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Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial

Journal of Pharmaceutical Analysis 2017年第4期7卷 237-243页

作者： Samira Filali Charlotte Bergamelli Mamadou Lamine Tall damien Salmon diane Laleye Carole dhelens Elhadji diouf Christine Pivot Fabrice Pirot Service pharmaceutique Plateforme FRIPHARMGroupement Hospitalier Edouard Herriot5 Place d′ArsonvalF-69437 Lyon Cedex 03France laboratoire de recherche et développement de pharmacie galénique industrielle Plateforme FRIPHARMFaculté de PharmacieLaboratoire de Biologie Tissulaire et Ingénierie Thérapeutique – UMR 5305Université Claude Bernard Lyon 18 Avenue RockefellerF-69373 Lyon Cedex 08France

A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens(0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to(i) prepare low-dose melatonin hard capsules for pediatric use controlled by two complementary methods and(ii) carry out a stability study in order to determine a use-bydate. Validation of preparation process was claimed as ascertained by mass uniformity of hard *** analysis by attenuated total reflectance Fourier transformed infrared(ATR-FTIR) of melatonin/microcrystalline cellulose mixture allowed to identify and quantify relative content of active pharmaceutical ingredients and excipients. Absolute melatonin content analysis by high performance liquid chromatography in 0.5 mg and 6 mg melatonin capsules was 93.6% ± 4.1% and 98.7% ± 6.9% of theoretical value, respectively. Forced degradation study showed a good separation of melatonin and its degradation products. The capability of the method was 15, confirming a risk of false negative d dissolution test were compliant over 18 months of storage with European Pharmacopoeia. Preparation of melatonin hard capsules was completed manually and melatonin in hard capsules was stable for 18 months, in spite of low doses of active ingredient. ATR-FTIR offers a real alternative to HPLC for quality control of highdose melatonin hard capsules before the release of clinical batches.

关键词： Melatonin Stability-indicating method High-performance liquid chromatography Multicomponent infrared analysis Clinical trial Autism

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Production and stability study of a hospital parenteral nutrition solution for neonates

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Journal of Pharmaceutical Analysis 2019年第2期9卷 83-90页

作者： Anne-Laure Yailian Céline Serre Justine Fayard Marina Faucon Patrick Thomaré Samira Filali Christine Pivot Florence Vételé Fabrice Pirot Emmanuelle Olivier Service Pharmaceutique Plateforme FripharmGroupe Hospitalier Centre Edouard HerriotHospices Civils de Lyon laboratoire de recherche et développement de pharmacie galénique industrielle UMR 5305Plateforme FripharmFaculté de PharmacieUniversité Claude Bernard Lyon 18 Service Pharmaceutique Site H?tel-DieuCentre Hospitalo-Universitaire de Nantes1place Alexis Ricordeau Service pharmaceutique Groupement Hospitalier EstHospices Civils de Lyon

Standard parenteral nutrition solutions are mixtures comprising interacting components that may degrade themselves over time. The objective of this study was to investigate the physicochemical and microbiological stability of a hospital preparation for parenteral nutrition in neonatology. The analyses were performed throughout the storage of the preparations at 2–8 °C(up to 4 months). The extent of stability was based on the determination of amino acids dosage, visual and physicochemical properties(glucose and electrolytes concentrations, pH and osmolality measurements, particle counting) and microbiological analysis(sterility test). A thermal degradation of ascorbic acid was conducted to evaluate the antioxidant properties of the parenteral mixture. Physicochemical and microbiological controls were found to comply with the specifications. Amino acids showed a good stability throughout the 4 months storage except for cysteine, which was progressively degraded to cystine, conferring a yellow coloration to parenteral solutions. Parenteral nutrition standards solutions remain stable for 4 months at 2–8 °C,ensuring safe administration in preterm infants.

