Pharmaceutics and Drug Design Commons^™

Brain Delivery Of Antibody-Derived Biologicals For Alzheimer’S Disease: An Updated Narrative Review, Rachita K. Sumbria, Ruben J. Boado

Pharmacy Faculty Articles and Research

Antibodies directed against β-amyloid (Aβ) have been developed for the treatment of Alzheimer’s disease (AD). However, the in vivo central efficacy is reduced by the poor penetration of antibodies across the blood–brain barrier (BBB). In addition, these antibodies have been associated with adverse effects like amyloid-related imaging abnormalities. Thus, the development of new antibody-based therapies for AD with improved transport across the BBB may improve efficacy and reduce adverse effects. Antibodies targeting the BBB transferrin receptor (TfR) are able to cross the BBB through receptor-mediated transcytosis, producing a global distribution throughout the brain. Along the same line, bispecific antibodies directed …

Comparative Physicochemical Characterization Of Porcine, Fish, And Bovine Gelatin In Gummy Candies: Toward Halal Nutraceutical Development, Marlyn Dian Laksitorini, Cici Darsih, Nunung Yuniarti, Rumiyati Rumiyati, Mohammad Zainal Abidin

Pharmaceutical Sciences and Research

Gummy candies have emerged as one of the most popular dosage forms for multivitamins and nutraceutical supplements, including those for brain health. Gelatin is the primary gelling agent used to achieve the gummy texture; however, the influence of different gelatin sources on the physicochemical properties of gummies has not been systematically examined. This study investigated the physicochemical characteristics of gummies prepared with porcine, bovine, and fish gelatin. The gummies were evaluated for mechanical properties (gumminess, hardness, cohesiveness, springiness, adhesiveness, and stringiness), color, water activity, antioxidant activity, and protein content. Additionally, the effects of intentional adulteration—specifically the addition of porcine gelatin …

Ethical Decision-Making Frameworks In Ai-Driven Pharmaceutical Research & Development, Dhaval Dinesh Panchal, Osama Mohd Hash Ansari, Sudha Divya Madhuri Kallam

Harrisburg University Dissertations and Theses

Artificial intelligence is increasingly being utilized in pharmaceutical research and development to speed up drug discovery, enhance clinical trial design, and support regulatory decision-making. However, the increasingly rapid adoption of AI in the pharma industry has outpaced the development of consistent ethical governance, raising concerns related to data privacy, transparency, regulatory compliance, and stakeholder trust. This study explored the methods by which project managers could develop and utilize ethical decision-making frameworks to facilitate responsible AI implementation in pharmaceutical research and development. Guided by the Responsible Innovation framework, this research employed a mixed-methods design combining semi-structured interviews and quantitative surveys with …

Structural Transformation Of A Hydrogel-Forming Cell Division Protein Zapb Of Multidrug Resistant Klebsiella Pneumoniae With Small Molecules, Ayesha Khan, M. Iqbal Choudhary, Sumaira Javaid, Humaira Zafar, Innokentiy Maslennikov, Atia-Tul Wahab

Pharmacy Faculty Articles and Research

Septal ring assembly protein ZapB (EMR18431.1) is involved in Z-ring formation, and nucleoid segregation during the bacterial cell division . It promotes cell division in the initial stages of the cell cycle through direct interaction with FtsZ, thus stimulating Z-ring assembly. The ZapB inhibition can make bacterial cell susceptible to primary antibiotics, and therefore considered as an important approach for adjuvent therapy against MDR bacterial infections. Hence in the current study, ZapB protein of multidrug resistant Klebsiella pneumoniae was cloned, and expressed in E. coli system. To understand its role, and to assess the mechanism of ZapB activation, the characteristic …

Patenting The Unexpected, Sean B. Seymore

Vanderbilt Law School Faculty Publications

Unexpected discoveries have transformed human existence. They’ve revolutionized science and spawned entire new fields of research. While unexpected discoveries seem inventive and worthy of patent protection, they don’t formally align with traditional patent theory. The bedrock principle that an invention begins with the conception of an idea in the inventor’s mind and ends with implementation doesn’t apply to unexpected discoveries. This misalignment is most acute for pharmaceuticals, where the discovery of new uses for old drugs has tremendous social and economic importance. Since a drug can inherently treat multiple conditions in a patient—even those unknown to the patient, doctor, or …

