Joey Bose’s Post

DDL 2024 CONFERENCE POSTER: The Evaluation of Equivalence of Mometasone Furoate Nasal Sprays via an In-Vitro Pathway using Dissolution, MDRS and Laser Diffraction techniques. Not attending DDL? Request a copy now: https://lnkd.in/dpnKm3g Authors: Lily Richards, Darren Long, Mervin Ramjeeawon, Hannah Stafford & Yuen Ting Wong In May 2023, the FDA updated the Fluticasone Propionate, Mometasone Furoate and Fluticasone Furoate nasal suspensions FDA bioequivalence guidelines to include dissolution testing as an in-vitro Bioequivalence (IVBE) requirement. This update has given generic companies the opportunity to understand better the product being formulated by detecting meaningful differences between the candidate Test and Reference product formulations. The differences between the products may be minor however the knowledge gained from the dissolution testing can be further expanded on by using other orthogonal techniques, such as Morphology Directed Raman Spectroscopy (MDRS) and Particle Size Distribution (PSD) by Laser Diffraction. These additional tests can give insights into the reasons for differences seen in the dissolution data by assessing the particle size within the bulk product formulation, whilst also giving API specific size and shape information, which are critical variables that will affect dissolution (and as a result for these products, the pharmacokinetic profile observed). This design of the experimental approach is not limited to nasal sprays and can also be used to aid in de-formulation, early screening and assessment of other OINDP delivery platforms. In this study, the dissolution profiles of two commercially available Mometasone Furoate nasal sprays, which have already been proven to be bioequivalent, were appraised, and differences between these two products were further assessed using MDRS and Laser diffraction to investigate and determine the reasons behind any differences seen. #Intertek #Nasal #DrugDelivery #DrugDevelopment #Pharmaceutical

Excited to share the publication of my Ph. D research hypothesis in the journal 'Current Pharmaceutical Design', explaining the state of the art in dental caries management and novel approaches to alter oral microbiota #dentalcaries #oralhealth #AMR #Researchhypothesis #microbialbiofilm

Using lipid-liquid crystal to enable sustained release drug delivery in this newly published paper in AAPS PharmSciTech. Subcutaneous injections of phosphatidylcholine (PC), sodium deoxycholate (NADC), and a mixture of them were found to be an effective option for treating cellulite. However, it is noteworthy that the injection of NADC may result in inflammation as well as necrosis in the injection area. The preparation of a sustained release formulation based on lipid-liquid crystal that controls the release of NADC could be a potential solution to address the issue of inflammation and necrosis at the site of injection. To present a practical and validated approach for accurately determining the concentration of NADC in LLC formulations, spectrofluorimetry was used based on the International Council for Harmonization (ICH) Q2 guidelines. Based on the validation results, the fluorometric technique has been confirmed as a reliable, efficient, and economical analytical method for quantifying NADC concentrations. The method demonstrated favorable attributes of linearity, precision, and accuracy, with an r2 value of 0.999. Furthermore, it exhibited excellent interday and intraday repeatability, with RSD values below 4%. The recovery percentages ranged from 97 to 100%, indicating the method’s ability to accurately measure NADC concentrations. The subcutaneous injection of the LLC-NADC demonstrated a reduction in inflammation and tissue necrosis in skin tissue, along with an increase in fat lysis within 30 days, when compared to the administration of only NADC solution. Moreover, the histopathological assessment confirmed that the use of the LLC formulation did not result in any detrimental side effects for kidney or heart tissue. maryam kouhjani Arezoo Saberi Farzin Hadizadeh Elham Khodaverdi @malihe karimi Elahe Gholizade Hossein Kamali Ali Nokhodchi American Association of Pharmaceutical Scientists (AAPS) | @aapscomms Daniel Davis, Ph.D., PharmD Michael Repka QI (Tony) ZHOU Claudio Salomon AAPS NIPER Student Chapter #drugdelivery #drugdevelopment Link: https://rdcu.be/dzTYw

Potential of polyether ionophore compounds as antimalarials through inhibition on Plasmodium falciparum glutathione S-transferase by molecular docking studies. https://ow.ly/2Sj550Qx3w9 #Pharmacy #Pharmacology #NaturalProduct #InfectiousDisease #Malaria

