Development and characterization of curcumin-loaded polycaprolactone nanoparticles by Design of Experiments

Objectives. Design of Experiments (DOE) is a powerful tool for identifying important formulation factors and process parameters in drug design and manufacturing, to ensure certain product specifications. This study aimed at manufacturing curcumin-loaded polycaprolactone nanoparticles (CURC-PCL NP), and used DOE in order to understand how formulation and process variables impact the drug delivery system’s characteristics. Polymeric nanoparticles are a suitable approach for incorporating hydrophobic drugs such as curcumin, in order to maximize the numerous beneficial effects, and to minimize the side effects and shortcomings such as low water-solubility and bioavailability. Material and methods. The CURC-PCL NP were prepared by the solvent displacement method. The effects of various formulation and process variables on the nanoparticles’ characteristics were investigated by employing a fractional factorial design with 19 runs. Outcomes. Regression equations were generated to predict the impact of changing variables on particle size, size distribution, zeta potential, drug content and entrapment efficiency. The statistical analysis indicated that the chosen model was robust, reliable and assured good experimental control. Conclusions. Overall, this study shows that DOE is useful in achieving the desirable goals in polymeric nanoparticle development, in the shortest time possible and with a reduced number of experiments

Eating habits and nutritional status of women with musculo-skeletal diseases

Different theories link chronic musculoskeletal pain with lifestyle components, including diet. However, nutritional assesment and optimization is not routinely included into the medical management of patients with muskuloskeletal diseases (MSKD). In this study we aimed to evaluate the diet and nutritional status of a group of women with MSKD and to assess the extent to which they comply with the general recommendations for a healthy diet. The results showed that 97% of the subjects included were overweight or obese, and the compliance to different general nutritional recommandations ranged between 3% to 57%. Furthermore, the quality of life of this patients measured through SF-36 question-naire was severly affected and the reported pain intensity on numeric pain scale had a mean of 8 (±1.3) in our study group. Although there are currently no specific guidelines for the nutrition of patients with chronic pain, an important first step would be to guide these patients towards an increase in diet quality and a healthy lifestyle by adhering to general nutritional recommendations regarding healthy eating

Comparison of seven prognostic tools to identify low-risk pulmonary embolism in patients aged <50 years

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Personality profiles of cultures: aggregate personality traits

Personality profiles of cultures can be operationalized as the mean trait levels of culture members. College students from 51 cultures rated an individual from their country whom they knew well (N = 12, 156). Aggregate scores on Revised NEO Personality Inventory scales generalized across age and gender groups, approximated the individual-level Five-Factor Model, and correlated with aggregate self-report personality scores and other culture-level variables. Results were not attributable to national differences in economic development or to acquiescence. Geographical differences in scale variances and mean levels were replicated, with Europeans and Americans generally scoring higher in Extraversion than Asians and Africans. Findings support the rough scalar equivalence of NEO-PI-R factors and facets across cultures, and suggest that aggregate personality profiles provide insight into cultural differences

A quality by design approach for the development of lyophilized liposomes with simvastatin

Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics. In the case of lyophilized liposomes, the choice of the optimum formulation and technological parameters has to be done, in order to protect the integrity of the liposomal membrane during lyophilization. Thus, the influence of several risk factors (3 formulation factors: PEG proportion, cholesterol concentration, the cryoprotectant to phospholipids molar ratio, and 2 process parameters: the number of extrusions through 100 nm polycarbonate membranes and the freezing conditions prior lyophilization) over the critical quality attributes (CQAs) of lyophilized long circulating liposomes with simvastatin (lyo-LCL-SIM), i.e. the size, the encapsulated SIM concentration, the encapsulated SIM retention, the Tm change and the residual moisture content, was investigated within the current study using the design of experiments tool of QbD. Moreover, the design space for lyo-LCL-SIM was determined, in which the established quality requirements of the product are met, provided that the risk factors vary within the established limits

Concepts and Challenges of Biosimilars in Breast Cancer: The Emergence of Trastuzumab Biosimilars

With the development of anti-human epidermal growth factor receptor 2 (HER2) monoclonal antibodies, trastuzumab-based therapy has become the standard of care among patients with early or advanced HER2-positive breast cancer. However, real-world data have shown that up to a half of patients do not receive trastuzumab or any other HER2-targeted agent, mainly due to high treatments costs. The prospect of a more enlarged access to trastuzumab treatment lies in the use of biosimilars, as the European and the US patent of the reference products has or will soon expire. Biosimilars are biologics highly similar in terms of quality characteristics, biological activity, safety and efficacy to already approved biologics. The biosimilarity of any European Union (EU)-approved biosimilar is guaranteed based on the comprehensive comparability exercise which includes comparative analytical, non-clinical and clinical studies. In the matter of biosimilars&rsquo; interchangeability and substitution, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have adopted different positions, triggering various discussions on the potential immunogenicity and efficacy in individual patients. As more biosimilars are gaining approval, the present review aims to offer concise information for oncologists and pharmacists about the production, approval, interchangeability, and substitution policies of biosimilars used in breast cancer therapy, with a special focus on trastuzumab

Antispasmodic Effect of Essential Oils and Their Constituents: A Review

The antispasmodic effect of drugs is used for the symptomatic treatment of cramping and discomfort affecting smooth muscles from the gastrointestinal, billiary or genitourinary tract in a variety of clinical situations.The existing synthetic antispasmodic drugs may cause a series of unpleasant side effects, and therefore the discovery of new molecules of natural origin is an important goal for the pharmaceutical industry. This review describes a series of recent studies investigating the antispasmodic effect of essential oils from 39 plant species belonging to 12 families. The pharmacological models used in the studies together with the mechanistic discussions and the chemical composition of the essential oils are also detailed. The data clearly demonstrate the antispasmodic effect of the essential oils from the aromatic plant species studied. Further research is needed in order to ascertain the therapeutic importance of these findings

Development of a Bilayer Tablet by Fused Deposition Modeling as a Sustained-Release Drug Delivery System

Three-dimensional printing by fused deposition modeling (FDM) coupled with hot-melt extrusion (HME) is a point of convergence of research efforts directed toward the development of personalized dosage forms. In addition to the customization in terms of shapes, sizes, or delivered drug doses, the modulation of drug release profiles is crucial to ensure the superior efficacy and safety of modern 3D-printed medications compared to those of conventional ones. Our work aims to solidify the groundwork for the preparation of 3D-printed tablets that ensure the sustained release of diclofenac sodium. Specifically, we achieved the fast release of a diclofenac sodium dose to allow for the prompt onset of its pharmacological effect, further sustaining by the slow release of another dose to maintain the effect over a prolonged timeframe. In this regard, proper formulation and design strategies (a honeycomb structure for the immediate-release layer and a completely filled structure for the sustained-release layer) were applied. Secondarily, the potential of polyvinyl alcohol to function as a multifaceted polymeric matrix for both the immediate and slow-release layers was explored, with the objective of promoting the real-life applicability of the technique by downsizing the number of materials required to obtain versatile pharmaceutical products. The present study is a step forward in the translation of HME-FDM-3DP into a pharmaceutical manufacturing methodology