2025 Novel Drug Approvals, Katherine Ghattas Pharmd, Amanda Rawa Pharmd

Transformative Medicine

The year 2025 marked another strong chapter in pharmaceutical innovation, with multiple novel therapies gaining approval from the U.S. Food and Drug Administration (FDA). These approvals reflect continued progress in addressing unmet medical needs across a wide range of disease states. This article reviews the FDA’s 2025 novel drug approvals, spotlighting a few therapeutic advancements and emerging trends. A comprehensive table of all approved agents is provided, along with a focused discussion of four particularly impactful therapies: donidalorsen (Dawnzera), taletrectinib (Ibtrozi), delgocitinib (Anzupgo), gepotidacin (Blujepa), etripamil (Cardamyst). Each of these agents represents a step forward in its respective field and …

Efficacy And Safety Of Stem Cell-Based Interventions For Burn Wound Healing: A Systematic Review And Meta-Analysis Of Pre-Clinical And Early Clinical Evidence, Prayuth Poowaruttanawiwit, Patsanan Kulla, Naveeya Pakpoomkamonlert

The Thai Journal of Pharmaceutical Sciences

Background: Burn injuries remain a major therapeutic challenge, with conventional treatments often failing to achieve complete functional skin regeneration. Stem cell-based interventions, including mesenchymal stem cells (MSCs) and exosome derivatives, have demonstrated regenerative and immunomodulatory potential, yet their translation to clinical practice remains limited.
Objectives: To systematically evaluate the efficacy and safety of stem cell-based therapies for burn wound healing across pre-clinical and clinical studies.
Materials and Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines, four databases (PubMed, Embase, Scopus, and Cochrane) were searched through April 2025. Eligible studies included randomized controlled trials and controlled pre-clinical …

Development Of Aqueous Dispersions Of Zein–Inulin Nanoparticles: Influence Of Formulation Variables On Physical Properties, Wanarat Sayamol, Supakarn Chamni, Jittima Chatchawalsaisin

The Thai Journal of Pharmaceutical Sciences

Background: Zein-based nanoparticles exhibit considerable potential for pharmaceutical and food applications. Incorporating inulin, a prebiotic polysaccharide, can improve their functional performance. Owing to the distinct solubilities of zein and inulin in aqueous ethanol, zein– inulin nanoparticles can be prepared through precipitation using their respective anti-solvents.
Objectives: This study aimed to systematically develop zein–inulin nanoparticles using the antisolvent precipitation method, with a focus on investigating the effects of formulation variables on particle characteristics and dispersion properties.
Materials and Methods: Zein–inulin nanoparticles were prepared using an anti-solvent precipitation method. Zein and inulin were separately dissolved in aqueous ethanol and water, respectively. The …

Receptor-Mediated Drug Delivery: Redefining Targeted Drug Conjugates In Oncology, Keon Niles Jafari, Charlene Chai, Shelby Kim, Kamaljit Kaur

Pharmacy Faculty Articles and Research

Targeted drug delivery (TDD), specifically through targeting ligand–drug conjugates, has reshaped oncology by enabling selective delivery of cytotoxic payloads to cancer cells while minimizing uptake by normal tissues. A key approach relies on exploiting overexpressed cell surface receptors (CSRs) to enable selective uptake of drug conjugates via receptor-mediated endocytosis. This review delineates four clinically validated CSRs (HER2, Trop-2, Nectin-4, and SSTR2) with several FDA-approved drug conjugates. Furthermore, emerging CSRs (EGFR, DLL3, and keratin 1) that may support next-generation TDD platforms for cancer treatment are also highlighted. We discuss how CSR type, density on cancer cells, and its mechanism of endocytosis, …

Gadolinium Nanoparticles: Emerging Platforms Beyond Imaging For Drug Delivery And Theranostics, Amir Nasrolahi Shirazi, Rajesh Vadlapatla, Ajoy Koomer, Heyam Zayed, Paris Marabut, Keykavous Parang

