Understanding the complexity of near-infrared quantification of highly porous patient-tailored drug products by utilizing chemometrics and stimulated Raman imaging.

Additively manufactured drug products, typically produced using small-scale, on-demand batch mode, require rapid and non-destructive quantification methods. A tunable modular design (TMD) approach combining porous polymeric freeze-dried modules and an additive manufacturing method, inkjet printing, was proposed in an earlier study to fabricate accurate and patient-tailored doses of an antidepressant citalopram hydrobromide. This approach addresses the unmet medical needs associated with antidepressant tapering.

Exploring the hydrate landscape using data mining on the Cambridge structural database (CSD).

With the continued relevance of drug hydrates in pharmaceutical sciences, a comprehensive understanding of hydrate and anhydrate forms is essential, not only through individual case studies but also from a broader, systematic perspective. The Cambridge Structural Database (CSD) is a well-established database for crystal structures of organic molecules and here, the structural features of pharmaceutically relevant compounds forming hydrates were explored. Drug anhydrate and hydrate subsets were generated and further classified into separate anhydrate and hydrate sets for free drug, cocrystal/solvate, salt, multicomponent cocrystal/solvate, and salt cocrystal/solvate systems.

Professor Lynne S. Taylor: Scientist, educator, and adventurer.

This special edition of the Journal of Pharmaceutical Sciences is dedicated to Professor Lynne S. Taylor (Retter Distinguished Professor of Pharmacy, Department of Industrial and Molecular Pharmaceutics, Purdue University), to honor her distinguished career as a pharmaceutical scientist and educator. The goal of this commentary is to provide an overview of Professor Taylor's career path, summarize her key research contributions, and provide some insight into her personal and professional contributions as an educator, mentor, wife, mother, friend, and adventurer.

THz-TDS transflection measurements as a process analyser for tablet mass.

Tablet content and content uniformity are essential for the market release of the drug product. For tablets, content and uniformity are determined by the weight ratio of active pharmaceutical ingredient in the tablet and the tablets' total mass. Novel process analytical technology tools for the control of the ratio of the active pharmaceutical ingredient have been proposed and implemented, but more robust, sensitive, and fast sensors for the control of tablet mass are desirable.

THz-TDS as a PAT tool for monitoring blend homogeneity in pharmaceutical manufacturing of solid oral dosage forms: A proof-of-concept study.

The process analytical technology (PAT) framework is well established and integral to facilitate process understanding, enable a transition from batch to continuous manufacturing, and improve product quality. Near-infrared (NIR) spectroscopy has been established as a standard PAT tool for many process analytical challenges, including monitoring powder blend homogeneity. However, alternative technologies for monitoring powder blending are of interest due to the importance of the blending step in manufacturing solid oral dosage forms.

Leucine as a Moisture-Protective Excipient in Spray-Dried Protein/Trehalose Formulation.

The incorporation of leucine (Leu), a hydrophobic amino acid, into pharmaceutically relevant particles via spray-drying can improve the physicochemical and particulate properties, stability, and ultimately bioavailability of the final product. More specifically, Leu has been proposed to form a shell on the surface of spray-dried (SD) particles. The aim of this study was to explore the potential of Leu in the SD protein/trehalose (Tre) formulation to control the water uptake and moisture-induced recrystallization of amorphous Tre, using lysozyme (LZM) as a model protein.

Lessons to Learn for 3D Printing of Drug Products by Semisolid Extrusion (SSE).

Semisolid extrusion (SSE) 3D printing (3DP) technology is emerging due to its simplicity and potential for on-site manufacturing of personalized drug products with tailored functionality (dose, release profile), as well as recognizability (size, shape, color). However, even a minor change in the composition of the ink (the feedstock material) and the printing process parameters can largely influence the outcome of printing. This paper summarizes the recent SSE 3DP studies, where the important factors affecting the quality of the printed drug products are discussed.

Ultrasound-Enhanced Fine-Needle Biopsy Improves Yield in Human Epithelial and Lymphoid Tissue.

