Pharmacy and Pharmaceutical Sciences Commons^™

Polmacoxib: A Drug Review, Sakeer Hussain, Dr. Subramanian Ramaswamy , Professor, Mahabaleshwar Mamadapur Assistant Professor, Ananthu Ajikumar

International Journal of Health and Allied Sciences

Polmacoxib, a novel nonsteroidal anti-inflammatory drug (NSAID), has shown a promised therapeutic option for the management of osteoarthritis and other inflammatory conditions. This drug review mainly aims to provide a comprehensive overview of polmacoxib, focusing on its pharmacological properties, clinical efficacy, safety profile, and potential therapeutic applications. Polmacoxib is a notable drug due to its dual mechanism of action, combining selective COX-2 inhibition with inhibition of carbonic anhydrase, which may contribute to its enhanced anti-inflammatory and analgesic effects. Being a selective COX-2 inhibitor, it helps minimize gastrointestinal side effects typically caused by conventional nonselective NSAIDs. Data from clinical studies suggest …

Mutational Scanning And Binding Free Energy Computations Of The Sars-Cov-2 Spike Complexes With Distinct Groups Of Neutralizing Antibodies: Energetic Drivers Of Convergent Evolution Of Binding Affinity And Immune Escape Hotspots, Mohammed Alshahrani, Vedant Parikh, Brandon Foley, Nishank Raisinghani, Gennady M. Verkhivker

Mathematics, Physics, and Computer Science Faculty Articles and Research

The rapid evolution of SARS-CoV-2 has led to the emergence of variants with increased immune evasion capabilities, posing significant challenges to antibody-based therapeutics and vaccines. In this study, we conducted a comprehensive structural and energetic analysis of SARS-CoV-2 spike receptor-binding domain (RBD) complexes with neutralizing antibodies from four distinct groups (A–D), including group A LY-CoV016, group B AZD8895 and REGN10933, group C LY-CoV555, and group D antibodies AZD1061, REGN10987, and LY-CoV1404. Using coarse-grained simplified simulation models, rapid energy-based mutational scanning, and rigorous MM-GBSA binding free energy calculations, we elucidated the molecular mechanisms of antibody binding and escape mechanisms, identified key …

Evaluating Workflow Efficiency: Two-Day Versus One-Day Pre-Planning In Outpatient Infusion Clinics, Amber Escobedo, Kent Wood, Danielle Gundrum, Kelsey Brown, Allie Snoke, Trenna Weathers

Annual Research Symposium

No abstract provided.

6,7-Dichloro-1h-Indole-2,3-Dione-3-Oxime Functions As A Superagonist For The Intermediate-Conductance Ca2+-Activated K+ Channel KCa3.1, Joshua A. Nasburg, Kyle C. Rouen, Connor J. Dietrich, Heesung Shim, Miao Zhang, Igor Vorobyov, Heike Wulff

Pharmacy Faculty Articles and Research

NS309 (6,7-dichloro-1H-indole-2,3-dione-3-oxime) is widely used as a pharmacological tool to increase the activity of small- and intermediate-conductance calcium-activated potassium channels. NS309 is assumed to function as a positive allosteric gating modulator. However, its binding site and the molecular details of its action remain unknown. Here, we show that NS309 has a profound effect on the calcium-dependent gating of the intermediate-conductance Ca2+-activated K+ channel KCa3.1. In inside-out experiments, 10 μM NS309 shifted the calcium EC50 from 430 to 31 nM. In whole-cell experiments, changing free intracellular calcium from 250 nM to 3 μM decreased the EC50 of …

Crosstalk Between Nnos/No And Cox-2 Enhances Interferon-Gamma-Stimulated Melanoma Progression, Anika Patel, Shirley Tong, Moom R. Roosan, Basir Syed, Amardeep Awasthi, Richard B. Silverman, Sun Yang

