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  • Review
  • Open Access
176 Views
23 Pages

Biosimilars: Bridging the Gap in Biologics, Access, and Affordability

  • Afza Rizwan,
  • Karan Dubey,
  • Vishal Malhotra and
  • Seema Bhatnagar

There is a growing global demand for cost-effective alternatives to high-priced biologic therapies, which has significantly accelerated the development of biosimilars and positioned them as sustainable and affordable treatment options. Biosimilars in...

  • Article
  • Open Access
517 Views
24 Pages

Assessment of Human Health Risks from Exposure to Lubricating Eye Drops Used in the Treatment of Dry Eye Disease

  • Marcelo de Oliveira,
  • Elaine S. de Pádua Melo,
  • Diego Azevedo Zoccal Garcia,
  • Vanessa Torres Braga,
  • Marta Aratuza Pereira Ancel and
  • Valter Aragão do Nascimento

Dry eye disease is a common condition in which tear production or quality is insufficient to lubricate the eyes properly. Standard treatment usually involves lubricating eye drops. In this study, we assessed the human health risks, including both non...

  • Review
  • Open Access
2 Citations
1,176 Views
36 Pages

The Future of Precision Medicine: Targeted Therapies, Personalized Medicine and Formulation Strategies

  • Gopinath Rongala,
  • Druva Sarika Rongala and
  • Appalaswamy Naidu Rongala

Medicine is accelerating rapidly, offering the advantages of site-specific delivery, minimized side effects, and improved treatment outcomes. A diverse array of chronic diseases, such as cancer, diabetes, asthma, myocardial infarction, and Alzheimer&...

  • Review
  • Open Access
822 Views
38 Pages

Promising Anti-Inflammatory Species from the Lecythidaceae Family: An Integrative Review

  • Queli Cristina Fidelis,
  • Letícia Paula Benvindo Trajano,
  • Efraim Costa Pereira,
  • Tatielle Gomes Dias,
  • Thamyres Freitas Fernandes,
  • Adriana Gomes Nogueira Ferreira,
  • Ana Lucia Fernandes Pereira,
  • Marcelino Santos Neto,
  • Richard Pereira Dutra and
  • Francisco Eduardo Aragão Catunda-Junior

Lecythidaceae species are known worldwide for their ability to produce edible nuts of high nutritional value, such as Brazil nuts, and are also used in traditional medicine in countries across America, Asia, and Africa. The potential of these species...

  • Article
  • Open Access
725 Views
14 Pages

Leveraging In Silico Data for the Development and Implementation of Multivariate Statistical Process Monitoring Models in Monoclonal Antibody Manufacturing

  • Sushrut Marathe,
  • Samira Beyramysoltan,
  • Giulia Marchese,
  • Elaheh Ardalani,
  • Nathaniel Berendson,
  • Theodore Vu,
  • Gabriele Bano and
  • Sayantan Chattoraj

The design and development of a robust and consistent manufacturing process for monoclonal antibodies (mAbs), augmented by advanced process analytics capabilities, is a key current focus area in the pharmaceutical industry. In this work, we describe...

  • Article
  • Open Access
1 Citations
2,861 Views
18 Pages

Enhanced Ocular Retention and Anti-Allergic Efficacy of a Novel HA–Ectoine–CMC Eye Drop for Dry Eye Disease Management

  • Jon Andrade del Olmo,
  • Alejandro Melero,
  • Ander Pino,
  • Nagore Martínez de Cestafe,
  • Oihane Gartziandia,
  • Miguel Ucelay López de Heredia,
  • Josune Torrecilla,
  • Laura Gómez,
  • Sandra Benito Cid and
  • Raúl Pérez González
  • + 1 author

Dry eye disease (DED) is a multifactorial ocular surface disorder that significantly affects vision and quality of life. While artificial tears are the standard first-line therapy, their effectiveness is limited by the complex pathophysiology of DED....

  • Review
  • Open Access
1,003 Views
21 Pages

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 cri...

