BioNxt Solutions has announced that it has received the Semaglutide active pharmaceutical ingredient (API), enabling the initiation of laboratory-scale formulation and testing of its oral dissolvable film (ODF) delivery system.

In collaboration with its qualified supply partners, BioNxt has secured high-purity Semaglutide as the central compound for its proprietary ODF formulation programme. The API's fundamental physical and chemical properties - such as solubility, molecular stability, and loading capacity - are foundational to formulation design and product performance. With the API now in hand, BioNxt's formulation team has begun pre-formulation and lab-scale trials to optimise delivery parameters.

The company said that initial research and development efforts will focus on optimising drug incorporation within the sublingual thin film matrix, characterising disintegration time, testing peptide stability under formulation conditions, and developing analytical methods to ensure uniformity, controlled release, and shelf-life performance.

Hugh Rogers, CEO at BioNxt Solutions, commented, "Having the API in-house allows us to translate theory into practice. We're focused on generating reliable data to inform formulation refinement and position the project for patent protection in the coming quarter.”

All laboratory development activities for the Semaglutide oral film are being conducted at BioNxt's German drug development partner, Gen-Plus GmbH, located in Munich. Gen-Plus, a licensed drug developer and manufacturer specialising in pharmaceutical thin film formulations and novel dosage forms, provides GMP-aligned laboratory infrastructure, in-house expertise in polymer science and peptide formulation, and regulatory readiness for clinical development in the European Union.

The Munich facility serves as BioNxt's core technical centre for thin film research, formulation prototyping, and early-stage product development. The Semaglutide programme builds on Gen-Plus's proven experience in oral and transdermal delivery technologies for both small molecules and complex biologics.

Semaglutide, currently marketed under the brand names Ozempic and Rybelsus, is a leading GLP-1 receptor agonist approved for the treatment of type 2 diabetes and obesity. Global demand for GLP-1 therapies is growing rapidly, with Semaglutide accounting for more than USD 29.3 billion in sales in 2024.

BioNxt's oral thin film version is intended to improve accessibility and patient compliance through a non-invasive delivery format. Semaglutide is the first in a planned series of GLP-1-based therapies being developed using BioNxt's proprietary ODF platform.

Headquartered in Vancouver, Canada, BioNxt Solutions focuses on next-generation drug delivery platforms, diagnostic screening systems, and API development. Its portfolio includes sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumours while reducing side effects.