References of "Ciza Hamuli, Patient"
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See detailComparing the qualitative performances of handheld NIR and Raman spectrophotometers for the detection of falsified pharmaceutical products
Ciza Hamuli, Patient ULiege; Sacre, Pierre-Yves ULiege; Waffo Tchounga, Christelle ULiege et al

in Talanta (2019), 202

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 ... [more ▼]

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 evaluate the performances of various NIR and Raman handheld spectrophotometers in specific brand identification of medicines through their primary packaging. Three groups of drug samples (artemether-lumefantrine, paracetamol, and ibuprofen) were used in tablet or capsule forms. In order to perform a critical comparison, the analytical performances of the two analytical systems was compared statistically using three methods: hierarchical clustering algorithm (HCA), data-driven soft independent modeling of class analogy (DD-SIMCA) and hit quality index (HQI). The overall results show good detection abilities for NIR systems compared to Raman systems based on Matthews’s correlation coefficients, generally close to one. Raman systems are less sensitive to the physical state of the samples than the NIR systems, it also suffers of the auto-fluorescence phenomenon and the signal of highly dosed active pharmaceutical ingredient (e.g. paracetamol or lumefantrine) may mask the signal of low-dosed and weaker Raman active compounds (e.g. artemether). Hence, Raman systems are less effective for specific product identification purposes but are interesting in the context of falsification because they allow a visual interpretation of the spectral signature (presence or absence of API). [less ▲]

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See detailField survey to evaluate the prevalence of poor quality anti-infective medicines in Cameroon
Waffo Tchounga, Christelle Ange ULiege; Ciza Hamuli, Patient ULiege; Sacre, Pierre-Yves ULiege et al

Conference (2019, May 20)

Poor quality medicines pose a threat to all health systems. It is obvious that they have harmful consequences not only from the point of view of public health, but also from the economic and socio ... [more ▼]

Poor quality medicines pose a threat to all health systems. It is obvious that they have harmful consequences not only from the point of view of public health, but also from the economic and socio-economic point of view [1]. Over the past 15 years, substandards and falsified drugs have received increasing attention in scientific publications. However, there is little reliable data determining their prevalence with accuracy due to the scarcity of well-designed studies identified as having good methodological quality as well as representative sampling strategy [2-4]. In this context, we have decided to evaluate the prevalence of poor quality anti-infective medicines in two Cameroon areas (Yaoundé and Douala), inspired by the Medicines Quality Assessment Reporting Guidelines (MEDGUARG) [3] and WHO recommendations [4] for the sampling strategy and the methodology. Our study will focus on the formal private sector. Pharmacies as well as drugs products will be sampled by a stratified random sampling strategy. The study will focus on two anti-infective medicines (ciprofloxacin and metronidazole 500mg tablets) in tablets, from 96 outlets in the cities of Yaoundé and Douala that are the two main cities (Yaoundé and Douala) of Cameroon representing almost 70% of private outlets of the country. Mystery shoppers will collect samples using a specific scenario. As a prelude to our field study, screening and dosage methods have to be developed and validated in Liège University. They se methods consist of vibrational spectroscopy (near infrared and Raman spectroscopy) as first screening techniques and HPLC for identification and assay. For vibrational spectroscopy, qualitative models will be developed for identification using chemometric tools. HPLC methods will be validated following the total error approach using accuracy profile as decision tool. The medicines collected will be first analysed visually (physical appearance tests), then field methods will be implemented (screening methods: Paper Analytical Devices (PADs), handled NIR device). Finally laboratory testing (assay and confirmation methods: HPLC reference method and pharmacotechnical tests) will be performed at LANACOME (Yaoundé, Cameroon). Suspect and unusual samples will be transported to Liège University for further analyses. All these methods will be applied according to a decision tree based on observed facts. The study will be submitted to the ethics committee of the Ministry of Health in Cameroon. An accurate and fast HPLC method for identification and quantification of both metronidazole and ciprofloxacin has been developed. Identification models for some brands of ciprofloxacin and metronidazole using handled NIR and Raman devices has been developed before implementation on field. This study will allow us to evaluate not only the prevalence of poor quality anti-infective medicines marketed in Cameroon but also outlets dispensing substandard and falsified medicines. They will be distinguished into sub-standard, degraded or falsified and classified according to their country of origin, manufacturer and city of sampling. The results will be notified to the drug regulatory authority in Cameroon and if poor quality medicines are detected, we will proceed with an alert to the WHO Global Surveillance System. The estimation of the prevalence of counterfeit and falsified anti-infective medicines would be extrapolated to the entire population and depending on the information obtained, evaluate the patient health risk exposed to substandard and falsified anti-infective medicines and develop capacity-building interventions in the fight against poor quality medicines. [less ▲]