Pharmacy Faculty Articles and Research

Background/Objectives: Interferon gamma (IFN-γ) in the melanoma tumor microenvironment plays opposing roles, orchestrating both pro-tumorigenic activity and anticancer immune responses. Our previous studies demonstrated the role of neuronal nitric oxide synthase (nNOS) in IFN-γ-stimulated melanoma progression. However, the underlying mechanism has not been well defined. This study determined whether the nNOS/NO and COX-2/PGE2 signaling pathways crosstalk and augment the pro-tumorigenic effects of IFN-γ in melanoma. Methods: Bioinformatic analysis of patient and cellular proteomic data was conducted to identify proteins of interest associated with IFN-γ treatment in melanoma. Changes in protein expression were determined using various analytical techniques including …

Safety Of Omadacycline Versus Standard-Of-Care Oral Antibiotic Treatment For Bone And Joint Infections: Interim Results From An Open-Label, Non- Inferiority, Randomized Controlled Trial, Amy Y. Kang, Guarina Garcia Delgado, Donna Phan Tran, Evelyn A. Flores, Vanessa Romo-Kozan, Isabel Payan, Loren G. Miller

Pharmacy Faculty Articles and Research

Background

The incidence of bone and joint infections (BJIs) continues to increase, and existing oral BJI antibiotics have limitations. Omadacycline may be a potential treatment option for BJI treatment due to activity against doxycycline-resistant S. aureus and ESBL-producing Enterobacterales for which there are often no viable oral options. However, the safety of omadacycline in this setting is poorly defined.

Methods

We performed an open label, randomized, controlled clinical trial of adults with BJIs in the outpatient setting. Participants were randomized to omadacycline-containing regimen (omadacycline 300mg po daily) or Standard-of-Care (SOC) antibiotics. Adjunctive antibiotics were permitted in addition to omadacycline. Safety …

Centella Asiatica: Recent Cosmeceutical Uses For Treatment Of Skin Diseases, Iman I. Soliman, Nouran Medhat, Huda Saleh, Mai El Halawany

Bulletin of Faculty of Pharmacy Cairo University

Centella asiatica is one of the well-known herbal species used in traditional medicine across Asia such as India, Indonesia, and China. It had been used as a medicinal plant for hundreds of years. Besides its general pharmacological activities such as neuroprotection, anti-cancer and anti-diabetes. It demonstrated effective dermatological actions as being a potent anti-inflammatory, antioxidant, healing and moisturizing properties. The major constituents responsible for these effects were triterpenoids. Triterpenoids included asciaticoside which was reported to induce collagen synthesis. Madecassoside was known for its wound healing properties. It was well known for its efficiency in improving the treatment of hypertrophic wounds. …

Orchestrating Cytosolic Access: The Partnership Of Cationic Lytic Peptide L17e And Potassium Channel Kca3.1, Keykavous Parang

Pharmacy Faculty Articles and Research

In this issue of Molecular Therapy, the study by Kuriyama et al.¹ represents an advance in the field of intracellular delivery systems by elucidating a novel mechanism for cytosolic delivery mediated by a cationic amphiphilic lytic peptide L17E (IWLTALKFLGKHAAKHEAKQQLSKL-amide). The investigators demonstrate that the peptide achieves cytosolic delivery primarily through transient plasma membrane disruption, bypassing some of the endocytic pathways, and highlight the pivotal role of the calcium-activated potassium channel KCa3.1, encoded by the gene KCNN4, in facilitating this process. These findings offer a deeper understanding of peptide-mediated delivery using a potassium channel and raise intriguing questions about …

A Practical Guide To Grade Adjustment Or Curving For Pharmacy And Other Professional Health Programs, Reza Mehvar

Pharmacy Faculty Articles and Research

The peer-reviewed literature on the adjustment or curving of assessments in health profession programs is almost non-existent. This communication aims to present potential methods of grade adjustment for individual questions or entire assessments. Simulated data for a 25-item assessment were used as an example to analyze the effects of different methods of grade adjustment on students’ scores. Grade adjustments were made by adjusting the points for individual questions or the scores for the entire assessment. Adjustment for the individual questions was carried out by dropping the question, adding points to those who missed the question, or adding a bonus point …

