RESEARCH GROUP

Oral drug delivery, pharmaceutics, biopharmaceutics and pharmaceutical technology

  

Group Leader	Prof. Lucia Zema
Permanent Members	Alessandra Maroni, Anastasia Foppoli, Matteo Cerea, Luca Palugan, Alice Melocchi
Adjunct Members	Saliha Moutaharrik, Marco Uboldi, Ilaria Filippin, Micol Cirilli
Web page	http://users.unimi.it/gazzalab/

 

DESCRIPTION
The following research topics are covered.

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 water swelling behavior of hydrophilic cellulose ethers, devices with different release mechanisms are designed, such as prolonged release matrices, coated systems for pulsatile or time-dependent colon delivery and expandable organ-retentive systems.

STUDY OF THE PHYSICAL AND TECHNOLOGICAL PROPERTIES OF BIOACTIVE COMPOUNDS
Physical properties of solid compounds of pharmaceutical interest are studied along with their impact on preformulation and formulation development of conventional dosage forms intended for different administration routes. Particularly, preformulation studies are carried out to explore the conditions under which new polymorphs are formed and the relevant biopharmaceutical repercussions by means of established 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); the properties of particulate materials, such as particle size distribution, specific surface area, flowability and compaction ability, are also studied as required for correct formulation of dosage forms.

FORMULATION AND EVALUATION OF GENERIC DRUG PRODUCTS
The design and manufacturing of oral generic formulations for immediate or modified release are carried out, and in vitro release testing methods for their comparative evaluation vs. reference products are set up, with special emphasis on interchangeable marketed products.

PHARMACEUTICAL APPLICATION OF HOT-PROCESSING TECHNIQUES
Hot-processing techniques enable fabrication of a variety of drug formulations because of the inherent versatility and viability. Recently, fused deposition molding (FDM) 3D printing and bioprinting have also been approached, which would fully match both the emerging needs for rapid prototyping and the increasing demand for therapy personalization. The feasibility of such techniques in the manufacturing of conventional dosage forms, particularly based on solid dispersions of drugs in polymeric carriers, and of delivery systems is investigated employing thermoplastic polymers of pharmaceutical use. Among these, shape memory materials are being explored for 4D printing of retentive devices intended for intravesical or intragastric drug administration.

DRUG AND NUTRACEUTICAL CAPSULAR DELIVERY PLATFORM
Delivery systems in the form of capsules with multiple separate compartments differing in composition, size and wall thickness are being developed. These systems are intended for oral administration of drugs or food supplements, and is fabricated via injection molding or 3D printing. The versatility in terms of type and dose of the active ingredients conveyed, even within the same system, and in the release kinetics that can be obtained, as well as the extemporaneous capsule filling, make the system interesting for personalized treatments.

SCIENTIFC COLLABORATIONS
The research group has ongoing collaborations with researchers from the following academic institutions:

• Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque (US-NM)
• Dipartimento di Ingegneria Meccanica e Industriale, Università degli Studi di Brescia, Brescia (I)
• Dipartimento di Chimica, Materiali e Ingegneria Chimica “G. Natta”, Politecnico di Milano, Milano (I)
• College of Pharmacy - Université Lille Nord de France, LILLE (F)
• Multiply Labs, San Francisco (US-CA)
• Dipartimento di Scienze degli Alimenti e del Farmaco, Università di Parma, Parma (I)
• Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Novara (I)
• Dipartimento di Biotecnologie e Bioscienze, Università degli Studi di Milano Bicocca, Milano (I)
• Department of Galenic Pharmacy and Pharmaceutical Technology, University of Lisbon, Lisbon (P)