Pharmaceutical and biotech industry perspectives on optimizing patient experience and treatment adherence through subcutaneous drug delivery design.

Subcutaneous (SC) drug delivery can be a safe, effective alternative to the traditional intravenous route of administration, potentially offering notable advantages for both patients and healthcare providers. The SC Drug Development & Delivery Consortium convened in 2018 to raise awareness of industry challenges to advance the development of patient-centric SC drug delivery strategies. The SC Consortium identified better understanding of patient preferences and perspectives as necessary to optimize SC product design attributes and help guide design decisions during SC product development. This manuscript provides a comprehensive overview of patient-centric factors for consideration in the SC drug delivery design and development process with the aim of establishing a foundation of existing knowledge for patient experiences related to SC drug delivery. This overview is informed by the outcomes of a multi-step survey of Consortium members and key pharmaceutical stakeholders. Framed in the context of the patient's treatment journey, the survey findings offer future perspectives to fill data gaps to advance patient-centric SC drug delivery.

SER recommendations on treatment of refractory Behçet's syndrome.

OBJECTIVE: To develop multidisciplinary recommendations based on available evidence and expert consensus for the therapeutic management of patients with refractory Behçet's syndrome (BS) (difficult to treat, severe resistant, severe relapse) to conventional treatment. METHODS: A group of experts identified clinical research questions relevant to the objective of the document. These questions were reformulated in PICO format (patient, intervention, comparison and outcome). Systematic reviews of the evidence were conducted, the quality of the evidence was evaluated following the methodology of the international working group Grading of Recommendations Assessment, Development, and Evaluation (GRADE). After that, the multidisciplinary panel formulated the specific recommendations. RESULTS: 4 PICO questions were selected regarding the efficacy and safety of systemic pharmacological treatments in patients with BS with clinical manifestations refractory to conventional therapy related to mucocutaneous and/or articular, vascular, neurological parenchymal and gastrointestinal phenotypes. A total of 7 recommendations were made, structured by question, based on the identified evidence and expert consensus. CONCLUSIONS: The treatment of most severe clinical manifestations of BS lacks solid scientific evidence and, besides, there are no specific recommendation documents for patients with refractory disease. With the aim of providing a response to this need, here we present the first official Recommendations of the Spanish Society of Rheumatology for the management of these patients. They are devised as a tool for assistance in clinical decision making, therapeutic homogenisation and to reduce variability in the care of these patients.

Feasibility of Invasive Brown Seaweed Rugulopteryx okamurae as Source of Alginate: Characterization of Products and Evaluation of Derived Gels.

Rugulopteryx okamurae (RO) is an invasive brown seaweed that causes severe environmental problems in the Mediterranean Sea. This work proposed an extraction method that enables their use as a raw material for producing sodium alginate. Alginate was successfully extracted from this invasive seaweed, with its gelling performance in the presence of Ca2+ ions comparable to existing commercial alginates. The mannuronic acid (M)-to-guluronic (G) acid ratio in the 1H-NMR profile indicated a higher percentage of G in the RO-extracted alginate, which implies a greater formation of so-called egg box structures. These differences resulted in their different rheological behaviour, as sodium alginate aqueous solutions exhibited a greater viscosity (η at 1 s-1 = 3.8 ± 0.052 Pa·s) than commercial alginate (2.8 ± 0.024 Pa·s), which is related to the egg box structure developed. When gelled in the presence of calcium, an increase in the value of the elastic modulus was observed. However, the value of the tan δ for the extracted alginate was lower than that of commercial alginate gels, confirming a structure more densely packed, which implies a different restructuring of the alginate chain when gelling. These results confirm the suitability of using invasive Rugulopteryx okamurae as a source of calcium alginate gels. In this way, sustainable bio-based materials may be produced from undesired biomass that currently poses a threat to the ecosystem.

Genotyping KIF1C (c.608G>A) Mutant Reveals a Wide Distribution of Progressive Ataxia in German Charolais Cattle.