Brain Delivery Of Erythropoietin Results In A Significant Reduction Of Brain Aβ And Spatial Memory Deficits In The App Knock-In Mouse Model, Rudy Tieu Chang, Devaraj V. Chandrashekar, Grace-Ann Chuli Roules, Emi Iwasaki, Nataraj Jagadeesan, Rachita K. Sumbria

Pharmacy Faculty Articles and Research

Background

Although novel treatments for Alzheimer’s disease (AD) have begun to show modest therapeutic effects, agents that target hallmark AD pathology and offer neuroprotection are desired. Erythropoietin (EPO) is a glycoprotein hormone with neuroprotective effects but is faced with challenges including limited brain uptake and increased hematopoietic side effects with long-term dosing. Therefore, EPO has been modified and bound to a chimeric transferrin receptor monoclonal antibody (cTfRMAb); the latter shuttles EPO past the blood-brain barrier (BBB) into brain parenchyma and reduces its plasma exposure and potential for side effects. Our study sought to characterize the safety and pharmacokinetics (PK) of …

Chronic Heavy Alcohol Intake And Liver-Specific Lrp-1 Reduction Increase Amyloidosis In Alzheimer’S Disease Mice, Devaraj V. Chandrashekar, G. Chuli Roules, Ross A. Steinberg, Urvashi R. Panchal, Nataraj Jagadeesan, Adenike Oyegbesan, Trinh Roselyn, Joshua Yang, Sharda R. Bhagwat, Hiya Rakholia, Rutvi D. Mevawala, Moom Roosan, Derick Han, Rachita K. Sumbria

Pharmacy Faculty Articles and Research

Background

Chronic heavy alcohol drinking may be a modifiable risk factor for Alzheimer’s disease (AD), but studies in rodent AD models more closely mimic chronic moderate alcohol drinking in humans and largely focus on the brain. The role of the liver, which is significantly impacted by chronic heavy alcohol intake, in driving brain changes in alcohol-dependent AD remains unexplored. Our study using intragastric-ethanol feeding, which mimics chronic heavy alcohol intake in humans, in C57BL/6J mice showed significant AD-relevant changes in the brain and liver. Therefore, we aimed to investigate how hepatic changes using this model of chronic heavy drinking drive …

Exosomes And Encapsulated Exomirs In Breast Cancer: Theragnostic Applications And Clinical Implications, Muhammad Imran Sajid, Shafia Bukhari, Hamid Ilyas, Rubina Malik, Minahil Fatima, Rakesh Kumar Tiwari, Surya M. Nauli, Khawaja Husnain Haider

Pharmacy Faculty Books and Book Chapters

Exosomes, released by cells, are small vesicles that have emerged as critical theranostic tools in breast cancer due to their unique ability to transport diverse biomolecules such as proteins, lipids, and RNAs, including microRNAs (ExomiRs). These vesicles are critical in modulating the tumor microenvironment, driving processes like cancer proliferation, invasion, metastasis, and drug resistance. Exosomal microRNAs such as ExomiR-21, ExomiR-1246, and ExomiR-155, with their profound influence on the gene expressions in the recipient cells, are the unsung heroes in tumor progression and immune modulation. This chapter delves into exosome's dual diagnostic and therapeutic potential in breast cancer. It highlights their …

The Landscape Of Cyclin‑Dependent Kinase 4/6 Inhibitors In Solid Malignancies: Emphasis On Immunotherapy Combinatorial Strategies, Maha R.A. Abdollah, Sara A. Hussein, Ahmed H. Saadawy, Eman Badr, Neamtullah Wael, Rasha M. Allam, Ahmed M. Al‑Abd, Ana Maria Roncero Sanchez, Mai Tolba

