Quality-by-Design-Based Development of a Voxelotor Self-Nanoemulsifying Drug-Delivery System with Improved Biopharmaceutical Attributes.

Low aqueous solubility and poor oral bioavailability are limiting factors in the oral delivery of voxelotor, an antisickling agent. To overcome these limitations, a voxelotor self-nanoemulsifying drug delivery system was developed. Various oils, surfactants, and cosurfactants were screened for their solubilization potential for the drug.

Quality of antimalarials in Kinshasa peri-urban areas with regard to local pharmaceutical legislation and regulation.

Background: In the context of old pharmaceutical legislation and regulations not adapted to current realities, the aim of the present study was to evaluate the existing pharmaceutical system in peri-urban areas of Kinshasa.

Methods: A prospective study was carried out during the period 2016-2018. The most used antimalarial medicines were identified through household and pharmaceutical establishment surveys.

Comparing the qualitative performances of handheld NIR and Raman spectrophotometers for the detection of falsified pharmaceutical products.

Over the last decade, the growth of the global pharmaceutical market has led to an overall increase of substandard and falsified drugs especially on the African market (or emerging countries). Recently, several methods using handheld/portable vibrational spectroscopy have been developed for rapid and on-field drug analysis. The objective of this work was to evaluate the performances of various NIR and Raman handheld spectrophotometers in specific brand identification of medicines through their primary packaging.

Detection of Poor Quality Artemisinin-based Combination Therapy (ACT) Medicines Marketed in Benin Using Simple and Advanced Analytical Techniques.

Background: Poor quality antimalarial medicines still represent a threat to the public health, especially in Sub-Saharan Africa which bears a disproportionate share of the global burden of malaria. It is essential and urgent to strengthen mechanisms against counterfeit medicines. One of the approaches is regular market surveillance through quality controls.

Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations.

As one of the world's most significant public health challenges in low- and middle-income countries, HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from counterfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviral medicines (ARV) and 4 major excipients. Design of experiments and design space methodology were initially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations and focusing on rapidity and affordability thus using short column and low cost organic solvent (methanol) in gradient mode with 10mM buffer solutions of ammonium hydrogen carbonate.

Development, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops.

Poor quality antimalarial drugs are one of the public's major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient local drug analysis laboratories. To tackle part of this issue, two spectroscopic methods with the ability to detect and to quantify quinine dihydrochloride in children's oral drops formulations were developed and validated.

Development of a liquid chromatographic method for the simultaneous quantification of curcumin, β-arteether, tetrahydrocurcumin and dihydroartemisinin. Application to lipid-based formulations.

A liquid chromatographic method was developed for the simultaneous separation of curcumin, β-arteether, tetrahydrocurcumin and dihydroartemisinin based on the design of experiments and the design space methodology. The influence of the percentage of organic modifier, flow rate of the mobile phase and column temperature on the analytes separation was investigated. The optimal chromatographic separation was achieved on a C18 column (125mm×4mm, 5μm) using an isocratic elution with a mobile phase consisting of methanol-ammonium acetate (pH 4; 10mM) (80:20, v/v) at a flow rate of 0.

Application of an innovative design space optimization strategy to the development of LC methods for the simultaneous screening of antibiotics to combat poor quality medicines.

The poor quality of medicines is a crucial problem of public health. Therefore, it is important to have analytical tools to attend decisions of the legal authorities while combating this offense. In this context, the main objective of this study was to develop generic methods able to trace, screen and determine several antibiotics and common associated molecules by mean of liquid chromatographic techniques.

Application of an innovative design space optimization strategy to the development of liquid chromatographic methods to combat potentially counterfeit nonsteroidal anti-inflammatory drugs.

In the context of the battle against counterfeit medicines, an innovative methodology has been used to develop rapid and specific high performance liquid chromatographic methods to detect and determine 18 non-steroidal anti-inflammatory drugs, 5 pharmaceutical conservatives, paracetamol, chlorzoxazone, caffeine and salicylic acid. These molecules are commonly encountered alone or in combination on the market. Regrettably, a significant proportion of these consumed medicines are counterfeit or substandard, with a strong negative impact in countries of Central Africa.