Bovine progressive ataxia in Charolais cattle was first described in the 1970s; then, cases were reported in Charolais worldwide. A homozygous loss-of-function mutation within the KIF1C gene (c.608G>A) was found to be responsible for this neurodegenerative disease. The aim of this study was to determine whether the mutated KIF1C allele segregates in the German Charolais population and whether the estimated breeding values for growth and muscle conformation are associated with the mutated genotypes. Genetic test results of the KIF1C:c.608G>A variant were available for 1315 Charolais cattle from 35 herds located in Germany. In addition, 324 samples from eight other beef cattle breeds were tested for the mutated KIF1C allele. We were able to demonstrate that the KIF1C mutation is common, with a frequency of 11.75% in the German Charolais population. All but two of the eight (2/8 = 25%) homozygous mutated individuals showed clinical signs consistent with progressive ataxia. The estimated breeding values of muscle conformation in 200- and 365-day-old animals indicated a significant superiority for homozygous mutated animals when compared either with heterozygous or homozygous wild-type genotypes; this was also the case for heterozygous genotypes in comparison with homozygous wild-type genotypes. For the estimated breeding values of daily weight gain in 200- and 365-day-old animals, the significant differences between homozygous mutated and heterozygous or wild-type genotypes were in favour of the homozygous mutant animals. There were no differences in the estimated maternal breeding values among all three KIF1C genotypes. For the first time, two German Angus cattle carrying the KIF1C mutation heterozygous were detected. The breeders' survey highlighted that increased awareness would facilitate increased conviction among breeders of the need for genetic testing in order to eliminate the lethal KIF1C allele.

Development and Characterization of Edible Films Based on Cassava Starch Modified by Corona Treatment.

Corona treatment (CT), a surface treatment widely used in the plastic industry, can be used to alter the properties of cassava starch. In the present work, CT was performed on dry granular starch (DS), water-suspended humid granular starch (HS), and gelatinized starch (GS). Different properties and structural characteristics of treated starches were studied. A lowering in pH was generally observed after CT and the rheological properties depended on the starch presentation. A reinforcement of DS and HS samples after CT was deduced from higher viscosity values in flow assays and viscoelastic moduli, but weak gels were obtained when CT was applied to GS. Changes in the A-type polymorphic structure, as well as a drop in relative crystallinity, were produced by CT for DS and HS. Additionally, changes in O-H and C-O-C FTIR bands were observed. Therefore, CT can be applied for starch modification, producing predominantly cross-linking in the DS and de-polymerization in the HS. Casting films made from the modified DS showed higher tensile strength and lower hydrophilicity, solubility, water absorption capacity, and water vapor permeability. Thus, the DS cross-linking induced by CT improved mechanical characteristics and hydrophobicity in edible films, which can be better used as packaging materials.

Volcanic tephra deposition dataset based on interpolated field measurements following the 2021 Tajogaite Eruption on La Palma, Canary Islands, Spain.

In 2021, the Tajogaite Volcano erupted along the western slope of the Cumbre Vieja on the island of La Palma, Canary Islands, Spain. Volcanic tephra blanketed a substantial proportion of the island. By our estimations, approximately 23,000,000 m3 of pyroclastic ashes and more coarse-grained particles were deposited unto La Palma's land surface in addition to the lava flow. Five months following the initial eruption, we measured the depth of the new ash layer across the island. We combined this data with drone-based observations to compile a dataset comprising the point distribution of ash depth. A spatial interpolation was then performed using Inverse Distance Weighting (IDW) to estimate the ash depth across the island at a 2 m spatial resolution. The interpolation performed well, yielding a root mean squared error (RMSE) value of 0.34 and thus, the dataset offers immense reuse potential for spatial inquiries related to evolutionary traits, vegetation patterns, and vegetation response to disturbance on oceanic islands. In addition, the data can be used to test different spatial interpolation techniques in an effort to improve the accuracy achieved using IDW.

