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• W2957885507 abstract "The present study was undertaken to formulate sugar free Montelukast sodium chewable tablets by direct compression method using various disintegrants and superdisintegrants. The substance used as disintegrants and superdisintegrants are maize starch, pregelatinized starch, sodium starch glycolate, croscarmellose sodium and crospovidone.A total of five formulations (F-I to F-V) of sugar free Montelukast sodium chewable tablets were prepared by direct compression method. All the formulations were evaluated for both pre compression and post compression parameters as per the requirements of standards.Preformulation study of API such as organoleptic properties, solubility, compatibility study and FT- IR drug - excipients interaction study were carried out. The prepared blends were also evaluated for precompression parameters such as angle of repose, bulk density, tapped density, compressibility index and hausner’s ratio. The prepared tablets were evaluated for post compression parameters such as thickness, hardness, weight variation, friability, disintegration, wetting time, water absorption ratio, taste evaluation, assay and in vitro drug release study.From the experimental results the following points can be summarized,• In the preformulation study Montelukast sodium showed similar color, taste and odor as per the I.P specification. The results of drug excipients compatibility study showed that the excipients selected for the formulation were compatible with the API and suitable for formulation development.• FT- IR spectral studies of pure drug and drug with excipients showed that there was no interaction between the drug and excipients used in the formulation.• The results of micromeritic properties indicate that the flow property of formulation F-V showed better flow property compared with other formulations.• All formulations possessed uniform thickness. The prepared tablets also possessed good mechanical strength with sufficient hardness.• All formulations of Montelukast sodium chewable tablets passed the weight variationtest since the values are within the acceptable variation limit (±7.5) of the tablet. All formulations of Montelukast sodium chewable tablets showed less than 1% weight loss and passed the friability test.• Disintegration time of Montelukast sodium chewable tablets were found between 1.10±0.01 to 5.21±0.015 minutes. Formulation F- V showed least disintegration time (1.10±0.01 min) compared with all other formulations.• Wetting time and water absorption ratio of Montelukast sodium chewable tablets werefound to be in the range between 30 to 73 seconds and 70% to 96% respectively.Formulation F-V prepared using crospovidone as superdisintegrant showed least wetting time (30±0.54 sec) and high water absorption ratio (96.80±0.58%) among all formulation. All formulations showed good taste and better mouth feel.• The content of Montelukast sodium in chewable tablets were found within the acceptable limits. (90-110%).• In the in vitro drug release study, formulation F-V prepared using crospovidone as superdisintegrant showed maximum drug release (97.29%) at the end of 30 minutes.• The obtained data suggested that formulation (F-V) containing crospovidone as super disintegrant showed better disintegration time(1.10±0.01 min), wetting time (30±0.54sec) and in vitro drug release (97.29%) and hence formulation F-V was considered as the optimized formulation based on rapid disintegration time, wetting time and in vitro drug release.• Comparative dissolution study of optimized formulation (F-V) and marketed product was carried out and the drug release of optimized formulation (F-V) was rapid (97.29%) compared to the marketed product (88.01%) at the end of 30 minutes. From the results it was concluded that the formulation F-V showed rapid drug release compared to the marketed product.• The stability results of optimized formulation (F-V) indicated that there were no significant changes found in physical appearance, thickness, hardness, average weight, friability, disintegration, assay and in vitro drug release even after stored at 25±2°C/60%±5%RH and 40±2°C/75%±5%RH for 3 months. The results showed that the optimized formulation F-V was stable even after stored at 25±2°C/60%±5%RHand 40±2°C/75%±5%RH for a period of three months." @default.
• W2957885507 created "2019-07-23" @default.
• W2957885507 creator A5000614087 @default.
• W2957885507 date "2018-10-01" @default.
• W2957885507 modified "2023-09-26" @default.
• W2957885507 title "Formulation and Evaluation of Sugar Free Chewable Tablets of Montelukast Sodium" @default.
• W2957885507 hasPublicationYear "2018" @default.
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