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Feature Papers to Celebrate the Inaugural Issue of Journal of...
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Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry

A special issue of Journal of Pharmaceutical and BioTech Industry (ISSN 2813-9380).

Deadline for manuscript submissions: 30 September 2025 | Viewed by 5727

Special Issue Editor

Prof. Dr. Fernando Albericio

E-Mail Website
Guest Editor
1. School of Chemistry and Physics, University of KwaZulu-Natal, Durban, South Africa
2. Department of Organic Chemistry, University of Barcelona, Barcelona, Spain
Interests: antimicrobial peptides; solid-phase chemistry; combinatorial chemistry; drug delivery systems; peptide drug conjugates; orthogonal chemistry; drug discovery; biomaterials
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The pharmaceutical and biotechnology industry continues to be one of the most important industry sectors for various reasons. It is essential for global health and the well-being of the public, as well as for the success of many countries’ economies. The discovery, development, manufacturing, and supply of pharmaceutical products, i.e., bench to bed, is one of the most versatile, multi-faceted, and innovative human endeavors. The aim of this Special Issue, titled "Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry", is to highlight cutting-edge studies in all aspects of the discovery, development, delivery, and manufacturing of drugs. We invite all authors to contribute original research articles and timely review articles. This Special Issue of the Journal of Pharmaceutical and BioTech Industry is also expected to showcase contributions from scientists, engineers, and formulators in academia, industry, and regulatory agencies. Besides studies conducted by a single university, laboratory, or company, collaborative studies performed by multiple constituencies, e.g., academia–industry, academia–regulator, or academia–industry–regulator, are especially welcome, as are inter- or multi-disciplinary studies. The authors should consult the aims and scope of the Journal of Pharmaceutical and BioTech Industry for a more detailed scope of the journal.

* We dedicate this Special Issue to the memory of our Founding Editor-in-Chief, Prof. Dr. Ecevit Bilgili, who initiated this Special Issue but sadly passed away during its preparation.

Prof. Dr. Fernando Albericio
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Pharmaceutical and BioTech Industry is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1000 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • drug discovery
  • drug development
  • drug delivery
  • drug manufacturing
  • pharmaceutical and biotech industry
  • pharmaceutics
  • regulatory sciences

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Published Papers (6 papers)