Recomendaciones SER sobre el tratamiento de la uveítis / SER recommendations for the treatment of uveitis

Objetivo: Elaborar recomendaciones basadas en la evidencia disponible y el consenso de expertos para el manejo terapéutico de los pacientes con uveítis no infecciosas, no neoplásicas y no asociadas a enfermedad desmielinizante. Métodos: Se identificaron preguntas clínicas de investigación relevantes para el objetivo del documento, reformuladas en formato PICO (paciente, intervención, comparación, outcome o desenlace) por un panel de expertos seleccionados en base a su experiencia en el área. Se realizó una revisión sistemática de la evidencia, graduándose de acuerdo a los criterios Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Subsecuentemente, se formularon las recomendaciones. Resultados: Se seleccionaron tres preguntas PICO, referentes a uveítis anteriores, no anteriores y complicadas con edema macular. Se formularon un total de 19 recomendaciones con base en la evidencia encontrada y/o en el consenso de expertos. Conclusiones: Se presenta el primer documento oficial de la Sociedad Española de Reumatología de recomendaciones para el tratamiento de las uveítis. Pueden aplicarse directamente al sistema sanitario español como herramienta de ayuda y homogenización terapéutica.(AU)

Objective: To develop evidence-based expert-consensus recommendations for the management of non-infectious, non-neoplastic, non-demyelinating disease associated uveitis. Methods: Clinical research questions relevant to the objective of the document were identified, and reformulated into PICO format (patient, intervention, comparison, outcome) by a panel of experts selected based on their experience in the field. A systematic review of the available evidence was conducted, and evidence was graded according to GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria. Subsequently, recommendations were developed. Results: Three PICO questions were constructed referring to uveitis anterior, non-anterior and complicated with macular edema. A total of 19 recommendations were formulated, based on the evidence found and/or expert consensus. Conclusions: Here we present the first official recommendations of the Spanish Society of Rheumatology for the treatment of non-infectious and non-demyelinating disease associated uveitis. They can be directly applied to the Spanish healthcare system as a tool for assistance and therapeutic homogenisation.(AU)

SER recommendations for the treatment of uveitis.

OBJECTIVE: To develop evidence-based expert-consensus recommendations for the management of non-infectious, non-neoplastic, non-demyelinating disease associated uveitis. METHODS: Clinical research questions relevant to the objective of the document were identified, and reformulated into PICO format (patient, intervention, comparison, outcome) by a panel of experts selected based on their experience in the field. A systematic review of the available evidence was conducted, and evidence was graded according to GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria. Subsequently, recommendations were developed. RESULTS: Three PICO questions were constructed referring to uveitis anterior, non-anterior and complicated with macular edema. A total of 19 recommendations were formulated, based on the evidence found and/or expert consensus. CONCLUSIONS: Here we present the first official recommendations of the Spanish Society of Rheumatology for the treatment of non-infectious and non-demyelinating disease associated uveitis. They can be directly applied to the Spanish healthcare system as a tool for assistance and therapeutic homogenisation.

Evaluation of rice bran varieties and heat treatment for the development of protein/starch-based bioplastics via injection molding.

Improper management of disposable plastics and resource depletion pose significant environmental challenges, prompting interest in alternatives like bioplastics. These novel materials can be produced from by-products of the agro-food industry, offering solutions and valorizing waste. Rice bran, a substantial by-product of rice processing, is abundant and cost-effective, rich in proteins and starch. These components can be transformed into industrial-grade bioplastics through proper processing. This study evaluates the impact of rice bran varieties and thermal treatment during processing on bioplastic development for injection molding. After defatting and sieving, rice bran was mixed with glycerol and subjected to injection molding at 150 °C. Results indicate that parboiled systems, especially from japonica rice bran, showed high viscoelastic moduli and tensile strength. These systems exhibited a denser structure, resulting in lower water absorption. This research sheds light on the connection between rice bran variety, heat treatment, and the final properties of derived bioplastics. This research contributes significantly to understand the relationship between the variety of rice bran and the impact of heat treatment on the ultimate properties of the derived bioplastics.

Zein as a Basis of Recyclable Injection Moulded Materials: Effect of Formulation and Processing Conditions.

