Pharmaceutical formulation development and contract services for optimisation of formulations for powders, capsules, liquids, solids, inhaled and nasal drug formulations
Pharmaceutical formulation development to determine the optimal dosage form, composition and manufacturing route is a fundamental part of pharmaceutical product development. Getting a drug formulation right helps to optimise drug delivery performance and product stability. Complex dosage forms, in particular, inhaled and nasal products can present unique challenges for controlling the performance of the drug product and impact bioavailability.
Our drug product formulation development teams offer design and optimisation of formulations for powders, capsules, liquids and solids, semi-solids, inhaled, nasal, nebulised and topical drug formulations. We provide focused understanding from an early stage of development for your new chemical entities (NCE) and generic products, starting with early feasibility through to development support, Phase I and Phase II clinical trials and transfer to commercial manufacturing.
Our expertise helps accelerate project timelines and includes pre-formulation, excipient-API compatibility assessment and optimisation, physicochemical testing, formulation screening, lab scale formulation and accelerated stability studies to achieve the desired characteristics.
The Intertek formulation development team enables small amounts of drug product materials to be developed using experimental design methodologies supported by testing at every stage with key performance analytics including solubility, dissolution, solid state characterisation and powder and particle morphology studies.
Integrated with analysis and stability storage, our specialists can screen a wide range of formulations in a timely and cost-effective manner in order to identify the most promising formulation to progress through to further development. As a result, we can save you time by reducing method and technology transfer time as well as effort.
With a holistic approach to service provision including raw material quality control, scale-up, pilot batch manufacturing and testing, GMP clinical batch manufacturing, impurities testing, as well as release testing with QP release, we offer a one-source solution for materials supplies for use in Phase I and II clinical trials.
With dedicated teams of experienced analysts and formulators, we offer a truly flexible, dedicated formulation specialists to help you arrive at the optimal formulation and manufacturing process for your API. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
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