Pharmaceutical Industry Research Articles

Designing, Optimising, and Assessing a Novel Emulgel Containing Minoxidil for Controlled Drug Release, Incorporating Marine-based Polymers.

This study aimed to develop an emulgel containing minoxidil as a drug for hair growth promotion in diseases, such as androgenetic alopecia, using gelling agents, such as chitosan and fucoidan. In this study, gelling agents were selected for the emulgel formulation. By various evaluation tests and through optimization, the chitosan-fucoidan combination was selected as the gelling agent for the preparation of emulgel using various evaluation parameters. X2, the best emulgel formulation, contained 2.54 % chitosan and 0.896 % fucoidan. Chitosan prolonged the duration of drug release, and controlled release was obtained. Fucoidan increased the gelling activity, water absorption rate, and stability of the formulation. In this study, the X2 formulation showed the highest percentage of drug release at the 12th hour. It was found to be 99.7%, which followed the zero-order release model. Owing to the wide range of biological activities of fucoidan, the loaded active substance can be protected, and at the same time, its potency can be improved, resulting in effective treatment. Because fucoidan has diverse properties and potential, it will be widely used in the biomedical and pharmaceutical industries in the future.

PDMS membrane incorporated by zeolites with tunable pore chemistry for dimethyl carbonate/methanol azeotropic mixture separation

The separation of organic-organic azeotropic mixtures is important in the petrochemical, agrochemical, and pharmaceutical industries, which is energy-intensive by using the current distillation technology. Pervaporation process is energy-efficient for azeotropic separation, while lacks of high-performing membrane materials. In this work, to realize efficient separation of dimethyl carbonate/methanol azeotropic mixtures, a benchmarked membrane, polydimethylsiloxane (PDMS), was incorporated by zeolites with tunable pore chemistry. Specifically, MFI-type zeolite was grafted by alkyl chains with different carbon numbers (C1, C4, C8), thereby providing tunable transport channels for organic molecules. Based on systematic characterizations (e.g., sorption and LF-NMR) and permeation test, we found that the organophilic alkyl chain can trap organic molecules into the zeolitic pores while may also hinder the organic diffusion through the zeolite due to the steric hindrance effect. The PDMS mixed-matrix membrane (MMM) with optimized C1-grafted MFI loading as high as 50 wt% exhibited separation factor of 3.6, and permeation flux of 11.5 kg m-2 h-1 for 30 wt% DMC-methanol azeotropic mixture at 40 °C. With slightly higher separation factor, the flux of PDMS MMM is 1.5-fold higher than that of the pure PDMS membrane. This work highlights the critical role of filler pore chemistry on the solution-diffusion transport and thus performance enhancement of MMM.

Patient-reported outcomes in sarcopenia: An ICFSR task force report.

The International Conference on Frailty and Sarcopenia Research (ICFSR) Task Force convened in March 2024 to address patient-reported outcomes measures (PROMs) in the field of sarcopenia. PROMs are crucial to enhance healthcare services at both individual and societal levels. PROMs complement objective outcome measures by capturing insights that patients are best suited to judge. In recent years, there has been an increase in the recognition of PROMs' importance within clinical trials by pharmaceutical industries and regulatory agencies. Consequently, it has become imperative to develop valid and reliable tools tailored to capture various aspects of patient's experience and health status. This report aims to present the state-of-the-art available and validated PROMs for sarcopenia that can be used within clinical settings by various stakeholders, and to highlight several research gaps and barriers that need to be addressed to expedite and improve the use of these outcome measures within the context of clinical trials.

Evaluation of gum odina/carbopol composite mucoadhesive hydrogel on pharmaceutical performance: Focusing on potential periodontal treatment.