The growing concern about reducing carbon footprint has led to the progressive replacement of traditional polymeric materials by natural-based biodegradable materials. However, materials from natural sources (i.e., plants) typically possess poorer mechanical properties when compared to conventional plastics. To counterbalance this, they need to be adequately formulated and processed to eventually meet the standards for certain applications. Zein is the major storage protein from corn and can be obtained as a by-product from the corn-oil industry. It is an excellent candidate for producing green materials due to its stability, biodegradability, renewability, and suitable mechanical and technical-functional properties. In the present work, zein was blended with a plasticizer (i.e., glycerol) at three different zein/glycerol ratios (75/25, 70/30, and 65/25) and then injection moulded at three different processing temperatures (120, 150, and 190 °C). The properties of both blends and bioplastics were evaluated using dynamic mechanical analysis (DMA), tensile tests, and water absorption capacity (WUC). The properties-structure interrelation was assessed through a scanning electron microscope. Generally, a higher zein content and processing temperature led to a certain reinforcement of the samples. Moreover, all bioplastics displayed a thermoplastic behaviour finally melting at temperatures around 80 °C. The lack of massive crosslinking enabled this melting, which finally could be used to confirm the ability of zein based materials to be recycled, while maintaining their properties. The recyclability of thermoplastic zein materials widens the scope of their application, especially considering its biodegradability.

Hybrid PET/MRI in Cerebral Glioma: Current Status and Perspectives.

Advanced MRI methods and PET using radiolabelled amino acids provide valuable information, in addition to conventional MR imaging, for brain tumour diagnostics. These methods are particularly helpful in challenging situations such as the differentiation of malignant processes from benign lesions, the identification of non-enhancing glioma subregions, the differentiation of tumour progression from treatment-related changes, and the early assessment of responses to anticancer therapy. The debate over which of the methods is preferable in which situation is ongoing, and has been addressed in numerous studies. Currently, most radiology and nuclear medicine departments perform these examinations independently of each other, leading to multiple examinations for the patient. The advent of hybrid PET/MRI allowed a convergence of the methods, but to date simultaneous imaging has reached little relevance in clinical neuro-oncology. This is partly due to the limited availability of hybrid PET/MRI scanners, but is also due to the fact that PET is a second-line examination in brain tumours. PET is only required in equivocal situations, and the spatial co-registration of PET examinations of the brain to previous MRI is possible without disadvantage. A key factor for the benefit of PET/MRI in neuro-oncology is a multimodal approach that provides decisive improvements in the diagnostics of brain tumours compared with a single modality. This review focuses on studies investigating the diagnostic value of combined amino acid PET and 'advanced' MRI in patients with cerebral gliomas. Available studies suggest that the combination of amino acid PET and advanced MRI improves grading and the histomolecular characterisation of newly diagnosed tumours. Few data are available concerning the delineation of tumour extent. A clear additive diagnostic value of amino acid PET and advanced MRI can be achieved regarding the differentiation of tumour recurrence from treatment-related changes. Here, the PET-guided evaluation of advanced MR methods seems to be helpful. In summary, there is growing evidence that a multimodal approach can achieve decisive improvements in the diagnostics of cerebral gliomas, for which hybrid PET/MRI offers optimal conditions.

Drug delivery breakthrough technologies - A perspective on clinical and societal impact.

The way a drug molecule is administered has always had a profound impact on people requiring medical interventions - from vaccine development to cancer therapeutics. In the Controlled Release Society Fall Symposium 2022, a trans-institutional group of scientists from industry, academia, and non-governmental organizations discussed what a breakthrough in the field of drug delivery constitutes. On the basis of these discussions, we classified drug delivery breakthrough technologies into three categories. In category 1, drug delivery systems enable treatment for new molecular entities per se, for instance by overcoming biological barriers. In category 2, drug delivery systems optimize efficacy and/or safety of an existing drug, for instance by directing distribution to their target tissue, by replacing toxic excipients, or by changing the dosing reqimen. In category 3, drug delivery systems improve global access by fostering use in low-resource settings, for instance by facilitating drug administration outside of a controlled health care institutional setting. We recognize that certain breakthroughs can be classified in more than one category. It was concluded that in order to create a true breakthrough technology, multidisciplinary collaboration is mandated to move from pure technical inventions to true innovations addressing key current and emerging unmet health care needs.

Protein Based Amorphous Solid Dispersion: a Case Study Investigating Different Whey Proteins at High Drug Loading.

