Developing a semi-solid topical drug product demands a deeper level of scientific and process understanding than traditional solid dosage forms. Every choice, from excipient interactions to the order of ingredient addition, shapes the product’s microstructure, physical stability, and patient experience. Because subtle processing shifts can alter drug release, texture, and long-term uniformity, early formulation decisions carry significant consequences across clinical, scale-up, and commercial phases.
A Quality by Design mindset is essential as teams navigate the challenges of scaling these systems. Equipment geometry, shear profiles, thermal control, and mixing efficiency rarely translate directly from bench to plant, creating risk for changes in emulsification, drug distribution, or air incorporation. A holistic, cross-functional approach that integrates formulation science with engineering, quality, and manufacturing readiness is critical for de-risking transitions and securing reliable production.
This session provides foundational insight into topical formulation development, key scale-up considerations, and practical strategies for maintaining Critical Quality Attributes across the product lifecycle.
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This case study shows how MedPharm demonstrated the clinical efficacy and tolerability of MedSpray® in a non-inferiority study against a marketed antifungal treatment. Building on strong preclinical performance, the optimized MedSpray® formulation delivered equivalent antifungal activity while improving tolerability and maintaining comparable recurrence rates. These results confirm that enhanced topical drug delivery can translate into meaningful clinical outcomes and support both regulatory and commercial success.
This case study shows how MedPharm improved topical and transdermal drug delivery performance using MedSpray® film-forming technology. By optimizing formulation design and comparing performance against marketed patches, gels, and creams, MedSpray® demonstrated higher drug permeation, improved release profiles, and greater formulation flexibility.
This case study shows how MedPharm improved topical and transdermal drug delivery using its MedSpray® film-forming technology. By combining thermodynamically optimized formulations with an aerosol-based delivery system, MedSpray® enhanced drug permeation through the skin, increased tissue retention, and enabled both immediate and sustained release profiles. The result was improved formulation performance, better patient usability, and a differentiated topical drug delivery platform.
This case study shows how MedPharm improved IVPT performance using MedFlux-HT®, an automated flow-through diffusion system. By maintaining optimal sink conditions and increasing sensitivity, MedFlux-HT® generated more reliable permeation data and enabled better formulation decisions.
This case study shows how MedPharm optimized skin explant models to improve stability and extend tissue viability for inflammation and wound healing studies. By preserving physiological relevance and enabling multi-endpoint analysis, the model generated more predictive data and supported better development decisions.
This case study shows how MedPharm developed a reconstructed nasal epithelium (RNE) model to improve prediction of nasal drug delivery performance. By replicating key physiological features and benchmarking against clinical data, the model generated more reliable, human-relevant data and supported better formulation decisions.
This case study shows how MedPharm improved nasal drug delivery modeling using advanced in vitro systems, including reconstructed human nasal epithelium and CT-based nasal casts (MedCast®). These approaches generated more predictive data, improved in vitro to in vivo correlation, and supported better formulation and development decisions.
This case study shows how MedPharm resolved scale-up stability challenges by identifying process-driven root causes and optimizing manufacturing parameters. Through targeted studies and process optimization, variability was reduced and a robust, reproducible scale-up strategy was established.
This case study shows how MedPharm solved solubility challenges in a small molecule formulation. The team identified the root cause of drug precipitation and optimized excipient selection. Through targeted solubility studies and formulation design, stability improved and regulatory risk was reduced. The result was a robust, scalable formulation that enabled continued development.
