Paola Minghetti

• PhD
• Professor at University of Milan

Background and importance The assessment of ‘in-use’ stability of biotechnological medicinal products is not typically required prior to regulatory approval. However, ‘in-use’ conditions (ie, handling, storage, transport) could compromise product stability and, consequently, affect safety and/or efficacy. Aim and objectives This work aimed to inve...

The COVID-19 outbreak is now one of the most critical crises to manage for most of national healthcare systems in the world. The situation is complicated by the absence of vaccines and authorized pharmacological treatments, except for remdesivir. In this context, many medicaments, including different Ebola and HIV antivirals, are used off-label in...

This is a brief overview on student engagement and perception of remote practical activities during the COVID-19 outbreak emergency. The topics that were heavily affected by these sudden and unexpected changes, where chemistry, biochemistry, bioinformatics, pharmacology, and compounding. This survey took responses from the students of both bachelor...

The COVID-19 outbreak is spreading worldwide pushing the national healthcare systems to find effective protocols to prevent contagion and to reduce the patients’ mortality and the severity of long-term effects. In the absence of authorised pharmacological treatments, chloroquine, and hydroxychloroquine, which are known as anti-malaria drugs, had be...

The COVID-19 outbreak is now one of the most critical crises to manage for most of the national healthcare systems in the world. In the absence of authorised pharmacological treatments, many antiretrovirals, including darunavir/cobicistat fixed combination, were used off-label in the hospital wards as life-treating medicines for COVID-19 patients....

Background and importance Medicine shortages in Italy are an increasing phenomenon with significant impact on clinical activity. Aim and objectives The aim of the study was to analyse the phenomenon, creating monitoring methods that can support the health workers (HW) involved in the problem. Material and methods The hospital pharmacy (HP) develo...

Background and importance Viable microorganisms and/or endotoxins administered parenterally via contaminated preparations may lead to nosocomial infections, SIRS/sepsis and increased mortality of patients. The pharmacist has the responsibility to ensure that the product is stable in the final administered preparation. Aim and objectives To verify...

Background and importance Monoclonal antibodies (mAb) are biotechnological products used as therapeutic agents. Because of their nature, mAb may go through a variety of chemical and physical degradation processes on handling. For this reason, extended in use conditions are not included in stability assessments prior to regulatory approval. Daratumu...

Background and importance Pneumatic delivery is not recommended for medicinal products that could undergo physical alteration of the active ingredient, such as protein denaturation (Peak, 2003). A review of the literature reveals that the solution air–liquid interface and number of travel cycles can be risk determining factors for compounded stabil...

Medication adherence is a growing concern for public health and poor adherence to therapy has been associated with poor health outcomes and higher costs for patients. Interventions for improving adherence need to consider the characteristics of the individual therapeutic regimens according to the needs of the patients. In particular, geriatric and...

Background Flecainide acetate (FlecAc) is an antiarrhythmic drug, effective in children and fetal tachyarrhythmias. FlecAc is commercially available as 50 mg–150 mg oral tablets or intravenous injectable solutions, approved only for use in adults. For paediatric use, an extemporaneous preparation has to be compounded, using the pure active principl...

Background Orodispersible films (ODF) have been proposed as a valid alternative to conventional oral dosage forms to personalise the therapies and to improve patient adherence, especially in special populations (e.g., dysphagics, paediatrics, geriatrics). Since manufacturing technologies used by the industries (e.g., the solvent-casting technique)...

Pharmaceutical compounded medicinal preparations are aimed to fulfill the special needs of a subpopulation of patients for whom a medicinal product is not commercially available. Nowadays, this activity remains an important component of pharmacy practice and an integral part of the modern healthcare system. In 2011, the Committee of Ministers of th...

Background The medicinal properties of cannabis are now recognized. Indeed, in many countries, lawmakers have introduced specific laws and programmes to allow patients to use cannabis preparations in various forms; nevertheless, controversial situations can still be found. In Europe, medicinal- grade cannabis is mainly available as standardized dri...

The data presented in this article are related to the research article entitled “Design of in vitro skin permeation studies according to the EMA Guideline on quality of transdermal patches” (https://doi.org/10.1016/j.ejps.2018.09.014) (Cilurzo et al., 2018) [1]. In vitro permeation studies are generally carried out by Franz's diffusion cell method...