PURPOSE: Whey protein isolate (WPI) has previously been shown to be a promising new excipient for the development of amorphous solid dispersions (ASD) at a high drug loading of 50% (w/w). Whilst WPI is a protein mixture, comprising mainly the three proteins ß-lactoglobulin (BLG), α-lactalbumin (ALA), casein glycomacropeptides (CGMP), the individual contributions of these three proteins to the overall performance of whey protein based ASDs has still not been investigated. In addition, the limitations of the technology at even higher drug loadings (i.e., more than 50%) have not yet been explored. In this study, BLG, ALA, CGMP and WPI were each prepared as ASDs with the two poorly water-soluble drugs (Compound A and Compound B) at 50%, 60% and 70% drug loadings. METHODS: Solid state characterization, dissolution rate and physical stability of the obtained samples were analyzed. RESULTS: All the obtained samples were amorphous and showed faster dissolution rates compared to the respective pure crystalline drugs. However, the BLG based formulations-at least for Compound A-were outperforming the other ASDs in terms of stability, dissolution enhancement and solubility increase. CONCLUSION: Overall, the study confirmed that the investigated whey proteins showed their potential in developing ASDs even at high drug loadings of up to 70%.

Application of the mineral-binding protein fetuin-A for the detection of calcified lesions.

Rationale: Calcium plays an essential role in the biology of vertebrates. Calcium content in body fluids is maintained within a narrow physiologic range by feedback control. Phosphate is equally important for metabolism and is likewise controlled, albeit over a wider range. This results in a nearly supersaturated state of calcium phosphate in body liquids driving mineral precipitation in soft tissues, which is actively prevented by calcification inhibitors. The hepatic plasma protein fetuin-A is a circulating mineralization inhibitor regulating calcium phosphate crystal growth and calcified matrix metabolism. Ectopic mineralization is associated with many pathological conditions aggravating their outcome. Current diagnostic methods lack sensitivity towards microcalcifications representing the initial stages of the process. Given the irreversibility of established calcifications, novel diagnostic tools capable of detecting nascent calcium phosphate deposits are highly desirable. Methods: We designed fluorescent fusion proteins consisting of fetuin-A coupled to a green or red fluorescent protein derivate, mEmerald or mRuby3, respectively. The proteins were expressed in mammalian cell lines. Sequence optimization resolved folding issues and increased sensitivity of mineral binding. Chimeric proteins were tested for their ability to detect calcifications in cell cultures and tissue sections retrieved from calcification-prone mice. Results: We employed novel genetically labeled fetuin-A-based fluorescent proteins for the detection of ectopic calcifications. We show that fetuin-A-based imaging agents are non-toxic and suitable for live imaging of microcalcifications beyond the detection limit of conventional staining techniques. The ability of fetuin-A to preferentially bind nascent calcium phosphate crystals allowed the resolution of histopathological detail of early kidney damage that went previously undetected. Endogenous expression of fetuin-A fluorescent fusion proteins allowed extended live imaging of calcifying cells with unprecedented sensitivity and specificity. Conclusion: Ectopic microcalcifications represent a major clinical concern lacking effective diagnostic and treatment options. In this paper, we describe novel highly sensitive fetuin-A-based fluorescent probes for imaging microcalcifications. We show that fusion proteins consisting of a fetuin-A mineral binding moiety and a fluorescent protein are superior to the routine methods for detecting calcifications. They also surpass in continuous live cell imaging the chemically fluorescence labeled fetuin-A, which we established previously.

Fibroma osificante periférico del recién nacido: Una potencial complicación posterior a la extracción de dientes natales

Las lesiones orales de tejido blando son infrecuentes en los recién nacidos, pueden conducir a una alimentación, crecimiento, y desarrollo cognitivo inapropiados. El fibroma osificante periférico es una lesión reactiva de la encía, con solo cinco casos reportados en recién nacidos. Objetivo: Reportar un caso de fibroma osificante periférico en un recién nacido, y discutir las complicaciones asociadas a dientes natales/neonatales. Caso clínico: Masculino de 4 meses de edad, mexicano, presentó dos dientes natales que fueron extraídos a los quince días de nacimiento. Posteriormente, se observó un crecimiento de tejido blando en esta área, con dos zonas radiopacas identificadas radiográficamente. Con el diagnóstico presuntivo de lesión reactiva, se procedió a la biopsia excisional, con evolución satisfactoria durante el seguimiento. Conclusiones: El fibroma osificante periférico debe considerarse como una potencial complicación por la presencia o extracción de dientes natales/neonatales, y debe tratarse oportunamente debido a sus repercusiones clínicas.