Antimicrobial buccal hydrogel made of polymers have gained tremendous utilisation in biomedical field. Dual drug loaded, porous materials are important areas of research for medical and pharmaceutical industries. In this regard, a series of hydrogels (F1, F2, F3) were prepared with gum odina and carbopol 940 in aqueous solution with calcium chloride as the cross linker and glycerol as plasticizer by ionotropic gelation method. The buccal hydrogel was evaluated for thermal stability (TGA/DSC) revealing them to be thermally stable. The SEM and AFM studies of the optimized formulation (F2) exhibits cracks and porous structure. It also depicted good injectability and self-healing. The XRD result displayed amorphous nature of the formulation (F2) making them soluble in buccal fluids. The chemical nature and interactions were analysed by FTIR study. The release profile portrayed controlled release patterns for amoxicillin trihydrate and fluconazole. Appreciable mucoadhesion time (6±0.7h) and strength (12.03±0.45g) was observed in case of F2. The optimized formulation F2 displayed good antifungal and antibacterial properties. Thus, it is concluded that the hydrogel formed were mucoadhesive and highly potent to carry drug molecules for controlled release in the buccal mucosa to treat several periodontal infections.

A Comprehensive Review of Challenges in Oral Drug Delivery Systems and Recent Advancements in Innovative Design Strategies.

The oral route of drug administration is often preferred by patients and healthcare providers due to its convenience, ease of use, non-invasiveness, and patient acceptance. However, traditional oral dosage forms have several limitations, including low bioavailability, limited drug loading capacity, and stability and storage issues, particularly with solutions and suspensions. Over the years, researchers have dedicated considerable effort to developing novel oral drug delivery systems to overcome these limitations. This review discusses various challenges associated with oral drug delivery systems, including biological, pharmaceutical, and physicochemical barriers. It also explores common delivery approaches, such as gastroretentive drug delivery, small intestine drug delivery, and colon-targeting drug delivery systems. Additionally, numerous strategies aimed at improving oral drug delivery efficiency are reviewed, including solid dispersion, absorption enhancers, lipidbased formulations, nanoparticles, polymer-based nanocarriers, liposomal formulations, microencapsulation, and micellar formulations. Furthermore, innovative approaches like orally disintegrating tablets (ODT), orally disintegrating films (ODF), layered tablets, micro particulates, self-nano emulsifying formulations (SNEF), and controlled release dosage forms are explored for their potential in enhancing oral drug delivery efficiency and promoting patients' compliance. Overall, this review highlights significant progress in addressing challenges in the pharmaceutical industry and clinical settings, offering novel approaches for the development of effective oral drug delivery systems.

A Comprehensive Appraisal of Bisbenzylisoquinoline Alkaloids Isolated From Genus Cyclea for Anticancer Potential.

The pharmaceutical industry and academia are continuously searching for novel and effective anticancer lead compounds to ensure patient safety, provide a cure, and surpass all other obstacles. Given the indeterminate nature of cancer etiology, the importance of drugs capable of targeting multiple pathways cannot be overstated. Among naturally occurring compounds, bisbenzylisoquinoline (BBIQ) alkaloids, such as berberine, tetrandrine, chelidonine, and berbamine, have demonstrated significant anticancer potential by modulating diverse signaling pathways. Several of these compounds are currently in clinical trials, highlighting their relevance in cancer treatment. This review emphasizes the need for further investigation into the anticancer properties of BBIQ alkaloids, particularly those isolated from eight Cyclea species in India. With around 27 BBIQ alkaloids identified, these compounds hold promise, especially in combating multidrug resistance-a critical challenge in cancer therapy. Given the rising cancer incidence, these alkaloids warrant a deeper exploration of their therapeutic potential.

Fabrication, modification, interaction mechanisms, and applications of fish gelatin: A comprehensive review.