关键词： Stability-indicating method study Parenteral nutrition Neonatology Amino acids High-performance liquid chromatographic

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Long-term stability of gentamicin sulfate-ethylenediaminetetraacetic acid disodium salt (EdTA-Na_2) solution for catheter locks

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Journal of Pharmaceutical Analysis 2018年第6期8卷 386-393页

作者： Anne-Sophie Fiolet Elise Jandot Pauline doucey Coralie Crétet Célia Brunel Christine Pivot Jean-Marc Ghigo Christophe Beloin david Lebeaux Fabrice Pirot Service Pharmaceutique Plateforme FRIPHARM Groupe Hospitalier Centre Edouard Herriot Hospices Civils de Lyon Unité de Génétique des Biofilms Département de Microbiologie Institut Pasteur Service de Microbiologie Unité Mobile de Microbiologie Clinique Assistance Publique-H?pitaux de Paris H?pital Européen Georges Pompidou Université Paris descartes 12 rue de l'Ecole de Médecine laboratoire de recherche et développement de pharmacie galénique industrielle UMR 5305 Plateforme FRIPHARMF-69373 Faculté de Pharmacie Université Claude Bernard Lyon 1 8 avenue Rockefeller

A lock solution composed of gentamicin sulfate(5 mg/mL) and ethylenediaminetetraacetic acid disodium salt(EdTA-Na2, 30 mg/mL) could fully eradicate in vivo bacterial biofilms in totally implantable venous access ports(TIVAP). In this study, fabrication, conditioning and sterilization processes of antimicrobial lock solution(ALS) were detailed and completed by a stability study. Stability of ALS was conducted for12 months in vial(25 °C 7 2 °C, 60% 7 5% relative humidity(RH), and at 40 °C 7 2 °C, RH 75% 7 5%)and for 24 h and 72 h in TIVAP(40 °C 7 2 °C, RH 75% 7 5%). A stability indicating HPLC assay with UV detection for simultaneous quantification of gentamicin sulfate and EdTA-Na2 was developed. ALS was assayed by ion-pairing high performance liquid chromatography(HPLC) needing gentamicin derivatization, EdTA-Na2 metallocomplexation of samples and gradient mobile phase. HPLC methods to separate four gentamicin components and EdTA-Na2 were validated. Efficiency of sterility procedure and conditioning of ALS was confirmed by bacterial endotoxins and sterility tests. Physicochemical stability of ALS was determined by visual inspection, osmolality, pH, and sub-visible particle counting. Results confirmed that the stability of ALS in vials was maintained for 12 months and 24 h and 72 h in TIVAP.

关键词： Gentamicin-EdTA-Na2 loaded antimicrobial lock solution Pharmaceutical compounding Stability indicating HPLC assay method Totally implantable venous access ports

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Anti-inflammatory and analgesic activities with gastroprotective effect of semi-purified fractions and isolation of pure compounds from Mediterranean gorgonian Eunicella singularis

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Asian Pacific Journal of Tropical Medicine 2015年第8期8卷 598-603页

作者： Monia deghrigue Carmen Festa Lotfi Ghribi Maria Valeria d’Auria Simona de Marino Hichem Ben Jannet Abderrahman Bouraoui laboratoire de développement chimique galénique et pharmacologique des médicaments (LR12ES09).Equipe de Pharmacologie marineFaculté de pharmacie de MonastirUniversité de Monastir department of Pharmacy University of Naples "Federico II" laboratoire de chimie hétérocyclique produits naturels et réactivité. Equipe de chimie médicinale et produits naturels (LR11ES39)Faculté des sciences de MonastirUniversité de Monastir laboratoire de chimie hétérocyclique produits naturels et réactivité.Equipe de chimie médicinale et produits naturels (LR11ES39)Faculté des sciences de MonastirUniversité de Monastir

Objective: To explore anti-inflammatory activities of organic extract and its semi-purified fractions(ethanol, acetone, methanol/dichloromethane) from the Mediterranean gorgonian Eunicella singularis. Methods: The anti-inflammatory and analgesic activities were evaluated, using the carrageenan-induced rat paw edema model and the acetic acid writhing test in mice. The gastroprotective activity was determined using HCl/et OH induced gastric ulcers in rats. The purification and structure elucidation of compound(s) from the more effective fraction were determined by chromatographic and spectroscopic methods and in comparison with data reported in the literature. Results: The fraction F-et OH showed an important antiinflammatory activity associated with significant analgesic and gastroprotective properties. The purification and structure elucidation of compound(s) from this fraction lead to the identification of one diterpenoid and four sterols. Conclusions: These results suggested that components from the active fraction can be used to treat various anti-inflammatory diseases.