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See detailComparing the qualitative performances of handheld NIR and Raman spectrometers for the analysis of falsified pharmaceutical products.
Ciza Hamuli, Patient ULiege; Waffo Tchounga, Christelle ULiege; Coic, Laureen ULiege et al

Poster (2018, September)

The last decade has seen a significant growth of the pharmaceutical market of emerging countries to the point that it has induced many falsifications. Research activities have followed this growth but not ... [more ▼]

The last decade has seen a significant growth of the pharmaceutical market of emerging countries to the point that it has induced many falsifications. Research activities have followed this growth but not proportionately. Recently, several chemical analysis methods for the detection of counterfeit or falsified drugs have been developed using spectroscopic techniques. In this study, different spectrometers were used to collect near-infrared (NIR) and Raman spectral data sets of selected drugs to help improve existing methods. The objective of this work was to evaluate the qualitative performances of the NIR and Raman spectrometers; two benchtop equipment (NIR and Raman) and four handheld ones (three Raman and one NIR) were used. In particular, we made a critical comparison in the evaluation of the accuracy of the prediction. The predictive ability of the different equipments was compared statistically using chemometrics: clustering algorithm, soft modeling (DD-SIMCA) and hard modeling (PLS-DA). All these chemometric strategies were applied on each equipment. Clustering approaches, DD-SIMCA and PLSDA enabled us to compare the qualitative performances of handheld NIR and Raman equipment and to make a critical analysis of their use in the field of the detection of falsified drugs. [less ▲]

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See detailInvestigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo
Kalenda Tshilombo, Nicodème ULiege; Ciza Hamuli, Patient ULiege; Mbinze Kindenge, Jérémie ULiege et al

in American Journal of Analytical Chemistry (2018), 9

In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension ... [more ▼]

In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension sold in some Congolese markets. The adaptation has been done by modifying the column dimensions and adjusting the flow rate. According to the intended deployment of these methods in Demo-cratic Republic of Congo (DRC), 3 factors (analyst, day and equipment) were in-volved in the validation step while applying the classic total error measurement approach with an accuracy profile as decision tool. Since adequate results were obtained in terms of selectivity, precision, trueness and accuracy (tolerance limits of life expectancy: -6.0% and 3.8%) for levels of interest concentration, the methods have been considered for routine use on several samples from different provenances and collected in 4 major DRC cities. Out of 278 samples collected, 200 were eligible for analysis from which 28% were found under standards with several figures: pH failure, out of specification for amoxicillin content, absence of potassium clavulanate, physical modifications of the powders. As evidenced by these findings, medicines of low-quality continue to be a major public health problem requiring appropriate action to effectively address this problem. [less ▲]

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See detailDéveloppement d’une méthode générique proche infrarouge (PIR) dans le contrôle qualité et la contrefaçon des médicaments.
Ciza Hamuli, Patient ULiege; Mbinze Kindenge, Jérémie; Sacre, Pierre-Yves ULiege et al

Poster (2018, January 31)

Les médicaments antirétroviraux de mauvaise qualité sont l'un des principaux problèmes de santé publique en Afrique. Ils constituent une menace réelle pour les malades vivant avec les VIH/sida. Pour ... [more ▼]