Lesões de tecidos moles orais são raras em recém-nascidos e podem levar a alimentação inadequada, crescimento e desenvolvimento cognitivo. O fibroma ossificante periférico é uma lesão reativa da gengiva, com apenas cinco casos relatados em recém-nascidos. Objetivo: Relatar um caso de fibroma ossificante periférico em recém-nascido e discutir as complicações associadas aos dentes natais/neonatais. Caso clínico: Um menino mexicano de 4 meses de idade apresentou dois dentes natais que foram extraídos quinze dias após o nascimento. Posteriormente, observou-se crescimento de tecidos moles nesta área, com duas zonas radiopacas identificadas radiograficamente. Com o diagnóstico presuntivo de lesão reativa, foi realizada biópsia excisional, com evolução satisfatória durante o seguimento. Conclusões: O fibroma ossificante periférico deve ser considerado como uma complicação potencial devido à presença ou extração de dentes natais/neonatais, devendo ser tratado prontamente devido às suas repercussões clínicas.

Oral soft tissue injuries are rare in newborns and can lead to inappropriate feeding, growth, and cognitive development. Peripheral ossifying fibroma is a reactive lesion of the gingiva, with only five cases reported in newborns. Objective: To report a case of peripheral ossifying fibroma in a newborn, and to discuss the complications associated with natal/neonatal teeth. Clinical case: A 4-month-old Mexican male presented two natal teeth that were extracted fifteen days after birth. Subsequently, soft tissue growth was observed in this area, with two radiopaque zones radiographically identified. With the presumptive diagnosis of reactive lesion, an excisional biopsy was performed, with satisfactory evolution during follow-up. Conclusions: Peripheral ossifying fibroma should be considered as a potential complication due to the presence or extraction of natal/neonatal teeth, and should be treated promptly due to its clinical repercussions.

SER-SEPAR recommendations for the management of rheumatoid arthritis-related interstitial lung disease. Part 2: Treatment.

OBJECTIVE: To develop multidisciplinary recommendations to improve the management of rheumatoid arthritis-related interstitial lung disease (RA-ILD). METHODS: Clinical research questions relevant to the objective of the document were identified by a panel of rheumatologists and pneumologists selected based on their experience in the field. Systematic reviews of the available evidence were conducted, and evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Specific recommendations were made. RESULTS: Six PICO questions were selected, three of which analysed the safety and effectiveness of glucocorticoids, classical synthetic disease-modifying anti-rheumatic drugs (DMARDs) and other immunosuppressants, biological agents, targeted synthetic DMARDs, and antifibrotic therapies in the treatment of this complication. A total of 12 recommendations were formulated based on the evidence found and/or expert consensus. CONCLUSIONS: We present the first official SER-SEPAR document with specific recommendations for RA-ILD management developed to resolve some common clinical questions, reduce clinical healthcare variability, and facilitate decision-making for patients.

SER-SEPAR recommendations for the management of rheumatoid arthritis-related interstitial lung disease. Part 1: Epidemiology, risk factors and prognosis.

OBJECTIVE: To develop multidisciplinary recommendations to improve the management of rheumatoid arthritis-related interstitial lung disease (RA-ILD). METHODS: Clinical research questions relevant to the objective of the document were identified by a panel of rheumatologists and pneumologists selected based on their experience in the field. Systematic reviews of the available evidence were conducted, and evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Specific recommendations were made. RESULTS: Six PICO questions were selected, three of which analysed the incidence and prevalence of RA-ILD, associated risk factors, and predictors of progression and mortality. A total of 6 specific recommendations on these topics, structured by question, were formulated based on the evidence found and/or expert consensus. CONCLUSIONS: We present the first official SER-SEPAR document with specific recommendations for RA-ILD management developed to resolve some common clinical questions and facilitate decision-making for patients.

Effect of solvent and additives on the electrospinnability of BSA solutions.

