Is our understanding of stability changing?

Chemistry, manufacturing and controls (CMC) and quality by design (QbD) thinking, carries over in formulations into stability considerations. Gain a greater understanding of stability testing and how new technologies and distribution platforms are making a difference.

Register Free: https://www.pharmtech.com/pt_w/stability-changing

Event Overview:

In this exclusive Drug Digest video interview, Chris Spivey, Editorial Director, Pharmaceutical Technology, talks with industry experts about various aspects of drug product stability testing. Stability studies involve a drug substance tested under storage conditions and assess its thermal stability and sensitivity to moisture. Over the last decade there has been some intermixing of supply chain storage and distribution systems, and traditional formulations taking these storage and delivery systems into account – continuous monitoring comes to mind. While long-term testing should be performed over a minimum of 12 months at 25 °C ± 2 °C/60% RH ± 5% RH or at 30 °C ± 2 °C/65% RH ± 5% RH. The intermediate and accelerated testing should cover a minimum of 6 months at 30 °C ± 2 °C/65% RH ± 5% RH. Accelerated Predictive Stability (APS) studies, carried out over a 3–4-week period and combining extreme temperatures and RH conditions (40–90 °C)/10–90% RH, have emerged as novel approaches to predict the long-term stability of pharmaceutical products in a more efficient and less time-consuming manner.

This episode of Drug Digest is sponsored by:

• Solvias

Key Learning Objectives:

• Most important aspects to test for in considering formulation choices, eg crystallization
• Is there a commercial trade-off to these choices?
• Understand potency loss versus microbial activity in high water content formulations
• Are accelerated tests an unalloyed aid, or are there downfalls?
• Special consideration needed for excipients versus API’s – (eg glycerol degradation)
• Delivery method formulation dependent stability considerations

Who Should Attend:

• Medicinal chemists
• CDMOs
• Formulation scientists
• Manufacturers
• Excipient and API manufacturers
• Purchasers and supply chain
• QA/QC personnel
• R&D personnel
• Development scientists

Speaker:

Nitin Swanaker
Pharma Applications Manager
BASF

Nitin Swanaker is a Formulation scientist with over 16 years of combined (academic research/training/industrial) experience, and a very strong track record of publications, primarily focused on various formulation aspects of small, peptide and protein molecules for oral and parenteral applications. He has vast experienced in solid, solution, suspension, semisolid products and novel drug delivery systems such as lipid- and polymer-based drug delivery systems (proliposomes and liposomes, liquid crystalline particles nanoparticles and microspheres) including their targeted drug delivery counterparts. He is well-versed in various characterization techniques used in formulation development, possesses a good understanding of various regulatory guidelines and cutting edge concepts and technologies.

Register Free: https://www.pharmtech.com/pt_w/stability-changing