We are the world’s leading provider of orally inhaled and nasal drug product design and development services.
We enable the seamless translation of pre-clinical development through to clinical manufacture of OINDPs through our unique processing technologies and formulation development tools. Our integrated development services in materials characterisation, formulation development and inhaled biopharmaceutics aids successful product development of OINDPs by understanding how material properties and processing conditions influence product functionality.
We are the market leaders in providing bespoke solutions to the development of OINDPs. Our technology platforms for advanced materials characterisation, formulation & device development, together with in silico modelling of OINDP in vivo behaviour, is acknowledged as cutting edge and market leading.
We can provide you with the solid foundation required for successful transition of early phase development programs, using our world-leading expertise in pre-formulation development of methods for inhaled drug product characterisation.
We understand poor pre-formulation studies may lead to delays in pre-clinical and clinical development programs. We can provide you with the solid foundation required for successful transition of early phase development programs through to clinical, using our world-leading expertise in development of methods for inhaled drug product characterisation, As part of our pre-formulation development package we are able to provide you with the following:
You will have access to our extensive expertise in developing orally inhaled and nasal drug products,
from the lab through to the clinic and product registration.
Product development starts with defining the critical material attributes (CMAs) of the device and formulation. This enables pre-selection of lead formulations and processes to best meet the defined target product profile. These formulations and processes are screened to identify critical quality attributes that impact drug product performance. Both formulations and processes are challenged and optimised to ensure that the drug product can be manufactured using the Quality by Design paradigm.
Our advanced analytical characterisation services and our understanding of how input material physico-chemical and mechanical properties affect product specification, functionality and stability of orally inhaled and nasal drug products was the foundation of our company.
Therefore we have developed a range of novel technologies for characterising critical material attributed of APIs and excipients and control methodologies required for optimising crystals, particles and powders for OINDPs.
These are accessible through our NANOPLEX service offering that include:
These tools have enabled us to characterise and address common pharmaceutical processing issues that include:
You can benefit from a range of tailored and robust formulation development solutions for all types of pMDIs and DPI device platforms, through our INTERHALE technologies.
Orally inhaled and nasal drug products are complex systems that are highly dependent on interactions between device and formulation components.
Our specialist understanding of the critical material attributes of devices, APIs and excipients enables pre-selection of lead formulations and process requirements to best meet a defined target product profile.
Formulations and processes are subsequently screened to identify critical quality attributes that impact drug product performance. Both formulations and processes are challenged and optimised to ensure that the drug product can be manufactured using the Quality by Design paradigm.
Our extensive expertise has enabled companies to accelerate early phase development programs and expedite first-in-human and proof of concept clinical trials.
Product Development, Testing, and Packaging Services
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