The Salunke Group
Research Programmes
Designing safer, usable medicines for children
Designing safer, usable medicines for children requires more than adapting adult products. Our research focuses on the scientific and practical challenges that shape paediatric medicines — from formulation design to real-world use.
Four interconnected research programmes
Our Research Programmes
Our work focuses on the decisions that determine whether paediatric medicines are safe, usable, and effective in practice. These programmes are closely connected and inform one another.
Programme 01
Excipient Safety Intelligence
Generating evidence and predictive approaches to support safe, justified excipient use in paediatric formulations.
Explore programme →Programme 02
Administration & Device Fit-for-Use
Studying how medicines behave during administration and how formulation design interacts with delivery devices in clinical practice.
Explore programme →Programme 03
Formulating Medicines for Children in Low-Resource Settings
Working with international partners to understand how medicines are handled, accepted, and used across real care environments.
Explore programme →Programme 04
AI-Enabled Quality by Design for Paediatrics
Applying data-driven and predictive methods to strengthen formulation decision-making and support evidence-based paediatric development.
Explore programme →How the programmes connect
These research areas are not independent silos. Excipient safety, formulation design, administration behaviour, and real-world use are deeply interconnected. By studying them together, we aim to support earlier, better-informed decisions in paediatric medicine development.
Opportunities for students & collaborators
Many projects within these programmes are suitable for Master’s dissertations, PhD research, and collaborative studies. If you are interested in working in paediatric formulation science or applying modelling approaches to medicine development, we welcome discussions.
Explore opportunities →Research Programme
Excipient Safety Intelligence
Understanding and justifying the safety of excipients used in paediatric medicines.
Context
Why This Area Matters
Medicines contain far more than their active ingredient. Excipients — the additional components that give a formulation its form, stability, and palatability — are often selected based on evidence generated in adults or older children. Yet neonates and young infants metabolise these substances very differently, and exposure thresholds that are considered acceptable for older patients may carry real risk in developing physiologies.
Despite this, excipient safety data for paediatric populations remains fragmented, and the tools for integrating toxicological knowledge with real formulation exposure are limited. This makes evidence-based decision-making during paediatric product development genuinely difficult — and the regulatory landscape reflects that difficulty.
Research Focus
What We Study
Our work generates the evidence and frameworks needed to assess and justify excipient use across the paediatric age range.
- Defining age-appropriate excipient exposure thresholds for neonates and young children
- Understanding developmental toxicity and neurotoxicity risks associated with common excipients
- Assessing route-dependent exposure and its implications for systemic safety
- Integrating toxicological and exposure data to support regulatory justification
- Building structured approaches to excipient selection in paediatric formulation design
- Identifying gaps in the evidence base and prioritising areas for further investigation
Methodology
How We Approach the Problem
This work combines experimental science with evidence synthesis and predictive modelling to build a more complete picture of excipient risk in paediatric contexts.
Formulation Science
Understanding how excipients behave within formulations and how their properties interact with dosage form design and administration.
Evidence Synthesis
Systematic review and integration of existing toxicological data across developmental age groups and exposure routes.
Predictive Modelling
Applying data-driven approaches to predict exposure and risk, supporting more defensible decisions earlier in development.
Project Areas
Example Research Topics
Projects in this area are regularly available for Master’s dissertations, doctoral research, and collaborative studies. Topics evolve as the field develops.
Defining exposure thresholds — Developing age-stratified safety thresholds for excipients commonly used in neonatal and paediatric formulations, using published toxicological data and pharmacokinetic modelling.
Route-of-administration effects — Comparing systemic exposure from oral, enteral, and parenteral routes for selected excipients, and the implications for formulation decisions.
Regulatory justification frameworks — Building structured approaches that allow formulators and regulators to assess and document excipient safety in paediatric submissions.
Developmental neurotoxicity assessment — Reviewing and synthesising the evidence base for neurotoxicity risk associated with excipients in early developmental exposure windows.
Collaboration & Impact
Where This Work Has Effect
This research informs paediatric formulation development, contributes to regulatory discussions on excipient safety, and supports the evidence base for policy and guideline development at national and international levels. It connects directly to our AI-Enabled QbD programme and provides foundational data for formulation decisions across all four research areas.
Opportunities
Get Involved
Projects in this area are suitable for Master’s dissertations, PhD research, and collaborative studies. Students with interests in paediatric formulation science, pharmaceutical safety, or regulatory science are encouraged to make contact.
We welcome enquiries from prospective PhD students, postdoctoral researchers, and collaborators from academia, industry, and regulatory bodies.