Thwala LN, Delgado DP, Leone K, Marigo I, Benetti F, Chenlo M, Alvarez CV, Tovar S, Dieguez C, Csaba NS, Alonso MJ (2018). Protamine nanocapsules as carriers for oral peptide delivery, J Control Release. 2018 Dec 10; 291:157-168

Peptides represent a promising therapeutic class with the potential to alleviate many severe diseases. A key limitation of these active molecules relies on the difficulties for their efficient oral administration. The objective of this work has been the rational design of polymer nanocapsules (NCs) intended for the oral delivery of peptide drugs. For this purpose, we selected insulin glulisine as a model peptide. The polymer shell of the NCs was made of a single layer of protamine, a cationic polypeptide selected for its cell penetration properties, or a double protamine/polysialic acid (PSA) layer. Insulin glulisine-loaded protamine and protamine/PSA NCs, prepared by the solvent displacement method, exhibited a size that varied in the range of 200-400 nm and a neutral surface charge (from +8 mV to -6 mV), depending on the formulation. The stability of the encapsulated peptide was assessed using circular dichroism and an in vitro cell activity study. Colloidal stability studies were also performed in simulated intestinal media containing enzymes and the results indicated that protamine NCs were stable and able to protect insulin from the harsh intestinal environment, and that this capacity could be further enhanced with a double PSA-Protamine layer. These NCs were freeze-dried and stored at room temperature without alteration of the physicochemical properties. When the insulin-loaded protamine NCs were administered intra-intestinally to diabetic rats (12 h fasting) it resulted in a prolonged glucose reduction (60%) as compared to the control insulin solution. This work raises prospects that protamine NCs may have a potential as oral peptide delivery nanocarriers.


The European Food Safety Authority (EFSA) has recently published a new guidance on the safety evaluation of nanotechnology in food and feed. The guidance ( covers areas such as novel foods, food contact materials, food and feed additives, pesticides, and provides applicants with the necessary information addressing potential risks arising from applications of nanotechnologies in the food and feed chain.


This new guideline promotes the safe development and innovation of nanotechnologies in the food sector, increasing the competitiveness of Italian and European companies.


ECSIN (European Center for the Sustainable Impact of Nanotechnology) Laboratory of ECAMRICERT SRL, has for years been a reliable partner to support companies in the safety assessment on a regulatory basis of nanotechnologies in the food sector.


Contact us for any need or clarification at +39 0425377501 or

Active packaging and nanomaterials: it can be done!

The European Food Safety Agency (EFSA) recently published a positive scientific opinion concerning the safety assessment of Selenium nanoparticles (50-90 nm) used as antioxidant in active packaging (Regulation 450/2009). Nanoparticles are incorporated in the adhesive between two layers of a multilayer plastic film at a concentration of o,002 mg/dm2, to be used in contact with food sensitive to oxidation such as meat, fish, dried fruit. The motivation at the basis of the positive opinion is the lack of nanoparticles migration into food from the packaging, which was assessed by applying standard protocols and dedicated nano-tecnhniques (e.g. A4F and TEM) which are also available in ECSIN.

So, good news for the innovative food packaging industry. ECSIN could be a reliable partner for companies willing to develop new nano-enabled packaging, supporting safety and efficacy assessment, as well as accompanying them along the authorization process according top regulation.

ECSIN presents nanotechnologies in packaging. The regulatory point of view

ECSIN presented, in late September 2017 at the Istituto Italiano Imballaggi in Milan, different practical aspects relevant for companies, linked to the application of nanotechnologies in packaging, mainly for food and cosmetics. The topics included functionality and regulations, physicochemical characterization, and sustainability. An extract of the presentations was published in three parts on the Magazine "the pcMAG", of which this is the first one. The article, in Italian, presents functionalities and regulations, and can be seen here.