Triboelectrification of Active Pharmaceutical Ingredients: Amines and Their Hydrochloride Salts.

The triboelectric properties of active pharmaceutical ingredients (APIs) contribute to problems during the manufacturing of pharmaceuticals. However, the triboelectric properties of APIs have not been comprehensively characterized. In this study, the effect of salt formulation on the triboelectric properties of APIs was investigated. The triboelectric properties of three groups of amines, namely tertiary amines, purine bases, and amino acids, and their hydrochlorides were evaluated using a suction-type Faraday cage meter. Most of the hydrochloride salts exhibited more negative charges than the corresponding free bases, and the degree by which the triboelectric property changed upon hydrochlorination depended on the structural groups of the compounds. In the case of tertiary amines, the change in the zero-charge margin upon hydrochlorination was negatively correlated with the zero-charge margin of the free base. In contrast, hydrochlorination of the amino acids led to a significant change in the zero-charge margin. In most cases, salt formation also affected the triboelectric properties of API powders. Controlling the triboelectric properties of APIs solves various problems caused by the electrification of raw material powders and granules during the production of pharmaceuticals, thereby increasing the quality of produced pharmaceuticals.

Nebivolol Polymeric Nanoparticles-Loaded In Situ Gel for Effective Treatment of Glaucoma: Optimization, Physicochemical Characterization, and Pharmacokinetic and Pharmacodynamic Evaluation.

Nebivolol hydrochloride (NEB), a 3rd-generation beta-blocker, was recently explored in managing open-angle glaucoma due to its mechanism of action involving nitric oxide release for the vasodilation. To overcome the issue of low ocular bioavailability and the systemic side effects associated with conventional ocular formulation (aqueous suspension), we designed and optimized polycaprolactone polymeric nanoparticles (NEB-PNPs) by applying design of experiments (DoE). The particle size and drug loading of the optimized NEB-PNPs were 270.9 ± 6.3 nm and 28.8 ± 2.4%, respectively. The optimized NEB-PNPs were suspended in a dual-sensitive in situ gel prepared using a mixture of P407 + P188 (as a thermo-sensitive polymer) and κCRG (as an ion-sensitive polymer), reported previously by our group. The NEB-PNPs-loaded in situ gel (NEB-PNPs-ISG) formulation was characterized for its rheological behavior, physical and chemical stability, in vitro drug release, and in vivo efficacy. The NEB-PNPs-loaded in situ gel, in ocular pharmacokinetic studies, achieved higher aqueous humor exposure (AUC0-t = 329.2 ng × h/mL) and for longer duration (mean residence time = 9.7 h) than compared to the aqueous suspension of plain NEB (AUC0-t = 189 ng × h/mL and mean residence time = 6.1 h) reported from our previous work. The pharmacokinetic performance of NEB-PNPs-loaded in situ gel translated into a pharmacodynamic response with 5-fold increase in the overall percent reduction in intraocular pressure by the formulation compared to the aqueous suspension of plain NEB reported from our previous work. Further, the mean response time of NEB-PNPs-loaded in situ gel (12.4 ± 0.6 h) was three times higher than aqueous suspension of plain NEB (4.06 ± 0.3 h).

Simultaneous Protein Adsorption and Viscosity Measurement using Micropillar-Enhanced Acoustic Wave (µPAW) Device for Pharmaceutical Applications.

At the early stages of drug development, the amount of drug materials is rather limited. In this case, viscosity measurement is often postponed to the later stages, where grams of proteins can be produced. Therefore, it is necessary to develop a viscometer capable of measuring the viscosity with high accuracy while requiring low sample volume. This study presents a novel viscosity measurement technique based on measuring the resonance frequency and motional resistance of a micropillar-enhanced acoustic wave (µPAW) device. The µPAW was developed by fabricating micropillars on the quartz crystal microbalance substrate in order to achieve ultra-high sensitivity, thanks to a unique coupling between the micropillar and the resonator. The experimental measurements demonstrated a nonlinear relationship between the density and viscosity of the fluid and the response of µPAW. A calibration correlation was developed using the response of µPAW in aqueous glycerol and sucrose solutions. The measurements were then extended using high-concentration BSA solutions as the model of protein solution. The main advantage of the µPAW device in this work over other viscometers is the ability to simultaneously measure solution viscosity and protein adsorption on the surface. This is a huge step forward in the development of sensing systems for the pharmaceutical industry, where real-time sensing of target biological proteins and measuring the viscosity of a solution is required.

