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Breathing health
Breathing health
ACTION PLANDevelopment of innovative medicines in form of inha-lable powdes applying a pulmonary drug delivery tech-nology platformThe research activities will apply the pulmonary drug delivery platform of “molecular coating” to four different pharmacologically active substances through: • development of 4 powder formulation for pulmonary administration along with the analytical methods for the quantitation of the substances in the medicinal product and in biological matrices• toxicity, efficacy and pharmacokinetics of the deve-loped pharmaceutical formulation in vitro on relevant cellular models and in vivo in rodents• development of a prototype of dry powder inhaler • development of a pilot prototype of a dosing machi-ne for the filling of hard gelatin capsules with the pow-ders developed using a quality by design approach to ensure rubust and easy industrial scale-up.This technological development will involve resear-chers, centres of the Emilia-Romagna High Technology Network (Biopharmanet-TEC, CIM, CIRI, Democenter) and three local companies (Chiesi, Bormioli Rocco, IMA).
Development of new inhalable powder drugs from a platform for pulmonary drug delivery
www.pulmomed.eu
PROJECT BACKGROUND The project aims to develop dry powders suitable for admi-nistration by inhalation applying particle engineering tech-nology of “molecular coating”. The therapeutic target of the new medicines are pulmonary inflammatory and degenerative diseases and Papilloma virus vaccination. In parallel, powder dosing equipment and dry powder inhaler suitable for the ad-ministration of the powders pre-dosed in rigid gelatine capsu-les will be engineered.
AIMS• Pharmaceutical development of 3 medicinal products for inhalation: two small molecules and one therapeutic protein.• Pharmaceutical development of 1 recombinant peptide-based vaccine for prevention of Human Papillomavirus infection.• Development of a new powder dosing apparatus and of a new dry powder inhaler in plastic easy to use and able to efficiently aerosolize a relatively large range of doses.
OUTCOMEExpected project outputs are:• 4 dry powders for the inhalation of synthetic and biotechnological drugs• a prototype of a dry powder inhaler using pre-dosed capsules able to comply with critical quality attributes of dose accuracy, precision and reproducibility• a prototype of dosing machine able to fill rigid gelatin capsules with the powder formulations produced with the “molecular coating” technology
PARTNERBPN -T Centro Interdiparimentale per l’Innovazione dei Prodotti per la Salute, Biopharmanet-Tec The Centre Biopharmanet-Tec is active in all the key domains of the development and manufacturing of new medicines: from drug disco-very to drug delivery, from pharmacology and toxicology, from bio-chemistry to molecular biology, encompassing also pharmaceutical nanotechnologies and advanced therapies.Prof. Ruggero Bettini • [email protected] www.biopharmanet-tec.it
CIRI-SDV - CIRI Scienze della Vita e Tecnologie per la SaluteThe CIRI-SDV laboratory has expertise in the design, fabrication and characterization of innovative polymeric materials for biomedical ap-plications. In the laboratory there are skills of nanotechnology such as electrospinning technology and surface modification and functionali-zation of materials and polymeric biomaterials. Prof.ssa Laura Calzà • [email protected] www.tecnologie-salute.unibo.it
CIM Centro Interdipartimentale Misure “Giuseppe Ca-snati”The Interdepartmental Centre Measurements (C.I.M.) was foun-ded in 1975 with the aim to make available to the institutes and departments of the University of Parma advanced measurement instruments, as well as to promote knowledge and the employ-ment of new methods of measurement.Prof. Gabriele Costantino • Direttore. [email protected] www.cim.unipr.it
Fondazione Democenter-SipeDemocenter-Sipe Foundation is an innovation center of the of the High Technology Network of Emilia-Romagna Region. Democenter-Sipe supports innovation acting as a facilitator and interface between rese-arch centers, public bodies and companies, dealing with the dissemina-tion and transfer of the research activities and results. Laura Aldrovandi • [email protected]
Chiesi Farmaceutici S.p.A.Headquartered in Parma, Italy Chiesi Farmaceutici is an in-ternational research-focused Healthcare group, with over 80 years of experience in the pharmaceutical industry. Chiesi researches, develops and markets innovative drugs in the re-spiratory therapeutics, specialist medicine and rare diseases areas.Alessandro Cavecchi • [email protected]
Bormioli Rocco S.p.A. - Bormioli Rocco PharmaBormioli Rocco Pharma is exclusively dedicated to the pro-duction of plastic and glass pharmaceutical packaging and devices, following the same demanding requirements that drive the pharma industry. The company has a long-term technology expertise in engineering and manufacturing complex plastic systems, proven by well-established part-nerships with top players in the pharma world. Anna Malori • [email protected] www.bormioliroccopackaging.com
IMA S.p.A.IMA Group is world leader in the design and manufacture of au-tomatic machines for the processing and packaging of pharma-ceuticals, cosmetics, tea, coffee and food. IMA Active, one of the three pharmaceutical divisions of the Group, is the partner for each solid dose processing phase: Granulation, Tableting, Capsu-le Filling and Banding, Weight Checking, Coating, Handling and Washing.Lorenzo Maldina • [email protected] www.ima-pharma.com
