ABSTRACT
Background: COVID-19 is caused by SARS-CoV-2 and has is responsible for over 619 million infections and over 6.5 million deaths globally since identification in 2019. Infection during pregnancy is associated with increased adversity including increased risks of admission to intensive care, increased ventilatory support, preeclampsia, preterm birth and maternal death. Vaccination remains the best protection against severe disease. The majority of trials for novel or repurposed COVID-19 therapies including mRNA vaccinations have excluded pregnant or lactating women despite being an at-risk population. Broccoli sprout extract contains a naturally occurring phytonutrient sulforaphane which upregulates the Nrf2 transcription factor resulting in expression of antioxidant proteins, anti-inflammatory effects and has demonstrated anti-viral effects in-vitro . Severe COVID-19 results in excessive cytokine production resulting in a proinflammatory state with significant oxidative stress and multi-organ dysfunction with evidence of placental abnormalities in almost half of infected mothers. Method(s): CO-Sprout is a pilot, double blinded, placebo controlled randomised trial that is recruiting pregnant women ( n = 60) between 20 and 36 weeks completed gestation with COVID-19 diagnosed within 5 days. Participants are randomised to either broccoli sprout capsules (containing 21 mg sulforaphane) or identical placebo (microcrystalline cellulose) twice daily for 14 days. The primary outcome will be duration (days) of COVID-19 related symptoms and other exploratory outcomes including unplanned hospital admissions, birth outcomes, inflammatory markers, microbiome and placental changes. Patients are recruited through maternity departments at Monash Health and Jessie McPherson Private Hospital. Result(s): Trial in progress. Conclusion(s): Trial results to be published after trial completion.
ABSTRACT
Excipients are critically important in converting active pharmaceutical ingredients (API) into drug products that have optimal stability, bioavailability, manufacturability, duration of action, and therapeutic benefits. They will play even greater roles in the future to enable drug targeting, delivery of biotech products and vaccines, gene therapy, continuous manufacturing, 3D printing, and so forth. This commentary describes the author’s experience in teaching a graduate course on excipients at St. John’s University to train students on optimal selection and appropriate use of excipients in formulating dosage forms and development of drug delivery systems. The course is offered in 15 two-hour sessions over a semester, and the course materials are divided into 13 modules on chemistry of different classes of polymeric and non-polymeric excipients and their application in dosage form development, including the use as solubilizing agents, lyophilizing agents, cryoprotectants, buffers, biodegradable materials, and carriers for amorphous solid dispersions and 3D printing. The development of coprocessed excipients, the need for new excipients, and the regulatory aspects of excipients are also covered. The course includes presentations by guest speakers from the industry, and the students also watch virtual presentations from experts that are publicly available from the internet. It is a popular course at St. John’s University taken by all graduate students in the pharmaceutics program. It is recommended that such courses are introduced in other pharmacy schools and academic institutions. The course may be adapted to meet specific needs of different academic programs. Professional associations, such as AAPS and CRS, industry groups like IPEC, and the pharmaceutical industry may be able to help in introducing such courses by providing lecture materials and guest lecturers.