MVIC Study – Different Methodologies for the Assessment o Surface Amorphicity

MVIC has, via its member company Adroit Science, in collaboration with Orion Pharma performed an investigation in an area which has recently attracted a lot of attention. The fact that processed (like milled or micronised) substances always will obtain surface amorphicity, with negative consequences for the performance, has been recognized for some time and was highlighted due to the recent FDA guidance (draft from April 2018). The work focused on the comparison of different methodologies for the assessment of small amount of surface amorphicity on commercial inhalation lactose grades and the results were presented at the 30th Symposium of The Finnish Society of Physical Pharmacy.

Determination of the absolute amount of low amorphous content in commercial inhalation lactose grades: TAM, DSC and GVS compared

Introduction

We addressed the following problems:

  • Processing destroys crystalline surfaces
  • Inconsistency in cohesive/adhesive behavior
  • Manufacturing problems
  • Absolute amount of amorphous content is unknown

We prove the accuracy and compare the sensitivity of the known methods used for quantification of absolute amorphous content of lactose and search for the most versatile method for industry…
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