Fish gelatin (FG) is an essential natural biopolymer isolated from aquatic sources and has been considered as a feasible substitute for mammalian gelatins. However, its inferior mechanical and gelling properties limit its applications. Consequently, FG has been modified using various methods. This review summarizes the extraction techniques (including traditional acid and alkaline methods, as well as newer technologies such as ultrasonic-assisted and microwave-assisted extraction), modification strategies (mechanical treatments, physical mixing with polysaccharides, utilization of the Hofmeister effect, chemical modifications, etc.), along with their mechanisms of action. Additionally, we discussed the applications of FG and its modified products. Furthermore, this review highlights the safety and prospects for FG and its derivatives. The mechanical properties and biological functions of FGs are enhanced after modification. Thus, modified FG composites exhibit diverse applications in areas such as foaming agents and emulsifiers, food packaging, three-dimensional printing, drug delivery systems and tissue engineering. This paper aims to provide comprehensive information for future research on FG with the intention of broadening its applicability within the industries of food, cosmetics, and pharmaceuticals. Nevertheless, the development of tough gels, aerogels, and stimuli-responsive hydrogels based on FG requires further investigation.

Enhancing thermostability of lysine hydroxylase via a semi-rational design

(2S,4R)-4-Hydroxylysine (4-OH-Lys), a derivative of L-lysine, possesses a unique chemical structure that makes it a crucial precursor for the synthesis of pharmaceutical molecules, with extensive applications in the pharmaceutical and biochemical industries. Lysine hydroxylase (K4H) catalyzes the conversion of L-lysine to 4-OH-Lys, offering advantages such as mild reaction conditions, straightforward reaction steps, good regioselectivity, and high catalytic efficiency compared to chemical synthesis and natural extraction methods. However, the low thermostability of K4H hinders its application in large-scale production. In this study, we employed a semi-rational design approach, guided by ΔΔG folding free energy calculations and message-passing neural networks to enhance the thermostability of K4H. After two rounds of evolution, we identified two beneficial mutants: M25 (S101P/Q257M) and M32 (Q257M/V298I). Thermostability assessments revealed that the half-lives (t1/2) of M25 and M32 at 40 °C were 23.9-fold and 13.3-fold higher than that of the wild-type (WT), with melting temperatures (Tm) exceeding those of WT by 4.2 °C and 8.3 °C, respectively. Molecular dynamics simulations illuminated the mechanisms underlying this enhanced thermostability. This work provides valuable insights into the thermostability of K4H and yields key mutants that are promising candidates for practical production of 4-OH-Lys.

Improved biosynthesis of tyrosol by epigenetic modification-based regulation and metabolic engineering in Saccharomyces cerevisiae.

Aromatic amino acids and their derivatives are high value chemicals widely used in food, pharmaceutical and feed industries. Current preparation methods for aromatic amino acid products are fraught with limitations. In this study, the efficient biosynthesis of aromatic amino acid compound tyrosol was investigated by epigenetic modification-based regulation and optimization of the biosynthetic pathway of aromatic amino acids. The production of tyrosol was significantly improved by the overexpression of m6A modification writer Ime4 and reader Pho92, and the positive regulator Gcr2. Introduction of Bbxfpk and deletion of Gpp1 further improved tyrosol production. Then the feedback inhibition of the shikimate pathway was relieved by the mutants Aro4K229L and Aro7G141S. The final tyrosol producing engineered strain was constructed by the deletion of PHA2, replacement of the native promoter of ARO10 with the strong promoter PGK1p, and introduction of tyrosine decarboxylase PcAAS. In the background of m6A modification regulation, this strain ultimately produced 954.69 ± 43.72 mg/L of tyrosol, promoted by 61.7-fold in shake-flask fermentation.