Objective: Needle biopsy is a common technique used to obtain cell and tissue samples for diagnostics. Currently, two biopsy methods are widely used: (i) fine-needle aspiration biopsy (FNAB) and (ii) core needle biopsy (CNB). However, these methods have limitations.

Amino acids as stabilizers for lysozyme during the spray-drying process and storage.

Amino acids (AAs) have been used as excipients in protein formulations both in solid and liquid state products due to their stabilizing effect. However, the mechanisms by which they can stabilize a protein have not been fully elucidated yet. The purpose of this study was to investigate the effect of AAs with distinct physicochemical properties on the stability of a model protein (lysozyme, LZM) during the spray-drying process and subsequent storage.

Tailor-Made Doses of Pharmaceuticals by Tunable Modular Design: A Case Study on Tapering Antidepressant Medication.

An abrupt cessation of antidepressant medication can be challenging due to the appearance of withdrawal symptoms. A slow hyperbolic tapering of an antidepressant, such as citalopram hydrobromide (CHB), can mitigate the withdrawal syndrome. However, there are no viable dosage forms on the market to implement the tapering scheme.

Screen11: validating a screening instrument for voice disorders in accordance with the COSMIN framework.

Purpose: Although numerous patient-reported outcome measures have been developed and validated to quantify the impact of voice problems on different aspects of life, to our knowledge no screening instrument exists that specifically captures voice disorders in a retrospective fashion. The aim of the present study was to examine the psychometric properties and diagnostic validity of a retrospective voice screening method, according to the COSMIN framework for health-related, patient-reported outcome measures. The items in Screen11 have been used to establish the prevalence of voice disorders in both general and occupation-specific populations in the Nordic countries.

Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trial.

Introduction: Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice.

Compaction Properties of Particulate Proteins in Binary Powder Mixtures with Common Excipients.

The increasing interest in protein- and peptide-based oral pharmaceuticals has culminated in the first protein-based products for oral delivery becoming commercially available. This study investigates the compaction properties of proteins in binary mixtures with common excipients up to 30% (/) of particulate protein. Two model proteins, lysozyme and bovine serum albumin, were compacted with either microcrystalline cellulose, spray-dried lactose monohydrate, or calcium hydrogen phosphate dihydrate at two different compaction pressures.

Binder jetting 3D printing in fabricating pharmaceutical solid products for precision medicine.

Current treatment strategies are moving towards patient-centricity, which emphasizes the need for new solutions allowing for medication tailored to a patient. This can be realized by precision medicine where patient diversity is considered during treatment. However, the broader use of precision medicine is restricted by the current technological solutions and rigid manufacturing of pharmaceutical products by mass production principles.

Towards simultaneous determination of tablet porosity and height by terahertz time-domain reflection spectroscopy.

The quality control of pharmaceutical tablets is still based on testing small sample numbers using at- and off-line testing methods. Traditional in-process controls, such as tablet mass, height, mechanical strength, and disintegration time are time- and resource-consuming and poorly suited to support an effective transition towards continuous manufacturing. Another suitable parameter to monitor during production would be tablet porosity.

Solid-state analysis for pharmaceuticals: Pathways to feasible and meaningful analysis.

The solid state of matter is the preferred starting point for designing a pharmaceutical product. This is driven by both patient preferences and the relative ease of supplying a solid pharmaceutical product with desired quality and performance. Solid form diversity is increasingly prevalent as a crucial element in designing these products, which underpins the importance of solid-state analytical methods.

Determination of the Prevalence of Knee and Hip Clinical Osteoarthritis in the Active Professional Male Footballer and Its Association with Pain, Function, Injury and Surgery.

Objective: To comment on and explore (1) the prevalence of clinical knee and hip osteoarthritis (OA); (2) the association between pain or function and clinical knee or hip OA; (3) the association between injury or surgery and clinical knee or hip OA.

Methods: Participants were recruited from FIFPRO members. A total of 101 footballers consented to answer (1) a developed questionnaire, (2) patient-reported outcome measures, and (3) be evaluated by their team physician for clinical knee or hip OA.

The structure of magnesium stearate trihydrate determined from a micrometre-sized single crystal using a microfocused synchrotron X-ray beam.

