OSD
Oral solid dose development, from early phases to manufacturing readiness
Accelerate your oral solid dose (OSD) development and turn complex formulation challenges into predictable outcomes.
Our data-driven approach de-risks your clinical progression by securing an early understanding of scalability, resulting in fewer trial batches and a reduced need for reformulation.
Do more with less and get it right first time
Our development services are based on a Quality-by-Design (QbD) approach, defining formulation and process from the start to ensure reliable performance and manufacturability. Programmes are designed for API-constrained conditions, using small-scale studies to evaluate performance under manufacturing-relevant conditions and reduce the need for trial and error, accelerating project success.
Our OSD development capabilities
Our expert teams utilise a broad suite of OSD capabilities to design, characterise, and optimise your formulations, ensuring high-quality, scalable products ready for clinical evaluation and commercial success.
- Material characterisation
- Dry and wet granulation
- Compaction and Compression simulation
- Tableting and hard capsule filling (multiple filling)
- Complex formulation development
- Process Development
- Reformulation and process optimisation
- GMP pilot-scale capability for all clinical phases
OSD formats
We support a comprehensive range of OSD formats, applying our specialized knowledge to select and develop the most effective presentation for your drug candidate's unique physical and pharmacokinetic properties.
- Powders and granules
- Tablets (standard, mini-tablets, ODTs, coated tablets, bi-layer tablets)
- Hard capsules (multi-fill)
- Controlled release formulations
Our formulation expertise
By aligning process development, risk assessment, and formulation directly with your Quality Target Product Profile (QTPP), our scientists deliver stable, bioavailable drug products for both new chemical entities and generics.
● Prototype development (QbD approach)
● Formula and process optimisation
● Fully integrated and complete analytical services
● Scale-up study, clinical batch and submission batch manufacturing
● Generic development
Why Recipharm
To deliver robust, scalable oral solid dose (OSD) products, we integrate deep expertise, advanced analytics and global quality systems from day one. Our agile approach de-risks your programme and ensures a predictable, successful transition to commercial manufacturing.
- Expert scientific problem-solving: We develop bespoke, phase-appropriate OSD strategies to solve your NCE and complex formulation challenges.
- Advanced predictive modelling: Leveraging our Recipredict platform, we help you conserve valuable API, secure early scale understanding and accelerate speed-to-clinic.
- Comprehensive analytical development: Through advanced analytical techniques and specialist expertise, our analytical services support your OSD method development, validation, stability studies and product characterisation.
- Global Quality Assurance (QA): Our integrated quality systems help safeguard regulatory compliance and consistency across your product lifecycle.
- Seamless project management: With full alignment from early-stage lab development through to GMP pilot and commercial scale, we help guarantee smooth tech-transfer for your OSD.
- Integrated Solutions: we support programmes from early development through to scale-up and commercial manufacturing.
Get to market faster with reliable, scalable development
We accelerate development timelines and deliver robust, scalable processes that support efficient market entry.
FAQs
We provide OSD development for tablets, hard capsules, powders and granules, including controlled release formulations for new chemical entities and for generic molecules. This includes complex dose forms such as Mini-tablets and dual-filled hard casules.
We support development from early phases, with a focus on phase 2 and 3 programmes where scale-up, API constraints and timelines are critical to progressing efficiently to market. We support development from GMP small-scale Phase 1, and subsequently support phase 2 and 3 programmes where scale-up, API constraints and timelines are critical to progressing efficiently to market
Applying a quality by design (QbD) approach powered by our Recipredict platform allows us to define formulation and process parameters early through predictive modelling. This ensures reliable performance, manufacturability and reduced risk during scale-up.
We design development programmes for API-constrained conditions, using small-scale studies and modelling to reduce API usage and limit iterative testing.
Our development approach can reduce API usage by up to 70%. This is achieved using micromeretic measurements, small-scale studies, modelling, simulation and targeted experimentation.
We significantly reduce development timelines by defining formulation and process parameters early, using small-scale studies and modelling to limit iterative testing. This enables faster decision-making and reduces rework during development, scale-up and tech transfer.
We develop processes with early involvement of our Material Science and Technology (MSaT) colleagues, defining critical parameters and process robustness early to support predictable scale-up and efficient tech transfer.
QbD is a structured approach that defines the design space and how formulation and process parameters impact product quality, enabling robust and reproducible processes ready for scale-up. In other words, it is the documented understanding of the impact of materials and process on the quality attributes.
