The aim of process development is to establish optimal process parameters and conditions for future large-scale batches or commercialization, ensuring that the product can be successfully manufactured in compliance with required quality and regulatory standards. This ultimately means that an in-depth understanding of the formulation is key.

Unlike solid dosage drug products and sterile injectables, topical and transdermal formulations often contain a higher number of excipients, making them more complex to develop and scale. Given that the processes that can be used for manufacturing a drug product are largely impacted by the specific components of that product’s composition, a strong comprehension of the formulation is key.

MedPharm was asked to provide multiple 25 kg batches of a complex cream for a Phase 2 atopic dermatitis clinical trial on behalf of a global pharmaceutical company. A failure to supply or delay would have carried significant financial consequences for the project. The client specifically valued MedPharm’s detailed understanding of the product’s multi-stage manufacturing […]

Challenging Skin Penetration Assumptions with GSK and the University of Reading New research is redefining assumptions about the skin penetration potential of large molecular weight drugs, offering hope for new therapies in difficult-to-treat dermatological diseases. It has long been believed that molecules above 1,000 Daltons cannot penetrate the skin at therapeutic levels, limiting their use […]

Reckitt Benckiser scientists came to MedPharm with a challenge: could we devise models to determine how well their flurbiprofen throat spray and lozenge deliver the drug into human pharynx tissue? In response, MedPharm’s team developed clinically relevant in vitro models and incorporated them into a comparative study evaluating the permeation of each flurbiprofen formulation. The […]