Sponsor's Content

Topical semi-solids, like creams, lotions and ointments are comprised of a complex mixture of microstructures or colloidal phases, frequently referred to as the Q3. These microstructures may include micelles, lamellar phases, polymer matrices, liquid crystalline and crystalline states of wax excipients, as well as the solid states of active pharmaceutical ingredients. Different topical medicated semi-solid formulations, spanning a range of treatment indications, reveal a variety of different microstructures.

The interview will examine the importance of Microstructure in topical pharmaceutical drug development and how BASF is playing an integral leading role in this ‘hot topic’ in the Industry. Information will be provided that highlights the importance of this topic as it relates to the FDA and complex regulatory landscape. BASF will also describe its current work in this area as well as future steps.

With the increase in the drug counterfeiting across the world, many countries along with the Global Standards body (GS1) have come up with various country regulations which can keep counterfeiting at bay. With Serialization and new traceability requirements in many countries, the life sciences industry is undergoing a paradigm shift in the way it labels and transacts sales of prescription drugs and biologic products.