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File Download – Nasal Technical Article
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Whitepaper: Advancements in Ophthalmic Drug Product Assessment
One-Pager: Capabilities
This one-page overview highlights MedPharm’s end-to-end capabilities in topical, transdermal, and transepithelial drug development. From early-stage formulation and in vitro testing through clinical trial material supply and commercial manufacturing, MedPharm supports programs at every stage to accelerate development and reduce risk.
Poster: Meeting the Draft Guidance for Topical Products
Demonstrating the Skin Penetration Potential of a Large Aptamer
This case study shows how MedPharm, in collaboration with GSK and the University of Reading, demonstrated the skin penetration and biological activity of a large aptamer using advanced skin models. The findings challenge traditional molecular weight limits in topical drug delivery and highlight the potential for large-molecule therapies in dermatology.
Proving Pharynx Formulation Equivalence with Clinically Relevant Models
This case study shows how MedPharm worked with Reckitt scientists to develop clinically relevant pharynx models for comparing drug delivery from a throat spray and a lozenge formulation. Using ex vivo and human tissue models, the team demonstrated equivalent flurbiprofen permeation across both dosage forms and supported the determination of a clinically relevant dose. These results enabled confident evaluation of formulation performance and helped inform product strategy.
Cost-Effective Process Development Delivers Critical Clinical Trial Supply
This case study shows how MedPharm used process development to support clinical trial supply for a complex topical formulation. By identifying critical process parameters and optimizing manufacturing conditions, the team improved product consistency and reduced scale-up risk. The optimized process enabled reliable, reproducible production of clinical batches and ensured on-time delivery for a Phase 2 clinical trial.
Article: Establishing a Rigorous and Robust Approach to Process Development
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.
In a recent two-part article with Manufacturing Chemist, Joseph Holt, Head of Process Development at MedPharm, explores the challenges facing developers when scaling-up processes for semisolid drug product production and highlights the additional difficulties associated with generic drug development and manufacturing.
Article: Excipient Selection in Topical Process Development
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.
Throughout drug product development, it is critical to understand the excipients, processing parameters, and quality attributes specific to the product so that optimal excipients and manufacturing methods can be established for future commercialization.