This work demonstrated the feasibility of the extemporaneous preparation of maltodextrins orodispersible films (ODF) by hot-melt ram-extrusion 3D printing. This method consists of three simple technological operations which can be also implemented in a pharmacy setting. First, maltodextrins, drug, and other excipients are mixed in a mortar and wett...

Tattoo prevalence has been increasing in the last 25 years, but specific regulations on tattoo inks are still missing. In the European Union, no supranational regulation is available and only few national provisions cover them. In the United States, tattoo inks are classified as cosmetics but are not approved for injection into the dermis. Health r...

Transdermal patches and medicated plasters are designed to sustain efficacious systemic or loco-regional drug concentrations, respectively. In both cases, drug skin permeation is a critical attribute from the early stage of the pharmaceutical development. In 2014, the EMA introduced the guideline "on the quality of transdermal patches", in which th...

Nowadays, the freeze-drying of liposome dispersions is still necessary to provide a solid dosage form intended for different routes of administration (i.e., parenteral, oral, nasal and/or pulmonary). However, after decades of studies the optimization of process conditions remains still challenging since the freezing and the dehydration destabilize...

The experience gained with biosimilars has made it clear that copies of complex drugs are more challenging to produce and put on the market than generics. In the case of so-called nonbiological complex drugs (NBCDs), the complexity can arise either from a complex active substance or by other factors, such as formulation or route of delivery. Regula...

Purpose In Italy, where the adoption of opioid analgesics in pain management has been historically poor, an increase in opioids consumption occurred between 2000 and 2015. The aim of this study is to assess, through specific time series analyses for trend changes, the impact of different intervening factors – such as the availability of new drugs,...

Background Antibiotic prophylaxis in obstetrics and gynaecology (O and G) surgery is known to be effective in reducing postoperative infections, hospitalisation and costs. In 2008, local guidelines on antibiotic prophylaxis in surgery were published as a result of a multidisciplinary work group (including hospital pharmacists) which involved seven...

Background Surgical site infection (SSI) following caesarean section is the most important risk factor for postpartum morbidity, patient hospitalisation and its costs. Guidelines are recommended for the use of antibiotic prophylaxis for caesarean section to prevent wound infection. Moreover, increasing concerns about the emergence of resistant stra...

Background Every year an increase in new cases of patients with chronic hepatitis C (CHC) from HCV has been registered. The availability of second-generation DAA (DAA-2) has permitted a rise of SVR rates compatible with a good safety profile. Purpose To research literature evidence regarding existence of tolerability and safety data obtained from...

Background According to the National Legal Framework (D. Lgs 507/92; D. Lgs 46/97), medical devices (MDs), as well as medications, must undergo clinical investigations following strict rules concerning context, ethics, objectives and methods that must be approved by local ethical committees (ECs). However, only a minority of studies submitted for a...

Background Efficacy of second-generation direct-acting antiviral agents (DAAs-2) in terms of sustained viral response (SVR) 12 weeks after the end of treatment (EOT) has widely been proven.1–5 However, long-term efficacy is still controversial due to the low number of available studies with a small number of patients. Purpose The objective of the...

Unlike generics, biosimilars are similar, but not equivalent, to the reference biological medicinal product. Therefore, if a patient experiences an adverse event, or a loss of efficacy, when transitioned to a biosimilar, the distribution of medical liability will be different from the case of both the originator and generics. Moreover, the case of...

This work aims to evaluate the possible use of a poly(sodium methacrylate, methyl methacrylate) (NaPMM2) plasticized by PEG400 in design orodispersible films (ODF). Placebo ODF prepared by solvent casting were intended to study the impact of the polymer/plasticizer ratio and residual moisture on disintegration time, stickiness and mechanical proper...

In recent decades, the contribution of health technology assessment (HTA) to the implementation of healthcare policies in developing countries is increasingly being acknowledged. Although the overall framework is fragmented and the available information is not fully consolidated, in Africa, Asia, and Latin America, there are several successful case...

Recently, an increasing number of pharmacists had to supply medicinal products based on Cannabis sativa L. (Cannabaceae), prescribed by physicians to individual patients. Cannabis olive oil preparation is the first choice as a concentrated extract of cannabinoids, even though standardized operative conditions for obtaining it are still not availabl...

Aim: This in vitro and in vivo study reports on silk fibroin (SF) scaffold, functionalized for in situ delivery of GABA and/or allopregnanolone (ALLO), as biomaterial for potential application in tissue engineering and nerve regeneration. Materials & methods: We evaluated the feasibility to design 2D scaffolds (films) made of regenerated Bombyx...

