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Reaserch group coordinated by Prof Andrea Gazzaniga  

Permanent staff: Dott.ssa Lucia Zema, Dott.ssa Alessandra Maroni, Dott. Matteo Cerea, Dott. Luca Palugan, Dott.ssa Anastasia Anna Foppoli, Dott.ssa Maria Dorly Del Curto


Research associates:
Dott.ssa Giulia Loreti, Dott.ssa Elena Macchi, Dott.ssa Alice Melocchi, Dott.ssa Clara Petroni

 

Study and Development of Oral Delivery Systems

The work is focused on drug delivery systems, mainly intended for the oral route of administration, able to control the rate, time and/or site of release. By exploiting the peculiar hydration properties of hydrophilic cellulose ethers, devices with differing release mechanisms are designed, such as prolonged release matrices and coated systems for pulsatile or time-dependent colon delivery. Pulsatile release allows time-programmed pharmacological treatments to be performed in the case of chronopathologies with mainly night or early morning symptoms, whereas colon delivery has proved effective for the local therapy of inflammatory bowel disease (IBD).

 

Design and Preparation of Oral Systems for Protein Delivery

With the aim of increasing the oral bioavailability of peptide and protein drugs, an array of formulation approaches have been proposed, such as in particular a selective delivery of such molecules to the colon. An important research topic concerns the design of therapeutic systems intended for colonic release, the manufacturing of which would be expected to involve no significant degradation processes of peptide drugs and meet industrial scale up requirements. In order to limit the enzymatic degradation and increase the extent of intestinal mucosa permeation of these drugs, suitable adjuvants, such as protease inhibitors and absorption enhancers with appropriate tolerability and compatibility characteristics, need to be included in the relevant delivery systems for the  oral route. In this respect, different preformulation, formulation, feasibility and stability studies are carried out along with the evaluation of the release performance using appropriate in vitro tests and animal models.

 

Investigation into the Use of Cyclodextrins as Formulation Aids

This research topic is related to the evaluation of cyclodextrins as formulation adjuvants. These differ from other pharmaceutical excipients because of their ability to form interaction compounds with a number of bioactive molecules, thus resulting in potential bioavailability- and/or stability-related benefits. A profitable use of cyclodextrins requires the development of dosage forms capable of conveying high drug loads, such as pellets. In this respect, the manufacturing of pellets containing cyclodextrin-based formulations is improved by means of statistical optimization processes. With the aim of overcoming the problems encountered when dosage forms intended for a prolonged release of poorly soluble drugs are concerned, the research is also focused on the assessment of the possible impact of cyclodextrins on the release kinetics of model bioactive compounds with such characteristics.

 

Study of the Solid State Properties of Bioactive Compounds

In this research domain, preformulation studies are carried out to investigate the solid state properties of a number of bioactive compounds and their impact on pharmaceutical development. In particular, the formation of new polymorphs and the possible biopharmaceutical repercussions are explored by means of consolidated techniques such as Fourier Transformed Infrared Spectroscopy (FTIR), Powder X Ray Diffraction (PXRD), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA) and Hot Stage  Microscopy (HSM).

 

Formulation and Evaluation of Generic Drug Products

Formulation activities are conducted aimed at the design and preparation of oral generics for either immediate or modified release. Moreover, in vitro release tests are set up and carried out in order to evaluate the performance of generic vs. reference preparations, particularly with regard to interchangeable marketed products.

 

Pharmaceutical Application of Extrusion Techniques

Although their exploitation in the pharmaceutical field is still limited, extrusion techniques would apply to the manufacturing of a variety of drug formulations because of the remarkable inherent versatility and feasibility potential. The possibility of preparing delivery systems by means of such techniques is thus investigated by employing hydrophilic or inert polymers of established pharmaceutical use. The materials to be processed, as such or in admixture with further excipients, require an attentive characterization in terms of “extrudability” with respect to both injection-molding and wet extrusion.

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