Review
Chemistry, Medicinal
Tomas Sou, Christel A. S. Bergstrom
Summary: Pulmonary drug delivery has advantages for both respiratory and systemic conditions, but there are still many aspects that need to be further investigated. Computational methods and simulation approaches have potential to be better utilized in the development of inhaled formulations.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Endocrinology & Metabolism
Janet B. McGill, Daniel Weiss, Marshall Grant, Marisa C. Jones, David M. Kendall, Byron J. Hoogwerf
Summary: Comparing inhaled insulin with short-acting insulin analogues showed that inhaled insulin can improve post-meal glucose levels and reduce the risk of hypoglycemia.
JOURNAL OF DIABETES
(2021)
Article
Pharmacology & Pharmacy
Zitong Shao, Waiting Tai, Yingshan Qiu, Rico C. H. Man, Qiuying Liao, Michael Y. T. Chow, Philip C. L. Kwok, Jenny K. W. Lam
Summary: This study developed an inhaled dry powder formulation of capreomycin targeting the lung using spray drying technique, showing promising pharmacokinetic performance with sustained drug concentration in the lungs. Compared to intravenous injection, inhaled capreomycin exhibited superior pharmacokinetics in both the lungs and plasma, indicating its potential as a more effective treatment option for MDR-TB.
Article
Biochemistry & Molecular Biology
Elif Vardar, Hui Yin Nam, Ganesh Vythilingam, Han Ling Tan, Haryanti Azura Mohamad Wali, Eva-Maria Engelhardt, Tunku Kamarul, Pierre-Yves Zambelli, Eleftheria Samara
Summary: The effective treatment of cartilage defects is a worldwide unmet need. Previous methods have failed to enhance the final stage of cartilage differentiation, resulting in scar tissue formation. In this study, the effect of recombinant insulin-like growth factor 1 loaded in fibrin microbeads on cartilage regeneration was investigated. The results showed that this method improved functional cartilage formation after 6 months.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2023)
Article
Biochemistry & Molecular Biology
Mia Danielsen, Paul Joseph Kempen, Thomas Lars Andresen, Andrew James Urquhart
Summary: The development of new and improved formulations for biopharmaceuticals is driven by the growing interest in this class of therapeutics and the challenges in formulation and delivery. Nanoclusters (NCs) are a type of formulation strategy where the biopharmaceutical is clustered reversibly to function as both the therapeutic and the vehicle. In this study, insulin NCs (INCs) were formulated using a new methodology of first crosslinking proteins followed by desolvation. The crosslinked INCs showed controlled synthesis, good biocompatibility, and slightly lower potency compared to the unmodified protein.
INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
(2023)
Article
Chemistry, Multidisciplinary
Caitlin L. Maikawa, Leslee T. Nguyen, Joseph L. Mann, Eric A. Appel
Summary: Excipients play a critical role in protein stability and absorption kinetics in pharmaceutical formulations. Recent research has identified an ultrafast absorbing insulin formulation that is the result of excipient modifications. The concentration of polyacrylamide-based copolymer excipient and the presence of phenoxyethanol are found to be important factors affecting insulin stability.
PHARMACEUTICAL RESEARCH
(2022)
Article
Pharmacology & Pharmacy
Manasa Tatipalli, Vijay Kumar Siripuram, Tao Long, Diana Shuster, Galina Bernstein, Pierre Martineau, Kim A. Cook, Rodrigo Cristofoletti, Stephan Schmidt, Valvanera Vozmediano
Summary: Quantitative pharmacology was used to select doses and sampling scenarios for the clinical evaluation of a new oral suspension of spironolactone in pediatric patients. A population pharmacokinetic model was developed and validated, with doses of 0.5 and 1.5 mg/kg leading to target exposures in different age groups. Two sampling scenarios were outlined to minimize burden on participating children while characterizing drug pharmacokinetics.
Article
Plant Sciences
Chun Fai Wong, Cheuk Ka Poon, Tsz Wai Ng, Hok Him Pan, Eng Cheng Khaw, Ki Fong Tsang, Yan Wing Mui, Yuk Hong Lo, Mui Fung Hao, Chun Hay Ko
Summary: This study evaluated the anti-inflammatory and toxicology effects of H. cordata essential oil-containing formulation, H16 aerosol, in vivo. The study found that H16 aerosol had anti-inflammatory and antipyretic effects, and it was safe for use. This suggests that H16 aerosol could be a new herbal therapy and contribute to the modernization of herbal medicine.
