Discriminatory Dissolution Method Development and Validation of Etoricoxib Tablets
Yasvanth Ashokraj,Atul Daroi,Raja Gupta,Aruna Khanolkar,Amol Kulkarni,Swati Laud,Milind Pokale,Sanjeet Shedge,Praveen Date +8 more
TL;DR: In this paper, the authors demonstrate the systematic development of a discriminatory dissolution method for etoricoxib, a BCS Class 2 drug exhibiting highly pH-dependent solubility, and simultaneously optimize and test for method variability, reproducibility, and robustness.
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Abstract: The availability of a discriminatory dissolution method for use in either quality control testing or product evaluation in quality by design trials is mandatory for products intended for the developed market. This study demonstrates the systematic development of a discriminatory dissolution method for etoricoxib, a BCS Class 2 drug exhibiting highly pH- dependent solubility. The pH, speed, and apparatus were simultaneously optimized and tested for method variability, reproducibility, and robustness. The discriminative power of the developed method was suitably demonstrated.
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Citations
Comparison of Downstream Processing of Nanocrystalline Solid Dispersion and Nanosuspension of Diclofenac Acid to Develop Solid Oral Dosage Form
TL;DR: A discriminatory dissolution method was developed to monitor changes in dissolution behavior due to crystal growth during processing and concluded that the one-step NanoCrySP technology was more efficient and required less downstream processing than the two-step wet media milling approach for conversion of nanocrystals to OSD.
7
Development and Validation of a Discriminatory Dissolution Testing Method for Orally Disintegrating Tablets (ODTs) of Domperidone
TL;DR: In this paper, a discriminative dissolution testing method for orally disintegrating tablets of domperidone was developed and validated using HPLC using a combination of water at pH 3 and acetonitrile (65:35 v/v).
Progressive tools and critical strategies for development of best fit PBPK model aiming better in vitro-in vivo correlation.
Arnav Golhar,Megha Sajakumar Pillai,Pooja Dhakne,Niraj Rajput,Tarang Jadav,Pinaki Sengupta +5 more
TL;DR: Various progressive dissolution models and tools, existing challenges and approaches for establishing best fit PBPK model aiming better in vitro-in vivo correlation (IVIVC), and strategies for proper selection of dissolution models as an input function in P BPK/PBBM modeling have been critically discussed.
5
Optimization and synthesis of etoricoxib-loaded low molecular weight chitosan nanoparticles
TL;DR: In this paper , the etoricoxib (ETX)-loaded low molecular weight of chitosan (LMWC) nanoparticles were obtained by ionic gelation method with sodium tripolyphosphate (TPP) as cross-linking agent.
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Dissolution testing of bilayer tablets: Method development, validation and application in post-marketing quality evaluation
Amjad Saeed Khan,Zafar Iqbal +1 more
TL;DR: In this article, a method was developed for simultaneous determination of dissolution rates of clopidogrel and aspirin from bilayer tablets using HPLC and HPLC analysis of dissolution samples.
References
Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms
TL;DR: The aims of this article are to clarify under which circumstances dissolution testing can be prognostic for in vivo performance, and to present physiological data relevant to the design of dissolution tests, particularly with respect to the composition, volume, flow rates and mixing patterns of the fluids in the gastrointestinal tract.
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TL;DR: In vitro dissolution testing plays a major role in FDA’s efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products.
Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products.
TL;DR: In vitro results combined with in silico simulations using GastroPlus support scientifically that a biowaiver for immediate release etoricoxib solid oral dosage forms is justified, and the drug can be classified as an intermediate class 1/2 drug rather than BCS class 2.
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TL;DR: It is demonstrated that hydrodynamic condition, type of dissolution testing used, and design of the paddles have an effect on dissolution rate, mass transfer rate, and the film thickness underlying the dissolution process.
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