Pharmacy

Given the pivotal role of CDK4/6 deregulation in the pathogenesis of various malignancies, CDK4/6 inhibitors have been incorporated into cancer treatment protocols. Beyond their antiproliferative effects, these inhibitors exhibit prominent immunomodulatory properties. Preclinical data indicated that CDK4/6 inhibitors enhance the tumor cell antigen presentation capacity and restrict the proliferation of immunosuppressive regulatory T-cells. Furthermore, studies showed that CDK4/6 inhibitors could enhance the development of memory T-cell in vivo in melanoma mouse models and in the clinical setting in breast cancer (BC) patients. In silico analysis identified 225 protein targets for CDK4/6 inhibitors involved in 57 immune-related pathways which further supported …

Corchorus Olitorius Exhibits Antiproliferative Potential Supported By Metabolic Profiling And Integrative Biological Analyses, Maha R.A. Abdollah, Salma Sameh, Ahmed Elissawy, Eman Al-Sayed, Rola Labib, Lan Ye, Fang-Rong Chang, Abdel Nasser B. Singab

Pharmacy

Herbal nutraceuticals could be employed as alternative or complementary routes for alleviating cancer. Corchorus olitorius (Malvaceae) was employed traditionally in the management of tumors. The study aimed to investigate the antiproliferative activity of C. olitorius leaves. In vitro cytotoxic and anti-angiogenic activities of C. olitorius were estimated. The bioactive fraction was subjected to in vivo study on BALB/ c female mice using Ehrlich Ascites Carcinoma model. UPLC-ESI-MS/MS analysis was done to determine the phytometabolites followed by in silico studies on the major identified compounds. The bioactive fraction possessed potent in vitro activity against A549 cells with IC50 = 7.8 µg/mL …

Immersive Medical Practice And Clinical Training: Virtual And Mixed Reality In Pharmacy And Orthopedic Surgery, Silas Semprini De Toledo Contaifer

Theses and Dissertations

Extended‑reality (XR) technologies including virtual reality (VR) and mixed reality (MR) offer new ways to improve training and surgical precision. This thesis evaluates their educational and clinical impact through two complementary studies.

Specific Aim 1 compared an immersive 360° video VR module with conventional training for teaching USP < 797> sterile‑compounding skills to second‑year PharmD students (N = 36). VR trainees raised their knowledge from 6.14 ± 1.55 to 8.69 ± 1.07, yet the overall post‑test advantage versus control was not statistically significant (U = 71.50, p = 0.21). Item‑level McNemar testing showed significant VR‑exclusive gains on three critical questions (K5, K6, …

Using Hyperactive Shp-2 Mutants, A Phosphatase, To Identify Interactions With The Rna Helicase Ddx3, Devin Montgomery

Theses and Dissertations--Pharmacy

Protein-protein interactions are critical in cellular signaling pathways. This project investigates binding interactions between SHP-2, a tyrosine phosphatase, and DDX3, an RNA helicase. There is a specific focus on the impact that gain-of-function SHP-2 mutations may impact binding to DDX3 via conformational change. Using immunoprecipitation protocols as well as western blotting we were able to provide insights into SHP-2 molecular mechanisms and subsequent binding to DDX3.

Anxiolytic Intervention: Modulation Of Cell Types Due To Nicotine Withdrawal, Taylor Elder

Theses and Dissertations--Pharmacy

Nicotine use disorder (NUD) remains a leading cause of preventable disease, yet the neurobiological mechanisms underlying nicotine withdrawal are incompletely understood. Emerging evidence implicates neuroimmune signaling and astrocytic regulation of glutamate in shaping the withdrawal-associated affective phenotype. This dissertation investigated these processes using multiple nicotine administration paradigms including osmotic minipump implant, cigarette smoke exposure, and nicotine vapor inhalation to model diverse routes of human nicotine intake.

