http://blog.pharmtech.com/2011/03/16/continued-focus-on-continuous-processing/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2011/03/16/continued-focus-on-continuous-processing/comment-page-1/#comment-38995 Mattingly Thu, 14 Jul 2011 23:29:58 +0000 http://blog.pharmtech.com/?p=3952#comment-38995 Ya learn somtnehig new everyday. It's true I guess! Ya learn somtnehig new everyday. It’s true I guess!

]]> http://blog.pharmtech.com/2011/03/16/continued-focus-on-continuous-processing/comment-page-1/#comment-35901 Ron Warrick Thu, 17 Mar 2011 06:32:07 +0000 http://blog.pharmtech.com/?p=3952#comment-35901 The main obstacle to continuous processing of solid dosage forms seems to be that it requires an interdisciplinary approach that is hardly in its infancy, involving formulators, engineers, regulators, and now academics, all of whom have incomplete and sometimes contradictory understanding of what is needed. Pharmacist formulators are not trained in the engineering aspects, neither engineers nor formulators are adequately trained in formulating for effective continuous processing, and regulators have overly imaginative expectations of how it should all operate. Added to this is that the pharmaceutical batch granulating processing itself is being done essentially the same way it was done a hundred years ago. Beyond the introduction of high shear granulators, fluid bed dryers and granulators, (utilized in a way that would be laughable in the food processing industry), little advance has been made in the basic dry and wet granulating processes, and nothing has occurred that could be called revolutionary in the way of simplification or cost reduction other than the introduction of some direct compression excipients and disintegrants. If anything, the equipment has become more costly and complex, but without a concomitant increase in quality or throughput. Taking these technologies and "continuizing" them is like making a stretch limousine or baja race car out of a Model T Ford - it can be done, but why not start with a leaner and more rational process? (MADG is a promising approach) It is time to question those unit operations that inherently make oversized agglomerates that then have to be correctly sized, and those that overwet the material using excess water that then has to be removed to the correct level by costly drying equipment, before leaping into converting them into continuous processes. The main obstacle to continuous processing of solid dosage forms seems to be that it requires an interdisciplinary approach that is hardly in its infancy, involving formulators, engineers, regulators, and now academics, all of whom have incomplete and sometimes contradictory understanding of what is needed. Pharmacist formulators are not trained in the engineering aspects, neither engineers nor formulators are adequately trained in formulating for effective continuous processing, and regulators have overly imaginative expectations of how it should all operate. Added to this is that the pharmaceutical batch granulating processing itself is being done essentially the same way it was done a hundred years ago. Beyond the introduction of high shear granulators, fluid bed dryers and granulators, (utilized in a way that would be laughable in the food processing industry), little advance has been made in the basic dry and wet granulating processes, and nothing has occurred that could be called revolutionary in the way of simplification or cost reduction other than the introduction of some direct compression excipients and disintegrants. If anything, the equipment has become more costly and complex, but without a concomitant increase in quality or throughput. Taking these technologies and “continuizing” them is like making a stretch limousine or baja race car out of a Model T Ford – it can be done, but why not start with a leaner and more rational process? (MADG is a promising approach) It is time to question those unit operations that inherently make oversized agglomerates that then have to be correctly sized, and those that overwet the material using excess water that then has to be removed to the correct level by costly drying equipment, before leaping into converting them into continuous processes.

]]>