JOURNAL OF ETHNOPHARMACOLOGY
(2022)
Review
Endocrinology & Metabolism
Mark A. Jarosinski, Balamurugan Dhayalan, Yen-Shan Chen, Deepak Chatterjee, Nicolas Varas, Michael A. Weiss
Summary: The discovery of insulin in 1921 initiated a century of innovation, leading to the development of synthetic insulins and the creative interaction between protein science principles and pharmaceutical applications. The focus of insulin analog design is to improve glycemic control and reduce the risk of hypoglycemia, aiming to mimic endogenous beta-cell secretion. Next-generation insulin analogs are exploring new frontiers such as glucose-responsive insulins and organ-selective analogs to meet unmet clinical needs.
MOLECULAR METABOLISM
(2021)
Article
Chemistry, Multidisciplinary
Yanfang Wang, Pengbo Chen, Wei Liu, Xiangqian Wei, Juan Zhang, Xinwei Wei, Yun Liu, Luxuan Rao, Shiming Zhang, Jicheng Yu, Xiao Ye, Jinqiang Wang, Zhen Gu
Summary: Researchers have developed a novel insulin nanocarrier system that can effectively and safely control blood glucose levels in type 1 diabetes patients for an extended period of time.
Article
Biochemistry & Molecular Biology
Lars Krogvold, Ida Maria Mynarek, Erica Ponzi, Freja Barrett Mork, Trine Witzner Hessel, Trine Roald, Nina Lindblom, Jacob Westman, Peter Barker, Heikki Hyoety, Johnny Ludvigsson, Kristian F. Hanssen, Jesper Johannesen, Knut Dahl-Jorgensen
Summary: The results suggest that antiviral treatment may help preserve insulin production in children and adolescents with new-onset type 1 diabetes.
Article
Medicine, General & Internal
Pierre Bailly, Pierre-Yves Egreteau, Stephan Ehrmann, Arnaud W. Thille, Christophe Guitton, Guillaume Grillet, Florian Reizine, Olivier Huet, S. Jaber, Emmanuel Nowak, Erwan L'her
Summary: This study aims to compare the effectiveness of inhaled sedation strategy versus intravenous sedation strategy in mechanically ventilated patients in ICU, with primary outcome being the occurrence of delirium and secondary outcomes including cognitive and functional outcomes.
Article
Pharmacology & Pharmacy
Sie Huey Lee, Wei Xuan Yap, Chloe Qiu Zhen Jiang, Wei Xuan Ler, Jeanette Woon Pei Teo, Say Kong Ng, Desmond Heng
Summary: The development of new biologics and the manufacturing of biosimilars are driving growth in the biotechnology industry. Non-invasive delivery methods are preferred over parental delivery due to their advantages. The use of dry powder inhalers (DPI) is being considered for biologics delivery, but optimizing aerosolization, bioactivity, and stability is challenging. This study used experimental design to propose a "Ready-to-Use" powder formulation platform that could expedite development and serve as a starting template for biologics DPI development.
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
(2022)
Article
Biochemistry & Molecular Biology
Huda S. AlSalem, Nisreen M. Abdulsalam, Najla A. Khateeb, Mona S. Binkadem, Nahlah A. Alhadhrami, Abdalla M. Khedr, Rehab Abdelmonem, Kamel R. Shoueir, Eman Hassan Nadwa
Summary: Chitosan was modified and functionalized to improve oral insulin delivery. The Cs-DNS NPs had a particle size of 33.29 ± 5.08 nm and positive zeta potential. In vitro experiments showed high insulin entrapment efficiency and gradual release at different pH levels. In vivo experiments demonstrated that insulin-incorporated Cs-DNS NPs effectively lowered serum glucose levels, with a bioavailability of 17.5 ± 0.31% and pharmacological availability of 8.6 ± 0.8%.
INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
(2023)
Article
Chemistry, Multidisciplinary
Caitlin L. Maikawa, Peyton C. Chen, Eric T. Vuong, Leslee T. Nguyen, Joseph L. Mann, Andrea D'Aquino, Rayhan A. Lal, David M. Maahs, Bruce A. Buckingham, Eric A. Appel
Summary: The study successfully created a stable co-formulation of monomeric insulin and amylin analogues using amphiphilic acrylamide copolymers, with synchronous pharmacokinetics and ultra-rapid action, offering potential to improve glucose management in patients with diabetes.
Article
Medicine, General & Internal
Deepak L. Bhatt, Michael Szarek, Bertram Pitt, Christopher P. Cannon, Lawrence A. Leiter, Darren K. McGuire, Julia B. Lewis, Matthew C. Riddle, Silvio E. Inzucchi, Mikhail N. Kosiborod, David Z. I. Cherney, Jamie P. Dwyer, Benjamin M. Scirica, Clifford J. Bailey, Rafael Diaz, Kausik K. Ray, Jacob A. Udell, Renato D. Lopes, Pablo Lapuerta, P. Gabriel Steg
Summary: The trial involving 10,584 patients with diabetes and chronic kidney disease showed that sotagliflozin resulted in fewer deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure compared to placebo. However, there were adverse events such as diarrhea, mycotic infections, and diabetic ketoacidosis associated with sotagliflozin.
NEW ENGLAND JOURNAL OF MEDICINE
(2021)
Review
Cell & Tissue Engineering
Hilary E. Murray, Ali Zafar, Khalid M. Qureshi, Michelle B. Paget, Clifford J. Bailey, Richard Downing
Summary: Pancreatic islet cell transplantation is effective for treating type 1 diabetes, but is limited by donor organ availability and transplant procedure factors. Human amniotic epithelial cells show potential for improving outcomes by protecting islet function.
JOURNAL OF TISSUE ENGINEERING AND REGENERATIVE MEDICINE
(2021)
Article
Endocrinology & Metabolism
Michelle B. Paget, Hilary E. Murray, Clifford J. Bailey, Richard Downing
Summary: The journey towards islet transplantation as a treatment for type 1 diabetes began with Paul Langerhans' discovery of tissue islands in the pancreas in 1869. Advances in biosciences, surgery, gene therapy, and clinical research have led to the development of surrogate insulin-secreting cells from pluripotent stem cells and non-beta cells within the pancreas. Additionally, xenotransplants such as porcine islets are being reconsidered as potential alternatives to overcome safety concerns and immune rejection.
DIABETES OBESITY & METABOLISM
(2022)
Article
Endocrinology & Metabolism
James R. Gavin, Clifford J. Bailey
Summary: This review examines recent real-world evidence (RWE) on the benefits of continuous glucose monitoring (CGM) in improving clinical outcomes, such as avoiding severe hypoglycemic and hyperglycemic crises, and enhancing measures of psychological health and quality of life. Additionally, it explores the role of CGM in optimizing health care resource utilization, including predicting T1D and applications in gestational diabetes, chronic kidney disease, and surgical monitoring.
DIABETES TECHNOLOGY & THERAPEUTICS
(2021)
Review
Endocrinology & Metabolism
Srikanth Bellary, Ioannis Kyrou, James E. Brown, Clifford J. Bailey
Summary: The prevalence of type 2 diabetes mellitus (T2DM) is increasing among the aging population, presenting challenges in management due to patient heterogeneity, comorbidities, susceptibility to hypoglycemia, increased dependence on care, and frailty. This review focuses on the pathophysiological mechanisms of T2DM in older individuals, new evidence on frailty and sarcopenia, clinical difficulties related to age-associated comorbidities, and implications for guidelines and therapeutic options, highlighting the impact of T2DM on an aging society.
NATURE REVIEWS ENDOCRINOLOGY
(2021)
Review
Endocrinology & Metabolism
Clifford J. Bailey, Caroline Day, Srikanth Bellary
Summary: This review evaluates the nephroprotective effects of sodium-glucose co-transporter-2 (SGLT2) inhibitors in people with type 2 diabetes, highlighting their ability to slow down the decline in glomerular filtration rate, reduce microalbuminuria, and slow or reverse proteinuria. These effects are not limited to diabetes patients and extend to non-diabetic, lean, and normotensive individuals as well. The mechanisms behind these effects include tubuloglomerular feedback, improved tubular oxygenation and metabolism, and reduced inflammation and fibrosis. The use of SGLT2 inhibitors has not shown increased risk of urinary tract infections or acute kidney injury.
