[Dermo-cosmetic control of cutaneous adverse effects in the oncological patient.] / Il controllo dermo-cosmetologico dei sintomi cutanei nel malato oncologico.

Cutaneous adverse effects are often associated to cancer therapies. Modifications of the aspect represent one of the factors responsible for quality of life decrese, particularly visible in women. It must be underlined also that in many female tumors the cutaneous adverse effects are often enhanced by the hormonal levels inducing skin damage and photoinduced reactions. In this scenario the cosmetic oncology plays a very important role. In fact, it is a branch of cosmetic, having high social and ethical value born to support oncological patients by physical appearance improvement. The skin and cutaneous annexes of the oncological patient are different in comparison to that of health people requiring particular attention. In first instance a high skin protection and hydration is necessary for such patients. For this reason, the cosmetic oncology supports the oncological patients in the improvement of their appearance by means of specific products and skin care procedures. Projects of cosmetic oncology, involving many territorial pharmacies, raised with the idea that the attenuation of the external signs therapy-induced can contribute to the improvement of the patient quality of life.

Bioadhesive Polymeric Films Based on Red Onion Skins Extract for Wound Treatment: An Innovative and Eco-Friendly Formulation.

The onion non-edible outside layers represent a widely available waste material deriving from its processing and consumption. As onion is a vegetable showing many beneficial properties for human health, a study aiming to evaluate the use of extract deriving from the non-edible outside layers was planned. An eco-friendly extraction method was optimized using a hydroalcoholic solution as solvent. The obtained extract was deeply characterized by in vitro methods and then formulated in autoadhesive, biocompatible and pain-free hydrogel polymeric films. The extract, very soluble in water, showed antioxidant, radical scavenging, antibacterial and anti-inflammatory activities, suggesting a potential dermal application for wounds treatment. In vitro studies showed a sustained release of the extract from the hydrogel polymeric film suitable to reach concentrations necessary for both antibacterial and anti-inflammatory activities. Test performed on human keratinocytes showed that the formulation is safe suggesting that the projected formulation could be a valuable tool for wound treatment.

Development and characterization of mucoadhesive-thermoresponsive gels for the treatment of oral mucosa diseases.

INTRODUCTION: The mucositis is an inflammatory, erosive and ulcerative process of the oral mucosa. It is usually caused by radiation, chemotherapy, infections, diabetes, smoking and it is characterized by severe pain and difficulty eating and can have a very serious impact on quality of life. A suitable treatment must ensure pain control and mechanical protection to promote mucosal healing. The purpose of this work was to study an in-situ gelling formulation to be sprayed onto the damaged oral mucosa by self-administration. The formulation must be able to quickly form a film when applied in the oral cavity. METHODS: many batches were prepared mixing a thermosensitive polymer (poloxamer PF127 or P123) with mucoadhesive polymers polyvinylpyrrolidone (PVP), sodium carboxymethyl cellulose (NaCMC), Carbopol 971P, chitosan (CS). By an experimental design three suitable formulations were identified and loaded with the model drug benzydamine hydrochloride. The hydrogel based on 25.50% PF127, 0.20% PVP and 0.35% CS maintained its original properties (gelling, rheological and mucoadhesive) after loading and showing a sustained drug release. CONCLUSIONS: the selected hydrogel showed to be suitable for the treatment of mucositis, able to reduce the number of daily administration and to protect the damaged mucosa from mechanical and chemical solicitations.

Dentifrice Based on Fluoride-Hydrotalcite Compounds: Characterization and Release Capacity Evaluation by Novel In Vitro Methods.

