The focus here moves from API to a dose form that can be trialled in pre-clinical studies. But, before moving to that Pre Clinical Formulation work, we can provide support that can help you make your decisions faster, and more precisely.
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A high proportion of our projects fall under this banner. We are used to developing methods for novel APIs and formulations and carrying out work to meet Regulatory submission requirements.
The wide range of equipment we have on site, coupled with inter disciplinary teams each able to pick up part of the work load means we can often move projects forward faster than a single team working on all aspects of the analytical development.
Physical Form Optimisation
Ensuring the size, surface area, porosity, chemical composition and crystalline structure meet requirements. All our analytical equipment described below is run to meet exacting pharmaceutical industry “Good Manufacturing Practise” (GMP) requirments.
Method Development and Validation
Developing and validating methods “fit for purpose” to meet regulatory / investor needs. Our support in this area has included developing and validating procedures using XRD, XRF, ICP, GC, GC-MS, HPLC, UV, FTIR, Particle Sizing, Surface area, and many others.
We have a wide range of facilities available to meet a range of ICH Conditions for both R&D and Commercial product stability studies. Short term physical stability studies are a particular focus, supported by our XRD, TGA, DSC, particle size, Porosity / surface area equipment. Our support can include the design of the stability study drafting and agreeing the stability protocol and final report.
Dose Form Optimisation
Clearly, a crucial step in deciding the route of administration and the manufacturing process to be used. We offer a complete range of tools to characterise your material including XRD, DSC, DVS, SEM, Surface Area, Porosity and Particle Size.
Drug Excipient Compatibility
We maintain a wide library of excipients, combined with strong experience in developing HPLC procedures. From this we have developed a number of methods for assessing compatibility and we are able to carry out this crucial task effectively and efficiently.
Assessing Dose Powder / Aerosol Device Compatibility
As a pulmonary dose form is developed a crucial aspect is the compatibility of the dose form and the device. We provide the ability to quickly and simply compare the performance of your formulations in a range of devices using our Laser Diffraction – Inhaler device connected approach.