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J. Pharm. BioTech Ind., Volume 2, Issue 3 (September 2025) – 6 articles

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21 pages, 1557 KB  
Review
Biopolymer Scaffolds in 3D Tissue Models: Advancing Antimicrobial Drug Discovery and Bacterial Pathogenesis Studies—A Scoping Review
by Jailson de Araújo Santos and Ariel de Almeida Coelho
J. Pharm. BioTech Ind. 2025, 2(3), 15; https://doi.org/10.3390/jpbi2030015 - 22 Sep 2025
Abstract
The growing threat of Antimicrobial Resistance (AMR) demands innovative drug discovery, yet conventional 2D cell cultures fail to accurately mimic in vivo conditions, leading to high failure rates in preclinical studies. This review addresses the critical need for more physiologically relevant platforms by [...] Read more.
The growing threat of Antimicrobial Resistance (AMR) demands innovative drug discovery, yet conventional 2D cell cultures fail to accurately mimic in vivo conditions, leading to high failure rates in preclinical studies. This review addresses the critical need for more physiologically relevant platforms by exploring recent advancements in bioengineered 3D tissue models for studying bacterial pathogenesis and antimicrobial drug discovery. We conducted a systematic search of peer-reviewed articles from 2015 to 2025 across PubMed, Scopus, and Web of Science, focusing on studies that used 3D models to investigate host–pathogen interactions or antimicrobial screening. Data on model types, biomaterials, fabrication techniques, and key findings were systematically charted to provide a comprehensive overview. Our findings reveal that a diverse range of biomaterials, including biopolymers and synthetic polymers, combined with advanced techniques like 3D bioprinting, are effectively used to create sophisticated tissue scaffolds. While these 3D models demonstrate clear superiority in mimicking biofilm properties and complex host–pathogen dynamics, our analysis identified a significant research gap: very few studies directly integrate these advanced bioengineered 3D models for high-throughput antimicrobial drug discovery. In conclusion, this review highlights the urgent need to bridge this disparity through increased research, standardization, and scalability in this critical interdisciplinary field, with the ultimate goal of accelerating the development of new therapeutics to combat AMR. Full article
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14 pages, 2108 KB  
Article
Modeling Power Consumption: A Novel Correlation for Stirred Media Mills with Variable Bead Filling Ratios
by Simay Ozsoysal, Hamidreza Heidari, Gulenay Guner, Donald J. Clancy and Ecevit Bilgili
J. Pharm. BioTech Ind. 2025, 2(3), 14; https://doi.org/10.3390/jpbi2030014 - 8 Sep 2025
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Abstract
Evaluating power consumption in stirred media mills over a wide range of process parameters is crucial for analyzing breakage kinetics and milling efficiency. Despite considerable research efforts, existing models predominantly rely on power-law approaches and fail to provide a holistic understanding of the [...] Read more.
Evaluating power consumption in stirred media mills over a wide range of process parameters is crucial for analyzing breakage kinetics and milling efficiency. Despite considerable research efforts, existing models predominantly rely on power-law approaches and fail to provide a holistic understanding of the relationship between process parameters and power consumption. The aim of this study is to introduce a new mathematical model that accurately captures this relationship, across all bead filling ratios (φ), using dimensionless numbers including power number (Ne) and Reynolds number (Re). First, we considered experimental data from literature and discriminated various models to correlate either Ne or Re separately for each φ (Class 1 models) or Ne to Reφ simultaneously (Class 2 models). The best performing model (Model 2.6 with SSR = 36.71, RMSE = 0.591, R2 = 0.99) was subsequently applied to a new set of experimental data, confirming that this model is highly robust and reliable across various conditions. To the best of our knowledge, in stirred media mill research, this work is the first to show that a simple four-parameter nonlinear model provides a robust fit for Ne data across varying rotor Re (200 to 1 × 106) and bead filling ratios (0.35–0.90). Full article
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5 pages, 185 KB  
Opinion
Frameworks for Ethical Conduct in Clinical Trials and Health Research in Africa
by Lembit Rägo and Jacqueline Sawyer
J. Pharm. BioTech Ind. 2025, 2(3), 13; https://doi.org/10.3390/jpbi2030013 - 8 Aug 2025
Viewed by 473
Abstract
Current estimates suggest that Africa contains about 14% of the world’s population and accounts for 20% of the global burden of disease. Yet, it accounts for a mere 3% of clinical trials globally. The time is ripe—even overdue—for determining how best to direct [...] Read more.
Current estimates suggest that Africa contains about 14% of the world’s population and accounts for 20% of the global burden of disease. Yet, it accounts for a mere 3% of clinical trials globally. The time is ripe—even overdue—for determining how best to direct future health research efforts. In response, a call has been heard for a continent-wide Africa-centric research ethics framework to redirect health research in Africa, as well as address the health research ethics malpractices that have violated the rights, dignity and well-being of participating African communities. Nevertheless, we should remain aware of what already exists and what continues to be of value. Creating parallel frameworks risks fragmentation of research, increased costs in having to meet differing requirements and delayed access of patients to new treatments. Existing international consensus documents which have evolved and been fine-tuned over time, offer guidance for ensuring ethical instigation and management of health research. The Declaration of Helsinki enunciates clear principles for ensuring the ethical conduct of clinical research, while CIOMS’ 2016 International Ethical Guidelines for Health-related Research involving Humans offer guidance for implementing these principles. It is failure to apply existing ethical principles and guidance—and not any perceived inadequacy of those principles—that has resulted in sub-optimal protection of African research participants. Full article
10 pages, 480 KB  
Article
Aerosol Characteristics of Nebulized Tranexamic Acid 100 mg/mL for Hemoptysis Treatment—Proof-of-Concept Study
by Gerrit Seifert, Frank Erdnüß, Wolfgang Kamin and Irene Krämer
J. Pharm. BioTech Ind. 2025, 2(3), 12; https://doi.org/10.3390/jpbi2030012 - 28 Jul 2025
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Abstract
Background: Off-label nebulization of tranexamic acid (TXA) solution is common practice for the treatment of hemoptysis. However, data regarding nebulization protocols, resulting aerodynamic parameters of the generated aerosol, and corresponding biopharmaceutical parameters are missing. The aim of this in vitro study was to [...] Read more.