Structural Features of the Glassy State and Their Impact on the Solid-State Properties of Organic Molecules in Pharmaceutical Systems.

This paper reviews the structure and properties of amorphous active pharmaceutical ingredients (APIs), including small molecules and proteins, in the glassy state (below the glass transition temperature, Tg). Amorphous materials in the neat state and formulated with excipients as miscible amorphous mixtures are included, and the role of absorbed water in affecting glass structure and stability has also been considered. We defined the term "structure" to indicate the way the various molecules in a glass interact with each other and form distinctive molecular arrangements as regions or domains of varying number of molecules, molecular packing, and density. Evidence is presented to suggest that such systems generally exist as heterogeneous structures made up of high-density domains surrounded by a lower density arrangement of molecules, termed the microstructure. It has been shown that the method of preparation and the time frame for handling and storage can give rise to variable glass structures and varying physical properties. Throughout this paper, examples are given of theoretical, computer simulation, and experimental studies which focus on the nature of intermolecular interactions, the size of heterogeneous higher density domains, and the impact of such systems on the relative physical and chemical stability of pharmaceutical systems.

Impact of formulation parameters on self-assembled liposomes (LeciPlex® III): A detailed investigation.

The present study investigated the feasibility of fabricating self-assembled liposomes, LeciPlex®, a phospholipid-based vesicular nanocarrier using cationic, anionic, and nonionic stabilizers. The phospholipid investigated was soy phosphatidylcholine and the nano-precipitation method based on solvent diffusion was applied as the fabrication technique of liposomes in this study. The effects of various formulation variables, such as lipid and stabilizer concentration, total solid concentration, and solvent type on the self-assembly of vesicles were studied for physical characterization including particle size analysis, differential scanning calorimetry, viscosity, optical transmittance, transmission electron microscopy, and small angle neutron scattering. All three LeciPlex® systems exhibited a direct relationship between particle size and phospholipid concentration. The two categoric variables, solvent, and stabilizer used to prepare LeciPlex® demonstrated a significant effect on particle size for all three LeciPlex® systems. Small angle neutron scattering, and optical transmittance confirmed the formation of micellar systems at a phospholipid: stabilizer ratio of 1:2 and vesicular systems at a ratio of 2:1 for the systems stabilized with anionic and nonionic surfactants. In contrast to this, the LeciPlex® formed with the cationic stabilizer Dioctadecyldimethylammonium bromide (DODAB), formed vesicles at both ratios. From these investigations, it was clear that the formulation space for LeciPlex® was diversified by the addition of cationic, anionic, and non-ionic stabilizers.

Nanometals incorporation into active and biodegradable chitosan films.

This study investigates the effects of incorporating ZnO, TiO2, and colloidal Ag nanoparticles on the antioxidant, antimicrobial, and physical properties of biodegradable chitosan films. The research focuses on addressing the growing demand for sustainable packaging solutions that offer efficient food preservation while mitigating environmental concerns. In this investigation, the physical properties including thickness, water content, solubility, swelling degree, tensile strength, and elasticity of the chitosan films were examined. Additionally, the samples were analyzed for total polyphenol content, antimicrobial activity, and antioxidant capacity. Notably, the incorporation of ZnO nanoparticles led to the lowest water content and highest strength values among the tested films. Conversely, the addition of colloidal Ag nanoparticles resulted in films with the highest antioxidant capacities (DPPH: 32.202 ± 1.631 %). Remarkably, antimicrobial tests revealed enhanced activity with the inclusion of colloidal silver nanoparticles, yet the most potent antimicrobial properties were observed in films containing ZnO (E.coli: 2.0 ± 0.0 mm; MRSA: 2.0 ± 0.5 mm). The findings of this study hold significant implications for the advancement of edible biodegradable films, offering potential for more efficient food packaging solutions that address environmental sustainability concerns. By elucidating the effects of nanoparticle incorporation on film properties, this research contributes to the ongoing discourse surrounding sustainable packaging solutions in the food industry.

Construction of a soybean protein isolate/polysaccharide-based whole muscle meat analog: Physical properties and freeze-thawing stability study.