Publish your papers in our Abstract/paper/poster today on Global Research Journal of Pharmaceutical & Drug Discovery , Submit your papers here: https://lnkd.in/gUY_w_Y Email: [email protected] Contact here: +447723493307 Pathology #DrugDiscoverySummit #PathologyResearch #InnovativeDrugs #DiseasePathology #DrugDevelopment #MolecularPathology #PharmaResearch #ClinicalPathology

On most days, Jomy Jose is found in the pathology lab, evaluating compounds for their toxicity, while on some days, she engages in academic pursuits. Jomy has contributed a chapter titled ‘Methods in Toxicologic Pathology' to 'Animal Models in Research: Principles and Practice’, published by Springer. This book, designed for scientists in pharmaceuticals, CROs, and CDMOs, highlights how understanding pathological methodologies can improve the assessment of compound toxicity. Effective evaluation of blood, body fluids, and tissue samples helps pinpoint target organs and determine safe dosage levels, addressing a major cause of drug attrition during pharmaceutical development. We hope that the scientific community will find value in Jomy’s work. #sailifesciences #cro #cdmo #pharma #pathology #academicwriting

Interested in exploring organellar ion channels in their native environment? You've gotta try ION Thallos-HTL - an all new way to localize Thallos, the best in class fluorescent ion indicator for measuring potassium channel activity, to intracellular compartments using Halotag technology. Discover the potential at https://lnkd.in/gdzUEMkD. #organelles #ionchannels #pharmacology #researchanddevelopment #scientificdiscovery #cellresearch #drugdiscovery #lifesciences

DDL 2024 CONFERENCE POSTER: The Evaluation of Equivalence of Mometasone Furoate Nasal Sprays via an In-Vitro Pathway using Dissolution, MDRS and Laser Diffraction techniques. Not attending DDL? Request a copy now: https://lnkd.in/dpnKm3g In May 2023, the FDA updated the Fluticasone Propionate, Mometasone Furoate and Fluticasone Furoate nasal suspensions FDA bioequivalence guidelines to include dissolution testing as an in-vitro Bioequivalence (IVBE) requirement. This update has given generic companies the opportunity to understand better the product being formulated by detecting meaningful differences between the candidate Test and Reference product formulations. The differences between the products may be minor however the knowledge gained from the dissolution testing can be further expanded on by using other orthogonal techniques, such as Morphology Directed Raman Spectroscopy (MDRS) and Particle Size Distribution (PSD) by Laser Diffraction. These additional tests can give insights into the reasons for differences seen in the dissolution data by assessing the particle size within the bulk product formulation, whilst also giving API specific size and shape information, which are critical variables that will affect dissolution (and as a result for these products, the pharmacokinetic profile observed). This design of the experimental approach is not limited to nasal sprays and can also be used to aid in de-formulation, early screening and assessment of other OINDP delivery platforms. In this study, the dissolution profiles of two commercially available Mometasone Furoate nasal sprays, which have already been proven to be bioequivalent, were appraised, and differences between these two products were further assessed using MDRS and Laser diffraction to investigate and determine the reasons behind any differences seen. Authors: Lily Richards, Darren Long, Mervin Ramjeeawon, Hannah Stafford & Yuen Ting Wong, Intertek, Saxon Way, Melbourn, Herts, SG8 6DN, UK #Intertek #Nasal #DrugDelivery #DrugDevelopment #Pharmaceutical

At Cliantha, we excel in clinical research for new chemical entities (NCEs), providing comprehensive design, execution, and analysis of trials to advance innovative treatments. To learn more, write to us at: [email protected]. #earlyphase #latephase #phase1 #phase2 #phase3 #phase4 #pharmaceuticals #drug #clinicaltrials #clinicalstudies #clinicalresearch #research #OphthalmologyResearch #Ophthalmology #OphthalmicTrials #NephrologyTrials #renal #kidney #nephrology

Potential of polyether ionophore compounds as antimalarials through inhibition on Plasmodium falciparum glutathione S-transferase by molecular docking studies. https://ow.ly/iVJx50Qx3wc #Pharmacy #Pharmacology #NaturalProduct #InfectiousDisease #Malaria