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Poster: Meeting the Draft Guidance for Topical Products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.
Roundtable: Increasing the Robustness of IVPT Experiments
In a recent Analytical Special Feature with Drug Development & Delivery, industry experts weigh in about the the impacts of AI and automation in analytical labs.
MedPharm CSO, Dr. Jon Lenn, discusses our unique automated diffusion cell system, MedFlux-HT®, and transepidermal water loss (TEWL) instrument used for IVPT studies.
Learn more about the advantages of these systems in the lab, and read the full feature here.
Case Study: Cost-effective process development of complex cream ensures consistent quality and on-time delivery of clinical trial material
MedPharm was asked to provide multiple 25 kg batches of a complex cream for an important Phase 2 atopic dermatitis clinical trial by a large global pharmaceutical company. Failure to supply or delay would have had major financial consequences for the project. Due to the nature of the request, the client valued MedPharm’s detailed understanding of the multi-stage manufacturing process.
Our experts used their understanding of the formulation and their many years of experience in scaling-up complex semi-solid products to identify the ‘Critical Process Parameters’ (CPP) as homogenization speed and time, and cooling rates at different stages. They laid out a suitable factorial design of 12 runs using 1kg lab reactors which model the large scale. The key ‘Critical Quality Attribute’ was identified to be the rheology profile of the final product. This work showed that the rheology could be particularly sensitive to the homogenization time and speed and appropriate parameters were set. An initial run at the larger scale confirmed that the process and parameters selected gave a product which met all specifications.
Subsequently, over 15 clinical batches were manufactured with reproducible quality using the optimized manufacturing process. Given the sensitivities to key parameters observed this almost certainly would not have happened without the process evaluation work. Additional large batch production would have wasted significant amounts of a high-value API and impacted the completion of the trial.
Teaming up with GSK and the University of Reading to demonstrate the skin penetration potential of a large aptamer
New research challenges current theories on skin penetration of large molecular weight drugs offering hope for the discovery of new treatments of difficult-to-treat dermatological diseases.
It is generally agreed that drugs with molecular weights above 1000 Daltons did not penetrate the skin at therapeutic levels and so weren’t applied topically for the treatment of dermatological diseases. However, researchers from GSK and the University of Reading teamed up with MedPharm to challenge this current theory. MedPharm created specific disease activity skin models for a study designed to test the penetration of a 22k Dalton aptamer, which is a type of RNA molecule receiving notable interest for its potential pharmaceutical activity.
The results revealed this aptamer both penetrated the skin and showed therapeutic activity. The findings were subsequently published in the Journal of Investigative Dermatology and suggest the boundaries of molecules suitable for topical treatments can be expanded. This offers hope for the discovery of new treatments of difficult-to-treat dermatological diseases.