Once the unique properties of your drug substance are assessed, one of Mikart’s formulation experts is assigned to your project to determine complementary excipients. Variables are introduced to challenge materials and processes as control and specification data present opportunities for improved batch design. The quality target product profile (QTPP) is defined based on information gathered during pre-formulation (drug substance properties, evaluation of RLD), and the critical quality attributes (CQA) of the dosage form are identified.
|Container/closure system compatibility studies|
|Drug-excipient interaction studies|
|Quality-by-design (QbD) principles|
|Tablet Scoring Studies|