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Efficacy of pharmaceuticals dosage form generally depends on their formulation properties and manufacturing methods, hence it is likely that the quality of dosage form may vary. Renin acts on angiotensinogen to form angiotensin I, which is converted to angiotensin II by angiotensin-converting enzyme (ACE). Angiotensin II, a potent vasoconstrictor increases blood pressure by increasing vasopressin production and aldosterone secretion. Enalaprilat, the active metabolite of enalapril, inhibits ACE, hence decreases levels of angiotensin II resulting in less vasoconstriction and decreased blood pressure. The study was exclusively experimental that used IP and other standard books to check in vitro quality of enalapril maleate tablet using different analytical techniques and procedure. Test for weight variation, hardness, friability, disintegration time, and dissolution were conducted. The dissolution test was performed at pH 6.8 for both the brands of the tablet. Further all the tablets passed weight variation, hardness, friability and disintegration test as per the pharmacopoeial standard. Hence we can conclude that both the brands of tablets are equal and both the brands contain equal quantity of active pharmaceutical ingredient (API). Both the brands having higher and lower costs exert similar action. Keywords: Enalapril maleate, In Vitro, Dissolution test, Enalapril

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Background Key pathologies in severe COVID-19 include immune cell activation, inflammatory cytokine release, and neutrophil extracellular trap release (NETosis), which are mediated by spleen tyrosine kinase (SYK) (Figure 1). Fostamatinib, an oral SYK inhibitor approved for chronic immune thrombocytopenia, has shown activity in vitro using plasma from patients with severe COVID-19, by abrogating the hyperimmune response triggered by anti-spike IgG; 1 inhibiting hyperactivation in platelets; 2 and blocking NETosis in neutrophils.3 R406, active metabolite of fostamatinib, protected against LPS-induced acute lung injury and thrombosis in mice.4,5 In clinical studies, fostamatinib reduced IL-6 in patients with rheumatoid arthritis.6 Therefore, a phase 2 study (NCT04579393) evaluated fostamatinib vs. placebo plus standard of care (SOC) in 59 hospitalized COVID-19 patients (manuscript pending). We initiated a phase 3 clinical study (NCT04629703) of fostamatinib for the treatment of COVID-19. Methods A double-blind, randomized, placebo-controlled, adaptive design, multi-center, Phase 3 study (NCT04629703) is underway to evaluate the safety and efficacy of fostamatinib in 308 adult patients with COVID-19 (Figure 2). Hospitalized patients without respiratory failure (with or without supplemental oxygen) were included. Patients with ARDS or using extracorporeal membrane oxygenation (ECMO) were excluded. Patients will receive fostamatinib 150 mg BID or placebo for 14 days; both arms receive SOC. The primary outcome will be progression to severe/critical disease (worsening in clinical status score on the 8-point ordinal scale) within 29 days of the first dose of study drug. Fostamatinib is investigational for COVID-19. Results Blinded update of trial in progress as of 28 April 2021. 12 patients have been randomized in North and South America. The clinical status score at Baseline was 5 (Hospitalized, requiring supplemental oxygen) in all 12 patients. Five patients had 8 adverse events (AE) (Fig 3). One AE (PE) was serious and is resolving. No deaths have been reported. At least two patients have been discharged (Day 5, Day 13) with continued dosing at home. Conclusion Fostamatinib has the potential to provide a treatment option for the hyperimmune complications of COVID-19. Disclosures Ziad Mallat, MD, PhD, Rigel Pharmaceuticals, Inc. (Consultant) Sandra Tong, MD, Rigel Pharmaceuticals, Inc. (Employee, Shareholder)

Calcium enriched herbal ice cream was developed using calcium gluconate (CG) as calcium source, Bacopa monniera whole plant extract (BME) is an herb containing saponins. Ice cream was prepared by incorporating CG and BME together. Preliminarily the range of CG and BME levels were fixed as 50-250 mg/100 mL and 10-50 mg/100 mL of ice cream mix respectively. Response surface methodology (RSM) was used to optimize the levels of two ingredients (CG and BME). Central Composite Rotatable Design using two variables and five responses comprising of sensory attributes was used for computation of optimized solution. All the responses fitted well into quadratic equation with R 2 [ 0.60. The optimum levels of CG and BME are 217.34 mg/100 mL and 10 mg/ 100 mL for preparation of experimental ice cream. RSM recommended with 87% acceptability for the optimum levels of CG and BME. Product is prepared with optimized solution and subjected to sensory evaluation. Keywords Calcium gluconate Á Bacopa monniera extract Á RSM Á CCRD Á Optimum levels Á Sensory analysis Abbreviations CG Calcium gluconate BM Bacopa monniera BME Bacopa monniera whole plant extract RSM Response surface methodology CCRD Central composite rotary design SNF Solid non fat