RESUMO
The additive technology or 2D and 3D printing are increasingly used in various industrial fields, from aeronautics to mechanics but also in the fields of health such as dentistry or for bone reconstructions. These techniques have been studied for about fifteen years by the academic community in the pharmaceutical field (medical device and drug), and recently they have started to be applied to produce drugs in industry and in hospitals. Indeed, the Food and Drug Administration approved in August 2015 the marketing of the first drug printed by additive technique, then in 2018 the first clinical trial using 3D printed drugs was carried out in Great Britain by a hospital pharmacy. 2D-3D printing is presented as one of the tools of a more personalized medicine, the techniques of additive printing allowing the production of tabs containing several drugs in one tab (polypills) and the development of custom modified-releases drugs. This approach could allow better acceptance of the finished product and secure manufacturing. The objective of this work is to highlight relevant printing technologies for implementation in hospital pharmacies, and to see how these technologies could lead to a change in pharmaceutical practices, to improve patient care.
Assuntos
Farmácias , Tecnologia Farmacêutica , Sistemas de Liberação de Medicamentos , Hospitais , Humanos , Impressão Tridimensional , ComprimidosRESUMO
Urea cycle disorders are a group of inherited orphan diseases leading to hyperammonemia. Current therapeutic strategy includes high doses of sodium benzoate leading to three or four oral intakes per day. As this drug is currently available in capsules or in solution, children are either unable to swallow the capsule or reluctant to take the drug due to its strong bitter taste. The objective of the present study was to develop solid, multiparticulate formulations of sodium benzoate, which are suitable for pediatric patients (i.e. flavor-masked, easy to swallow and with a dosing system). Drug layering and coating in a fluidized bed were applied for preparing sustained-release granules. Two types of inert cores (GalenIQ® and Suglets®) and three different polymers (Kollicoat®, Aquacoat® and Eudragit®) were tested in order to select the most appropriate polymer and starter core for our purpose. Physical characteristics and drug release profiles of the pellets were evaluated. A Suglets® core associated with a Kollicoat® coating seems to be the best combination for an extended release of sodium benzoate. A curing period of 8 h was necessary to complete film formation and the resulting drug release pattern was found to be dependent of the acidity of the release medium.
Assuntos
Preparações de Ação Retardada/química , Implantes de Medicamento/química , Benzoato de Sódio/química , Cápsulas/química , Química Farmacêutica/métodos , Liberação Controlada de Fármacos , Excipientes/química , Pediatria/métodos , Polímeros/química , Soluções/químicaRESUMO
Ion-exchange microspheres (MS) designed as a drug delivery system for embolization coupling ability to occlude vessels and chemotherapy were used to evaluate a manufacturing process allowing to control the drug release rate through reduction of diffusion rate of the drug within the particle by impregnation of calcium alginate inside the porous MS. Impregnation was performed by diffusion of sodium alginate inside DEAE-Trisacryl(R) MS, dispersion of the MS in deionised water and gelling alginate by adding CaCl(2) to the dispersed MS. Studied parameters were alginate concentration, alginate diffusion time and calcium concentration. Indomethacin was loaded into the MS by eluting an aqueous indomethacin solution through a chromatographic column packed with impregnated MS. Indomethacin loading was reduced by alginate. Swelling studies showed indomethacin loading enhanced the hydrophobicity of MS while impregnation had no effect. This had an incidence on indomethacin release rate, which was assessed using the rapid elution of PBS through loaded impregnated MS packed in a column. Indomethacin loading reduced its own rate of release. MS impregnated with 2% w/v alginate gelled with a 40 mM calcium solution presented the lower release rate. This work indicated the manufacturing conditions to display a calcium alginate matrix effect on indomethacin release from DEAE-Trisacryl MS.
Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Indometacina/administração & dosagem , Alginatos , Algoritmos , Resinas de Troca Aniônica , Anti-Inflamatórios não Esteroides/química , Química Farmacêutica , DEAE-Celulose , Preparações de Ação Retardada , Difusão , Composição de Medicamentos , Excipientes , Liofilização , Indometacina/química , Cinética , Microesferas , Tamanho da Partícula , Espectrofotometria UltravioletaRESUMO
While home-based chemotherapy improves comfort and quality of life of patients, quality and safety conditions must be equivalent to hospital settings. In addition, organization is much more complex. At the hospital at home "Assistance publique-Hôpitaux de Paris", prescribers are potentially spread across 21 health facilities. The administration of chemotherapy is performed by about 300 nurses at the patient's home in Paris and its suburbs. Centralized preparations of chemotherapy began in September 2009 by the pharmacy department of Georges-Pompidou European hospital, with a progressive increase of the activity. This article describes the quality insurance system established with this new organization to meet the specific challenges of home therapy: choice of eligible anticancer drugs, computerized information systems and networking with other heath facilities, secure transport conditions, traceability from the prescription to the administration, security of administration. This experience can offer an important support for other centres in their approach of quality insurance for home chemotherapy.