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Drug Delivery and Regulatory Science  

Drug Delivery and Regulatory Science
Drug Delivery and Regulatory Science


Group LeaderProf.ssa Paola Minghetti
Permanent MembersFrancesco Cilurzo, Francesca Selmin, Chiara Gennari, Antonella Casiraghi, Silvia Franzé, Umberto M. Musazzi
Adjunct MembersPaolo Rocco, Sara Manellari,Liliana Angelo, Francesco Rama, Paola Volontè


The following research topics are covered.

Dermal and transdermal administration
The research group has proven experience in the study of skin permeation of pharmacologically active molecules, to verify their potential cutaneous administration, and in the design of dosage forms intended for local, loco-regional and systemic administration.
In vitro permeation studies - Understanding the ability of a molecule to permeate the kin and the amount accumulated is essential to design medicinal products, cosmetics and medical devices intended for skin application. The research activity aims to (i) develop in vitro methods enabling to provide predictive data of the in vivo behavior and (ii) to evaluate he permeation capability of specific substances, with particular regards to the application of chemical or physical methods intended to improve the permeation of substances with unfavorable chemical-physical characteristics.
Transdermal patches – Based on the twenty years’ experience acquired in this section, rhe research activities deals with the design of new polymeric materials to be used in the development of adhesive matrices and the optimization of biopharmaceutical performances in terms of physical stability of the substance loaded in the matrix; adhesive properties; release profile and permeation through the skin. The characterization of the technological properties of patches and the determination of the permeation profile of the active ingredient are carried out according to the methods indicated in the “Guideline on quality of transdermal patches” and / or described in the main pharmacopoeias (Ph. Eur., USP and JP).
In situ film forming systems - The research activities concerning these new pharmaceutical forms are focused on the systematic study of the formulation variables able to influence their technological (i.e., film formation time, elasticity and stickiness) and biopharmaceuticals performances (i.e, penetration of the active ingredient in the skin).
Nanovectors for the treatment of skin diseases - The research activity is mainly aimed at the design of deformable liposomes able to facilitate the penetration of the loaded pharmacologically active molecules. The versatility of these nanovectors lies on the one hand in the possibility to carry active molecules with very different chemical-physical properties thanks to the modulation of the composition of the lipid bilayer and to functionalize their surface by means of special directing agents that can favor localization in the skin or permeation of the encapsulated substance. Other formulation approaches concern the development of nanogels, nanoemulsions and nanoparticles.
The characterization of the dimensions of the nanosystems is performed by dynamic light scattering (DLS) or nanoparticle tracking analysis (NTA). Since in the case of vesicles the fluidity of the lipid bilayer is a critical parameter, a mechanical method has been developed to quickly and routinely evaluate the influence of the different formulation variables on the elasticity of liposomes.

Parenteral administration
Biodegradable implants - Critical issues related to the development of biodegradable systems in the form of microparticles for drug release, or in the form of films or sponges for tissue engineering are object of investigation. The studies are focused on the modulation of drug release and on the identification of the appropriate sterilization process. Microsphere with a target size produced by "spray-drying", emulsion and solvent evaporation or "solvent extraction" techniques using a cross-flow emulsion system. The films are obtained by solvent evaporation or extrusion techniques. The sponges are prepared by lyophilization.
Nanovectors - The research activity focuses mainly on the design of biodegradable nanoparticulate systems or liposomal systems for the delivery of both biological drugs and small molecules. The production processes, the mechanisms underlying the release of the loaded active ingredient and, in collaboration with other research groups, cellular trafficking, are studied. Surface decoration with targeting moyeties that promote diffusion through keratinized or non-keratinized biological membranes are also under study.

Oromucosal preparations
Orodispersible dosage forms - Orodispersible dosage forms, once administered into the buccal cavity, dissolve in few seconds, making the active ingredient rapidly available for absorption. They can be produced by solvent casting, hot-melt ram extrusion and lyophilization and used to deliver nutrients or other substances as food supplements, or pharmaceutical substances. The research activity is aimed at identifying new polymeric materials suitable for the development of these pharmaceutical forms and, considering the absence of compendial characterization methods, at the development of assays for quality control.
Mucoadhesive pharmaceutical forms - The research is focused on the identification of new materials with a low swelling index, or production processes that limit this phenomenon, and at the same time allow the modulation of the release kinetics. The pharmaceutical forms of interest are lyophilized tablets, films and microparticles. Finally, the research is aimed at understanding the mechanisms responsible for adhesion to the mucosa.

Regulatory science
Regulatory science provides a multidisciplinary approach aimed at the development and application of scientific methods for the continuous improvement of decision-making and political processes, of authorities and manufacturing companies, in the attempt to define and guarantee the quality, efficacy and safety of a medicinal product or of another product of the health area.

  • Medicinal products - The activity is mainly aimed at the analysis of Community legislation on medicinal products, with particular regard to the production and marketing of originating biotechnological medicines and their copies (biosimilars), non-biological complex medicines (NBCDs, Non Biologic Complex Drugs) originators and their copies, Advanced Therapy Medicinal Products (ATMPs), radiopharmaceuticals and medicinal gases.
  • Products with healthy activity - The activity is mainly aimed at the analysis of EU and national regulations on medical devices, biocides, cosmetic products and foods, with particular reference to nutrition and health claims provided on food products (claims), novel foods, foods for specific groups and food supplements. The evolution of legislation is constantly monitored to assess its impact on the national market and on operators in the sector.
  • Intermediate and final distribution – Medicinal products and medical devices have been regulated for more than a century. However, in recent decades, starting respectively with Directive 2001/83 / EC for medicinal products and the “new approach” directives for Medical Devices, the complexity of regulation has grown exponentially. These rules, together with the numerous national reforms concerning the pharmaceutical market, have had direct repercussions on intermediate and final distribution. Consequently, the activity includes constant updates and insights into national and regional legislation related to the intermediate and final distribution.
  • Development of technological and biopharmaceutical assays - The activity is aimed at the development of in vitro methods to determine the mechanism of action of medical devices and permeation assays through biological tissues, and to reduce the studies to be carried out in vivo.
  • Development of the professional activity of the pharmacist - The research group studies the different aspects of the practical activity of the pharmacist and their impact on health systems, on the use of medicinal products and on patient care, to promote the development of the profession in the interest of the community.

The research group has collaborations with researchers belonging to the following academic sites:

  • Department of Drug Science and Technology - University of Torino
  • Department of Pharmacy, Health and Nutrition Sciences - University of Calabria
  • Institute of Pharmacy - Kazan Medical State University, Russian Federation
  • Universidad Nacional de Córdoba - Argentina
  • Pharmaceutical Technology - National and Kapodistrian University of Athens, Greece
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