A numerical study on the mixing time prediction of miscible liquids with high viscosity ratios in turbulently stirred vessels

Mixing processes are crucial in industrial applications, including food, pharmaceutical, and chemical manufacturing, to ensure product homogeneity and quality control. Effective control of high-viscosity fluid mixing is essential due to intricate mixing dynamics involved. This study evaluates blending time predictions from two Computational Fluid Dynamics (CFD) methodologies for simulating the mixing of two miscible liquids with high contrasting viscosities. The investigation employed a scalar transport model coupled with a Reynolds-Averaged Navier-Stokes (RANS) Finite Volume Method (FVM) solver and a Lattice Boltzmann Large Eddy Simulation (LB-LES) solver to assess flow parameters against experimental data. Blending times were validated against Electrical Resistance Tomography (ERT) based measurements in a 2.6-litre baffled vessel agitated by a Rushton turbine under turbulent conditions. Results indicated both models align closely with experimental trends of dimensionless blending time relative to fluid properties; however, accuracy reduced as viscosity ratios exceeded a critical Reynolds number threshold.

D-Histidine modulated chiral metal-organic frameworks for discriminating 3,4-Dihydroxyphenylalanine enantiomers based on a chemiluminescence quenching mode.

Drug enantiomers often display distinguishable or even opposite pharmacological and toxicologic activities. Therefore it is of great necessity to discriminate enantiomers for guaranteeing safetyness and effectiveness of chiral drugs. Facile chiral discrimination has long been a noticeable challenge because of the minimal differences in physicochemical properties of enantiomers. As one of high-performance chirality selection components, chiral metal-organic frameworks (CMOFs) are bringing new opportunities for the establishment of chiral discrimination platform with merits of high enantioselectivity, low cost, and facile operation. By introducing D-Histidine as a modulator, a CMOFs material termed as D-Histidine-ZIF-8 was prepared on chitosan (CS) with an in-situ growth protocol. The positively charged CMOFs/CS hybrids were adsorbed onto negatively charged polystyrene microplate via electrostatic interaction to form a chiral discrimination interface. This interface can effectively adsorb 3,4-Dihydroxyphenylalanine (DOPA) enantiomers, and the adsorbed molecules can be quantitated based on their quenching behavior on the chemiluminescent (CL) signal of Co2+-catalyzed luminol-H2O2 reaction. The results of contact angle measurements and density functional theory calculations imply that CMOFs/CS have stronger affinity towards D-isomer than L-isomer. Thus the sensitivity for quantifying D-isomer is 2.93 times of that for L-isomer, demonstrating the enantioselectivity of the CMOFs/CS hybrids. The content of D-isomer in nonracemic mixtures of DOPA enantiomers and real samples were assayed with satisfactory results, showing the practicality of this method. The strategy also exhibited discrimination capacity for many other chiral molecules. The CMOFs/CS hybrids prepared with in-situ growth protocol display satisfactory selectivity for discriminating enantiomers. Due to usage of multi-well microplate platform, the method is anticipated to achieve high-throughput assay in the future work. This study paves a pathway for facile chiral discrimination based on a chemiluminescence quenching mode to meet the demand of drug development and manufacture.

Smart working during the COVID-19 pandemic: the prevalence of musculoskeletal and visual disorders in administrative staff of a large international company.

During the COVID-19 Pandemic, the use of digital devices during work activities has increased with important repercussions on the psychological and physical well-being of the employees. The aim of this study was to investigate the prevalence of musculoskeletal and visual disorders related to the use of computers and home workstation. The study is a cross-sectional study. A checklist, from the National Institute of Health, was administered to white collar workers of a large international pharmaceutical company based in Italy. Our study showed that postural breaks have a protective effect on neck/shoulder pain (OR 0.32, CI 0.16-0.62), back and lower extremity pain (OR 0.35, CI 0.18-0.69), and eye burning (OR 0.50, CI 0.27-0.94) of study participants. The research recommends that remote employees who often change their workstations should establish a suitable work environment and obtaining enough risk training from an occupational physician. This is essential for maintaining their mental and physical well-being.

In vitro and in vivo characterization of Invega Sustenna® (paliperidone palmitate long-acting injectable suspension).