Chapter 2 examines the effects of these three modes of administration on neuroinflammation and validation of nicotine delivery. Nicotine exposure was confirmed through receptor [³H]Epibatidine nAChR binding assay and serum cotinine measurements. …

Leveraging Transcriptomics And Behavior To Investigate Potential Neuronal And Glial Drivers Of Substance Use Disorder Endophenotypes, Jack V. Keady

Theses and Dissertations--Pharmacy

Over 54 million Americans needed substance use treatment in 2023. While there are many facets of substance use disorder, two major issues of interest are the negative reinforcing aspects of substances of abuse, manifesting in part as withdrawal symptomologies, and why a subset of people who use substances of abuse escalate to a use disorder. Nicotine exposure models were used to investigate the mechanisms of withdrawal endophenotypes, as smoking is the leading cause of preventable death in the United States, and a fentanyl self-administration model was used to probe individual differences in escalation phenotypes, as 80% of overdose deaths in …

The Impact Of Maternal Environmental Exposures On The Immune Landscape Of The Maternal-Fetal Interface, Heather E. True

Theses and Dissertations--Pharmacy

Maternal environmental exposures and inflammation are known to impact fetal development in utero as well as increase the risk for chronic diseases later in life. Therefore, it is essential that we understand how the maternal environment alters placental structure and immune function.

Therefore, we isolated fetal (chorionic villous) tissues from the placentas of healthy pregnant participants (control) and those with inflammatory conditions, including SARS-COV-2 infection, pregravid obesity, and opioid use disorder. Isolated placental leukocytes were subjected to a series of assays to uncover the phenotypic, functional, and transcriptional (single-cell RNA-sequencing) landscape of placental immune cells. Additional placental tissues were subjected …

Folic Acid-Decorated Lipidic Nanocapsules Co-Loaded With Atorvastatin And Curcumin To Enhance Glioma Targeting In Mice, Mahitab Bayoumi, John Youshia, Osama Abdelkawy, Sara Abdelgaber, Mona Arafa, Maha Nasr, Omaima Sammour

Pharmacy

Background: Glioma remains an intractable and highly aggressive brain tumor, mainly due to the daunting obstacle presented by the blood-brain barrier (BBB). To overcome this challenge and enhance therapeutic efficacy, a dual-drug delivery system was engineered. This system co-encapsulated curcumin, a nutraceutical with multitargeted anticancer potential, with atorvastatin calcium, a repurposed anticancer agent, within lipidic nanocapsules (LNCs). Methods: LNCs were prepared via the phase inversion temperature method and optimized using a Box–Behnken design. The optimized LNCs were subsequently functionalized with folic acid (FA) to enable active targeting. FA-LNCs were characterized using, XPS, TEM, in vitro release, and MTT cytotoxicity …

Preliminary Evaluation Of Bahamian Botanicals For Tropical Applications, Michelle Antoinette Outten

Selected Full-Text Master Theses 2021-

This thesis explores the phytochemical composition and cosmetic potential of three Bahamian botanicals- Mosiera longipes (MLE), Tabebuia bahamensis (TBE), and Momordica charantia (MCE)---traditionally used in local bush medicine. Methanolic and aqueous extracts were prepared and incorporated into topical cream formulations. While HPLC-DAD analysis was performed, no compounds were definitively identified due to hardware limitations; chromatographic data remain preliminary, providing a foundation for future validation. Formulations were assessed for stability under centrifugation, thermal cycling, and long-term storage. All samples demonstrated acceptable initial pH values within the skin-compatible range (4.5-5.5): BWE (5.63 ± 0.04), TBE (5.47 ± 0.02), MLE (5.72 ± 0.04), …

Investigating Antimicrobial Efficacy Of Turmeric And Rosemary Oil Against Staphylococcus Aureus, Aishwarya Tripathi

Selected Full-Text Master Theses 2021-

This study investigates the antimicrobial efficacy of turmeric (Curcuma longa) and rosemary essential oil (Rosmarinus officinalis) against Streptococcus aureus, with a comparative analysis to phenoxyethanol, a widely used synthetic preservative. The growing consumer demand for natural cosmetic formulations have intensified the search for plant-derived alternatives to synthetic preservatives. Turmeric and rosemary oil were selected based on their documented antimicrobial, antioxidant, and anti-inflammatory properties. The objective of this research was to evaluate whether these natural agents can serve as effective preservatives in topical gel formulations, either individually or in combination, and how their efficacy compares to phenoxyethanol.