Pharmacy Faculty Articles and Research

Gadolinium nanoparticles (GdNPs) have gained increasing attention as multifunctional metal-based nanoplatforms that extend far beyond their traditional use as magnetic resonance imaging (MRI) contrast agents. Their specific magnetic properties, tunable physicochemical features, and tunable biocompatibilities with biocompatible coatings give them great potential as drug delivery and theranostic applications. They offer greater stability, lower systemic toxicity, and more surface modification options compared to molecular gadolinium chelates. The functionalized GdNPs not only show excellent properties as drug carriers for their specific indications but also serve as agents in various imaging modalities with superior therapeutic efficacy by means of radio sensitization and magnetically …

Evidentiary Standards For Newly Approved Antibiotics For Uncomplicated Urinary Tract Infections, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez, John H. Powers Iii

Pharmacy Faculty Articles and Research

Importance: Uncomplicated urinary tract infections (uUTIs) are among the most common bacterial infections and are typically treated with existing oral antibiotics. In 2024–2025, the FDA approved two new oral agents, sulopenem etzadroxil/probenecid and gepotidacin, via expedited review pathways, for the treatment of uUTIs. Objective: To assess the clinical significance and regulatory evidence supporting FDA approval of sulopenem/probenecid and gepotidacin for uUTI, and to analyze the adherence of pivotal phase III trials to regulatory standards for approval and FDA guidelines. Design, Setting, and Participants: Comparative descriptive analysis of publicly available data from phase 3 randomized, double-blind, active-controlled clinical …

Microbiome-Responsive Hydrogels: From Biological Cues To Smart Biomaterials, Rajesh Vadlapatla, Amir Nasrolahi Shirazi, Ajoy Koomer, Judy Weng, Matthew Ernest Ghilarducci, Alai Qudus, Keykavous Parang

Pharmacy Faculty Articles and Research

Background: Stimuli-responsive hydrogels (SRHs) are smart polymeric materials that undergo reversible physicochemical changes in response to abiotic cues and externally applied fields, enabling applications in drug delivery, wound healing, and tissue engineering. However, they exhibit limited biological specificity and do not adequately reflect the dynamic, disease-relevant complexity of native tissue microenvironments. Microbe-colonized tissues display distinctive biochemical features driven, shaped by microbial metabolism, including localized pH gradients, short-chain fatty acid production, secretion of quorum-sensing molecules, biofilm formation, and expression of specialized enzymes. These endogenous, spatiotemporally regulated signals are closely linked to host physiology and pathology but remain underutilized in hydrogel …

Optimization Of A Kcc2 Small Molecule Agonist And The Development Of An In-Silico Model Of Intermolecular Dynamics For The Rational Design Of Therapeutics Against Opioid Use Disorder, William H.D. Ho, Alfred Amendolara, Kenyon Mitchell, Jaden Miner, Braxton Bingham, Andrew Payne

Annual Research Symposium

Roseman University Research Symposium

Wednesday, February 18, 2026 | 3:00 – 6:00 pm (local time)

Tumor Targeting With Peptide-Drug Conjugates: Showcasing Key Progress And Hurdles, Keykavous Parang, Thuy Do, Clare Dinh, Dorna Davanidavari, Max Foroughi, Troy Khong, Mahsa Moazen, Amir Nasrolahi Shirazi

Pharmacy Faculty Articles and Research

Peptide-drug conjugates (PDCs) are modular, targeted therapeutics composed of a homing peptide linked to a cytotoxic or modulating drug payload via a cleavable/non-cleavable linker. PDCs utilize peptide targeting to enhance the delivery of potent drugs to tumors, providing advantages such as superior tissue penetration, reduced immunogenicity, and simpler manufacture compared to antibody-drug conjugates (ADCs). A comparison of PDCs versus ADCs highlights that PDCs’ small size (~1-3 kDa) enables deeper tumor penetration and faster clearance, whereas ADCs (~150 kDa) benefit from prolonged circulation but suffer from limited tissue diffusion. This review surveys recent advances in PDC design and application. We discuss …

Protein Allostery Probed By Ligands Across Sites, Virgil A. Woods

Dissertations, Theses, and Capstone Projects

Allostery is a pervasive regulatory principle throughout biology, yet the structural pathways by which distal inputs alter active‑site chemistry within protein structures remain incompletely defined and exploited. This dissertation uses protein tyrosine phosphatase 1B (PTP1B) as a tractable model to map those pathways with complementary experimental and computational tools. I integrate high‑resolution hydrogen-deuterium exchange mass spectrometry (HDX-MS), room-temperature crystallography, NMR, steady-state kinetics, crystallographic pseudo-ensembles, and machine-learning-guided ligand discovery. The working premise is that regulation reflects redistribution within a conformational ensemble rather than a binary switch. That orthogonal perturbations by small molecules, mutations, and protein partners can be used to both …

