Atacama's Webinar presentation "Pneumatic Dry Granulation - A dry process to improve oral formulation design time and resource requirements" from Innovative but Practical Technologies to Tame Difficult APIs for Formulation Development & GMP Manufacture

Listen the webinar presentation from here.
 
Q1. You reported on Paracetamol and Avicel PH105. Any other substance investigated?
 
A1. Yes, we also have detailed study results on Ibuprofen, Paracetamol (fast acting formula) and Metformin. Further study results for Simvastatin, Clopidogrel, Riboflavin and Dicaphos / Vivapur will be available in the next quarter.
 
Furthermore we have successfully granulated with regard to both flowability and compactibility: acebutolol, L-arginine (a nutraceutical), sodium valproate, ketoprofen , fluoxetine, sumatriptan, and nicorandil and 6 other new APIs from pharma companies.
 
Q2. Is it also possible to develop formulations on a (very) small scale, like required for NCEs?
 
A3. Yes, since the technology allows us to start with a minimum of 250g. We are also about to develop a system that can handle API tests from 50g upward. Also: the results are easily transferable to scale-up (1 ton / day) since it is the same machinery.
 
Q3. What are typical drugloads achievable i.e. for Paracetamol ?
 
A3. The PDG technology has demonstrated in all the cases we have worked that we achieve typically between 70 and 95% of drugload. For Paracetamol the trial set-up was working with 80% drugload, which was later on increased to 85%. We have also granulated quite a few materials including Metformin 100% pure (but in order to obtain a valid tablet profile there always has to be a minimum amount of excipients used, i.e. 5%).
 
Q4. As to how far can PDG granules ameliorate dissolution problems ?
 
A4. PDG granules are soft and porous and the initial substance is very little compacted, therefore making them ideal for further processing (after-mix, add-on galenic processes, final tableting). With Paracetamol we have results showing that the dissolution is comparable to the fastest dissolving Paracetamol in the market.
 

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