关键词： Eunicella singularis Anti-inflammatory activity Analgesic activity Gastroprotective effect diterpenoid Sterols

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Anthelmintic activity of Saba senegalensis(***.) Pichon (Apocynaceae) extract against adult worms and eggs of Haemonchus contortus

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Asian Pacific Journal of Tropical Biomedicine 2016年第11期6卷 945-949页

作者： Mohamed Bonewendé Belemlilga Aristide Traoré Sylvin Ouédraogo Adama Kaboré Hamidou Hamadou Tamboura Innocent Pierre Guissou laboratoire de développement du Médicament Centre de recherche sur le médicament Ecole Doctorale de la SantéUniversité de Ouagadougou Ecole Doctorale de Santé département Médecine Pharmacopée Traditionnelles–pharmacie (MEPHATRA-Ph) Institut de Recherche en Sciences de la Santé (IRSS/CNRST) département Productions Animales Institut de l’Environnement et de Recherches Agricoles(INERA/CNRST)

Objective: To evaluate the anthelmintic property of Saba senegalensis(***) Pichon(Apocynaceae)(S. senegalensis) on Haemonchus contortus that is traditionally used in Burkina Faso for its gastrointestinal parasites ***: The lyophilized aqueous decoction of leaves of S. senegalensis at concentrations of 0.10, 1.00, 3.00, 10.00 and 15.00 mg/m L was used on eggs and adult worms of Haemonchus contortus collected from gastrointestinal tract of small ***: The LC_(50) on adult worms was 6.79 mg/m L and 3.25 mg/m L for the leaves of S. senegalensis and the levamisole(reference drug), respectively. Inhibition of hatching assay showed a concentration-dependent manner with an inhibition of 93.63% at the concentration of 15.00 mg/m L of S. ***: These results indicate that the aqueous extract of S. senegalensis possesses an anthelmintic property and may justify its use in traditional medicine for the treatment of gastrointestinal parasites.

关键词： Saba senegalensis Anthelmintic properties Haemonchus contortus In vitro Burkina Faso

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Effect of Water Quality on Heavy Metal Redistribution and Mobility in Polluted Agricultural Soils in a Semi-Arid Region

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Pedosphere 2019年第6期29卷 730-739页

作者： Rim AZOUZI Abdelkrim CHAREF Lamia AYEd Samia KHAdHAR laboratoire Géoressources Centre des Recherches et Technologies des EauxSoliman 8020(Tunisia) laboratoire d’Analyse Traitement et Valorisation des Polluants de l’Environnement et des ProduitsFacultéde PharmacieRue AvicenneMonastir 5000(Tunisia)

Mornag Plain is a coastal area of the Mediterranean basin, which has undergone an agricultural industrial boom. The aim of this study was to investigate the different water qualities used for irrigation on heavy metal mobility in these polluted agricultural soils. The geo-accumulation indices for heavy metals (Ni, Cr, Pb, Cd, Cu, and Zn) revealed that industrial activities and used treated wastewater (TWW) contributed to soil pollution, and water irrigation always decreased this contamination. After long-term use of different water types, high perturbation of heavy metal redistribution has occurred. Groundwater use altered all heavy metal redistributions in the irrigated soil among various soil-solid and soil-solution fractions, as compared to the unirrigated soil. Slight acid water use transferred some metals from different solid phase components into water-soluble and exchangeable fractions. However, TWW use transformed some Ni, Cr, Cd, Cu, and Zn from water-soluble and exchangeable fractions to less labile fractions, particularly into organically bound fractions. Reuse of conventional water within the same soil decreased the whole soil redistribution index values, indicating tendency to return to the pattern of distribution of groundwater-irrigated soil.