Anti-caries activity of fluoride ions is due to the protection against demineralization and the enhancement of remineralization of tooth enamel. Dentifrices available on the market contain sodium fluoride, sodium monofluorophosphate, stannous fluoride, and amine fluoride as source of these ions. A new compound working both as fluoride ion source and as abrasive was projected. Hybrids based on F- ions intercalated between the lamellae of hydrotalcite-like compounds (HTlc-F), namely MgAl-HTlc-F and ZnAl-HTlc-F, were prepared and characterized. Then, three different percentages (2, 3, and 4%) of both HTlc-F compounds were assayed. After the rheological characterization, the dentifrices containing 3 and 4% of MgAl-HTlc-F and ZnAl-HTlc-F, respectively, resulted to be the most suitable ones. Two novel in vitro methods, "rotary toothbrush method" and "manual brushing method," were developed and used in order to study the F- ions release from the prepared dentifrices. The obtained results showed that the dentifrice containing ZnAl-HTlc-F (4%) was the most effective in releasing fluoride ions. The "rotary toothbrush method" resulted to be the most suitable as the simulation of the brushing movements is standardizable and reproducible.

Nanostructured hybrids for the improvement of folic acid biopharmaceutical properties.

OBJECTIVES: Folic acid (FA) is an important source for the prevention of many diseases. However, its use is limited because the very low solubility (<10 mg/l particularly in the gastric environment) responsible for the incomplete adsorption of the administered dose. This study proposes a technological strategy to overcome this problem enhancing FA dissolution rate by means of a formulation able to make completely bioavailable the whole administered dose. METHODS: Folic acid was intercalated in the layered double hydroxides (LDHs) MgAl-LDH and ZnAl-LDH. The obtained inorganic-organic nanostructured hybrids MgAl-LDH-FA and ZnAl-LDH-FA were deeply characterized and used to prepare immediate release tablets presenting very simple compositions. The hybrids, both as simple powders and as tablets, were submitted to in-vitro release studies mimic the gastric environment conducted both in sink and non-sink conditions. KEY FINDINGS: Folic acid release from hybrids, as single powders or as tablets, resulted enhanced in both experiments in comparison with crystalline FA. CONCLUSIONS: Obtained results showed that FA-LDH nanostructured hybrids are a promising strategy able to enhance the active ingredient dissolution at low pH values representing a promising approach suitable to realize innovative and effective nutraceutical products.

Capreomycin inhalable powders prepared with an innovative spray-drying technique.

The aim of the work was to produce inhalable capreomycin powders using a novel spray-drying technology. A 2(3) factorial design was used to individuate the best working conditions. The maximum desirability was identified at the smallest mean volume diameter (dv) and span, and the highest yield. Powders were characterized for size, morphology, flowability and aerodynamic properties. Mathematical models showed a good predictivity with biases lower than 20%. The maximum conformity with desirability criteria was obtained spraying a 10mg/mL bacitracin solution at 111 °C with the 4 µm pore size membrane. By processing capreomycin sulfate with the parameters optimized for bacitracin, an inhalable powder was obtained (i.e., yield of 82%, dv of 3.83 µm, and span of 1.04). By further optimization, capreomycin sulfate powder characteristics were improved (i.e., yield, ∼71%; dv, 3.25 µm; span, 0.95). After formulation with lactose, emitted dose and respirable fraction of 87% and ∼27% were obtained, respectively. Two capreomycin sulfate powders with suitable properties for inhalation were produced using the nano spray-dryer B-90.

Intercalation compounds of hydrotalcite-like anionic clays with anti-inflammatory agents, II: Uptake of diclofenac for a controlled release formulation.

The purpose of this study was to investigate whether hydrotalcite is able to intercalate diclofenac, a nonsteroidal anti-inflammatory drug, and release it in a controlled manner. Layered Mg-Al hydrotalcite in the chloride form was used as a host, and the intercalation compound was prepared by Cl-/diclofenac anionic exchange. Drug release from the intercalation compound was performed in vitro in simulated intestinal fluid at pH 7.5 according to USP 24 and in a pH 7.0 solution designed to mimic the ionic conditions of the small intestine. Results from the intercalation process show that hydrotalcite is able to intercalate diclofenac with a simple procedure and with a good drug loading (55% wt/wt). The in vitro drug release was remarkably lower than that from the corresponding physical mixture at both pH 7.5 and pH 7.0. In the latter case, the release was not complete at 24 hours. The kinetic analysis shows the importance of the diffusion through the particle in controlling the drug release rate. The obtained results show that hydrotalcite may be used to prepare modified release formulations.