particle engineering
Spray drying capability
Spray Drying Services
APIs, Drug Product Intermediates, Excipients
Spray drying is a primary technology for addressing poor bioavailability. Spray dried dispersions, through stabilising the amorphous form of a drug substance, are a well recognised approach to make poorly soluble compounds clinically effective, often dramatically improving bioavailability compared to the crystalline form.
With 70% to 80% of new drug candidates having low aqueous solubility, enabling technologies are required to enhance bioavailability. Whereas micronization is a good solution for dissolution rate limited solubility, spray drying is best employed when absolute solubility is the issue and the physical form of the API must be altered.
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Spray drying is also highly effective for:
- Drying directly from solution – avoiding the need for precipitation and separation
- Drying temperature sensitive products – an alternative to lyophilisation
- Inhalables – small particle sizes
- High volume products – large capacities and energy efficient
Spray drying is a well proven and highly scalable technology and can support drug substance and product development from bench to large commercial scale.
EUROAPI has the widest range of pharma spray drying scales available on the market
- Proof of concept at benchtop lab scale (Buchi) – Output: grams
- GMP ‘Kilo’ Lab scale (Procept SD1) – Output: kilograms
- Clinical and small commercial (GEA PSD2): 10’s kilograms
- Commercial scale (GEA PSD4): 100’s kilograms
- Largest commercial pharma spray dryer in the world (GEA TFD250): 10’s to 100’s metric tons
- All scales supported by advanced mathematical modelling and simulation
Our key skill set is rapid and effective scale up of your process using the minimum of your precious Active Pharmaceutical Ingredient (API)
- We appreciate the huge effort and expense that goes into producing your API
- EUROAPI employs sophisticated mathematical modelling and simulation techniques to make sure we achieve the right process conditions faster for your product
- This approach means we use the minimum quantity of API to reach suitable conditions for GMP manufacturing
- The Haverhill site in the UK has been working with industrial scale pharmaceutical spray drying for over 20 years
Spray drying facilities
EUROAPI has experience of commercial pharma spray drying since 2001
The Haverhill site has produced, tested and released more than 5000 MT of spray dried pharmaceutical products in that time
Large range of spray drying scales
- Procept SD1 - GMP lab scale spray drying for tech transfer and scale-up support.
- GEA PSD 2 – aqueous and organic solvent capable (≤ 70kg batches)
--> Agitated vacuum dryer for secondary drying of spray dried powder.
- GEA PSD 4 – aqueous only – plans available for upgrade to solvent capability (80 – 500kg batches).
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GEA TFD250 – aqueous only, 500 – 5000kg batches
--> Bioburden management capability - dry heat and chemical sanitisation, fine filtration
--> Largest pharma spray dryer in the world
EUROAPI employs sophisticated mathematical modelling to determine the dryer conditions to achieve the desired product characteristics
- Minimises use of valuable starting materials
- Allows more rapid progress from ‘technical’ to GMP batches