /ml were attained in 2.58 ± 1.22 h and 1.29 ± 0.75 h for the test and reference products, respectively, while AUCO- was 45996 ± 10427 and 50253 ± 8283 ng.h/ml, respectively. At 90% confidence interval, the C max, AUC 0-t and AUC0- values of the test preparation were 96.4 - 101.3, 100.2 -101.9 and 98.5 - 99.8%, respectively, of the values for the reference. The t1/2 values were found to be 4.50 ± 1.25 and 2.20 ± 2.59 h for the reference and test products. Conclusion: On the basis of the pharmacokinetic data, it can be said that the test aceclofenac sustained release formulation and the reference product were bioequivalent in some respects. However, the test formulation exhibited a longer elimination half-life (t1/2), thus demonstrating sustained release properties, unlike the reference.
Formulation and Evaluation of Once Daily Sustained release matrix tablet of Pramipexole Dihydrochloride
Patel Nishi A,Makwana Sandip T,Patel Zubin P,Solanki Sejal M
International Journal For Pharmaceutical Research Scholars , 2012,
Abstract: The objective of this study was to formulate & evaluate sustained release matrix tablet of PramipexoleDihydrochloride. Pramipexole Dihydrochloride being highly water soluble drug so, hydrophilic matricesalone are not able to control the drug release for 24 hours. Matrix forming agents like hydroxyl propylmethyl cellulose, rosin & glyceryl behenate in varying concentrations were studied to get the desiredsustained release profile over a period of 24 hours. The granules were evaluated for bulk density, angleof repose, compressibility index. Matrix tablets were evaluated for weight variation, hardness, friability& in-vitro release. Release profile of F11 with 15% gum rosin and 25% glyceryl behenate was found tobe 99.7% in 24 hrs which was considered as the optimized formulation. Release profile of formulationF11 was found to be very close to theoretical profile of Pramipexole. The drug release followed zeroorder and found to be diffusion controlled with erosion having high correlation for Higuchi relatedpattern.
Gum copal and gum damar: Novel matrix forming materials for sustained drug delivery  [cached]
Morkhade D,Fulzele S,Satturwar P,Joshi S
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: This study concerns the evaluation of natural gum copal and gum damar as novel sustained release matrix forming materials in tablet formulation. Along with the physicochemical properties, gum copal and gum damar were characterized for molecular weight, polydispersity index and glass transition temperature. Matrix tablets were prepared by wet granulation technique using isopropyl alcohol as a granulating agent. Diclofenac sodium was used as a model drug. Tablet weight (250 mg) and diameter (9 mm) was kept constant. Tablets were evaluated for pharmacotechnical properties, drug content uniformity and in vitro drug release kinetics. Effect of gum concentration (10, 20 and 30% w/w with respect to total tablet weight) on in vitro drug release profile was examined. Both the gums produced matrix tablets with good strength and acceptable pharmacotechnical properties. Matrix tablets with 30% w/w gum copal and gum damar showed sustained drug delivery beyond 10 h. Drug release from gum copal matrix tablets followed zero order kinetics while gum damar (10 and 20% w/w) was found suitable to formulate the insoluble plastic matrix that releases the drug by diffusion. It is concluded that both gums possess substantial matrix forming property that could be used for sustained drug delivery.
Preparation and In Vitro Evaluation of Sustained-Release Matrix Tablets of Flutamide Using Synthetic and Naturally Occurring Polymers
Jaber Emami,Mona Tajeddin,Fatemeh Ahmadi
Iranian Journal of Pharmaceutical Research , 2008,
Abstract: Frequent dosing of the potent anti-androgen, flutamide, is necessary to reach a therapeutic level for the treatment of prostatic carcinoma. Sustained delivery of the drug could reduce the adverse effects such as gastrointestinal disorders and improve patient compliance. In the present study sustained-release matrix tablets of flutamide were prepared by direct compression method using different polymers. Cellulose ethers (HPMC and NaCMC), natural gums (guar and xanthan gums) and compressible Eudragits (RSPO and RLPO) and their combinations were used in different ratios to examine their influence on tablet properties and drug release profile. Tablets were evaluated by measurement of hardness, friability, content uniformity, weight variation and drug release pattern. All the tablets met the pharmacopoeial requirements for physical tests, based on USP 29. Almost in all formulations, with increasing the percentage of polymer, release rate decreased, though drug release pattern was mainly dependent on the type of polymer. Formulations H2F4 (contained 25% HPMC) and S3F4 (contained around 40% RSPO) met the desired requirements for a sustained-release dosage form. These two formulations released their drug content with a first order kinetic.
