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    Emerging technologies in solid drug delivery: An interview with Nadia Passerini

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    Nadia Passerini is interviewed by Hannah Makin, Commission Editor. Nadia Passerini is Associate Professor of Pharmaceutical Technology at the University of Bologna (Bologna, Italy). She obtained the degree in Pharmaceutical Chemistry and Technology at the University of Bologna in 1992 and the PhD in Pharmaceutical Science in 1997. Her research focuses on the study of drug delivery systems, developing new technologies and new apparatus for the production of solid dosage forms (microparticles, granules and tablets), which can optimize the bioavailability of drugs according to the specific needs of the therapy. Furthermore, she is interested in the solid-state characterization of the produced delivery systems in order to correlate their physicochemical properties to the in vitro release of the drugs. Currently, her research focuses in particular on the production and characterization of microparticles produced by the spray congealing technology. She is author of over 50 international peer-reviewed publications and over 50 contributions (poster and oral presentations) to national and international conferences

    Therapeutic Delivery

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    Delivering therapeutics in a way that is right for the patient - safe, painless, reliable, targeted, efficient and cost effective - is the fundamental aim of scientists working in this area. Correspondingly, this evolving field has already yielded a diversity of delivery methods, including injectors, controlled release formulations, drug eluting implants and transdermal patches. Rapid technological advances and the desire to improve the efficacy and safety profile of existing medications by specific targeting to the site of action, combined with the drive to improve patient compliance, continue to fuel rapid research progress. Furthermore, the emergence of cell-based therapeutics and biopharmaceuticals such as proteins, peptides and nucleotides presents scientists with new and exciting challenges for the application of therapeutic delivery science and technology. Successful delivery strategies increasingly rely upon collaboration across a diversity of fields, including biology, chemistry, pharmacology, nanotechnology, physiology, materials science and engineering. Therapeutic Delivery recognizes the importance of this diverse research platform and encourages the publication of articles that reflect the highly interdisciplinary nature of the field. In a highly competitive industry, Therapeutic Delivery provides the busy researcher with a forum for the rapid publication of original research and critical reviews of all the latest relevant and significant developments, and focuses on how the technological, pharmacological, clinical and physiological aspects come together to successfully deliver modern therapeutics to patients. The journal delivers this essential information in concise, at-a-glance article formats that are readily accessible to the full spectrum of therapeutic delivery researchers

    Pharmaceutics

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    Pharmaceutics is an open access journal which provides an advanced forum for the science and technology of pharmaceutcs and biopharmaceutics

    Recenti applicazioni della tecnologia spray congealing: produzione di sistemi microparticellari per il miglioramento delle proprietà biofarmaceutiche di APIs BCS classe II.

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    Tra le numerose strategie tecnologiche che possono essere utilizzate per migliorare le proprietà biofarmaceutiche di molecole appartenenti alla classe II del Biopharmaceutic Classification System (BCS), negli ultimi anni si è assistito ad un crescente interesse per l’impiego della tecnologia spray congealing. Brevemente, la tecnologia spray congealing (anche conosciuta come spray chilling o spray cooling) si basa sull’atomizzazione di un fluido costituito da un eccipiente bassofondente (< 90 °C) allo stato fuso in cui è disperso o disciolto un farmaco. L’atomizzazione porta alla formazione di gocce che solidificano per raffreddamento durante la caduta, portando alla formazione di microparticelle. E’ un processo veloce, one-step e solvent-free, potenzialmente adatto per il continuous manufacturing. Da anni il mio gruppo di ricerca studia le applicazioni in campo farmaceutico e nutraceutico di questa tecnologia. Ricerche precedenti hanno evidenziato che, studiando opportunamente la formulazione, lo spray congealing permette di produrre microparticelle in grado di controllare il rilascio di farmaci, mascherare sapori sgradevoli, proteggere dalla degradazione sostanze attive o, infine, aumentare la solubilità e/o la velocità di dissoluzione di molecole. In questa comunicazione verranno presentati recenti sviluppi ottenuti impiegando un nuovo eccipiente (Gelucire 48/16), testando come APIs modello alcune molecole appartenenti alla classe II BCS con caratteristiche chimico-fisiche diverse (punto di fusione, pKa, ecc). I sistemi microparticellari prodotti sono stati caratterizzati per quanto riguarda le dimensioni, la morfologia (SEM), l’efficienza di incapsulazione e le proprietà dello stato solido (analisi DSC, XRD, FT-IR). Inoltre è stata valutata la solubilità dei farmaci e sono stati effettuati tests di dissoluzione a diversi pH. Infine sono stati eseguiti studi di stabilità. Tutti i sistemi microparticellari ottenuti hanno forma regolare e sferica e dimensioni medie intorno ai 200 μm (molto scorrevoli ed adatti alla somministrazione orale). L’efficienza di incapsulazione è sempre superiore al 95%. I tests in vitro hanno evidenziato per tutti i farmaci esaminati un significativo aumento della loro solubilità in acqua e della velocità di dissoluzione. Dati preliminari (6 mesi) suggeriscono la stabilità dei sistemi in condizioni normali. I risultati ottenuti hanno confermato la potenzialità della tecnologia spray congealing per migliorare significativamente la solubilità e la velocità di dissoluzione di molecole BCS classe II