A growing interest has arisen in recreating real meat by mimicking its texture characteristics and muscle fiber structure. Our previous work successfully created meat analog fiber based on soybean protein isolate (SPI) and sodium alginate (SA) with the wet-spinning method. In this work, we analyzed the microstructure, texture profile, and water retainability of the assembled plant-based whole muscle meat analog (PMA) made of SPI/SA-based meat analog fiber and systematically studied the effect of different combinations and contents of transglutaminase (TG), salt, and soybean oil on the rheological behavior of the formulated adhesive. The estimated optimal condition that has the most similar texture characteristic with real chicken breast meat is: for every 1:1 mass ratio of simulated plant meat fibers to the adhesive, add 0.1 % TG enzyme addition in the adhesive and 100 mM NaCl addition. The physical behavior of PMA during cryopreservation was investigated through freeze-thaw cycles and freezing times. The addition of a small amount of oil and salt can efficiently prevent the PMA through freezing conditions which is comparable with the addition of D-Trehalose (TD). Overall, this study not only created a plant-based whole muscle meat analog product that is similar in texture to real chicken breast meat but also provided a new direction for constructing fiber-rich structure protein-based muscle meat analogs and their further commercialization.

Control of the Iron State in Pharmaceuticals Used for Treatment and Prevention of Iron Deficiency Using Mössbauer Spectroscopy.

Various iron-containing medicaments, vitamins and dietary supplements are used or developed for treatment and prevention of the iron deficiency anemia which is very dangerous for human and may cause various disorders. From the other hand, blood losses, iron poor diet, microelements (co-factors) deficiency, metabolic failures, absorption problems, etc. can change the iron status and affect the health. These pharmaceuticals contain iron compounds in the ferrous and ferric states. It is known that ferrous salts are more suitable for the intestinal intake than ferric ones. On the other hand, pharmaceutically important ferritin analogues contain ferric hydrous oxides and appear to be effective for both injections and peroral administration. 57Fe Mössbauer spectroscopy is a unique physical technique which allows one to study various iron-containing materials including pharmaceuticals. Therefore, this technique was applied to study iron-containing pharmaceuticals for the analysis of the iron state, identification of ferric and ferrous compounds, revealing some structural peculiarities and for detection of aging processes in relation to the iron compounds. This review considers the main results of a long experience in the study of iron-containing pharmaceuticals by Mössbauer spectroscopy with critical analysis that may be useful for pharmacists, biochemists, biophysicists, and physicians.

Comprehensive evaluation of polymer types and ratios in Spray-Dried Dispersions: Compaction, Dissolution, and physical stability.

Amorphous solid dispersion (ASD) is a well-established strategy for enhancing the solubility and bioavailability of poorly soluble drugs. A significant portion of ASD products are in tablet form. However, the influence of common polymers and drug loading on the manufacturability of ASD tablets remains underexplored. This study focuses on investigating spray-dried ASDs from a tableting perspective by evaluating their physiochemical and mechanical properties. Itraconazole (ITZ) and indomethacin (IND), at the drug loadings ranging from 10% to 50%, were prepared with two polymers, hydroxypropyl methylcellulose acetate succinate (HPMCAS) and polyvinylpyrrolidone (PVP), serving as representative systems. Our findings revealed that increasing the drug loading resulted in a decreased surface area in ITZ-HPMCAS, IND-HPMCAS, and IND-PVP ASDs. However, this trend was not observed in ITZ-PVP dispersions, possibly due to the morphological disparities. Compaction results demonstrated that tabletability improved with decreasing drug loadings, except for ITZ-PVP dispersions. A partial least square analysis underscored particle surface area as the key factor influencing the tensile strength of ASD tablets. Additionally, our study disclosed that ITZ-PVP ASDs exhibited the worst release profiles and stability performance. The comprehensive journey from characterizing ASD particles to analyzing their compaction behavior and investigating drug release and physical stability offered profound insights into the attributes crucial for the downstream processing of amorphous pharmaceuticals.

A Rational Hierarchy to Capture Raw Material Attribute Variability in the Pharmaceutical Drug Product Development and Manufacturing Lifecycle.

