24/7 BIOPHARMA - issue 1 / October 2024

CORDENPHARMA

CTD 4 is designed to incorporate technologies to enhance bioavailability and enable manufacture of highly complex OSD products. Depending on clinical trial dosing needs, minitablets are a practical way of delivering APIs to patients. Encapsulating these versatile forms has proven to be effective in adjusting dosage strengths and exploring modified release profiles. Among minitablets’ distinct advantages, the form’s accurate incremental dosing can support more robust clinical trial data. This delivery system, however, requires experience in terms of developing a suitable tableting process and analytical methods to analyse these mighty minitablets. With access to this technology early in development, researchers can take better advantage of the safety and efficacy this form can offer. For much of recent development history, producing straight API-in-capsule clinical supply has been the go-to approach for rapid manufacture and entry for FIH clinical trials and precision powder encapsulation systems that facilitate manufacture. At CordenPharma we deploy Harro Höfliger encapsulation for clinical scale production. These systems have the accuracy, speed and volume to meet today’s increasingly complex clinical supply needs cost-effectively. In addition, CordenPharma’s Drug Product Innovation Centre of Excellence can formulate NMEs with challenging properties – such as peptides and small molecules with limited solubility, permeability, very low drug load, high potency and limited stability – into Oral Solid Dose drug products. Our enabling technologies such as spray drying, hot melt extrusion, nanomilling and micronisation solve solubility induced absorption issues. For peptides or large molecules that exhibit limited bioavailability caused by poor permeability through the intestinal barrier, lipid-based formulations (e.g. SEDDS / SMEDDS, sLNP, Cochleates) or permeation enhancer-based formulation technologies are required. To address these challenging APIs, we apply innovative formulation approaches to provide prototypes for animal in vivo investigations for oral peptide delivery. All formulations can be manufactured as a solid form, allowing for larger production scales. To help pharmaceutical developers bring their IP innovations to markets and patients even more successfully, CordenPharma expanded Small Molecule service offerings since 2023 to include solid-state development. The Solid-State Centre of

Highly Potent & Oncology platform accelerates OSD clinical trial development with

bioavailability enhancement.

[CordenPharma Photo] – Dispensing Highly Potent APIs for OSD Clinical Trial Manufacturing at CordenPharma Plankstadt (DE).

Excellence in CordenPharma Liestal, Switzerland, is now fully complete and in production, generating an impressive track record in solving challenges with solid-state form and isolation strategies, as well as helping customers to move their assets to a better physicochemical state suitable for subsequent processing and drug product finishing. Experts from our Solid-State CoE work closely together with our Drug Product Innovation Centre of Excellence in Plankstadt to provide integrated Drug Substance and Drug Product development solutions to our customers. By combining customised solid form APIs with bespoke Drug Product formulation process development and manufacturing of the final drug, we support innovators with all the necessary bioavailability requirements, even for low soluble APIs with a high drug load.

Small Molecule platform integrates solid-state API development with drug product

bioavailability enhancement.

24 TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024