Impact of Time on Parameters for Assessing the Microstructure Equivalence of Topical Products: Diclofenac 1% Emulsion as a Case Study.

The demonstration of bioequivalence proposed in the European Medicines Agency's (EMA's) draft guideline for topical products with the same qualitative and quantitative composition requires the confirmation of the internal structure equivalence. The impact of the shelf-life on the parameters proposed for internal structure comparison has not been studied. The objectives of this work were: (1) to quantify the effect of the time since manufacturing on the mean value and variability of the parameters proposed by the EMA to characterize the internal structure and performance of topical formulations of a complex topical formulation, and (2) to evaluate the impact of these changes on the assessment of the microstructure equivalence.

Erratum: Mangas-Sanjuán, V.; et al. Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence. 2019, , 503.

The authors wish to make the following corrections to this paper [...

Relationship between rheological properties, in vitro release and in vivo equivalency of topical formulations of diclofenac.

Determination of bioequivalence remains a challenge in generic topical drug development. To support pharmacokinetic studies, strategies to demonstrate microstructure sameness of the products being compared include in vitro evaluations, such as the comparison of rheological properties, droplet size and in vitro release rates. Nevertheless, defining the appropriate acceptance range to consider equivalence between test and reference formulation is complex.

Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence.

Demonstration of similar microstructure is essential for demonstrating the equivalence of generic topical products since the microstructure of semisolids may affect the drug release. The objective of this study was to compare the microstructure-defining physical parameters of different batches of a reference ointment containing calcipotriol and betamethasone (Daivobet 50 µg/0.5 mg/g) in order to define the acceptance range that allows concluding equivalence between these batches.

A novel lidocaine hydrochloride mucoadhesive films for periodontal diseases.

Periodontal diseases are inflammatory disorders caused primarily by dental plaque microorganisms that even may need surgery to remove damaged tissue. Adhesive biocompatible films may be an adequate form in order to improve drug retention or prevent microbial infections by covering the surgical site. In recent years, much attention has been focused on biocompatible inexpensive polymers, for biomedical and pharmaceutical potential applications.

Ionic Hydrogel Based on Chitosan Cross-Linked with 6-Phosphogluconic Trisodium Salt as a Drug Delivery System.

In this work, 6-phosphogluconic trisodium salt (6-PGNa) is introduced as a new aqueous and nontoxic cross-linking agent to obtain ionic hydrogels. Here, it is shown the formation of hydrogels based on chitosan cross-linked with 6-PGNa. This formulation is obtained by ionic interaction of cationic groups of polymer with anionic groups of the cross-linker.

Gallium plasmonic nanoparticles for label-free DNA and single nucleotide polymorphism sensing.

A label-free DNA and single nucleotide polymorphism (SNP) sensing method is described. It is based on the use of the pseudodielectric function of gallium plasmonic nanoparticles (GaNPs) deposited on Si (100) substrates under reversal of the polarization handedness condition. Under this condition, the pseudodielectric function is extremely sensitive to changes in the surrounding medium of the nanoparticle surface providing an excellent sensing platform competitive to conventional surface plasmon resonance.

Immunosensing platform based on gallium nanoparticle arrays on silicon substrates.

Gallium nanoparticles (GaNPs) of different sizes are deposited on Si(100) substrates by thermal evaporation. Through ellipsometric analysis, it is possible to investigate the plasmonic effects in the GaNPs and exploit them to develop biosensors. The excitation of the resonant modes for certain incidence angles leads to negative values of the imaginary part of the pseudodielectric function (<εi>) obtained in ellipsometry.

[Surveillance and control of methicillin-resistant Staphylococcus aureus in Spanish hospitals. A GEIH-SEIMC and SEMPSPH consensus document].

Methicillin-resistant Staphylococcus aureus (MRSA) is an important pathogen, both in-hospital and in the community. Although there are several guidelines with recommendations for the control of this microorganism, the measures proposed are not uniformly implemented in Spanish hospitals. The objective of this document is to provide evidence-based recommendations that are applicable to Spanish hospitals, with the aim of reducing transmission of MRSA in our health care centers.

[Utility and advantages of single tracer subareolar injection in sentinel lymph node biopsy in breast cancer].

Introduction: Sentinel lymph node (SLN) biopsy is a reliable technique for determining axillary status in patients with early breast cancer. This technique is a minimally invasive procedure that can avoid the use of lymphadenectomy in patients without axillary involvement. We present a validation study of SLN biopsy with subareolar injection of 99mTc-nanocolloids.

Chemometric studies of vinegars from different raw materials and processes of production.

The phenolic composition, aroma compounds, and organic acid content of 83 vinegars have been determined. Multivariate analysis techniques have been used to classify these vinegar samples according to raw material (white wine, red wine, apple, honey, alcohol, balsamic, and malt) and production process (with and without aging in wood). Cluster analysis grouped the samples according to production process.