Les médicaments antirétroviraux de mauvaise qualité sont l'un des principaux problèmes de santé publique en Afrique. Ils constituent une menace réelle pour les malades vivant avec les VIH/sida. Pour aborder une partie de ce problème, une méthode analytique permettant de détecter et de quantifier les antirétroviraux ; la spectroscopie Proche Infrarouge (PIR) a été sélectionnée pour l'analyse des médicaments ARV en raison de son faible coût, de sa rapidité et de son caractère non destructif ne nécessitant pas d’étape de préparation des échantillons. Compte tenu de ces avantages, le PIR pourrait être utilisé en première ligne dans la lutte contre la contrefaçon des médicaments ARV. Les spectres proches infrarouges des différents échantillons des médicaments ARV contenant Zidovudine ont été prélevés et comparés avec le spectre proche infrarouge de Zidovudine SCR. L’analyse de ces différents spectres a permis de sélectionner une gamme spectrale comprise entre 4500 et 8000 cm-1 dans laquelle le principe actif et les excipients absorbent modérément. La présente étude a permis de démontrer le potentiel ainsi que l’intérêt de la spectrophotométrie proche infrarouge dans la détection rapide des médicaments contrefaits [less ▲]

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See detailLes risques toxicologiques liés aux médicaments de qualité inférieure
Marini Djang'Eing'A, Roland ULiege; Kalenda Tshilombo, Nicodème ULiege; Ciza Hamuli, Patient ULiege et al

Conference (2017, October 19)

Objective: Poor quality medicines regrouping counterfeit/falsified, sub-standards and degraded are a scourge for developing countries (1). Their public health consequences are often observed for cases of ... [more ▼]

Objective: Poor quality medicines regrouping counterfeit/falsified, sub-standards and degraded are a scourge for developing countries (1). Their public health consequences are often observed for cases of low dosage of active ingredients and sometimes for the absence of these. On the basis of the observed facts as well as suspected reported cases, we were interested in deepening the information through laboratory tests. Methods: Liquid chromatography (LC), thin layer chromatography (TLC), nuclear magnetic resonance (NMR), mass spectrometry (MS), Raman imagery (Rim) and near infrared spectroscopy (NIR) were used as targeted analytical techniques in this study, associated with the principal component analysis (PCA), while the suspect samples were obtained via the public health authorities of the DR Congo, Benin and Rwanda after their seizure. Results: The observed cases are presented by therapeutic class, namely: - analgesics: (1) cases of tablets supposed to contain paracetamol and which have caused abnormal adverse effects in patients who have consumed it, namely sedative effects, polyuria and hypotension. Using LC and complementary surveys by people interview, we were able to demonstrate the presence of a benzodiazepine and at very high doses. (2) Cases of paracetamol syrup whose excipient (glycerol) was substituted by diethylene glycol and which had caused the death of a hundred babies. Using the NIR and the PCA, we were able to elucidate this substitution. - antimalarials: (case 1) cases of arthemether-lumefantrine tablets which had no therapeutic effect. By means of TLC and LC, the absence of these two active ingredients was clearly demonstrated, but the presence of starch was revealed by Rim. (Case 2) case of quinine tablets that had no expected pharmacological effect. The use of several combined techniques (TLC, LC-MS, NMR and Rim) made it possible to demonstrate the presence of a substance with an imidazole structure (antamoeba). - antibiotics: (1) amoxicillin powder which after reconstitution in hospital caused poisoning of the babies until death for some. The reconstitution of the suspension had revealed the misuse of hydrogen peroxide instead of distilled water. (2) Finally a large-scale study (80 samples of amoxicillin powder) showed that 8% of the samples were above the claimed dosage. Conclusion: The cases presented indicate that there are effectively poor quality medicines and that they are responsible of public health problems and in particular of toxicity. Appropriate measures should be taken to protect users. [less ▲]

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See detailConception, développement et optimisation des Nanoparticules lipidiques solides contenant du Temozolomide comme agent anticancéreux
Ciza Hamuli, Patient ULiege; Ilangala Booka, Ange; Prakash Rao, B. et al

Poster (2017, March 29)

