The safety of tattoo inks: Possible options for a common regulatory framework

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 risks for consumers may derive from microbiological contamination and the presence of toxic substances or nanomaterials. However, current regulations and non-binding recommendations, where present, only address the microbiological and chemical risks, completely overlooking nanotoxicity. The aim of this paper is to promote awareness of the risks associated with tattoo inks and the nanomaterials contained therein. In particular, the need for a harmonised regulation or, at least, a set of minimal requirements is highlighted to improve the safety of tattoo inks and market surveillance by regulatory authorities

LIBS Collection Optics : comparative analysis of different mirror-based configuration

We have evaluated the efficiency of different reflection based optical systems using numerical simulation. We have realized and started testing the most promising one

Effect of the temporal integration on the accuracy of the measured concentration in LIBS measurements

We have developed a simulation program that allows to calculate the plasma emission spectrum of a coal sample in a LIBS experiment. We used the acquired data to evaluate the effect of temporal integration on the accuracy of measured concentration obtained using the calibration free method

Design and development of topical liposomal formulations in a regulatory perspective

The skin is the absorption site for drug substances intended to treat loco-regional diseases, although its barrier properties limit the permeation of drug molecules. The growing knowledge of the skin structure and its physiology have supported the design of innovative nanosystems (e.g. liposomal systems) to improve the absorption of poorly skin-permeable drugs. However, despite the dozens of clinical trials started, few topically applied liposomal systems have been authorized both in the EU and the USA. Indeed, the intrinsic complexity of the topically applied liposomal systems, the higher production costs, the lack of standardized methods and the more stringent guidelines for assessing their benefit/risk balance can be seen as causes of such inefficient translation. The present work aimed to provide an overview of the physicochemical and biopharmaceutical characterization methods that can be applied to topical liposomal systems intended to be marketed as medicinal products, and the current regulatory provisions. The discussion highlights how such methodologies can be relevant for defining the critical quality attributes of the final product, and they can be usefully applied based on the phase of the life cycle of a liposomal product: to guide the formulation studies in the early stages of development, to rationally design preclinical and clinical trials, to support the pharmaceutical quality control system and to sustain post-marketing variations. The provided information can help define harmonized quality standards able to overcome the case-by-case approach currently applied by regulatory agencies in assessing the benefit/risk of the topically applied liposomal systems. Graphical abstract: [Figure not available: see fulltext.

Fixed Versus Free Combinations of Antihypertensive Drugs: Analyses Of Real-World Data Of Persistence With Therapy In Italy

Purpose: To analyse the pattern of use and cost of antihypertensive drugs in new users in an Italian population, and explore the patient/treatment factors associated with the risk of therapy discontinuation. Patients and methods: In this retrospective study, information was collected from a population-based electronic primary-care database. Persistence with medication use 1 year from therapy initiation was evaluated for each user using the gap method. Each new user was classified according to his/her pattern of use as: \u201ccontinuer\u201d, \u201cdiscontinuer\u201d \u201cswitching\u201d or \u201cadd-on\u201d. A Cox regression model was used to analyse the factors influencing therapy discontinuation. Primary-care costs comprised specialists\u2019 visits, diagnostic procedures and pharmacologic therapies. Results: Among 14,999 subjects included in persistence analyses, 55.1% of cases initially started on monotherapy were classified as discontinuers vs 36.5% of cases taking combination therapy (42.3% vs 32.7%, respectively, for free and fixed combinations, P < 0.01). Old age, high cardiovascular risk and being in receipt of fixed-combination therapy were associated with greater persistence. Overall, the primary-care cost/person/year of hypertension management was 3c\u20ac95.3 (IQR, 144.9). The monotherapy cost was \u20ac88 per patient (IQR, 132.9), and that for combination therapy was \u20ac151\ub1148.3. The median cost/patient with a fixed combination was lower than that for a free combination (\u20ac98.4 (IQR, 155.3) and \u20ac154.9 (IQR, 182.6), respectively). Conclusion: The initial type of therapy prescribed influences persistence. Prescribing fixed combinations might be a good choice as initial therapy

Femtosecond Laser Ablation: Fundamentals and Applications

Abstract Traditionally nanosecond laser pulses have been used for Laser-induced Breakdown Spectroscopy (LIBS) for quantitative and qualitative analysis of the samples. Laser produced plasmas using nanosecond laser pulses have been studied extensively since 1960s. With the advent of short and ultrashort laser pulses, there has been a growing interest in the applications of femtosecond and picosecond lasers for analysis of materials using LIBS and LA-ICP-MS. The fundamentals of laser ablation process using ultrashort laser pulses are not still fully understood. Pulse duration of femtosecond laser pulse is shorter than electron-to-ion energy transfer time and heat conduction time in the sample lattice. This results in different laser ablation and heat dissipation mechanisms as compared to nanosecond laser ablation. In this chapter, the focus will be on understanding the basics of femtosecond laser ablation processes including laser target interaction, ablation efficiency, ablation threshold, laser plasma interactions, and plume hydrodynamics. Analytical figures of merit will be discussed in contrast to nanosecond LIBS. Introduction Laser ablation (LA) and laser-produced plasmas (LPP) have been studied extensively for more than 50 years since the discovery of lasers in the 1960s. The physics involved in laser-plasma generation and subsequent evolution is very complex and contains many processes like heating, melting, vaporization, ejection of particles, and plasma creation and expansion. The laser ablation craters and plasmas produced are dependent on laser beam parameters such as pulse duration, energy, and wavelength, along with the target properties and surroundin

Study of fractal objects by means of low angle light scattering

Low angle elastic light scattering techniques have been successfully applied to the study of solid particle size distributions. In this work we evaluate the possibility of extending this method to the study of fractal objects, like aggregating colloids. We present computer simulations on a peculiar iterative inversion scheme to recover the cluster gyration radiuses distribution. The computer simulations are made assuming realistic estimates of the noise associated to the measurements and the results of the data inversion procedure will be compared with the input data. The rate of convergence with the number of iterations will also be discussed. \ua9 1987 SPIE