Fda Policy Shift On Clinical Efficacy Study Requirements For Monoclonal Antibody Biosimilars, Rileigh Rahrig, Madilyn Paphanchith, Allie Honigford, Daniella Egbujor, Haley Brown, Jenny Magana Figueroa, Connor Dains, Brenna Hissong, Kyle W. Parker

Pharmacy and Wellness Review

Biologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using …

Impact Of Apitegromab On Motor Function In Spinal Muscular Atrophy, Jordyn Linfield, Ashley Jacob, Haylee Whyde, Owen Fox, Kaitlyn Bowden, Connor Dains, Brenna Hissong, Manoranjan D'Souza

Pharmacy and Wellness Review

Spinal muscular atrophy (SMA) is an inherited neuromuscular disorder characterized by the progressive loss of alpha motor neurons in the anterior horn of the spinal cord, leading to muscle weakness, atrophy, and impaired motor function.¹ SMA remains an extensive and difficult-to-treat condition, with only three disease-modifying therapies currently available to patients. A new investigational agent with a unique mechanism of action, apitegromab (SRK-015), has shown promising results in recent clinical trials. The safety and efficacy of apitegromab in patients with SMA have been explored in several clinical trials, with the TOPAZ and SAPPHIRE studies being the most notable. This …

Evaluation Of Peptides And Peptide–Doxorubicin Conjugates Designed And Synthesized For Targeting Triple-Negative Breast Cancer Via Cell-Surface Receptors, Shih-Jing (Jane) Yao

Pharmaceutical Sciences (PhD) Dissertations

A significant problem faced in oncology is the lack of chemotherapeutic agents that are tumor site-specific, resulting in reduced therapeutic efficacy and unintended infliction of harm to surrounding healthy tissues and cells that often lead to serious side effects. Current strategies being explored to circumvent this issue aim to refine delivery of  chemotherapeutic agents specifically to tumor sites, which may be achieved via conjugation of these agents to biomarker-specific ligands. This forms the foundation of ligand-targeted drug delivery. Among different breast cancers, treatment of the triple-negative breast cancer (TNBC) subtype has been particularly challenging, largely due to the absence of …

Evaluation Of The Physical Properties And In Vitro Safety Of Chitosan-Quercus Infectoria Topical Gel, Rani Naga Rakshitha Tillapudi

Theses, Dissertations and Capstones

Due to ongoing inflammation, inadequate blood flow, oxidative stress, and reduced tissue regeneration, chronic diabetic wounds heal slowly, which is a serious health concern. It is important to examine novel strategies that tackle these issues because conventional treatments frequently fail. Therefore, this study examined the physical properties and biocompatibility of a novel topical gel formulated with chitosan and Quercus infectoria gall extract.

Over 28 days, pH, spreadability, texture, homogeneity, color, and drug concentration were assessed. UV-visible spectrophotometry and FTIR analysis were used to establish chemical stability. The MTT assay was used to test its safety in human dermal fibroblast adult …

Nanocomposite Mediated Delivery Of 5-Fluorouracil Using Silver Nanoparticles To Promote Wound Healing, Kamal Nath Kasi

Theses, Dissertations and Capstones

Chronic wounds, particularly in diabetic patients, remain a significant clinical challenge due to the complex interaction of persistent infection, chronic inflammation, and impaired cellular regeneration. Conventional drug therapies often fail to achieve effective treatment due to rapid drug degradation, poor targeting, and localized toxicity. This study explores a nanotechnology-based approach by developing and evaluating 5-FU loaded AgNP (AgNP–5FU) as a controlled drug delivery system. AgNP (AgNP) were synthesized and characterized using scanning electron microscopy (SEM), energy dispersive X-ray (EDX) analysis, particle size, and zeta potential analysis, while Fourier Transform Infrared Spectroscopy (FTIR) analysis suggested possible interaction between 5-FU and the …