Solid Lipid Nanoparticles loaded Temozolomide were prepared by simple hot nanoemulsion method and evaluated for their in vitro drug release profile. Glyceryl Monostearate was used as lipid core; Tween 80 ... [more ▼]

Solid Lipid Nanoparticles loaded Temozolomide were prepared by simple hot nanoemulsion method and evaluated for their in vitro drug release profile. Glyceryl Monostearate was used as lipid core; Tween 80 and Pluronic F-68 as surfactant and cosurfactant. The preformulation studies (FT-IR and DSC) revealed that the excipients used are compatibles to the drug. Four formulation parameters were optimized to obtain high quality nanoparticles. The physicochemical properties of the TMZD-SLNs were investigated by particle size analysis, zeta potential measurement, drug entrapment efficiency (EE), stability and in vitro release behavior. There was no significant change in term of physicochemical properties and drug release profile between predicted and actual values. The TMZD-SLNs showed stable size distribution at 151.4 nm with Z-potential of -24.2 mV, ideal drug EE (58.14±0.44%) and relative long term physical stability after being stored for 3 months. The drug release of TMZD-SLNs up to 24 hours exhibited a sustained profile compared to its release from Temozolomide aqueous solution which made it a promising carrier for oral sustained release drug delivery systems. Kinetic of drug release from optimized formulation was found to be zero order (time independent). It also showed almost linear regression in Higuchi’s plot which confirms that diffusion is one of the mechanisms for drug release. In conclusion, this study showed that it was possible to obtain by this method Temozolomide solid lipid nanoparticles with small particle size and ideal EE and finally obtain the sustained release of the drug, meanwhile avoiding adverse side effects by the conventional formulation [less ▲]

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See detailINVESTIGATION DE LA QUALITE D’ANTIBIOTIQUES A BASE D'AMOXICILLINE DANS LE CADRE DE LA SURVEILLANCE DU MARCHE OFFICIEL ET PERIPHERIQUE DE QUELQUES VILLES DE LA R.D. CONGO
Kalenda Tshilombo, Nicodème ULiege; Ciza Hamuli, Patient ULiege; Mavungu Landu, Don Jethro ULiege et al

Poster (2017, March)

Drug counterfeiting is a sad and worrisome reality, especially in developing countries where quality control is not effective and sometimes not existing at all despite political will of governments. The ... [more ▼]

Drug counterfeiting is a sad and worrisome reality, especially in developing countries where quality control is not effective and sometimes not existing at all despite political will of governments. The consequences are harmful in particular for substandard medicines that pose more threats to populations in those countries due to their direct negative impact on patients such as failure of medical treatment including development of drug resistance and even death. Socio-economic consequences and negative reputation concerning the pharmaceutical industry are also observed. Unfortunately accurate detailed data on such medicines are not easy to obtain. Most of the time available data are often estimated from case reports or studies carried out in a specific area and during a defined period.Health authorities’ in the Democratic Republic of Congo are trying to identify this scourge by set up several strategies to fight against. One of them is built on the best knowledge of drugs from several horizons through the assessment of their quality to allow appropriate measurement. In this context, we have focused our study towards amoxicillin alone and/or combined with potassium clavulanate since it is one the very used medicines in pediatric medications. The formulations are powder for suspension. Two analytical methods were developed based on the USP monography, applying isocratic liquid chromatography. Prior to their application in routine, we evaluated the suitability of these methods through validation applying the accuracy profile of total error. Since it was planned to transfer the methods to DRC, several operating factors were taken into account namely operator, day and equipment. Interesting results were obtained in terms of trueness (relative biases below than 2.3%), precision (RSD of Intermediate precision below 2.8%), accuracy (beta-expectation tolerance intervals between -6.0% and 3.8%) for the concentration levels of interest. The latter were able to allow monitoring the quality of the two active ingredients here above in the 65 samples from Congolese market. They were collected in Kinshasa, Lubumbashi, Matadi and Kolwezi at official and non-official medicines distributors, in peripheral area. The dramatic results obtained confirm that substandard and counterfeit medicines remain a crucial problem on public health in low-income countries. Appropriate measures are really needed to set up the drug quality improvement. [less ▲]

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