The work aimed to evaluate the feasibility to design hyaluronic acid (HA) decorated flexible liposomes to enhance the skin penetration of nifedipine. Egg phosphatidylcholine (e-PC) based transfersomes (Tween 80) and transethosomes (ethanol) were prepared. HA was reacted with 1,2-dipalmitoyl-sn-glycero-3-phosphoethanolamine (HA-DPPE) and two molar r...

Eudragit® RL (EuRL) matrices have between proposed to release a drug to the skin. However, no information is available on both viscoelastic and adhesive properties of such compositions. This work focuses on the evaluation of both rheological and texture properties of EuRL differently plasticized with tributyl citrate (TBC) or triacetin (TRI) in ord...

Orodispersible dosage forms have a growing presence in the pharmaceutical market because their administration can improve the bioavailability of some drugs and their prescription can ameliorate patient adherence and/or compliance. Here, we review the main features of orodispersible tablets, including oral lyophilisates, and orodispersible films alo...

Barrier creams (BC) are marketed as cosmetic products or locally-applied medical devices to protect skin against damages induced by chemical agents or physical insults. However, the determination of the BC effectiveness is still a matter of discussion at both the clinical and the regulatory level. In this context, this work aimed at the development...

The data presented in this article are related to the article titled "Molecular Dynamics as a tool for in silico screening of skin permeability" [1]. Knowledge of the confidence interval and maximum theoretical value of the correlation coefficient r can prove useful to estimate the reliability of developed predictive models, in particular when ther...

Prediction of skin permeability can have manifold applications ranging from drug delivery to toxicity prediction. Along with the semi-empirical or mechanistic models proposed in the last decades, Molecular Dynamics simulations have recently become a fruitful tool for investigating membrane permeability, in particular as they allow the involved mech...

The use of nanoemulsions in cosmetic products has been enlarged in the last decades because of several formulative advantages (e.g., the improved self-life stability, better texture properties). In addition, nanoemulsions seemed to improve the penetration of active ingredients through the human skin, comparing to conventional emulsion. In this cont...

In this work we made an attempt to assess the effect of drug-induced changes of flexibility on the penetration of deformable vesicles into the human skin. Eight cationic liposomes with different degrees of flexibility were obtained by entrapping unfractionated heparin, enoxaparin and nadroparin. The deformability was studied by a novel, facile and...

Background Moderate to severe ulcerative colitis (UC), a chronic inflammatory disease affecting young adults, has a significant impact on patients’ quality of life. Different biological agents (BAs) have been approved for the treatment of patients who have responded inadequately to conventional therapy but the selection of BAs is still controversia...

Background This work aimed to provide useful information on the incidence of the choice of formulation in semi-solid preparations of iron-oxide nanoparticles (IONs). The appropriate analytical methods to assess the IONs physical stability and the effect of the semi-solid preparations on IONs human skin penetration were discussed. The physical stabi...

The growing application of nanomaterials in healthcare products (i.e., cosmetics, medical devices, and medicinal products) has encouraged the upgrade of the regulatory framework within the European Community (EC) to better control their use and manage the risk of negative effects on human health and environment. Unfortunately, despite the efforts o...

The industrialization of medicinal products has permitted us to reach important results in terms of quality, efficacy, safety, and availability of drugs; however, not all the legitimate expectations of patients are met. When an authorized medicinal product is not available on the market, the physician can prescribe other pharmacological treatments...

Introduction Almost 8,000 rare diseases exist worldwide, affecting approximately 350 million people. Nevertheless, only 5% receive a specific authorized or licensed treatment. The need for effective and rapidly available therapies is still unmet for many patients. Objective The objective is to define repurposing versus off-label drugs, and to eval...

Purpose: The different stages of antineoplastic agent management build up a complex process, from supply to prescription, preparation, and administration. All steps in this process must be carefully monitored in order to control/reduce the risk of errors that can impact on patient safety. This work overviews the prevention of medication errors in...

Background/aim: Topical β-blockers have recently been proposed as a valid alternative to oral drugs for treating cutaneous infantile haemangiomas, but clinical results in the literature are inconsistent due to the empirical choice of topical preparations. The current investigation aimed to rationalize the selection of a semi-solid vehicle for a lo...

The possible use of regenerated silk fibroin gels as in situ film forming formulations for cutaneous administration of drugs was studied. Ethanol was selected as volatile and skin tolerant solvent to favor the sol-gel transition of silk fibroin solutions. Glycerin was chosen to ameliorate the gel texture profile. Eighteen placebo formulations were...