The aim of this study was to comprehensively characterize paliperidone palmitate (PP) long-acting suspension (Invega Sustenna®) through reverse engineering. We developed a series of analytical methods to assess critical quality attributes of four batches of Invega Sustenna®. The size distributions of the four batches of suspensions were measured using laser diffraction, and variations in the D50 and D90 parameters were observed. The morphology of suspension was determined through scanning electron microscope (SEM), which exhibited irregular granular shape across all batches. The size distributions determined by SEM images were similar to the laser diffraction results. Thermal characteristics were detected using differential scanning calorimetry (DSC) and crystalline properties were assessed by powder X-ray diffraction (PXRD), displaying consistency among the four batches in these two aspects. In vitro dissolution methods (sample separation and dialysis bag methods) were developed to evaluate the release behaviors of Invega Sustenna® and four lots showed a similar dissolution pattern. Furthermore, following a single-dose intramuscular administration to rats, two batches of Invega Sustenna® with the largest size differences demonstrated comparable plasma concentration-time profiles and pharmacokinetics parameters, indicative of one month long-acting release. In summary, we established a systematic quality characteristics assessment for Invega Sustenna®, including particle size distribution, particle morphology, thermal characteristics, crystalline properties, in vitro dissolution kinetics and in vivo pharmacokinetics. Our work will assist pharmaceutical companies and regulatory agencies in the development and regulatory assessment of novel or generic products of long-acting injectable suspension.

CUTTING-EDGE DEVELOPMENTS IN HPLC FOR IDENTIFYING PROCESS IMPURITIES: A REVIEW ON METHOD OPTIMIZATION AND VALIDATION

High-Performance Liquid Chromatography (HPLC) is a widely utilized column chromatography technique in biochemistry and analytical sciences for the separation, identification, and quantification of active compounds. Renowned as a leading separation technology, HPLC plays a pivotal role in detecting, separating, and quantifying pharmaceutical drugs. The development and validation of HPLC methods are essential in novel drug discovery, development, manufacturing, and various human and animal studies. This review highlights the comprehensive processes involved in the development and validation of HPLC methods. Method development is influenced by factors such as the chemical structure of molecules, synthetic pathways, solubility, polarity, pH, pKa values, and the activity of functional groups. Validation, as per ICH Guidelines, encompasses key parameters including accuracy, precision, specificity, linearity, range, limits of detection and quantification, robustness, and system suitability testing.

Biochemical features and biotechnological potential of a proteolytic extract from a psychrophilic Antarctic bacterium.

Proteases are hydrolases that act on peptide bonds, releasing amino acids and/or oligopeptides, and are involved in essential functions in all organisms. They represent an important segment of the global enzyme market, with applications in the food, leather, detergent, and pharmaceutical industries. Depending on their industrial use, proteases should exhibit high activity under extreme conditions, such as low temperatures, e.g. cold-active protease may have potential uses in the detergent industry. Cold-active enzymes show high catalytic constants (kcat) at low temperatures and thermolability, allowing their inactivation at moderate temperatures. This work aimed to characterize an extracellular proteolytic extract produced by an Antarctic isolate identified as Flavobacterium sp. strain AU13, and to evaluate its biotechnological potential as a detergent additive. By mass spectrometry analysis, we identified a major 50kDa protease, with high identity with an epralysin from Pseudomonas fluorescens Pf0-1, an alkaline extracellular metalloprotease belonging to the serralysin subfamily. The AU13 proteolytic extract showed metalloprotease activity and, maximal activity over a wide pH range (pH 5 to 8); it also showed maximal activity at 40°C, suggesting that this extracellular protease is a cold-active enzyme. The AU13 proteolytic extract demonstrated stable and compatible activity with surfactants and oxidants, making it a promising additive for commercial laundry detergents. Its ability to function effectively in cold-water washing conditions offers a significant advantage over conventional enzymes, potentially improving energy efficiency in industrial processes. The biochemical properties and performance of the AU13 proteolytic extract in the presence of laundry detergents, suggest that AU13 produces an extracellular protease with a biotechnological potential.

