Alternatives When an Authorized Medicinal Product is Not Available

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 in the following scenario: off-label prescriptions, extemporaneous preparations, compassionate use of medicinal products, and medicinal products authorized in foreign countries. The best solution among these alternatives should be evaluated case-by-case on the basis of good scientific evidence, expert medical judgement, and published literature, also keeping an eye on the availability, the cost, and the regulatory requirements at a national level

Data on spray-drying processing to optimize the yield of materials sensitive to heat and moisture content

Full dataset used to evaluate the spray-drying process parameters on the preparation of a micronized powder made of maltodextrin (MDX) is herein reported. The process parameters (namely, feed flow rate (FFR); inlet temperature (Tin); nozzle pressure (PN); noozle diameter (DN) and difference of pressure between cyclone and chamber (ΔP)) were screened through a Central Composite Design (25−1; 2∗5; nC=2) using the following responses: product yield, powder size and size dispersity (span) and the outlet temperature of the exhausted air (Tout). Data indicate that, in the considered range, only the product yield and the powder median diameter were influenced by the process. The product yield progressively increased on increasing inlet temperature and decreasing the amount or the size of droplets to be dried. The powder median diameter was positively influenced only by the nozzle diameter. This data presented in this article completes a wider work related on “Maltodextrins as drying auxiliary agent for the preparation of easily resuspendable nanoparticles” (Magri et al., 2019). Keywords: Spray-drying, Maltodextrins, Process optimizatio

Feeding Next‐Generation Nanomedicines to Europe: Regulatory and Quality Challenges

New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.Nanomedicines are revolutionizing the prognosis of many human diseases but their peculiar physicochemical properties are raising new challenges in regulatory approval. Current open issues regarding regulatory qualification and physicochemical characterization of nanosystems are critically discussed, considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued.imag

Preparation and characterization of caffeic acid grafted PLGA microspheres

Introduction Phenolic compounds are known to have antioxidant properties mainly because they can act as free-radical scavengers since the hydroxyl groups can donate an electron or hydrogen atom to a free radical. Recently, phenolic compounds grafted onto the backbone of poly(lactide-co-glycolide) (PLGA) were proposed as novel biodegradable materials stable to sterilization by gamma- irradiation at the dose of 25 kGy [1]. Nevertheless, no information on the feasibility to encapsulate biological drug products have been available

The management of upper gastrointestinal symptoms: A study on community pharmacies in Italy

Upper gastrointestinal (GI) symptoms are usual complaints among patients presenting to Italian community pharmacies. However, information on treatment history of those patients is often lacking. This descriptive, cross-sectional study aims at exploring the medication history of individuals with upper GI tract symptoms visiting one of the 20 enrolled community pharmacies, over a period of 7 months, based on the administration of a questionnaire. Of 1,020 interviewees, 62.1% had asked for a medical consultation. The most frequent symptom was epigastric burning (31.8%), followed by acid regurgitation (14.6%) and post-prandial fullness (12.0%). Of the 1,609 therapies, proton pump inhibitors constituted the most represented therapeutic class (35.6%) followed by antacids (17.5%) and alginate-based products (17.2%). In treating symptoms, 38.1% of the patients do not seek medical advice, while 42.0% rely on non-prescription therapies. As findings suggest, support to patients with GI disorders in community pharmacies can be enhanced for a safer self-medication

On the selection of an opioid for local skin analgesia: Structure-skin permeability relationships

Recent studies demonstrated 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 morphinan core. Log P, log D, solid-state features and solubility were determined. Docking simulations were performed using supramolecular assembly made of ceramide VI. The modifications on position 3 of the morphinan core resulted the most relevant in determining both physicochemical characteristics and diffusion pattern. The 3-methoxy group weakened the cohesiveness of the crystal lattice structure and increased the permeation flux (J). Computational studies emphasized that, while permeation is essentially controlled by molecule apolarity, skin retention depends on a fine balance of polar and apolar molecular features. Moreover, ChemPLP scoring the interactions between the opioids and ceramide, correlated with both the amount retained into the epidermis (Qret) and J. The balance of the skin penetration properties and the affinity potency for μ-receptors evidenced hydromorphone as the most suitable compound for the induction of local analgesia

3D printed mucoadhesive orodispersible films manufactured by direct powder extrusion for personalized clobetasol propionate based paediatric therapies

The aim of this work is the development and production by Direct Powder Extrusion (DPE) 3D printing technique of novel oral mucoadhesive films delivering Clobetasol propionate (CBS), useful in paediatric treatment of Oral Lichen Planus (OLP), a rare chronic disease. The DPE 3D printing of these dosage forms can allow the reduction of frequency regimen, the therapy personalization, and reduction of oral cavity administration discomfort. To obtain suitable mucoadhesive films, different polymeric materials, namely hydroxypropylmethylcellulose or polyethylene oxide blended with chitosan (CS), were tested and hydroxypropyl-& beta;-cyclodextrin was added to increase the CBS solubility. The formulations were tested in terms of mechanical, physico-chemical, and in vitro biopharmaceutical properties. The film showed a tenacious structure, with drug chemical-physical characteristics enhancement due to its partial amorphization during the printing stage and owing to cyclodextrins multicom-ponent complex formation. The presence of CS enhanced the mucoadhesive properties leading to a significant increase of drug exposure time on the mucosa. Finally, the printed films permeation and retention studies through porcine mucosae showed a marked retention of the drug inside the epithelium, avoiding drug systemic absorption. Therefore, DPE-printed films could represent a suitable technique for the preparation of mucoad-hesive film potentially usable for paediatric therapy including OLP