  • Article
  • Open Access
1 Citations
1,323 Views
14 Pages

Modeling Power Consumption: A Novel Correlation for Stirred Media Mills with Variable Bead Filling Ratios

  • Simay Ozsoysal,
  • Hamidreza Heidari,
  • Gulenay Guner,
  • Donald J. Clancy and
  • Ecevit Bilgili

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 appr...

  • Opinion
  • Open Access
1 Citations
1,500 Views
5 Pages

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 d...

  • Article
  • Open Access
3,829 Views
10 Pages

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 biop...

  • Review
  • Open Access
4 Citations
6,744 Views
29 Pages

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 quantu...

  • Article
  • Open Access
874 Views
13 Pages

PMSSO-Hydrogels as a Promising Carrier for B12 Vitamin

  • Daniil Ialama,
  • Polina Orlova,
  • Anna Skuredina,
  • Ivan Meshkov,
  • Aziz Muzafarov and
  • Irina Le-Deygen

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...

  • Feature Paper
  • Article
  • Open Access
3 Citations
2,775 Views
20 Pages

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...

  • Article
  • Open Access
1,092 Views
13 Pages

Poor drug entrapment, burst release, and variable drug release profiles are the most critical challenges associated with biodegradable-polymer-based microspheres. In this study, biodegradable-polymer-based microspheres were used to entrap an antiplat...

  • Article
  • Open Access
2,152 Views
19 Pages

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...

  • Article
  • Open Access
1,459 Views
16 Pages

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...

  • Article
  • Open Access
2 Citations
2,649 Views
18 Pages

Effect of Ethanol on the Solubility and Apparent Specific Volume of Sodium Sulfadiazine in Aqueous Mixtures

  • Daniel R. Delgado,
  • Fleming Martinez,
  • María Ángeles Peña,
  • Abolghasem Jouyban and
  • William E. Acree

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...

  • Article
  • Open Access
1 Citations
2,113 Views
13 Pages

A selective inhibitor of cyclooxygenase-2 (COX-2), Celecoxib (CEB), known for its anti-inflammatory properties, can exhibit polymorphism, with Form III often emerging as an undesired crystalline impurity during the green manufacturing process of the...

  • Article
  • Open Access
4 Citations
4,028 Views
16 Pages

Lidocaine plays a significant role in postoperative analgesia by effectively reducing pain. However, due to its short half-life, it is challenging for lidocaine to achieve the desired duration of analgesia in clinical settings. Drug delivery systems...

  • Article
  • Open Access
2 Citations
4,130 Views
16 Pages

A Precipitation-Based Process to Generate a Solid Formulation of a Therapeutic Monoclonal Antibody: An Alternative to Lyophilization

  • Athanas A. Koynov,
  • Wei Lin,
  • Jameson R. Bothe,
  • Luke Schenck,
  • Bibek Parajuli,
  • Zhao Li,
  • Richard Ruzanski,
  • Natalie Hoffman,
  • Derek Frank and
  • Zachary VanAernum

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 degrada...

  • Review
  • Open Access
6 Citations
6,331 Views
34 Pages

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. De...

  • Article
  • Open Access
3 Citations
3,258 Views
18 Pages

Celecoxib (CEL), a nonsteroidal anti-inflammation drug (NSAID), is categorized as a Class II drug (low solubility, high permeability) in the Biopharmaceutics Classification System (BCS). The aim of this study is to develop a novel formulation of CEL...

  • Article
  • Open Access
7 Citations
3,549 Views
16 Pages

Preparation of Indomethacin Co-Crystals; Comparison of XRD, THz, and FT-IR Spectral Analyses; and Enhancement of Solubility

  • Chih-Chin Hsu,
  • Chih-Tse Hung,
  • Ya-Hsuan Lin,
  • Hua-Jeng Tsai,
  • Po-Chih Hu,
  • Yi-Ping Lin,
  • Jyh-Chern Chen,
  • Shen-Fu Hsu and
  • Hsyue-Jen Hsieh

Background: The aqueous solubility of indomethacin, a poorly water-soluble anti-inflammatory drug, was enhanced by co-crystallization with co-formers. The co-crystals were characterized and compared by an X-ray diffraction (XRD) analysis, terahertz (...

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J. Pharm. BioTech Ind. - ISSN 2813-9380