Formulations In Clinical Development Research Articles

Vaccine formulations in clinical development for the prevention of severe acute respiratory syndrome coronavirus 2 infection.

The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to an unprecedented effort toward the development of an effective and safe vaccine. Aided by extensive research efforts into characterizing and developing countermeasures towards prior coronavirus epidemics, as well as recent developments of diverse vaccine platform technologies, hundreds of vaccine candidates using dozens of delivery vehicles and routes have been proposed and evaluated preclinically. A high demand coupled with massive effort from researchers has led to the advancement of at least 31 candidate vaccines in clinical trials, many using platforms that have never before been approved for use in humans. This review will address the approach and requirements for a successful vaccine against SARS-CoV-2, the background of the myriad of vaccine platforms currently in clinical trials for COVID-19 prevention, and a summary of the present results of those trials. It concludes with a perspective on formulation problems which remain to be addressed in COVID-19 vaccine development and antigens or adjuvants which may be worth further investigation.

Long-Acting Muscarinic Antagonists Under Investigational to Treat Chronic Obstructive Pulmonary Disease.

IntroductionBronchodilators are the cornerstone of chronic obstructive pulmonary disease (COPD) therapy and long-acting muscarinic antagonists (LAMAs) as a mono or combination treatment play a pivotal role. Several LAMAs are already available on the market in different formulations, but developing a new compound with a higher M3 receptor selectivity and a lower affinity to M2 receptors to increase the therapeutic effect and minimize the adverse effects is still a goal. Moreover, new formulations could improve adherence to therapy.Areas CoveredThis systematic review assesses investigational long-acting muscarinic antagonist in Phase I and II clinical trials over the last decade. It offers insights on whether LAMAs and/or their new formulations in clinical development can become effective treatments for COPD in the future.Expert OpinionResearch on LAMA seems to have come to a standstill, the few new molecules under study do not show distinctive characteristics compared to the previous ones. Muscarinic antagonist/β2-agonist (MABAs) appear to be the major innovation currently under investigation, and they could theoretically open new research frontiers on the effect between adrenergic and muscarinic interaction in the same cell.

Vaccine formulations in clinical development for the prevention of severe acute respiratory syndrome coronavirus 2 infection

Vaccine formulations in clinical development for the prevention of severe acute respiratory syndrome coronavirus 2 infection

Revolutionary impact of nanovaccines on immunotherapy

Over the past few decades public health has been immensely improved by preventing various types of diseases using vaccination, a method implying attenuated, killed or part of a microorganism to activate the immune system against it. Recently, nanovaccines have attracted a lot of attention as a new approach for enhancing the immune responses against immunogenic molecules. A wide variety of nanomaterials are reported as proper candidates for nanovaccination. Currently, the focus is the development of new formulations that trigger strong anti-cancer responses by presenting tumor antigens either directly to T immune cells or indirectly to antigen-presenting cells, holding great promise for safe, non-invasive, and cost-effective therapy of cancer. This review focuses on the critical aspects in the design of biomaterial based nanovaccines and reviews the state of the art of the formulations in clinical development and those currently available in the market. Focal points•BedsideUnderstanding the complex potential of the immune system to prevent and treat various diseases such as cancer, will contribute to the scientific advance in the development of new therapeutic strategies and will allow for the discovery of alternative treatments for deadly diseases.•BenchsideMany of the immunostimulative pathways involved in the suppression of cancer tumor growth have been identified and additional research is still needed to recognize the molecular mechanisms of the immunotherapeutic strategies.•IndustryThe discovery of new non-toxic immunotherapeutic compounds may pave the way towards developing new cancer tumor therapeutic approaches. A major effort in the identification of preventing approaches is also needed to develop preventive nanoformulations for healthy people who are at the risk of cancer.•CommunityThe treatment of cancer by cheap, efficient and as less invasive as possible methodologies will have a great impact on the quality of life of the patients.•GovernmentsSince the development of anticancer nanoformulations needs extensive support from the authorities for success in clinical translation, the financial investments of the governments is necessary to translate the research in the lab to the bedside. The governmental support can also increase the years of healthy life of the patients and minimize the associated costs overtime.

Abuse-Deterrent and Tamper-Resistant Opioid Formulations

About one in every three individuals will experience chronic pain in their lifetime, and opioids are known to be an effective means to treat this condition. Much attention, however, has been given to the fact that prescription opioid analgesics are some of the most frequently abused drugs, and misuse is prominent in patients with chronic pain. Several new opioid formulations that are designed to prevent or deter the abuse of opioids are currently in development, and two have been approved for marketing (morphine sulphate co-formulated with naltrexone hydrochloride [Embeda®] and a new formulation of the extended-release oxycodone [OxyContin®]). In this article, we review the various types of abuse-deterrent and tamper-resistant formulations in clinical development. We believe that continued advances in opioid formulations can help mitigate risk for those with legitimate need for pain control, but only if used rationally in the context of good clinical practice.