Electrospun nanofibrous membranes have attracted the interest of the scientific community over the past decades due to their unique properties (e.g., high surface area, enzyme encapsulation high efficiency in filtering). Among the most promising membranes are those derived from natural polymers, which are not based on fossil fuels and most of them are highly biocompatible. In this regard, this study is focused on the development and characterization of electrospun nanofibrous membranes of bovine serum albumin (BSA) with potential applications in several fields, from tissue engineering to advanced filtering. Although the globular structure of BSA hinders the generation of nanofibers, some previous studies have succeeded in its electrospinning. However, they made use of either toxic reagents or co-electrospinning with synthetic polymers, which resulted in poorer biocompatibility. To prevent this, the present study explores the impact of non-hazardous reagents on the formation of BSA nanofibers. As a result, it was observed that the addition of ethanol (EtOH) in the solvent mixture and the thermal denaturation of BSA favored the electrospraying of nanoparticles (∼ 300 nm). It was also noticed that the presence of hydroxypropyl methylcellulose (HPMC) favors the formation of nanofibers (∼ 60 nm). However, bead formation was found in these membranes. This work contributes to clarifying the influence of solvents and surfactants when proteins are electrospun, enabling the manufacture of bio-based nanofibrous mats with applications in different fields (e.g., filtering, biomaterials, active packaging).

Smart design of patient-centric long-acting products: from preclinical to marketed pipeline trends and opportunities.

INTRODUCTION: We see a development in the field of long-acting products to serve patients with chronic diseases by providing benefits in adherence, efficacy, and safety of the treatment. This review investigates features of long-acting products on the market/pipeline to understand which drug substance (DS) and drug product (DP) characteristics likely enable a successful patient-centric, low-dosing frequency product. AREAS COVERED: This review evaluates marketed/pipeline long-acting products with greater than 1 week release of small molecules and peptides by oral and injectable route of administration (RoA), with particular focus on patient centricity, adherence impact, health outcomes, market trends, and the match of DS/DP technologies which lead to market success. EXPERT OPINION: Emerging trends are expected to change the field of long-acting products in the upcoming years by increasing capability in engineered molecules (low solubility, long half-life, high potency, etc.), directly developing DP as long-acting oral/injectable, increasing the proportion of products for local drug delivery, and a direction toward more subcutaneous, self-administered products. Among long-acting injectable products, nanosuspensions show a superiority in dose per administration and dosing interval, overwhelming the field of infectious diseases with the recently marketed products.

Optimization of Multiple W1/O/W2 Emulsions Processing for Suitable Stability and Encapsulation Efficiency.

Double emulsions are a type of multiple emulsions, which can be defined as a multicompartmentalized system where the droplets are dispersed into the continuous phase containing other emulsions. Although double food-grade emulsions have been manufactured, there is a lack of scientific background related to the influence of different processing conditions. This work analyses the influence of processing variables in (W1/O/W2) double emulsions: passes through the valve homogenizer, pressure applied, lipophilic emulsifier concentration, the ratio between the continuous phase (W2) and the primary emulsion (W1/O), and the incorporation of xanthan gum (XG) as a stabilizer. The results obtained show that these emulsions can be obtained after selecting suitable processing conditions, making them easily scalable in industrial processes. In terms of droplet size distribution, the input of higher energy to the system (20 MPa) during emulsification processing led to emulsions with smaller droplet sizes (D3,2). However, more monodispersed emulsions were achieved when the lowest pressure (5 MPa) was used. As for the number of passes, the optimal (emulsions more monodispersed and smaller droplet sizes) was found around 2-3 passes, regardless of the valve homogenizer pressure. However, emulsions processed at 20 MPa involved lower encapsulation efficiency (EE) than emulsions processed at 5 MPa (87.3 ± 2.3 vs. 96.1 ± 1.8, respectively). The addition of XG led to more structured emulsions, and consequently, their kinetic stability increased. The results obtained indicated that a correct formulation of these W1/O/W2 double emulsions allowed the optimal encapsulation of both hydrophilic and lipophilic bioactive compounds. Thus, the development of food matrices, in the form of multiple emulsions, would allow the encapsulation of bioactive compounds, which would result in the development of novelty food products.