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Research

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20 pages, 8094 KiB  
Article
Detection and Quantification of Visual Tablet Surface Defects by Combining Convolutional Neural Network-Based Object Detection and Deterministic Computer Vision Approaches
by Eric Freiermuth, David Kohler, Albert Hofstetter, Juergen Thun and Michael Juhnke
J. Pharm. BioTech Ind. 2025, 2(2), 9; https://doi.org/10.3390/jpbi2020009 - 15 May 2025
Viewed by 123
Abstract
Tablet surface defects are typically controlled by visual inspection in the pharmaceutical industry. This is an insufficient response variable for knowledge-based formulation and process development, and it results in rather limited robustness of the control strategy. In this article, we present an analytical [...] Read more.
Tablet surface defects are typically controlled by visual inspection in the pharmaceutical industry. This is an insufficient response variable for knowledge-based formulation and process development, and it results in rather limited robustness of the control strategy. In this article, we present an analytical method for the quantitative characterization of visual tablet surface defects. The method involves analysis of the tablet surface by a digital microscope to obtain optical images and three-dimensional surface scans. Pre-processing procedures are applied for the simplification of the data to allow the detection of the imprint characters and tablet surface structures by a Faster R-CNN object detection model. Geometrical variables like perimeter and area were derived from the results of the object detection model and statistically analyzed for a selected number of tablets. The analysis allowed the development of product-specific acceptance criteria by a small reference dataset, and the quantitative evaluation of sticking, picking, chipping, and abrasion defects. The method showed high precision and sensitivity and demonstrated robust detection of visual tablet surface defects without false negative results. The image analysis was automated, and the developed algorithm can be operated by a simple routine on a standard computer in a few minutes. The method is suitable for industrial use and enables advancements in industrial formulation and process development while providing a novel opportunity for the quality control of visual tablet surface defects. Full article
(This article belongs to the Special Issue Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry)
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19 pages, 4421 KiB  
Article
Utilization, Expenditure, and Price Trends of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in the US Medicaid Programs: An Empirical Data Analysis of over Three Decades
by Zuhair A. Alqahtani, Xiaomeng Yue and Jeff J. Guo
J. Pharm. BioTech Ind. 2025, 2(2), 7; https://doi.org/10.3390/jpbi2020007 - 1 May 2025
Viewed by 169
Abstract
Aims: To describe and analyze trends in the utilization, spending, and average per prescription price of disease-modifying antirheumatic drugs (DMARDs) in the US Medicaid population. Methods: Using the publicly available national outpatient Medicaid State Drug Utilization Data, a retrospective, descriptive trend analysis was [...] Read more.
Aims: To describe and analyze trends in the utilization, spending, and average per prescription price of disease-modifying antirheumatic drugs (DMARDs) in the US Medicaid population. Methods: Using the publicly available national outpatient Medicaid State Drug Utilization Data, a retrospective, descriptive trend analysis was conducted on DMARDs from 1991 to 2022. Annual prescription counts and reimbursement amounts were calculated for nonbiologic and biologic DMARDs. Average per prescription price and Market share competition were calculated and analyzed for DMARDs. Results: Medicaid utilization of nonbiologic peaked in 2021 with 884,000 while biologic DMARDs with 688,000 prescriptions. In 2022, biologic utilization took the lead and exceed nonbiologic with 1.5 million prescriptions. Over the last 32 years, biologics captured 94% of Medicaid expenditures toward DMARDs, of which, 56% was toward adalimumab alone. On the other hand, spending on conventional DMARDs accounted for 33% while 67% accounted toward Janus Kinase Inhibitors. Biologic DMARDs average prices increased from around $800 to around $6000. However, the average adalimumab price increased 12-fold from around $1200 in 2003 to over $15,000 in 2021. Medicaid spending toward adalimumab increased by 179%. Conclusions: The substantial increase of DMARDs utilization and expenditure contributed significant burden to Medicaid budget. Introducing biosimilars into the market in the past few years is eroding the market share for several established biologics. Further cost-containment policies may be necessary for costly DMARD pharmacotherapy. Full article
(This article belongs to the Special Issue Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry)
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16 pages, 2125 KiB  
Article
FERMENZA®: A Patented Bioactive Fermented Product Developed Through Process Optimization
by Sudip Ghosh and Munna Bhattacharya
J. Pharm. BioTech Ind. 2025, 2(2), 6; https://doi.org/10.3390/jpbi2020006 - 30 Apr 2025
Viewed by 140
Abstract
This study investigates the comparative impact of fermentation versus conventional extraction methods on the bioactive potency of “FERMENZA”, a patented, affordable, natural fermented cider-based topical formulation. Through comprehensive in vitro analysis, the fermented extract demonstrated superior antioxidant efficacy, with an IC50 value [...] Read more.
This study investigates the comparative impact of fermentation versus conventional extraction methods on the bioactive potency of “FERMENZA”, a patented, affordable, natural fermented cider-based topical formulation. Through comprehensive in vitro analysis, the fermented extract demonstrated superior antioxidant efficacy, with an IC50 value of 0.77 ± 0.03 mg/mL, significantly outperforming solvent and steam-distilled extracts, which showed IC50 values of 2.49 ± 0.01 mg/mL and 4.11 ± 0.03 mg/mL, respectively. Notably, the nitric oxide scavenging activity of the fermented extracts was markedly higher than that of conventional extracts, with IC50 values ranging from 1.12 ± 0.03 to 2.29 ± 0.03 mg/mL. Fermentation also enhanced total phenolic content (TPC), with mixed fruit extracts (pomegranate-beetroot, banana-papaya) reaching TPC levels of 2.43 ± 0.03 mg gallic acid equivalent/g, surpassing individual and conventionally processed samples. The study employed a Quality by Design approach to optimize fermentation conditions, achieving peak yields of gallic acid and TPC at 35 °C and 72 h, which further validates the process affordability. Under these conditions, the fermented extracts from pomegranate and beetroot demonstrated exceptional antimicrobial properties against E. coli, S. aureus, P. aeruginosa, P. acne, and M. furfur, with minimum inhibitory concentration values ranging from 0.25 mg/mL to 0.60 mg/mL, superior to those observed in conventionally extracted samples from pomegranate and beetroot. These findings highlight the efficacy of fermentation in enhancing bioactive compound availability, positioning FERMENZA as a potent fermented formulation for probable skin and hair-related cosmeceutical applications. Full article
(This article belongs to the Special Issue Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry)
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18 pages, 6442 KiB  
Article
Effect of Ethanol on the Solubility and Apparent Specific Volume of Sodium Sulfadiazine in Aqueous Mixtures
by Daniel R. Delgado, Fleming Martinez, María Ángeles Peña, Abolghasem Jouyban and William E. Acree, Jr.
J. Pharm. BioTech Ind. 2025, 2(2), 5; https://doi.org/10.3390/jpbi2020005 - 31 Mar 2025
Viewed by 357
Abstract
The main objective of this research was to correlate the equilibrium solubility of sodium sulfadiazine in several {ethanol (EtOH, 1) + water (2)} mixtures reported in mass/volume and mass/mass percentages at different temperatures. Aqueous solubility of sodium sulfadiazine decreases almost linearly with decreasing [...] Read more.
The main objective of this research was to correlate the equilibrium solubility of sodium sulfadiazine in several {ethanol (EtOH, 1) + water (2)} mixtures reported in mass/volume and mass/mass percentages at different temperatures. Aqueous solubility of sodium sulfadiazine decreases almost linearly with decreasing temperature, but it decreases non-linearly with the addition of EtOH to water. Logarithmic solubility was adequately correlated with a bivariate model involving temperature and mixture composition. These solubility results were also well correlated with the Jouyban–Acree-based models. Moreover, an adapted version of the Jouyban–Acree model was used to represent the density of the saturated solvent mixtures at different temperatures. Furthermore, the apparent specific volumes of this drug at saturation were also calculated from densities of saturated solutions and cosolvent mixtures free of drug as well as from the respective mixture compositions. These findings provide valuable insights into the solubility and volumetric behavior of sodium sulfadiazine, which could be useful for pharmaceutical formulation and process optimization. Full article
(This article belongs to the Special Issue Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry)
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16 pages, 2180 KiB  
Article
A Precipitation-Based Process to Generate a Solid Formulation of a Therapeutic Monoclonal Antibody: An Alternative to Lyophilization
by Athanas A. Koynov, Wei Lin, Jameson R. Bothe, Luke Schenck, Bibek Parajuli, Zhao Li, Richard Ruzanski, Natalie Hoffman, Derek Frank and Zachary VanAernum
J. Pharm. BioTech Ind. 2025, 2(1), 2; https://doi.org/10.3390/jpbi2010002 - 31 Jan 2025
Viewed by 1710
Abstract
Lyophilization, or freeze-drying, is the default technique for the manufacture of solid-state formulations of therapeutic proteins. This established method offers several advantages, including improved product stability by minimizing chemical degradation, reduced storage requirements through water removal, and elimination of cold chain dependence. However, [...] Read more.
Lyophilization, or freeze-drying, is the default technique for the manufacture of solid-state formulations of therapeutic proteins. This established method offers several advantages, including improved product stability by minimizing chemical degradation, reduced storage requirements through water removal, and elimination of cold chain dependence. However, the lyophilization process itself presents limitations. It is a lengthy, batch-based operation, potentially leading to product inconsistencies and high manufacturing costs. Additionally, some proteins are susceptible to structural alterations during the freezing step, impacting their biological activity. This paper presents an alternative approach based on the co-precipitation of protein and excipients using an organic solvent. We explore the impact of various processing parameters on the viability of the formulation. We also provide an extensive characterization of proteins reconstituted from precipitated formulations and compare protein stability in solution and in lyophilized and precipitated solid formulations under long-term, accelerated, and stressed storage conditions. Full article
(This article belongs to the Special Issue Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry)
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Review