Assessing the robustness of a drug product formulation and manufacturing process to variations in raw material (RM) properties is an essential aspect of pharmaceutical product development. Motivated by the need to demonstrate understanding of attribute-performance relationships at the time of new product registration and for subsequent process maintenance, we review practices to explore RM variations. We describe limitations that can arise when active ingredients and excipients invariably undergo changes during a drug product lifecycle. Historical approaches, such as Quality-by-Design (QbD) experiments, are useful for initial evaluations but can be inefficient and cumbersome to maintain once commercial manufacturing commences. The relatively miniscule data sets accessible in product development - used to predict response to a hypothetical risk of variation - become less relevant as real-world experience of actual variability in the commercial landscape grows. Based on our observations of development and manufacturing, we instead propose a holistic framework exploiting a hierarchy of RM variability, and challenge this with common failure modes. By explicitly incorporating higher ranking RM variations as perturbations, material-conserving experiments are shown to provide powerful and enduring robustness data. Case studies illustrate how correctly contextualizing such data in formulation and process development can avoid the traps of historical QbD approaches and become valuable for evaluating changes occurring later in the drug product lifecycle.

Complexities related to the amorphous content of lactose carriers.

Although the amount of amorphous content in lactose is low, its impact on the performance of a dry powder inhalation formulation might be high. Many formulators and regulatory agencies believe that the levels of amorphous content should be controlled once there is a relationship with the final product performance. This is however not an easy task. The current paper elaborates on multiple challenges and complexities that are related to the control of the amorphous content in lactose. The definition and quantification methods of amorphous lactose are reviewed, as well as challenges related to thermodynamic instability. Additionally, current monographs and recent position papers considering this parameter are discussed to provide an overview of the regulatory landscape. Development of a control strategy is recommended, provided that the amorphous content at a specific moment in the process has shown to have an impact on the performance of the dry powder inhaler.

Immobilized glucoamylase based on ZIF-8: Preparation, response surface optimization, characterization.

The glucoamylase@ZIF-8 was prepared using ZIF-8 material as the carrier in this study. The preparation process was optimized by response surface methodology, and the stability of glucoamylase@ZIF-8 was determined. The material was characterized by scanning electron microscopy, X-ray diffraction, and Fourier transform infrared spectroscopy. The results showed that the optimum preparation process of glucoamylase@ZIF-8 was 1.65 mol 2-methylimidazole, 5.85 mL glucoamylase, 33°C stirring temperature, 90 min stirring time, and 84.0230% ± 0.6006% embedding rate. At 100°C, the free glucoamylase completely lost its activity, whereas the glucoamylase@ZIF-8 still had a retained enzyme activity of 12.0123% ± 0.86158%; at pH 3-6, the highest activity of glucoamylase@ZIF-8 was 95.9531% ± 0.96181%, and about 80% of glucoamylase activity could be retained under alkaline conditions. When the ethanol concentration was 13%, the retained enzyme activity was 7.9316% ± 0.19805%, significantly higher than free enzymes. The Km of glucoamylase@ZIF-8 and free enzyme were 1235.6825 and 80.317 mg/mL, respectively. Vmax was 0.2453 and 0.149 mg/(mL min), respectively. The appearance, crystal strength, and thermal stability of glucoamylase@ZIF-8 were improved after optimization, and they had high reusability.

[Research progress and maturity assessment of continuous manufacturing of traditional Chinese medicine].

The pharmaceutical manufacturing model is gradually changing from intermittent manufacturing to continuous manufacturing and intelligent manufacturing. This paper briefly reviewed the supervision and research progress in continuous pharmaceutical manufacturing in China and abroad and described the definition and advantages of continuous pharmaceutical manufacturing. The continuous manufacturing of traditional Chinese medicine(TCM) at the current stage was summarized in the following three terms: the enhancement of the continuity of intermittent manufacturing operations, the integration of continuous equipment to improve physical continuity between units, and the application of advanced process control strategies to improve process continuity. To achieve continuous manufacturing of TCM, the corresponding key technologies, such as material property characterization, process modeling and simulation, process analysis technology, and system integration, were analyzed from the process and equipment, respectively. It was proposed that the continuous manufacturing equipment system should have the characteristics of high speed, high response, and high reliability, "three high(H~3)" for short. Considering the characteristics and current situation of TCM manufacturing, based on the two dimensions of product quality control and production efficiency, a maturity assessment model for continuous manufacturing of TCM, consisting of operation continuity, equipment continuity, process continuity, and quality control continuity, was proposed to provide references for the application of continuous manufacturing technology for TCM. The implementation of continuous manufacturing or the application of key continuous manufacturing technologies in TCM can help to systematically integrate advanced pharmaceutical technology elements and promote the uniformity of TCM quality and the improvement of production efficiency.