Eight gel-based formulations were …

On! Original Flavor Oral Nicotine Pouch Characterization: Biorelevant In Vitro Nicotine Release Apparatus Assessment, Jason C. Funderburk, Melissa Morgan, Maria Lasaosa Garcia, Andreas S. L. Mendez, Matthew S. Halquist

Graduate Research Posters

Background: Oral nicotine pouch (ONP) use is rising. The sales of ONPs in 2019 were 126 million units, increasing to 808 million units in 2022. Understanding ONP in vitro release is critical for assessing exposure to ONP products.

Methods: The commercial brand ON! ONPs with nicotine label claims of 2, 4, and 8 mg, were evaluated in vitro for cumulative nicotine release using the bidirectional transmucosal apparatus (BTA) for 90 minutes. Nicotine quantification was performed by HPLC-PDA. For pH determination, ONP samples were prepared in water or artificial saliva (pH 6.8) with measurements for 30 minutes. BTA results were compared …

Roselle And Red Ginger: A Potential Combination Of Medicinal Plants For Hypertension Therapy, Ranum Wanudya Yunas, Siti Irma Rahmawati, Fadlina Chany Saputri, Asep Bayu, Giuseppina Chianese, Masteria Yunovilsa Putra

Pharmaceutical Sciences and Research

Hypertension is a prevalent cardiovascular condition that significantly increases the risk of heart disease and stroke. Effective management is essential to prevent severe complications. Roselle (Hibiscus sabdariffa L.) and red ginger (Zingiber officinale var. rubrum) are two medicinal plants known for their antihypertensive properties. Roselle contains bioactive compounds such as anthocyanins that exhibit vasodilatory and angiotensin-converting enzyme (ACE) inhibition, while red ginger is rich in gingerols and shogaols, which possess anti-inflammatory and vasodilatory properties. The complementary mechanisms of action of these two plants, including ACE inhibition, antioxidant activity, and modulation of vascular tone, result in a more …

Investigating The Bioactivity Potential And Standardization Of Two Stingless Bee Propolis From East Kalimantan, Paula Mariana Kustiawan, Muhammad Ali Syahbana, Rika Pratika, Muhammad Nor Ichsan, Ika Ayu Mentari, Indah Hairunnisa, Irfan Muris Setiawan, Putri Hawa Syaifie, Donny Ramadhan, Chanpen Chanchao

Pharmaceutical Sciences and Research

The standardization of raw materials from nature is essential before they are made into products. Until now, there is still limited information regarding the standardization of propolis from stingless bees. This research aims to determine the bioactivity with standardized specific and non-specific parameters of ethanol extracts from Homotrigona apicalis and Homotrigona fimbriata propolis. The methods include organoleptic tests, tests for water-soluble and ethanol-soluble compound content, drying shrinkage tests, specific gravity tests, water content tests, metal contamination tests, phytochemical screening, and determining total phenolic and flavonoid content. The free radical scavenging capacity was measured using the DPPH (1,1-diphenyl-2-picrylhydrazyl) method, and antimicrobial …

Optimization Of External Disintegrating Materials In Wet Granulation Formulation Of Ondansetron Tablets, Yandi Permana, Syahrul Tuba, Taufik Riyadi, Sugindro Sugindro

