Case objective

A pharmaceutical company sought to expand the therapeutic and commercial value of a clinically validated oral small molecule by developing a topical formulation targeting a dermatological indication.

The strategic aims were to reduce systemic exposure while maintaining efficacy, target the relevant skin layer, and shorten development timelines by leveraging existing oral data. However, significant uncertainty existed about whether the API, which had been optimised for systemic delivery, could achieve meaningful dermal penetration in a topical dosage form. The sponsor required a suitable semi-solid formulation and evidence of targeted skin penetration with controlled systemic exposure before committing to clinical development.

To address these challenges, the sponsor required a partner capable of translating oral CMC knowledge into a robust topical development strategy, supported by human-relevant performance data to mitigate risk ahead of clinical progression.

Our approach

Nuvisan implemented an integrated formulation CMC strategy, combining scientific rigour with pragmatic and decision-oriented tools across three parallel workstreams.

The first workstream focused on rational formulation design. Drawing on the existing physicochemical characterisation of the oral API, our experts translated oral development knowledge into a topical-relevant understanding of solubility, permeability and excipient behaviour. Multiple semi-solid systems, including creams, gels and ointments, were screened and progressively optimised with emphasis on dermal bioavailability, patient usability and tolerability.

The second workstream centred on data-driven performance assessment. Throughout the program, in vitro permeation testing (IVPT) was used as a decision-enabling tool rather than as a single endpoint. Study designs were adapted by development stage: an early screening mode for rapid go/no-go decisions across multiple candidates, and an advanced comparative mode to support final ranking of formulations.

The third workstream established an integrated CMC decision framework, bringing together IVPT dermal delivery data, API solubility and stability findings, excipient compatibility results, drug product prototypes stability data and scale-up feasibility assessments. Evaluating these data streams in parallel rather than sequentially, our team was able to conduct a risk-based selection of optimal candidates without overloading the program.

Our findings

The integrated approach yielded clear and actionable outcomes. The API demonstrated feasible dermal delivery in topical prototypes, despite initial optimisation for systemic exposure.

In total, 20 solvents were screened and our team prepared 10 semi-solid formulation prototypes for comparative evaluation. Performance differentiation across prototypes was sufficiently clear to support confident ranking. Following that a lead formulation and a qualified back-up were selected, both aligned with the target product profile and suitable for clinical progression.

The parallel, integrated workstream design – running CMC, stability and IVPT assessments simultaneously – reduced overall development timelines by approximately 30 per cent compared to a conventional sequential approach. This enabled the sponsor to advance the program with confidence and pace.

Conclusion and client impact

Nuvisan successfully helped the sponsor in identifying new therapeutic value for an existing oral compound by demonstrating its suitability for topical administration through a rigorous and efficient development strategy.

The result was a de‑risked route‑of‑administration switch prior to clinical investment and the confident selection of a lead clinical candidate plus a qualified back‑up. Taken together, these outcomes allowed the sponsor to progress towards clinical proof-of-concept smoothly.

This case study illustrates how Nuvisan's integration of formulation science, CMC expertise and translational tools can inform strategic lifecycle management decisions, providing scientific confidence and operational efficiency at a critical stage of drug development.

Our case-specific key technologies

Facing similar challenges? This is how Nuvisan’s experts can help

When considering a route-of-administration change or a lifecycle extension, early integration of formulation science with predictive in vitro tools is critical to confident, data-driven decisions. Our multidisciplinary team partners with pharmaceutical developers to translate existing CMC knowledge into new delivery strategies. By combining scientific depth with operational efficiency and fit-for-purpose study designs, Nuvisan helps sponsors mitigate development risk while advancing their programs at pace.

Our services for topical repositioning programs include:

• Translation of oral API knowledge into topical formulation design strategy
• Semi-solid formulation development and optimisation
• IVPT studies using qualified human skin explant models
• Bioanalytical method development for skin compartment quantification
• Integrated CMC and performance data interpretation
• GMP scale-up and manufacturing
• ICH stability studies and analytical packages
• End-to-end program management and governance.

Considering a route-of-administration switch or lifecycle extension for your compound? Contact our formulation and CMC experts to discuss how Nuvisan can support your development strategy.