Epigallocatechin gallate, one of the most active antioxidant compounds, has a low chemical stability and ability to permeate the human epidermis. The encapsulation in polymeric micelles would be beneficial to improve both stability and permeation of epigallocatechin gallate and, therefore, to facilitate the pharmacological effects. Polymeric micell...

Classical multicomponent preparations mostly derived from traditional usages in Western and Eastern phytotherapy have been under-evaluated for a long time as potential new pharmaceutical products. The regulatory scenario, in particular at the European level, has only recently considered these aspects proposing harmonized guidelines for the pharmace...

Treatment goals in asthma patients are the achievement of a good control of symptoms and the reduction of the risk of exacerbation. However, a "one-size-fits-all" therapeutic strategy is no longer appropriate to effectively pursue these goals, due to the heterogeneity of asthma. To make the treatment scenario even more complex, asthma patients ofte...

What is known and objective: Despite the widespread use of proton pump inhibitors (PPIs), little is known about the appropriateness of treatment according to the indications reported by patients and their involvement in the process of treatment discontinuation. In patients who are unlikely to benefit, the medication should be stopped and dose tape...

This study aimed to identify a new skin penetrating peptide (SPP) able to enhance unfractionated heparin (UFH) permeation through human epidermis by screening a phage display peptide library. The effects of the synthetized heptapeptide (DRTTLTN) on human stratum corneum organization were investigated by ATR-FTIR spectroscopy and molecular dynamics...

This chapter provides an overview of drug price and reimbursement regulations in Italy within the general context of Italian pharmaceutical policy. Reimbursement and ex-factory prices are negotiated by the National Drug Agency and the relevant company, whereas the distribution margins and VAT (Value Added Tax) are set by law. The pharmaceutical com...

One of the most critical quality attributes of orodispersible films (ODFs) is related to the development of dosage forms with tensile properties suitable for the packaging and patient's handling. Aiming to develop a strategy to reinforce the tensile properties, the current work reported the feasibility to improve the tensile strength of maltodextri...

Background: The appropriate management of chronic insomnia is crucial and prescribing of hypnotic drugs is common. Regular and prolonged use of hypnotics should be avoided because of the risk of tolerance to effects, dependence and an increased risk of adverse events. In 2012, updated Beers criteria for potentially inappropriate medication in olde...

Mucosa of the buccal cavity is considered a convenient and easily accessible site for the administration of drugs intended for both local and systemic delivery. Aiming to optimize the pharmacokinetic, buccal mucoadhesive drug delivery systems are proposed. Mucoadhesion is a complex process involving chemical interactions between mucin and polymers....

OBJECTIVE: Regional analysis and subsequent standardization of mandatory drugs supplied to the Advanced Rescue Means (ARM) in Lombardy. BACKGROUND: Drugs supplied for Advanced Rescue Means of AREU STUDY DESIGN: Observational, retrospective, analytical, single cohort study on drugs supplied to the advanced rescue means (ARM) of the Lombardy region....

Hyperphosphatemia increases the risk of cardiovascular morbidity but the use of medicines as a source of phosphate has not been investigated yet. This study aims to explore the use of absorbable phosphate-containing drugs in CKD patients. Incident CKD patients were identified within the Arianna database (containing data from 158,510 persons in Case...

Supersaturated systems have attracted interest to enhance the skin penetration because of the low cost and reduced risks of irritation with respect to other approaches. The mechanism is simply based on the increased drug driving force for transit out of the dosage form and penetrate the stratum corneum. Supersaturated systems can be obtained by pre...

Recent studies demonstrate that post-herpetical and inflammatory pain can be locally managed by morphine gels, empirically chosen. Aiming to rationalize the selection of the most suitable opioid for the cutaneous delivery, we studied the in vitro penetration through human epidermis of eight opioids, evidencing the critical modifications of the morp...

The impending expiration of patent protection for recombinant insulins provides the opportunity to introduce cost-saving copies, named biosimilars, onto the market. Although there is broad experience in the production and characterisation of insulins, the development of copies is still a challenge. In this paper, the main features of insulins and t...

Background: Xanthine oxidase (XO) inhibitors are largely the treatment of choice for gout, but allopurinol is often inappropriately used for asymptomatic hyperuricemia. There is little evidence that allopurinol is useful in preventing cardiovascular diseases and therapeutic decisions must the balance the expected benefit with the potential harm....

