Currently, oral pharmaceutical products are designed as fit-for-purpose for the clinical phase and focused only on the adult population. However, a universal product design is possible across all phases of clinical development by pairing lipid multiparticulates (LMPs) with an oral dosing device for solids dispensing. This product is universal to all ages–amenable to the broadest range of patient groups’ abilities, maintains the flexibility of dose adjustment for ascending dose and efficacy studies in early phases, and can be progressed to commercial manufacture with minimal scale-up effort.
As an oral drug delivery technology, LMPs are suitable for application across the development spectrum. LMPs offer excellent flow characteristics, formulations with tunable performance and pharmacokinetics, inherent taste masking and can improve stability for some compounds. Implementation of LMPs in early development provides continuity in clinical performance and stability while eliminating the need for multiple delivery technologies, development of separate products for pediatric and geriatric patients or significant re-formulation efforts.
Objectives
- Introduce the innovative formulation platform offered by lipid multiparticulates (LMPs)
- Discuss the development benefits and solutions offered by LMPs:
- Universal, applicable to all patient classes
- Enable rapid development with continuity across phases/development stages
- Tunable performance with desirable formulation characteristics
- Minimal scale-up effort required to go from early phase to commercial manufacturing
- Established success in development, clinical and commercial manufacturing
Daniel Kuntz, Associate Principal Engineer, Lonza Pharma & Biotech