Background: Off-label nebulization of tranexamic acid (TXA) solution is common practice for the treatment of hemoptysis. However, data regarding nebulization protocols, resulting aerodynamic parameters of the generated aerosol, and corresponding biopharmaceutical parameters are missing. The aim of this in vitro study was to investigate the aerosol characteristics of nebulized sterile, aqueous TXA solution. Methods: TXA solution 100 mg/mL was nebulized for 2 min by a multi-dose vibrating mesh nebulizer using 15 L/min and 30 L/min air flow rates. The generated aerosol was analyzed by a Next Generation Cascade Impactor. For each air flow rate, the mean Fine Particle Dose (FPD), Fine Particle Fraction (FPF), the Mass Median Aerodynamic Diameter (MMAD), and Geometric Standard Deviation (GSD) were quantified. Results: Nebulization at 15 L/min air flow rate resulted in a MMAD of 6.68 ± 0.23 µm and GSD of 2.02 ± 0.16. The FPD < 5 µm was 16.56 ± 0.45 mg, the FPF < 5 µm 28.91 ± 3.40%. Nebulization at 30 L/min air flow rate revealed a MMAD of 5.18 ± 0.12 µm and GSD of 2.14 ± 0.10. The FPD < 5 µm was 16.30 ± 1.38 mg, the FPF < 5 µm 35.43 ± 0.59%. Conclusions: Nebulization of TXA 100 mg/mL solution by a specified vibrating mesh nebulizer generated an aerosol particle distribution and deposition pattern suitable for the treatment of hemoptysis with bronchial origin. Full article
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29 pages, 1169 KB  
Review
Harnessing AI and Quantum Computing for Accelerated Drug Discovery: Regulatory Frameworks for In Silico to In Vivo Validation
by David Melvin Braga and Bharat S. Rawal
J. Pharm. BioTech Ind. 2025, 2(3), 11; https://doi.org/10.3390/jpbi2030011 - 17 Jul 2025
Viewed by 2490
Abstract
Developing a new drug costs approximately one to three billion dollars and takes around ten years; however, this process has only a ten percent success rate. To address this issue, new technologies that combine artificial intelligence (AI) and quantum computing can be leveraged [...] Read more.
Developing a new drug costs approximately one to three billion dollars and takes around ten years; however, this process has only a ten percent success rate. To address this issue, new technologies that combine artificial intelligence (AI) and quantum computing can be leveraged in the pharmaceutical industry. The RSA cryptographic algorithm, developed by Rivest, Shamir, and Adleman in 1977, is one of the most widely used public-key encryption schemes in modern digital security. Its security foundation lies in the computational difficulty of factoring the product of two large prime numbers, a problem considered intractable for classical computers when the key size is sufficiently large (e.g., 2048 bits or more). A future application of using a detailed structural model of a protein is that digital drug design can be used to predict potential drug candidates, thereby reducing or eliminating the need for time-consuming laboratory and animal testing. Knowing the molecular structure of a possible candidate drug can provide insights into how drugs interact with targets at an atomic level, at significantly lower expenditures, and with maximum effectiveness. AI and quantum computers can rapidly screen out potential new drug candidates, determine the toxicity level of a known drug, and eliminate drugs with high toxicity at the beginning of the drug development phase, thereby avoiding expensive laboratory and animal testing. The Food and Drug Administration (FDA) and other regulatory bodies are increasingly supporting the use of in silico to in vitro/in vivo validation methods and assessments of drug safety and efficacy. Full article
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13 pages, 1770 KB  
Article
PMSSO-Hydrogels as a Promising Carrier for B12 Vitamin
by Daniil Ialama, Polina Orlova, Anna Skuredina, Ivan Meshkov, Aziz Muzafarov and Irina Le-Deygen
J. Pharm. BioTech Ind. 2025, 2(3), 10; https://doi.org/10.3390/jpbi2030010 - 23 Jun 2025
Viewed by 381
Abstract
The development of novel dosage forms of vitamin B12 is an urgent task for addressing vitamin deficiency in individuals with gastrointestinal diseases or those following stringent dietary limitations. The study illustrates the fundamental possibility of employing a non-toxic and biocompatible organosilicon hydrogel [...] Read more.
The development of novel dosage forms of vitamin B12 is an urgent task for addressing vitamin deficiency in individuals with gastrointestinal diseases or those following stringent dietary limitations. The study illustrates the fundamental possibility of employing a non-toxic and biocompatible organosilicon hydrogel with significant sorption capacity for B12 delivery. Research indicated that 40 min of incubation suffices for optimal loading efficiency, influenced by both external diffusion and intradiffusion factors. The release of B12 in a medium that mimics the human gastrointestinal tract transpires almost entirely within a timeframe that aligns with physiological conditions. Consequently, organosilicon hydrogels serve as potential vehicles for the administration of vitamin B12. Full article
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