Meta-analysis of RNA-Seq datasets allows a better understanding of P. tricornutum cellular biology, a requirement to improve the production of Biologics

The marine diatom Phaeodactylum tricornutum is currently used for various industrial applications, including the pharmaceutical industry as a cost-effective cell biofactory to produce Biologics. Recent studies demonstrated that P. tricornutum can produce functional monoclonal antibodies, such application is currently limited by the production yield that hinders industrialization. Therefore, it is necessary to understand and control the cell biology of P. tricornutum to improve the Biologics production yield. Transcriptomic analyses have recently been used by the pharmaceutical industry to improve the production of Biologics in mammalian cells, especially Biologics titer and cell productivity. Hence, in the present work, we performed a meta-analysis of seven publicly available RNA-Seq datasets from different strains of P. tricornutum, for which the culture conditions were chosen as similar as possible. We analyzed the differential expression of genes that are involved in biological processes that are well known to potentially impact the bioproduction and critical quality attributes of Biologics. Therefore, the expression of genes involved in the N-glycan biosynthesis, protein export and secretion, protein quality control and proteasome, as well as those encoding proteases were analyzed and compared. The results pave the way towards optimizing Biologics production in P. tricornutum and highlight that the Pt4, Pt3 Ov and Pt8 strains seem to be the most promising P. tricornutum strains.

Molecular docking-guided in-depth investigation of the biological activities and phytochemical and mineral profiles of endemic Phlomis capitata.

Phlomis capitata is an endemic species of flowering aromatic and medicinal plant in the family Lamiaceae, native to regions of the Mediterranean and nearby areas. Understanding the chemical compounds present in P. capitata can reveal potential medicinal properties. The present study examines the quantification of bioactive phytochemicals, antioxidant capacity and enzyme inhibitory evaluation of P. capitata extract against key enzymes involved in the pathogenesis of Alzheimer's, diabetes mellitus, epilepsy and glaucoma for the first time. The mechanisms of enzyme inhibition activity of the predominant compounds in extract were also interpreted by molecular docking studies. Chemical characterization of the extract was performed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) (phytochemical profile) and inductively coupled plasma-mass spectrometry (mineral composition) analysis. Furthermore, the binding interactions of major phytochemicals with all enzymes were investigated by molecular docking studies. LC-MS/MS analysis of the P. capitata revealed the identification of 19 compounds predominated by quinic acid (4.883 mg g-1), followed by chlorogenic acid (4.36 mg g-1), vanilic acid (3.405 mg g-1), naringenin (2.571 mg g-1) and cyranoside (1.101 mg g-1). It was determined that the mineral element was rich (K, Ca, Al and Mg) and did not exceed the toxicity limits. The P. capitata extract demonstrated remarkable antioxidant activities in the order: 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid (IC50: 20.533 μg mL-1) < 2,2-diphenyl-1-picrylhydrazyl (IC50: 23.151 μg mL-1) < N,N-dimethyl-p-phenylenediamine (IC50: 45.221 μg mL-1) and cupric reducing antioxidant capacity (0.889 μg mL-1) < Fe3+ reducing (0.969 μg mL-1) < ferric reducing antioxidant potency (0.974 μg mL-1). Moreover, of all the enzyme inhibitory assays (acetylcholinesterase, butyrylcholinesterase, α-amylase, α-glucosidase, and human carbonic anhydrases I and II), the extract showed outstanding inhibitory activities (IC50 values of 3.26, 7.15, 6.15, 6.81, 15.21 and 11.93 μg mL-1, respectively). In summary, the findings show that P. capitata is a versatile raw material that can be used in the pharmaceutical, cosmetic and food industries to develop products that promote health. © 2025 The Author(s). Journal of the Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

