Services
Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.
Feasibility Studies
Compounding, Single and Multi-Layer Extrusion
Small and Large Molecules
Strand, Tube and Film Extrusion
Highly Potent APIs and DEA Controlled Substances
From Concept Through Commercial Manufacturing
What is HME?
HME involves the application of heat, shear and pressure to melt polymers, excipients and APIs, facilitating their uniform dispersion and subsequent formation into various dosage forms. This continuous and reproducible process is pivotal in the pharmaceutical industry for formulating poorly water-soluble APIs, including BCS class II and IV compounds, as well as highly potent APIs (hormones, steroids, cytotoxics), controlled substances (Schedule I-V) and large molecules (proteins, peptides, nucleotides).
Capabilities of Agno Pharma’s HME Expertise
Agno Pharma understands the importance of polymer selection and supply in the development of long-acting implantables hence we have established strong relationships with the world’s leading suppliers of biodurable and biodegradable polymers. We regularly utilize HME while developing long-acting implantables with poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), thermoplastic polyurethane (TPU), ethylene vinyl acetate (EVA), silicones (LSR and HCR) and other engineered polymers.
Key Capabilities of Agno Pharma’s HME Expertise:
- Enhanced Solubility and Bioavailability: Agno Pharma employs HME to convert APIs into amorphous solid dispersions, thereby enhancing their solubility and bioavailability by preventing crystallization and improving dissolution rates.
- Controlled Release Polymer Based Systems: Utilizing HME, Agno Pharma designs and manufactures long-acting implantables that offer sustained and controlled drug delivery. This includes developing monolithic, reservoir and other unique systems, with precise release kinetics, suitable for various therapeutic needs.
- Versatility in Dosage Forms: With HME, Agno Pharma produces a wide array of form factors such as rods for ophthalmic and subcutaneous implants, tubes for reservoir systems, and films for transdermal patches, catering to diverse pharmaceutical applications.
- Process Optimization: Agno Pharma applies rigorous process optimization strategies to mitigate challenges such as thermal degradation of APIs and polymer interactions, ensuring the stability and efficacy of the final dosage forms.
Agno Pharma’s Commitment
Agno Pharma’s commitment to specialized technologies like HME is emphasized by our comprehensive capabilities in design, formulation, and manufacturing of pharmaceutical-grade products. Whether for new chemical entities, lifecycle management strategies, or generic formulations, our specialized expertise in HME enables us to deliver innovative solutions that meet stringent regulatory standards and exceed client expectations.
Agno Pharma leverages decades of combined expertise on Hot Melt Extrusion to support the development, clinical manufacture and commercial supply of long-acting implantables.