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34 pages, 1227 KiB  
Review
Non-Traditional Natural Stabilizers in Drug Nanosuspensions
by Simay Ozsoysal and Ecevit Bilgili
J. Pharm. BioTech Ind. 2024, 1(1), 38-71; https://doi.org/10.3390/jpbi1010005 - 13 Dec 2024
Cited by 3 | Viewed by 2399
Abstract
Poor solubility of many drugs, with ensuing low bioavailability, is a big challenge in pharmaceutical development. Nanosuspensions have emerged as a platform approach for long-acting injectables and solid dosages that enhance drug bioavailability. Despite improvements in nanosuspension preparation methods, ensuring nanosuspension stability remains [...] Read more.
Poor solubility of many drugs, with ensuing low bioavailability, is a big challenge in pharmaceutical development. Nanosuspensions have emerged as a platform approach for long-acting injectables and solid dosages that enhance drug bioavailability. Despite improvements in nanosuspension preparation methods, ensuring nanosuspension stability remains a critical issue. Conventionally, synthetic and semi-synthetic polymers and surfactants are used in nanosuspension formulations. However, no polymer or surfactant group is universally applicable to all drugs. This fact, as well as their toxicity and side effects, especially if used in excess, have sparked the interest of researchers in the search for novel, natural stabilizers. The objective of this paper is to provide a comprehensive analysis of non-traditional natural stabilizers reported in the literature published over the last decade. First, physical stability and stabilization mechanisms are briefly reviewed. Then, various classes of non-traditional natural stabilizers are introduced, with particular emphasis on their stabilization potential, safety, and pharmaceutical acceptability. Wherever data were available, their performance was compared with the traditional stabilizers. Furthermore, the benefits and limitations of using these stabilizers are examined, concluding with future prospects. This review is expected to serve as a valuable guide for researchers and formulators, offering insights into non-traditional natural stabilizers in drug nanosuspension formulations. Full article
(This article belongs to the Special Issue Feature Papers to Celebrate the Inaugural Issue of Journal of Pharmaceutical and BioTech Industry)
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