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Speaker at Pharma Virtual 2020 2020 - Daniela Monti
University of Pisa, Italy
Title : Nanostructured Formulations in Skin Cancer: Challenges and Perspectives


The incidence of skin cancer, the most common malignant disease that mainly affects the Caucasian population, is increasing worldwide. There are three main types of skin cancers: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and melanoma. The first two are grouped as non-melanoma skin cancers: BCC is characterized by local tissue damage and seldom leads to metastasization while SCC can recur and metastasize. Melanoma is a cancer with dark pigment that develops from the  pigment-containing cells known  as melanocytes.   Surgical  excision  of these malignancies has  been the preferred treatment of patients for decades. However, the decision to perform surgery can be affected by various considerations, including comorbidities of the patient, the anatomical site of the lesion and potential intolerance for repeated excisions. Topical treatment of skin cancer may therefore be more appropriate in certain instances, e.g. when the patients present with field cancerization or multiple clinical and subclinical lesions over a large anatomical area. Topical treatment potentially allows for higher drug levels  at  the  tumour  site,  and may  result  in  less  overall  toxicity than  systemic  agents.  Despite  the numerous positive  aspects, the topical way is also not without limitations, such as poor bioavailability, undesirable local side effects compromising the therapeutic efficacy (erythema, paresthesia, rash, edema, contact dermatitis). An ideal treatment should be developed taking into account the good patient compliance, a better overall efficiency of the treatment, a toxicity as low as possible, a high ability to  reach  the  target  site  in  an  amount  sufficient  to  give  the  therapeutic  effect.    The  success  of  the  topical  therapy  depends  on  both the pharmacologically active substance and the formulation strategy. Researchers have focused on developing new drugs and new combination of molecules, such as conventional cancer chemotherapeutics and phytochemical compounds promising as anti-cancer drugs or as lead compounds in the synthesis of new drugs. The physicochemical properties of molecules, such as size and Log P, are important issues in selecting a candidate for topical delivery.  Nanotechnology based formulations can help in achieving our goal: enhancement of drug bioavailability and reduction of skin irritation by avoiding direct contact of the drug with the skin’s surface.  Delivery of drugs using nanotechnologies, not only, can improve drug stability, but also can help to overcome the stratum corneum, main barrier to penetration. The assessment of the drug penetration profile into the skin layers can be performed with in vitro penetration studies on porcine ear skin, allowing the determination of the amount of penetrated drug within the stratum corneum, epidermis and dermis and hair follicles and the relative penetration depth. .       


Dr. Monti graduated in Chemistry and Pharmaceutical Technology in 1987 and received the PhD in "Design, Development and Bio-evaluation of Drugs" in 1993 and continued to work in the technological and biopharmaceutical field. In 2000, she became Assistant Professor of Pharmaceutical Technology at the Department of Pharmacy, University of Pisa. Her scientific research is oriented towards the study of drug delivery systems to the cutaneous, ungual, ocular, vaginal and buccal site, the use of cell cultures to evaluate toxicity on corneal epithelium cells of ophthalmic excipients and the cosmetic field, by focusing attention on the irritating and corrosive effect, on the one hand, and cutaneous permeation/penetration of cosmetic ingredients, on the other one. From 1997 to 2000 he participated in the European project BIOMED-2, (BMH4-97-2324) entitled "Evaluation of oculotoxicity of drugs in vitro" with the following European partners: University of Tampere (Finland), University of Bremen (Germany), University of Ioannina (Greece), Orion Corporation Ltd. and Oy Star AB, (Finland). She is also responsible for several research projects involving international companies. Furthermore, she is the author of many publications in international journals with referee, of patents and presented her research at national and international meetings. She has been reviewer for many scientific journals such as International Journal of Pharmaceutics, Journal of Controlled Release, Journal of Pharmacy and Pharmacology, European Journal of Pharmaceutical Sciences, European Journal of Pharmaceuticals and Biopharmaceutics, Pharmaceutics and AAPS PharmSciTech.