Dalibor Jeremic

AQbD-driven UHPLC method for simultaneous quantification of budesonide, glycopyrronium bromide, and salbutamol sulphate: a unified approach for inhalation product and bioanalytical applications

Alessio Gaggero, Dalibor Jeremic, Anna Fedorko, Jesús Alberto Afonso Urich

Inhalation therapies often combine budesonide, glycopyrronium bromide, and salbutamol sulphate, necessitating analytical methods capable of their simultaneous quantification. Conventional UHPLC methods typically address these active pharmaceutical ingredients (APIs) individually, leading to inefficiencies in development, validation, and regulatory alignment. Analytical Quality by Design …

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Author response for "AQbD-based development of a stability-indicating UHPLC-PDA-QDa method for triptorelin in parenteral formulations"

Jesús Alberto Afonso Urich, Viktoria Marko, Anna Fedorko, Dalibor Jeremic

Author response for "AQbD-based development of a stability-indicating UHPLC-PDA-QDa method for triptorelin in parenteral formulations"

Jesús Alberto Afonso Urich, Viktoria Marko, Anna Fedorko, Dalibor Jeremic

Application of Lactose Co-Processed Excipients as an Alternative for Bridging Pharmaceutical Unit Operations: Manufacturing an Omeprazole Tablet Prototype via Direct Compression

Raymar Andreína Lara García, Jesús Alberto Afonso Urich, Andreina Isabel Afonso Urich, Dalibor Jeremic et autres

Improving the manufacturability of drug formulations via direct compression has been of great interest for the pharmaceutical industry. Selecting excipients plays a vital role in obtaining a high-quality product without the wet granulation processing step. In particular, for diluents which are usually …

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Evaluation of Analytical Quality by Design Approaches on the Development and Optimization of Size Exclusion Chromatography Analytical Procedures for Bovine Serum Albumin

Alessio Gaggero, Dalibor Jeremic, Reingard Sattler, Amrit Paudel et autres

ABSTRACT The development of analytical procedures, following the International Council of Harmonisation (ICH) regulatory requirements, is crucial for managing the lifecycle of methodologies. This study applies analytical quality by design (AQbD) principles to optimize size exclusion chromatography (SEC) determination for bovine serum …

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AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion Applications

Alessio Gaggero, Viktoria Marko, Dalibor Jeremic, Carolin Tetyczka et autres

In response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a UPLC-ELSD method to quantify Medium-Chain Triglycerides (MCTs) in Labrafac™ WL 1349 for nanoemulsion applications. This procedure, crafted using Analytical Quality by Design (AQbD) …

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AQbD-based development of a stability-indicating UHPLC-PDA-QDa method for triptorelin in parenteral formulations

Jesús Alberto Afonso Urich, Viktoria Marko, Anna Fedorko, Dalibor Jeremic

, with UV detection at 280 nm, was applied. The method was subjected to forced degradation studies under hydrolytic (acidic and basic), oxidative, and thermal stress conditions to demonstrate its stability-indicating capability. These results support its overall suitability for routine quality control …

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Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles

Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Böehm, Raymar Andreína Lara García et autres

The development of analytical procedures, in line with the recent regulatory requirements ICH Q2 (R2) and ICH Q14, is progressing, and it must be able to manage the entire life cycle of the methodology. This is also applicable to and especially challenging …

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Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Böehm, Raymar Andreína Lara García et autres

A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, which …

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PEGylation of a glycosaminoglycan-binding, dominant-negative CXCL8 mutant retains bioactivity in vitro and in vivo

Tanja Gerlza, Christina Trojacher, Dalibor Jeremic, Elmar Krieger et autres

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Targeting glycosaminoglycans in the lung by an engineered CXCL8 as a novel therapeutic approach to lung inflammation

Tiziana Adage, Viktória Kónya, Corinna Weber, Elisabeth Strutzmann et autres

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A Combinatorial Approach to Biophysically Characterise Chemokine-Glycan Binding Affinities for Drug Development

Tanja Gerlza, Bianca Hecher, Dalibor Jeremic, Thomas J. Fuchs et autres

Chemokine binding to glycosaminoglycans (GAGs) is recognised to be an important step in inflammation and other pathological disorders like tumor growth and metastasis. Although different ways and strategies to interfere with these interactions are being pursued, no major breakthrough in the development …

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