The salient stakeholders of industrial downsizing: the contribution of boundary object and systemic shock

Purpose The identification of salient stakeholders remains an issue in stakeholder theory (ST). The articulation of ST with the concepts of boundary object and systemic shock contributes to tackle this point. A boundary object is the “stake” that aggregates a stable network of interdependent actors “holding” interest in it. They compromise to satisfy their interests and collectively reach an equilibrium. Design/methodology/approach In a deductive approach, to illustrate the conceptual framework, empirical evidence is provided by an in-depth case study based on semi-directive interviews and the secondary data (Eisenhardt, 1989; Yin, 2017) of an industrial downsizing that included massive dismissals and involves a multi-stakeholder network. I use a temporal bracketing methodology (Langley et al., 2013) to analyze the dynamic process of interactions between stakeholders. The evolution of interactions is analyzed before the public announcement, during the implementation of the downsizing, and after the closure. The case is Gamma-Alpha (GA), a large German pharmaceutical company, that decided to cut 1250 positions in its Geneva entity and to close the office. Findings This research contributes to the understanding of employment relationships through the lenses of ST. A managerial decision affecting a boundary object involving workers could lead to a systemic shock inducing network change that would require attention from managers in order to successfully implement their decision. It also highlights how and when stakeholders (employees, trade-unions, government, etc.) have more opportunities to influence firm behavior. Originality/value Our main contribution comes from enriching the literature on stakeholder theory with the concepts of boundary object and systemic shock, which results in a crucial conceptual advance: stakeholder saliency is not an intrinsic characteristic but depends on the boundary object that connects the stakeholder’s interests with those of the firm. Moreover, defining a systemic shock affecting the boundary object characterizes the event that triggers interactions between stakeholders and the dynamic evolution of the network.

Environment, Climate, and Diabetes: An International Topic.

Every person with diabetes is affected by changes in the environment and climate. At the same time, the therapy of many people itself has a negative impact on these factors. One might assume that the relevant professional associations and health organizations, as well as health policymakers, have initiated appropriate activities. The manufacturers of antidiabetic drugs and medical devices used in diabetes therapy are aware of the problems at hand. To what extent they really implement changes in the production, storage, and transport of their products is not easy to assess. In summary, it should be said that the importance of environmental factors for people with diabetes and their therapy is probably still not sufficiently recognized.

Patterns of willingness to share health data with key stakeholders in US consumers: a latent class analysis.

To identify distinct patterns in consumer willingness to share health data with various stakeholders and analyze characteristics across consumer groups. Data from the Rock Health Digital Health Consumer Adoption Survey from 2018, 2019, 2020, and 2022 were analyzed. This study comprised a Census-matched representative sample of U.S. adults. Latent class analysis (LCA) identified groups of respondents with similar data-sharing attitudes. Groups were compared by sociodemographics, health status, and digital health utilization. We identified three distinct LCA groups: (1) Wary (36.8%), (2) Discerning (47.9%), and (3) Permissive (15.3%). The Wary subgroup exhibited reluctance to share health data with any stakeholder, with predicted probabilities of willingness to share ranging from 0.07 for pharmaceutical companies to 0.34 for doctors/clinicians. The Permissive group showed a high willingness, with predicted probabilities greater than 0.75 for most stakeholders except technology companies and government organizations. The Discerning group was selective, willing to share with healthcare-related entities and family (predicted probabilities >0.62), but reluctant to share with other stakeholders (predicted probabilities <0.29). Individual characteristics were associated with LCA group membership. Findings highlight a persistent trust in traditional healthcare providers. However, the varying willingness to share with non-traditional stakeholders suggests that while some consumers are open to sharing, others remain hesitant and selective. Data privacy policies and practices need to recognize and respond to multifaceted and stakeholder-specific attitudes. LCA reveals significant heterogeneity in health data-sharing attitudes among U.S. consumers, providing insights to inform the development of data privacy policies.