Pharmaceutical Sciences and Research

Inadequate management of chemotherapy-induced side effects, including nausea and vomiting, can impact the healing response of cancer patients. Ondansetron, a preferred medication for the treatment, is classified as a biopharmaceutic classification system (BCS) class II drug, which limits its bioavailability. To enhance its solubility, sodium starch glycolate (SSG) and pregelatinized starch (PG) are used as super disintegrants. This study investigates the impact of these super disintegrants on ondansetron dissolution and identifies the optimal formulation. Ondansetron tablets were prepared using the wet granulation method, with nine formulations varying in SSG and PG concentrations (0%, 1%, 3%, 5%, and 7%). The tablets …

Utilizing Water Hyacinth (Eichhornia Crassipes) From Srandakan Bantul, Indonesia For ‘Bright Fever Patch’ As An Alternative Children’S Fever Therapy, Anggita Kamalia Niswara, Nabillah Ainun Kusrinanti, Rizqi Amalia Firdaus, Azis Ikhsanudin

Pharmaceutical Sciences and Research

In 2022, Indonesia experienced a public health crisis involving acute kidney failure in children, traced to paracetamol syrup contaminated with ethylene glycol and diethylene glycol. This underscores the urgent need for safer antipyretic alternatives. This study investigates the antipyretic potential of transdermal patches formulated with ethanol extract of water hyacinth (Eichhornia crassipes) leaves sourced from Srandakan, Bantul, Yogyakarta. Extract concentrations of 0.8%, 1.0%, and 1.2% were tested, alongside a negative control (no extract) and a positive control (paracetamol). The patches underwent evaluations for organoleptic properties, weight uniformity (0.41±0.02 to 0.52±0.02 g), thickness (0.36±0.03 to 0.41±0.03 mm), water absorption …

Mitigating The Risk Of Qtc Prolongation When Using Haloperidol For Acute Treatment Of Cannabinoid Hyperemesis Syndrome In Adolescents And Young Adults, Sandra Merino, Lissette Tordera, Allison Jun, Sun Yang

Pharmacy Faculty Articles and Research

Background/Objectives: Cannabinoid Hyperemesis Syndrome (CHS), associated with long-term cannabinoid use, has been increasingly observed in emergency room visits as more states in the U.S. have legislatively permitted medical and recreational marijuana use. The acute management of CHS primarily focuses on antiemetic treatment and supportive care. However, both the condition itself and the antiemetic drugs, such as haloperidol, may cause QTc prolongation. Methods: We reported two adolescent cases admitted to the emergency department for acute antiemesis management of CHS who received haloperidol treatment. A literature review was performed through October 2024 for previously published cases of QTc prolongation and/or …

Advancing Continuous Manufacturing: The Role Of Process Analytical Technology In Process Development, Samuel R. Henson

Electronic Theses and Dissertations

The pharmaceutical industry is actively pursuing technologies which improve manufacturing processes with the goal of producing high-quality pharmaceutical products for patients, manifesting in an industry-wide investment in continuous manufacturing (CM). Process analytical technology (PAT) has been recognized for its successful monitoring of critical quality attributes during routine production and is often cited alongside CM due to its ability to make timely, in-line measurements of intermediate materials. Various PAT tools are valuable in process development, particularly as continuous wet granulation processes are developed for use within pharmaceutical manufacturing. This work applied PAT and chemometric modeling during CM process development to enhance …

Formulation And Characterization Of Biologics – From Sirna To Monoclonal Antibodies, Chinmay M. Jogdeo

Theses & Dissertations

Biologics are a rapidly growing class of therapeutics, encompassing a wide range of modalities, with gene therapy products and monoclonal antibodies (mAbs) constituting the majority. Proper formulation and characterization of these complex therapeutics is crucial to ensure their safety and therapeutic efficacy.

This dissertation focuses on two main areas: the development of a novel renal-targeted siRNA delivery system and the assessment of structural and conformational stability of mAbs in a simulated subcutaneous (SC) environment.

The first part of this dissertation presents the synthesis and characterization of a novel renal-targeted polymer for selective siRNA delivery to injured kidneys. Inulin was modified …