Background Xanthine oxidase (XO) inhibitors are largely the treatment of choice for gout, but allopurinol is often inappropriately used for asymptomatic hyperuricemia. There is little evidence that allopurinol is useful in preventing cardiovascular diseases and therapeutic decisions must the balance the expected benefit with the potential harm. Obj...

Low molecular weight heparins (LMWHs) are obtained from unfractionated heparin (UFH) through different depolymerization methods (DM), which produce compounds having specific chemical features and biological activity. It is then supposed that LMWHs also exhibit different skin permeability properties. The current work aimed to get an insight on the i...

This study explored the effect of aminoacids as non-traditional plasticizers of maltodextrins fast dissolving films. 5% w/w glycine and proline decreased the glass transition temperature (Tg) of maltodextrins from 102.6±2.0°C to 73.1±1.4°C and 76.1±0.7°C, respectively; meanwhile the binary mixture made with lysine had a Tg value of 83.6±2.2°C. At t...

Polyethylene glycols (PEGs) are a wide family of synthetic polyethers available in a range of molecular weights. Due to their multifunctional properties, PEGs are used both as such and/or in the form of nonionic derivatives in the formulation of cosmetics and medical products. In consideration of their physicochemical characteristics, they can pene...

The recent availability of biosimilars as a result of the expiry of the patents of first-generation biotechnological drugs may theoretically reduce the direct costs of such treatments, making their use accessible to a larger number of patients. However, the currently available clinical data refer to a relatively small number of patients, and do not...

Aim: Although propranolol is widely used in the treatment of infantile hemangiomas, the standard 40 mg tablet needs to be fractioned to obtain 10 mg parts, with even lower doses (i.e., 2-3 mg/kg/day divided into 2-3 daily doses) required in infants. This study evaluated the weight and dose uniformity in split quarters of propranolol tablets. Meth...

Pharmaceutical preparations are medicines that the pharmacist makes for the special needs of the patients that the pharmaceutical industry can’t comply for economic and logistic reasons. Pharmacy compounding is still an important component of pharmacy practice and a valuable therapeutical service that is an integrant part of the modern health care...

Silk fibroin scaffolds obtained via regeneration by Ajisawa's reagent (CaCl2/H2O/EtOH, mole ratio 1:8:2) and freeze-drying followed by steam sterilization resulted unstable when incubated in physiological medium over 1-month period since the oxygen diffusivity and mechanical resistance to compression significantly decreased. Blending of regenerated...

Introduction: Methyl methacrylate copolymers (Eudragit®) have been exploited to develop transdermal patches, medicated plasters (hereinafter patches) and, more recently, film-forming sprays, microsponges and nanoparticles intended to be applied on the skin. Areas covered: The article reviews the information regarding the application of Eudragits...

The literature data suggest the capacity of biomacromolecules to permeate the human skin, even though such a transdermal permeation appears to be governed by physicochemical parameters which are significantly different compared to those ruling the skin permeation of small molecules. On these grounds, the present study was undertaken to investigate...

A water based polymeric dispersion for PSA adhesive preparation for transdermal system comprising: a) an aqueous dispersion of a polymer of an acrylate and/or a methacrylate ester, b) a plasticizer c) a shrinkage reducing agent able to reduce the shrinkage of the water PSA dispersion when spread onto a surface to width values lower than 20 mm after...

This work aims to elucidate the mechanism by which N-methylpyrrolidone (NMP) enhances the skin permeation of a compound by combining experimental data with molecular dynamic (MD) simulations. The addition of 10% NMP significantly increased the propranolol (PR) permeation through the human epidermis (~ 15 µg/cm2 vs ~ 30 µg/cm2) while resulted ineffi...

Abstract This work aims to establish if the assays recently introduced by EMA (Guideline on quality of transdermal patches-draft) and USP (Specific tests for transdermal delivery systems) to characterize transdermal patches (TP) are suitable for medicated plasters (MP). Six approved MP differing for type and characteristics of adhesive and backing...

Objectives Community pharmacists are the most accessible healthcare professionals. They interact with a large number of patients who often show emotional concern. Their stressful and complex role is widely acknowledged, nonetheless research on their personal life is practically non-existent. Thus, we set out to qualitatively explore the emotional p...

Background: Opioid consumption data in Italy have been widely studied. However, only aggregate data can be found in the published literature, and differences are expected by distribution setting (community pharmacies and hospitals). The aim of our paper is to analyse opioids sales trends in Italy in the decade 2000-2010, in an effort to explore su...

