Use of sodium dichloroisocyanurate (NaDCC) and a pharmaceutical formulation prepared therefrom

Inventors

Padmanabhan, Sriram • JADHAV, Vinod Ramchandra

Assignees

Sava Healthcare Ltd

Abstract

The present disclosure relates to use of Sodium 3,5-dichloro-2,4,6-trioxo-1,3,5-triazinan-1-ide having a chemical structure: for the treatment and/or prevention of COVID-19 infection. The present disclosure further relates to a pharmaceutical formulation that is administered in the form of dry powder inhalation (DPI) to the subject. The dry powder inhalation formulation comprises a micronized Sodium 3,5-dichloro-2,4,6-trioxo-1,3,5-triazinan-1-ide, a first lactose, a second lactose, and at least one excipient. The pharmaceutical formulation of the present disclosure increases the bioavailability of the NaDCC, has patient compliance, and reduced adverse effects.

Core Innovation

The invention relates to a pharmaceutical formulation using sodium 3,5-dichloro-2,4,6-trioxo-1,3,5-triazinan-1-ide (NaDCC) for treatment and/or prevention of COVID-19. It provides an inhalable dry powder formulation comprising micronized NaDCC together with a first lactose and a second lactose, with the lactose components adsorbed on the micronized NaDCC surface.

The formulation defines particle-size ranges for the micronized NaDCC, the first lactose, and the second lactose, and specifies a weight ratio between the first lactose and the second lactose. The DPI further includes at least one excipient, with example excipients indicated as glacial acetic acid, cyanuric acid, citric acid, magnesium stearate, hydrophilic colloidal silica (AEROSIL 200), and L-Leucine.

The document states that the proposed DPI provides increased bioavailability, tolerability, stability, and non-cytotoxicity. It also reports inhibition of COVID-19 virus replication, anti-viral activity associated with ACE2 inhibition, antibacterial and antifungal activity, microbial load reduction in plant extracts, and inhalation toxicity findings in rats with no significant changes in lung or BALF biomarkers and no significant histopathology after short dosing and withdrawal.

Claims Coverage

The provided content explicitly identifies one independent claim. That claim contains five inventive features covering micronized NaDCC, dual lactose fractions with defined particle sizes, a lactose weight-ratio constraint, adsorption of both lactose components on NaDCC, and an inhalable dry powder format with at least one excipient.

Claim coverage is centered on an inhalable dry powder formulation in which micronized NaDCC has a defined particle size, two lactose fractions have defined particle sizes, the first-to-second lactose weight ratio is constrained, and both lactose fractions are adsorbed onto the NaDCC surface, together with at least one excipient.

Stated Advantages

Documented Applications