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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 capsules.Multicomponent 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 < 0.01%. Stability test and 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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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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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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