CURRENT DIABETES REPORTS
(2022)
Article
Biochemistry & Molecular Biology
Isaac Ampong, O. John Ikwuobe, James E. P. Brown, Clifford J. Bailey, Dan Gao, Jorge Gutierrez-Merino, Helen R. Griffiths
Summary: High dietary fat intake reduces the levels of odd chain saturated fatty acids, affects gut microbiota and liver lipid metabolism, and is associated with increased risk of metabolic diseases.
INTERNATIONAL JOURNAL OF BIOCHEMISTRY & CELL BIOLOGY
(2022)
Editorial Material
Biochemistry & Molecular Biology
J. Michael Conlon, Peter R. Flatt, Clifford J. Bailey
Editorial Material
Endocrinology & Metabolism
Clifford Bailey
LANCET DIABETES & ENDOCRINOLOGY
(2021)
Review
Endocrinology & Metabolism
Guntram Schernthaner, Kerstin Brand, Clifford J. Bailey
Summary: Metformin, a drug used for treating type 2 diabetes, has been replaced to some extent by newer antidiabetic medications. However, research on its potential cardiovascular benefits continues.
METABOLISM-CLINICAL AND EXPERIMENTAL
(2022)
Review
Pharmacology & Pharmacy
Clifford J. Bailey, Mike Gwilt
Summary: The clinical literature review shows that metformin treatment in Covid-19 patients with diabetes can improve clinical outcomes, reduce admission into intensive care, and decrease mortality. The pleiotropic actions of metformin, such as reducing insulin resistance and inflammation, may play a role in these effects. Modulation of the ACE2 protein via the AMP kinase pathway could also be involved. However, caution should be exercised in patients with severe Covid-19, as metformin withdrawal may be necessary to avoid acidosis and lactic acidosis.
FRONTIERS IN PHARMACOLOGY
(2022)
Review
Endocrinology & Metabolism
Christophe De Block, Clifford Bailey, Carol Wysham, Andrea Hemmingway, Sheryl Elaine Allen, Jennifer Peleshok
Summary: Tirzepatide is a novel drug that improves glycemic control and aids weight loss in patients with type 2 diabetes. It also shows potential for treatment of other conditions. Clinical trials have demonstrated that Tirzepatide has better effects on reducing glycated hemoglobin and body weight compared to GLP-1 receptor agonists, with a lower risk of hypoglycemia.
DIABETES OBESITY & METABOLISM
(2023)
Article
Endocrinology & Metabolism
James R. R. Gavin III, Clifford J. Bailey
Summary: Randomized controlled trials show the benefits of continuous glucose monitoring (CGM) in intensive insulin regimens for diabetes patients. Other studies have investigated CGM's impact on nonintensive therapies, leading to changes in payer coverage and expanding use. This article reviews recent real-world studies, highlights key lessons, and discusses increasing access to CGM for all diabetes patients.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Review
Pharmacology & Pharmacy
Keith G. Thomas, Natalie J. Klempel, Peter R. Flatt, Clifford J. Bailey, R. Charlotte Moffett
Summary: This short review examines the early studies performed with Syn A in animals and diabetic patients, finding that excess glucagon secretion from pancreatic alpha-cells is a problem in both type 1 and type 2 diabetes. Therefore, therapeutic strategies aimed at limiting the number or function of alpha-cells might be worthy of reconsideration.
JOURNAL OF PHARMACY AND PHARMACOLOGY
(2023)
Article
Biochemistry & Molecular Biology
Clifford J. Bailey, Peter R. Flatt, J. Michael Conlon
Summary: Long-acting analogues of GLP-1 and GLP-1R/GIP-R dual agonists have shown high efficacy in lowering glucose levels and promoting weight loss. These peptide-based therapies provide a promising approach for treating T2D and obesity. Semaglutide, an GLP-1R agonist, has shown particularly high efficacy and is available in oral and injectable formulations. Other pharmacological approaches, such as monoclonal antibodies and agonists targeting different receptors, are also being explored for chronic weight management. However, the high demand for GLP-1R agonists as anti-obesity agents has caused a shortage, leading to their prioritized use in T2D therapy.