Investigation on Physico Chemical and X-ray Shielding Performance of Zinc Doped Nano-WO3 Epoxy Composite for Light Weight Lead Free Aprons.

This report addresses a way to reduce the usage of highly toxic lead in diagnostic X-ray shielding by developing a cost-effective, eco-friendly nano-tungsten trioxide (WO3) epoxy composite for low-weight aprons. Zinc (Zn)-doped WO3 nanoparticles of 20 to 400 nm were synthesized by an inexpensive and scalable chemical acid-precipitation method. The prepared nanoparticles were subjected to X-ray diffraction, Raman spectroscopy, UV-visible spectroscopy, photoluminescence, high-resolution-transmission electron microscope, scanning electron microscope, and the results showed that doping plays a critical role in influencing the physico-chemical properties. The prepared nanoparticles were used as shielding material in this study, which were dispersed in a non-water soluble durable epoxy resin polymer matrix and the dispersed materials were coated over a rexine cloth using the drop-casting method. The X-ray shielding performance was evaluated by estimating the linear attenuation coefficient (µ), mass attenuation coefficient (µm), half value layer (HVL), and X-ray percentage of attenuation. Overall, an improvement in X-ray attenuation in the range of 40-100 kVp was observed for the undoped WO3 nanoparticles and Zn-doped WO3 nanoparticles, which was nearly equal to lead oxide-based aprons (reference material). At 40 kVp, the percentage of attenuation of 2% Zn doped WO3 was 97% which was better than that of other prepared aprons. This study proves that 2% Zn doped WO3 epoxy composite yields a better particle size distribution, µm, and lower HVL value and hence it can be a convenient lead free X-ray shielding apron.

Advances in the development of tailor-made color alcoholic beverages based on an accelerated maturation process.

The study of the evolution of color of alcoholic beverages subjected to accelerate maturation process using heat-treated French oak wood fragments is presented. The results show that it is possible to obtain tonalities like aged beverages in 4 weeks. In this sense, the fragments conditioned at 150 °C (light toasted) proportionated colors like white wine, pale straw, and pale gold. On the other hand, the fragments that received a heat treatment at 200 °C (medium toasted) present yellow tones such as old gold, amber, and deep gold. Finally, the fragments treated at 250 °C (heavily toasted) are those with the most intense yellow tones, classified as sweet chestnut, sherry, russet, muscat, and tawny. The studies of kinetic maturation concluded that the mathematical model of parabolic diffusion could correctly describe the process. Based on this, it is concluded that the heat treatment increases the cavities of the most exposed surface of the wood, increasing the maximum humidity of the materials by 20 %; in such a way that during the first two weeks, there is a diffusion of the solution to the active sites. Wood bioactive compounds on the outer surface achieve a rapid extraction, such as flavonoids, which oxidize rapidly within the solution, generating an increase in yellow color. The previous results were corroborated in a real case analysis using Tequila which can be concluded that the proposed process can give the beverage similar colors to an aged, extra-aged, and ultra-aged class in less than 4 weeks.

Alkaline Treatment Investigation for Sedge Fibers (Cyperus malaccensis): A Promising Enhancement.

Natural fibers have some advantages in comparison to synthetic fibers, especially because they are more environmentally friendly. For this reason, using them as a reinforcement for polymeric matrices is growing exponentially. However, they present the disadvantage of having the hydrophilic nature, which strongly reduces the interface interaction. Sedge fibers have been investigated when reinforcing an epoxy matrix in terms of ballistic properties and mechanical performance. Aiming to enhance the fiber-matrix interface, an alkali treatment was proposed. The group conditions were divided into three NaOH concentrations (3%, 5%, and 10%), as well as the three periods of immersion (24, 48, and 72 h). Therefore, nine different conditions were investigated in terms of their thermal behaviors, chemical structures, physical structures, and morphological aspects. Based on TGA curves, it could be noticed that treatments related to 3% NaOH for 24 h and 48 h exhibited better thermal stability properties. For the time of 48 h, better thermal stability with for a decay of the thermal DSC curve was shown for all treatment conditions. The FTIR spectra has shown a reduction of waxes for higher NaOH concentrations. The XRD diffractogram exhibited an increase in the crystallinity index only for 5% NaOH and an immersion time of 48 h. The morphological aspects of fibers treated with 5% and 10% of NaOH have shown that the treatments have damaged the fiber, which highlighted the crystallinity index reductions.