Crystalline magnesium stearate has been extensively used as an additive in pharmaceutical and other industries for decades. However, the lack of suitably large crystals has hindered the determination of the crystal structure and thereby a more fundamental understanding of the structure-functionality relationship. Presented here is the structure of magnesium stearate trihydrate as determined from X-ray diffraction data of a micrometre-sized single crystal measured at a fourth-generation synchrotron facility.

Terahertz time-domain spectroscopy for the investigation of tablets prepared from roller compacted granules.

Roller compaction before tableting is a common unit operation to increase the processability of powders. Terahertz time-domain spectroscopy (THz-TDS) has recently been introduced as a potential process analytical technology (PAT) for measuring tablet porosity based on the refractive index of the tablet. Tablet porosity is a governing parameter for tablet disintegration and dissolution.

Profiles of early career insecurity and its outcomes in adolescence: A four-wave longitudinal study.

This study investigated the developmental profiles of perceived early career insecurity (ECI) and their outcomes among adolescents (n = 1416) during a critical educational transition from basic education to upper secondary education. We found three distinct latent profiles with varying amounts of ECI: Profile 1: Moderate and decreasing ECI before the transition (57%); Profile 2: Low-decreasing ECI before the transition but increasing ECI after the transition (31%); and Profile 3: High and stable ECI during the transition (12%). Moreover, the ECI profiles related to school and life satisfaction as well as to school stress and dropout intentions in a meaningful way consistent with the stressor hypothesis.

Comparative study between a gravity-based and peristaltic pump for intravenous infusion with respect to the generation of proteinaceous microparticles.

Subvisible particles generated during the preparation or administration of biopharmaceuticals might increase the risk of immunogenicity, inflammation, or organ dysfunction. To investigate the impact of an infusion system on the level of subvisible particles, we compared two types of infusion sets based on peristaltic movement (Medifusion DI-2000 pump) and a gravity-based infusion system (Accu-Drip) using intravenous immunoglobulin (IVIG) as a model drug. The peristaltic pump was found to be more susceptible to particle generation compared to the gravity infusion set owing to the stress generated due to constant peristaltic motion.

Exploring the Solid-State Landscape of Carbamazepine during Dehydration: A Low Frequency Raman Spectroscopy Perspective.

The solid-state landscape of carbamazepine during its dehydration was explored using Raman spectroscopy in the low- (-300 to -15, 15 to 300) and mid- (300 to 1800 cm) frequency spectral regions. Carbamazepine dihydrate and forms I, III, and IV were also characterized using density functional theory with periodic boundary conditions and showed good agreement with experimental Raman spectra with mean average deviations less than 10 cm. The dehydration of carbamazepine dihydrate was examined under different temperatures (40, 45, 50, 55, and 60 °C).

Removing siloxanes and hydrogen sulfide from landfill gases with biochar and activated carbon filters.

Landfill gas (LFG) is formed by microorganisms within a landfill; it can be utilized as a renewable fuel in power plants. Impurities such as hydrogen sulfide and siloxanes can cause significant damage to gas engines and turbines. The aim of this study was to determine the filtration efficiencies of biochar products made of birch and willow to remove hydrogen sulfides, siloxanes, and volatile organic compounds from the gas streams compared to activated carbon.

Co-administration of Intravenous Drugs: Rapidly Troubleshooting the Solid Form Composition of a Precipitate in a Multi-drug Mixture Using On-Site Raman Spectroscopy.

Intravenous drugs are often co-administrated in the same intravenous catheter line due to which compatibility issues, such as complex precipitation processes in the catheter line, may occur. A well-known example that led to several neonatal deaths is the precipitation due to co-administration of ceftriaxone- and calcium-containing solutions. The current study is exploring the applicability of Raman spectroscopy for testing intravenous drug compatibility in hospital settings.

Compaction Behavior of Co-Amorphous Systems.

Co-amorphous systems have been shown to be a promising strategy to address the poor water solubility of many drug candidates. However, little is known about the effect of downstream processing-induced stress on these systems. The aim of this study is to investigate the compaction properties of co-amorphous materials and their solid-state stability upon compaction.