SDN - 118
SDN – 118 is a novel formulation of an existing anti-depressant with high potential for suicidal ideation. The formulation is based on SPARC’s proprietary overdose prevention technology platform in which the system reduces the release rate and extent of the drug on ingestion of multiple pills - either intentionally or accidentally.
Overdose Proof-of-Concept study for SDN - 118 has been planned in Q4 FY19. This study is designed to mimic the overdose condition in-vivo but without exposing the human subjects to toxic levels of the study drug.
Overdose Prevention Technology:
Suicide from intentional overdose is one of the top 10 leading causes of death in the USA. SPARC has developed a platform technology that has ability to reduce the chances of death by intentional or accidental overdose.
In this technology, formulation contains an API which could be either embedded or coated with a reverse enteric polymer having pH specific solubility only in acidic pH along with pH modulator and other excipients.
When a single pill is ingested, it disintegrates in the stomach and releases the pH modulator in a quantity that does not affect the pH micro environment of the stomach thereby dissolving reverse-enteric polymer leading to delivery of the therapeutic dose. However, when multiple pills encounter stomach, sufficient pH modulator is released to change the stomach pH micro environment restricting the rate and extent of drug release thereby reducing the potential harm due to overdose.