Formulation and Evaluation of Amikacin Sulfate Loaded Dextran Nanoparticles against Human Pathogenic Bacteria.

Amikacin sulfate-loaded dextran sulfate sodium nanoparticles were formulated, lyophilized (LADNP), and then analyzed. The LADNP had a -20.9 ± 8.35 mV zeta potential, PDI of 0.256, and % PDI of 67.7. The zeta average nano size of LADNP was 317.9 z. d.nm, while the dimension of an individual particle was 259.3 ± 73.52 nm, and nanoparticle conductivity in colloidal solution was 2.36 mS/cm. LADNP has distinct endothermic peaks at temperatures at 165.77 °C, according to differential scanning calorimetry (DSC). The thermogravimetric analysis (TGA) showed the weight loss of LADNP, which was observed as 95% at 210.78 °C. XRD investigation on LADNP exhibited distinct peaks at 2θ as 9.6°, 10.4°, 11.4°, 18.9°, 20.3°, 24.4°, 28.2°, 33.2°, 38.9°, and 40.4° confirming crystalline structure. The amikacin release kinetics from LADNP revealed zero order kinetics with a linear release showed zero order kinetics with 37% of drug release in 7 h and had an R2 value of 0.99. The antibacterial effect of LADNP showed broad-spectrum activity against tested human pathogenic bacteria. The preset study demonstrated that LADNP is a promising antibacterial agent.

Smart Specification Setting for Dry Powder Inhalation Carriers.

The specifications of excipients are important to pharmaceutical manufacturers to ensure that the final product can be manufactured robustly over the entire lifecycle of a drug product. Particle size specifications are key for dry powder inhalation excipients and they should be agreed between users and suppliers. The current paper evaluates two development strategies to set particle size specifications. It is shown that the application of quality-by-design principles to specification setting could result in broader specifications, while it guarantees that efficacy, safety and manufacturing of the medication is not affected. A multitude of reasons exist to keep specifications broader than the production capability range, including improved risk-mitigation and potentially reduced regulatory challenges during and after registration.

Selected Aspects of the Analytical and Pharmaceutical Profiles of Nifurtimox.

Nifurtimox is a nitroheterocyclic drug employed for treatment of trypanosomiases (Chagas disease and West African sleeping sickness); its use for certain cancers has also been assessed. Despite having been in the market for over 50 years, knowledge of nifurtimox is still fragmentary and incomplete. Relevant aspects of the chemistry and biology of nifurtimox are reviewed to summarize the current knowledge of this drug. These comprise its chemical synthesis and the preparation of some analogues, as well as its chemical degradation. Selected physical data and physicochemical properties are also listed, along with different approaches toward the analytical characterization of the drug, including electrochemical (polarography, cyclic voltammetry), spectroscopic (ultraviolet-visible, nuclear magnetic resonance, electron spin resonance), and single crystal X-ray diffractometry. The array of polarographic, ultraviolet-visible spectroscopic, and chromatographic methods available for the analytical determination of nifurtimox (in bulk drug, pharmaceutical formulations, and biological samples), are also presented and discussed, along with chiral chromatographic and electrophoretic alternatives for the separation of the enantiomers of the drug. Aspects of the drug likeliness of nifurtimox, its classification in the Biopharmaceutical Classification System, and available pharmaceutical formulations are detailed, whereas pharmacological, chemical, and biological aspects of its metabolism and disposition are discussed.

Morphological distribution mapping: Utilisation of modelling to integrate particle size and shape distributions.

The aim of this work was to develop approaches to utilize whole particle distributions for both particle size and particle shape parameters to map the full range of particle properties in a curated dataset. It is hoped that such an approach may enable a more complete understanding of the particle landscape as a step towards improving the link between particle properties and processing behaviour. A 1-dimensional principal component analysis (PCA) approach was applied to create a 'morphological distribution landscape'. A dataset of imaged APIs, intermediates and excipients encompassing particle size, particle shape (elongation, length and width) and distribution shape was curated between 2008 and 2022. The curated dataset encompassed over 200 different materials, which included over 150 different APIs, and approximately 3500 unique samples. For the purposes of the current work, only API samples were included. The morphological landscape enables differentiation of materials of equivalent size but varying shape and vice versa. It is hoped that this type of approach can be utilised to better understand the influence of particle properties on pharmaceutical processing behaviour and thereby enable scientists to leverage historical knowledge to highlight and mitigate risks associated to materials of similar morphological nature.