Formulation Development and Evaluation of Bi-Layer Tablet Containing Acetaminophen and Aceclofenac Layer by Solid Dispersion Technique
Mondal S Md,Islam A,Islam A Md,Abuzar S Md
International Journal For Pharmaceutical Research Scholars , 2013,
Abstract: The objective of the study was to formulate bilayer tablets consisting of Acetaminophen and aceclofenacfor immediate drug release. Bilayer tablets were prepared by using granules of Acetaminophen and soliddispersion of aceclofenac. Granules of Acetaminophen were prepared by wet granulation technique byusing sodium starch glycolate (SSG) as super disintegrant, and sodium lauryl sulphate (SLS) used assurfactants to promote drug release in solid dispersion of aceclofenac. Bilayer tablets were evaluated forhardness, friability, weight variation, thickness and drug content uniformity and subjected to in vitrodrug release studies. The amount of Acetaminophen and aceclofenac released at different time intervalswere estimated by HPLC method. The bilayer tablets showed no significant change either in physicalappearance, drug content or in dissolution pattern after storing at 40 °C/75% relative humidity (RH) for3 months. Dissolution results of the entire tablet were analyzed with dissolution efficiency (% DE).These results indicated that release of the drug from the tablet was increased by content of superdisintegrants and surfactants in solid dispersion technique.
Rajiya Begum.G,Aleemuddin.MA,Gowtham.T,Thrishala.B
International Research Journal of Pharmacy , 2012,
Abstract: The aim of the study was to prepare and evaluate the Chlorzoxazone sustained release tablets by using natural gums in order to reduce the dose frequency and to improve the patient compliance. The tablets were prepared by direct compression method using natural gums such as Acacia (F1, F2 and F3), Guargum (F4, F5 and F6) and Tragacanth (F7, F8 and F9) at different concentrations. The tablets were evaluated for weight variation, hardness, friability, thickness, drug content uniformity and in-vitro drug release. All the formulations have passed in physical characterization as per the standard limits in average weight, hardness, thickness, friability and drug content. FT-IR studies, reveals that the drug was compatible with excipients. Based on the in-vitro drug release F3, F6 and F9 showed sustained release effect up to 12 hours (98.2%, 86.4% and 91.6%). Optimized formulation F6 was subjected to stability studies for two months at 28oc and 45oc with 75±5% RH as per ICH guidelines and result does not shows any changes in physical parameters and in-vitro release studies.
Katariya Chaitali Ramesh,Goli Ravali,Chaudhari Shilpa Praveen
International Research Journal of Pharmacy , 2012,
Abstract: Two hydrophobic polymers Eudragit RL 100 and Eudragit RS 100 were used for preparing sustained release lamivudine tablet. In this study the effect of the thermal and solvent treatment on drug release, tensile strength was studied. Increasing the sintering duration increase in the sustained release and also increase in hardness of tablet. FTIR, XRD and DSC study shows no chemical interaction between drug and polymer and no polymorphic changes in drug due to sintering. SEM analysis conformed the redistribution of polymer and smoother tablet. The solvent treatment gives more sustained release of drug compare to thermal treatment.
Pawar V. T.,Pishawikar S. A,More H. N.
International Research Journal of Pharmacy , 2011,
Abstract: An attempt has been made to develop a simple, economic, sensitive and reproducible spectrophotometric method for quantitative estimation of Aceclofenac and Paracetamol from bulk drug and in pharmaceutical formulations.The method employing Q absorbance ratio method is very simple method and can be employed for routine analysis of Aceclofenac (ACE) and Paracetamol (PARA). The proposed method for simultaneous estimation of Aceclofenac and Paracetamol utilizes the spectrum mode of analysis of Jasco V-530 spectrophotometer. The method utilizes 274 nm and 268 nm as an analytical wavelength for estimation of Aceclofenac and Paracetamol. Once the absorptivity values are determined very little time is required for analysis, as it would only require determination of absorbance’s of the sample solution at two selected wavelengths and few simple calculations. The accuracy of the method was determined by investigating the recovery of the two drugs using spiked concentrations of the standard drug. The results indicated excellent recoveries ranging from 100.49 to 101.33 % for the two drugs. Precision for tablet analysis was determined by analysis of tablets containing Aceclofenac and Paracetamol. Result of tablet analysis indicated that there was no interference of the common excipients used in the tablet formulation. Validation of this method is done as per ICHQ2B guidelines. The proposed method is highly sensitive and successfully applied for the analysis of Aceclofenac and Paracetamol in tablet formulation.
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