    CHAPTER 3 - Nanomaterials for oral drug administration

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    In the last decade, a wide variety of oral nano-scaled drug delivery systems have been developed. This book chapter first gives a background on the challenges associated with the design of oral drug formulations, in relation to the well-known barriers presented by the gastrointestinal tract. Then, the most common nanomaterials used for oral formulations, which are classified as nanocrystals and nanosuspensions, polymeric, lipid and inorganic-based nanocarriers are described, plus a view on the most advanced nanomaterials, such as hybrid, protein and stimuli-responsive nanocarriers. Specifically, the properties, advantages and disadvantages of the different nanomaterials are reported. The design aspects of nanosystems for the targeting of specific gastrointestinal regions are also highlighted. Finally, critical considerations on the approaches to convert nanocarriers into final dosage forms suitable for oral administration, which are crucial to make these nanocarriers clinically and commercially available, are provided

    Polymer films comprising material secreted by gastropods

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    The present invention refers to a film, comprising at least one polymer and a material secreted by a gastropod, in particular snail slime. The present invention also relates to a 5 procedure for the preparation and to uses of such film, in particular medical and cosmetic uses, including veterinary uses. Further objects of the present invention include kits, films for the storage and/or packaging of food, patches, masks and similar cosmetic products comprising such film

    FILM POLIMERICI COMPRENDENTI MATERIALE SECRETO DA GASTEROPODI

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    La presente invenzione si riferisce ad una pellicola o film, comprendente un polimero ed un materiale secreto da un gasteropode, in particolare bava di lumaca. La presente invenzione riguarda inoltre il procedimento di preparazione e gli usi, in particolare gli usi medici e gli usi cosmetici, anche veterinari, di tale composizione. Sono altresì oggetto della presente invenzione kit, pellicole per la conservazione e/o il confezionamento di cibi, cerotti, maschere e prodotti cosmetici simili comprendenti tale composizione

    Multi-composite system for the delivery of alendronate to bone tissue

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    Bakground The bisphosphonate (BPs) class drug, is widely employed for the treatment of a variety of bone disorders. In this work Sodium Alendronate (AL) was utilised as model Bisphosphonate drug. AL is often administered orally or via injection showing many side effects. Recently different release approaches have been evaluated in order to targeted AL delivery to bone. In particular calcium phosphate cements (CPCs) have been investigated as potential carries of BPs [1, 2]. The CPCs are bioactive and biodegradable grafting materials made of powders of suitable composition which, when mixed with a liquid phase, give a modulable paste which stiffens during the setting reaction and sets as primarily calcium-deficient hydroxyapatite. Unfortunately, the loading of AL interferes with the conversion of pristine powders (like alfa-tricalcium phosphate, alfa-TCP) into hydroxyapatite, increasing the setting times and worsening the mechanical properties. Therefore, the amount of AL that can be directly loaded is limited (1.8 mg / g) [1, 2]. Consequently, the drug encapsulation might overcome this drawback. The aim of this work was to develop an innovative drug delivery system potentially useful for the delivery of AL to bone tissue. In particular, we propose the use of Solid Lipid Microparticles (MPs), up to now mainly used for oral and topical drug delivery, as carrier for AL, due to the favourable biocompatibility and lower toxicity of the lipids compared with many polymers. Thus a multicomposite delivery platform consisted of a biomimetic-tricalcium phosphategelatin cement (CPCs) enriched with alendronate-loaded MPs (MPs-AL) was developed. Main results For the preparation of the MPs, the spray congealing technology was employed [3]. In particular six different excipient were considered: Stearic acid, Stearyl alcohol, Cutina® HR, Precirol® ATO 5 and Tristearin. In order to screen the effect of types, dimensions and amount of unloaded MPs on the CPCs most important mechanical properties a Design of Experiment (DoE) was employed. Then, MPs loaded with 10 % w/w of AL were produced using the different carriers. All MPs-AL exhibited a spherical shape, encapsulation efficiency higher than 90% and prevalent particle size ranging from 100-150 micron. Solid state characterization by means of DSC, HSM and X-ray powder diffraction demonstrated that encapsulation of the drug into MPs did not alter its crystal structure. MPs-AL addition to the cement provoked a modest lengthening of the setting times and of the hardening reaction leading to the complete transformation of alfa-TCP into calcium-deficient hydroxyapatite, without significantly affect the cement mechanical properties. Then MPs loaded with different concentration of AL (10%, 20% and 30%) were embedded into the CPC. The in vitro AL release studies from the multi-composite system (carried out in PB buffers at pH 7.4 at 37°C) showed that all the system allowed a controlled release of the drug over time. Therefore the results of this study demonstrated that it was possible to increase the amount of AL into the CPCs up to 10 time compared to the value previously reported [1,2]. Moreover, the use of MPs as carriers to enrich bone cement formulation with AL was a successful strategy to develop a system for the controlled local delivery of the drug. Future and prospective To value the effect of the AL release from CPCs-MPs system on cellular proliferation and differentiation, in vitro studies using osteoblasts and osteoclasts cell cultures are in progress. The obtain results suggest that this designed composite system could be useful for the delivery of other drugs (i.e. antibiotic, antiinflammatory agents and anticancer drugs) to bone tissue
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