Embedding a Sensitive Liquid-Core Waveguide UV Detector into an HPLC-UV System for Simultaneous Quantification of Differently Dosed Active Ingredients during Drug Release.

Rebecca Chamberlain,Bjoern B Burckhardt,Hellen Windolf,Björn Fischer,Jörg Breitkreutz

doi:10.3390/pharmaceutics14030639

Rebecca Chamberlain, Bjoern B Burckhardt + Show 3 more

Open Access

https://doi.org/10.3390/pharmaceutics14030639

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Journal: Pharmaceutics	Publication Date: Mar 14, 2022
Citations: 5	License type: CC BY 4.0

Affiliation: Heinrich Heine University Düsseldorf

Abstract

Individual dosing of pharmaceutics and personalized medicine have become important with regard to therapeutic safety. Dose adjustments, biorelevant drug release and combination of multiple active substances in one dosage form for the reduction in polymedication are essential aspects that increase the safety and acceptance of the patient’s pharmacotherapy. Therefore, not only innovative drug products but also new analytical methods are needed during the drug development phase and for quality control that can simultaneously determine different active ingredients and cover wide concentration ranges. We investigated a liquid-core waveguide UV absorbance flow cell detector coupled to an existing HPLC-UV system. A Teflon AF 2400 capillary tubing of 20 cm length was connected in series to the HPLC flow line and enabled a lower limit of quantification of 1 ng/mL pramipexole (increase in sensitivity by 20 compared to common 0.9 cm flow cells). This allowed the low-concentration of pramipexole and the higher concentrations of levodopa and benserazide occurring during drug release to be determined in a single chromatographic run within 22.5 min.

Highlights

Current therapy guidelines for the treatment of non-communicable diseases (e.g., ESC guideline on hypertension) have recently changed their recommendations based on the latest scientific data towards a dual combination at the initiation of therapy [1]
Polyvinyl alcohol (PVA) was chosen as a matrix for pramipexole, and EVA was used for the matrix of the fixed combination of levodopa and benserazide within one filament
The was improved by a factor of 20LCWwith internal reflection

Summary

Introduction

Current therapy guidelines for the treatment of non-communicable diseases (e.g., ESC guideline on hypertension) have recently changed their recommendations based on the latest scientific data towards a dual combination at the initiation of therapy [1]. A rational extension of this approach is to offer such dual or multiple combinations directly in one dosage form to increase patient adherence by reducing the number of drug products to be taken [2]. According to the FDA, a combination product is defined as a dosage form containing two or more drugs in a single pill [3]. Is the combination of drugs of interest, but personalized medicine focuses on individual dosing for each patient in terms of age, weight and comorbidities. With 3D printing it is possible to fabricate complex geometries that incorporate multiple APIs with diverse release kinetics [5–8]. This potentially allows various active ingredients to be combined in a single 3D printed tablet.

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