An oromucosal mucoadhesive suspension (OMS) able to combine the peculiarities of prolonged release mucoadhesive microparticles with those of an immediate release oromucosal solution is described. Microparticles were obtained by ionotropic gelation of alginate blended with another mucoadhesive material in a one step process where the cross-linking b...

Objective: To evaluate the feasibility of a transdermal patch containing propranolol (PR). Method: Skin penetration enhancers (SPEs) able to improve the skin permeability of PR were selected and a quality by design approach was applied to the development of the patch by a 2(4) full factorial design. The permeation profile of PR from the formulat...

The objectives of the present study were to determine the effects of the brewing method on the amount of the major catechins, methylxanthines, total polyphenols and antioxidant capacity in green and black teas, and to correlate the chemical composition of tea infusions to their sensorial properties by the combined use of the electronic nose and ton...

Melatonin (5-methoxytryptamine) is a natural occurring molecule which exerts physiologic role of circadian sleep-wake cycle in humans. Melatonin is secreted from the pineal gland placed in the center of the brain, far from blood-brain barrier. Thanks to its ascertained safety in humans and low cost, melatonin is widely employed in the market of dru...

Il primo riconoscimento dei radiofarmaci come prodotti medicinali risale agli anni Cinquanta. È infatti nel 1948 che John E. Christian della Purdue University, Illinois, scrive: “Radioactive isotopes when used for therapeutic and diagnostic purposes are in the true sense of the word drugs and are so classified and regulated under Section 505 of the...

The protection rights of low molecular weight heparins (LMWHs) are expired or are expiring, so the extent and nature of the studies required to obtain a market authorization for LMWH copies represents a hot topic. FDA classifies LMWHs as semisynthetic drugs and their copies as generics whereas the EMA views them as biological medicines and conseque...

This work aimed to develop membranes made of regenerated keratin and ceramides (CERs) to match the barrier property of the human stratum corneum in in vitro percutaneous absorption studies. The membrane composition was optimized on the basis of the in vitro drug diffusion profiles of ibuprofen, propranolol and testosterone chosen as model drugs on...

In this paper, we report a case of misidentification of medicinal plants involving dried petals of Papaver rhoeas (red poppy) contaminated with Papaver bracteatum (scarlet poppy) petals. Preliminary TLC analysis indicated the presence of thebaine either in the fluid extracts or in the petals. It was therefore necessary to carry out an accurate bota...

The effect of a homologue series of nonionic surfactants, namely poly(ethylene glycol) (PEG) fatty acid esters, differing in oxyethylene (PEG 8, PEG 12, and PEG 40) and fatty acid (stearate, mono and di-laurate, and mono and di-oleate) chain lengths, on in vitro skin permeability of ketoprofen (KTP) vehicled in plasters was investigated. The drug d...

Introduction: Transdermal patches and medicated plasters (patch) represent well-established prolonged release dosage forms. Even if satisfactory adhesion to the skin is strictly linked to the efficacy and safety of the therapeutic treatment, nowadays numerous reports of in vivo 'adhesion lacking' are still addressed to regulatory agencies. The adh...

This paper reports the feasibility to prepare a biodegradable material stable to γ-irradiation by grafting of poly(lactide-co-glycolide) with pyrogallic acid (PLGA-g-PA) and ferulic acid (PLGA-g-FA) in mild condition. Only the grafting procedure with PA did not modify molecular weight (Mw) of the starting polymer and PLGA-g-PA showed antioxidant pr...

This paper deals with the current regulatory and legal settings of traditional plant food supplements and herbal medicinal products in the European Union (EU). Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, in...

In the European Union (EU), the regulatory policy for biosimilars has enabled different biosimilar products to be marketed through an abridged application, which allows the applicant to submit a reduced dossier. Nevertheless, some manufacturers of biological products that share some characteristics with copies have opted for a full application; the...

Regenerated silk fibroin (SF) is a promising biomaterial to design drug delivery systems. To guarantee satisfactory prolonged release of loaded drugs, the native β-sheet conformation of SF is generally induced by a final curing which can determine instability of the loaded drug. This work aimed to investigate the influence on SF conformation of the...

The current work aimed to propose a system of scoring to rationalize and support the selection of the optimal diameter and length of needles. Four formulations at different viscosity and needles ranging from 21 to 26 G and length ranging from 16 to 40 mm were used. Plunger-stopper breakloose force, maximum force (F max), and dynamic glide force wer...