关键词： Exchangeable fraction Geo-accumulation index Labile fraction Mobility factor Organically bound fraction Redistribution index Treated wastewater Water-soluble fraction

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World Journal of Gastroenterology 2016年第2期22卷 490-500页

作者： Hussein Akil Aurélie Perraud Marie-Odile Jauberteau Muriel Mathonnet laboratoire Homéostasie Cellulaire et Pathologies(LHCP-EA3842) Facultéde Médecine et de PharmacieFédération de Recherche GEIST87025 LimogesFrance Service de Chirurgie digestive Générale et EndocrinienneCHU de Limoges87042 LimogesFrance Service d’Immunologie CHU de Limoges87042 LimogesFrance

Colorectal cancer(CRC) is the second most common cause of cancer-related death in western countries. Approximately one-quarter of newly diagnosed patients for CRC have metastases, and a further 40%-50% experience disease recurrence or develop metastases after all standard therapies. Therefore, understanding the molecular mechanisms involved in the progression of CRC and subsequently developing novel therapeutic targets is crucial to improve management of CRC and patients' long-term survival. Several tyrosine kinase receptors have been implicated in CRC development, progression and metastasis, including epidermal growth factor receptor(EGFR) and vascular EGFR. Recently, tropomyosin-related kinase B(Trk B), a tyrosine kinase receptor, has been reported in CRC and found to clearly exert several biological and clinical features, such as tumor cell growth and survival in vitro and in vivo, metastasis formation and poor prognosis. Here we review the significance of Trk B and its ligand brain derived-neurotrophic factor in CRC. We focus on their expression in CRC tumor samples, and their functional roles in CRC cell lines and in in vivo models. Finally we discuss therapeutic approaches that can lead to the development of novel therapeutic agents for treating Trk B-expressing CRC tumors.

关键词： Colorectal cancer Tyrosine kinase receptor B Brain-derived neurotrophic factor Therapeutic targets Cell survival

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Induction of antiproliferative effect by diosgenin through activation of p53, release of apoptosis-inducing factor (AIF) and modulation of caspase-3 activity in different human cancer cells

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Cell Research 2004年第3期14卷 188-196页

作者： Cecile CORBIERE,Bertrand LIAGRE,Faraj TERRO,Jean-Louis BENEYTOUT laboratoire de Biochimie UPRES EA 1085 Faculté de pharmacie rue du docteur Marcland 87025 Limoges Cedex France laboratoire de Biochimie UPRES EA 1085 Faculté de pharmacie rue du docteur Marcland 87025 Limoges Cedex France Service d'Histologie et Biologic Cellulaire Faculte de Medecine rue du docteur Marcland 87025 Limoges Cedex France laboratoire de Biochimie UPRES EA 1085 Faculté de pharmacie rue du docteur Marcland 87025 Limoges Cedex France

Previously, we demonstrated that a plant steroid, diosgenin, altered cell cycle distribution and induced apoptosis in the human osteosarcoma 1547 cell line. The objective of this study was to investigate if the antiproliferative effect of diosgenin was similar for different human cancer cell lines such as laryngocarcinoma HEp-2 and melanoma M4Beu cells. Moreover, this work essentially focused on the mitochondrial pathway. We found that diosgenin had an important and similar antiproliferative effect on different types of cancer cells. In addition, our new results show that diosgenin-induced apoptosis is caspase-3 dependent with a fall of mitochondrial membrane potential, nuclear localization of AIF and poly (AdP-ribose) polymerase cleavage. diosgenin treatment also induces p53 activation and cell cycle arrest in the different cell lines studied.

关键词： diosgenin apoptosis p53 AIF caspase cancer cells.

