Bio-Analytical Method Development for Estimation of Levofloxacin: Application in Estimation of Drug in Nano-formulations and Pharmacokinetic Studies

Maurya, Priyanka; Kumar, Abhiram; Singh, Samipta; Nisha, Raquibun; Pal, Ravi Raj; Chourasia, Manish K.; Saraf, Shubhini A.

doi:10.5530/ijper.55.3s.189

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“…Taken together, the findings of the study can be explored further for QbD optimization and the development of novel OTFs with various drugs in the future. 27,28…”

Section: Discussionmentioning

confidence: 99%

Quality by Design (QbD) Aided Formulation Optimization of Amlodipine Besylate Oral Thin Film

Kumar,

Singh

et al. 2024

Ind. J. Pharm. Edu. Res

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Background: Oral Thin Film (OTF) is an emerging approach for oral drug delivery but still there exists a scarcity of evidence for formulation optimization techniques. Herein, we aim to develop OTFs optimized by the QbD approach. Materials and Methods: OTFs were prepared by solvent casting method using Amlodipine as an active ingredient and excipients such as Pectin, Aspartame, Tween 80, and Glycerine. The developed formulation was optimized using QbD software Design Expert version 8.0.4, USA. The independent variables of the experiment were selected as A-pectin, B-Tween-80, and C-glycerine, and the dependent variables were R1-tensile strength (kg/cm 2 ), R2-permeation rate (µg/cm 2 /hr), R3-disintegration time (in a sec). Finally, the software suggested optimized formulation based on a desirability value closer to 1. Results: The optimized oral films were comparatively evaluated and characterized by various techniques. The drug release was found to be ~96% at 10 min for OTFs and ~94% at 20 min for oral fast-dissolving tablets. The amlodipine was scanned in the UV range of 200 to 400 nm and the λ max was observed to be at 240±2 in a Phosphate of pH 6.8. Conclusion: All results are found satisfactory and well within the acceptance range. This ensures that similar formulations can be optimized by using this technique in the future.

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“…Taken together, the findings of the study can be explored further for QbD optimization and the development of novel OTFs with various drugs in the future. 27,28…”

Section: Discussionmentioning

confidence: 99%

Quality by Design (QbD) Aided Formulation Optimization of Amlodipine Besylate Oral Thin Film

Kumar,

Singh

et al. 2024

Ind. J. Pharm. Edu. Res

View full text Add to dashboard Cite

show abstract

Bio-Analytical Method Development for Estimation of Levofloxacin: Application in Estimation of Drug in Nano-formulations and Pharmacokinetic Studies

Cited by 1 publication

References 0 publications

Quality by Design (QbD) Aided Formulation Optimization of Amlodipine Besylate Oral Thin Film

Quality by Design (QbD) Aided Formulation Optimization of Amlodipine Besylate Oral Thin Film

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