Project

The project aims to develop dry powders suitable for administration by inhalation applying particle engineering technology 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 administration of the powders pre-dosed in rigid gelatine capsules 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.

Outcome

Expected 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

Action plan

Development of innovative medicines in form of inhalable powdes applying a pulmonary drug delivery technology platform The research activities will apply the pulmonary drug delivery platform of “molecular coating” to four different pharmacologically active substances through:
1) 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
2) toxicity, efficacy and pharmacokinetics of the developed pharmaceutical formulation in vitro on relevant cellular models and in vivo in rodents
3) development of a prototype of dry powder inhaler
4) development of a pilot prototype of a dosing machine for the filling of hard gelatin capsules with the powders developed using a quality by design approach to ensure rubust and easy industrial scale-up.
This technological development will involve researchers, centres of the Emilia-Romagna High Technology Network (Biopharmanet-TEC, CIM, CIRI, Democenter) and three local companies (Chiesi, Bormioli Rocco, IMA).

PARTNERS

BPN -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 discovery to drug delivery, from pharmacology and toxicology, from biochemistry to molecular biology, encompassing also pharmaceutical nanotechnologies and advanced therapies.
Reference person: Prof. Ruggero Bettini
ruggero.bettini@unipr.it

website

CIRI-SDV – CIRI Scienze della Vita e Tecnologie per la Salute

The CIRI-SDV laboratory has expertise in the design, fabrication and characterization of innovative polymeric materials for biomedical applications. In the laboratory there are skills of nanotechnology such as electrospinning technology and surface modification and functionalization of materials and polymeric biomaterials.
Referece person: Prof.ssa Laura Calzà
laura.calza@unibo.it

website

CIM – Centro Interdipartimentale Misure “Giuseppe Casnati”

The Interdepartmental Centre Measurements (C.I.M.) was founded 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 employment of new methods of measurement.
Reference person: Prof. Gabriele Costantino, Direttore
gabriele.costantino@unipr.it

website

FONDAZIONE DEMOCENTER-SIPE

Democenter-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 research centers, public bodies and companies, dealing with the dissemination and transfer of the research activities and results.
Reference person: Laura Aldrovandi
l.aldrovandi@fondazionedemocenter.it

website

Chiesi Farmaceutici S.p.A.

Headquartered in Parma, Italy Chiesi Farmaceutici is an international research-focused Healthcare group, with over 80 years of experience in the pharmaceutical industry. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare diseases areas.
Reference person: Alessandro Cavecchi
a.cavecchi@chiesi.com

website

Bormioli Pharma S.r.l.

Bormioli Rocco Pharma is exclusively dedicated to the production 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 partnerships with top players in the pharma world.
Reference person: Anna Malori
anna.malori@bormiolipharma.com

website

IMA S.p.A.

IMA Group is world leader in the design and manufacture of automatic machines for the processing and packaging of pharmaceuticals, 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, Capsule Filling and Banding, Weight Checking, Coating, Handling and Washing.
Reference person: Lorenzo Maldina
maldinal@ima.it

website

Project POR-FESR 2014-2020, AXIS 1 Research and Innovation. 1.2.2 Action