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Lanthanide-based bulky counterions against aggregation-caused quenching of dyes in fluorescent polymeric nanoparticles

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Aggregate 2022年第1期3卷 168-177页

作者： Caterina Severi Satu Lahtinen Jaana Rosenberg Andreas Reisch Tero Soukka Andrey S.Klymchenko laboratoire de Biophotonique et Pathologies Faculte de PharmacieUMR 7021 CNRSUniversite de StrasbourgCedexIllkirchFrance department of Biotechnology University of TurkuTurkuFinland

dye-loaded polymeric nanoparticles(NPs)are promising bioimaging agents because of their available surface chemistry,high brightness,and tunable optical ***,high dye loadings can cause the aggregation-caused quenching(ACQ)of the encapsulated ***,we proposed to mitigate the ACQ inside polymeric NPs by insulating cationic dyes with bulky hydrophobic *** order to implement new functionalities into dye-loaded NPs,here,we extend the concept of bulky counterions to anionic lanthanide-based *** show that by employing Gd-based counterions with octadecyl rhodamine B loaded NPs at 30 wt% versus polymer,the fluorescence quantum yield can be increased to 10-fold(to 0.34).Moreover,Gd-anion provides NPs with enhanced contrast in electron microscopy.A combination of a luminescent Eu-based counterion with a far-red to near-infrared cyanine 5 dye(did)yields Forster resonance energy transfer NPs,where the UV-excited Eu-based counterion transfers energy to did,generating delayed fluorescence and large stokes shift of -340 *** studies reveal low cytotoxicity of NPs and their capacity to internalize without detectable dye leakage,in contrast to leaky NPs with small *** findings show that the aggregation behavior of cationic dyes in the polymeric NPs can be controlled by bulky lanthanide anions,which will help in developing bright luminescent multifunctional nanomaterials.

关键词： aggregation-caused quenching dye-loaded polymeric nanoparticles fluorescence microscopy

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Quality Control of Paracetamol Generic Tablets Marketed in Benin and Search of Its Two Impurities P-Aminophenol and P-Nitrophenol by HPLC-UV/Visible

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American Journal of Analytical Chemistry 2022年第11期13卷 449-460页

作者： Yemoa Loconon Achille Agbokponto Janvier Engelbert Assanhou Assogba Gabin Adetona Pauline doffon Parfait Ganfon Habib Roland Marini djang’eing’a laboratoire de Chimie analytique et Analyse des Médicaments Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé. Université d’Abomey Calavi Cotonou Bénin laboratoire de pharmacie galénique et de Technologie Pharmaceutique Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin laboratoire de Pharmacognosie et de de Phytothérapie Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin laboratoire de Chimie Analytique Pharmaceutique Departement de Pharmacie Université de Liège (ULiège) Liège Belgium

In this work, we evaluated the quality of paracetamol generic tablets while seeking its two main impurities namely 4-para-aminophenol (4-AP) and 4-para-nitrophenol (4-NP) which have nephrotoxic and teratogenic properties. Ninety-four (94) samples were collected at various levels of the medicine supply chain and illegal markets in Benin for quality control tests such as visual inspection, pharmacotechnical tests as mass variation, disintegration test, dissolution test, followed by HPLC UV-Vis identification and assay of paracetamol, 4-AP and 4-NP. The analytes were separated on C18 Lichrocart column (250 mm × 4.0 mm i.d, 5 μm);the mobile phase was MeOH:10 mM ammonium acetate buffer pH 6.8 (35:65) pumped at a flow rate of 1 ml/min. The detection was done at 245 nm. Analysis of our results shows that 77.7% of the samples did not comply with the visual inspection test requirements, 2.1% did not pass the mass variation test, 24.3% of the sample batches didn’t comply with the disintegration test requirements. In addition none of these uncomply batches passed the dissolution test, even if the identification test indicated that all samples contained paracetamol. None contained 4-NP (acceptance limit d 4-AP but within acceptance limit (4-AP etamol assay, 80.9% complied with the specifications of the pharmacopoeias taken as reference (90% - 110%;USP). Further, broader studies should be conducted according to the same rules of good practice for a more comprehensive analysis of the situation. Generally the quality control of paracetamol in most African countries, particularly in Benin, is based on pharmacotechnical tests and paracetamol assay. This work, in addition to the usual tests, showed the importance to search for paracetamol and other drugs’ impurities during their routine quality control.

关键词： Quality Control Substandard Medicines Paracetamol P-Aminophenol P-Nitrophenol Benin

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