API solid state characterization in preformulation studies

15 September
09:00 – 12:00 (3 hours)
Provided by: Dr. Judith Aronhime, Consultant: Pharmaceutical polymorphism and solid state analysis, Israel

Solid oral dosage forms are the most cost-effective means of drug delivery. Many challenges need to be overcome for a successful development. One important step is finding a suitable solid crystalline form of the active pharmaceutical ingredient (API) for accomplishing successful biostudy. Also, a robust manufacturing process and consistent quality of the pharmaceutical product is crucial for manufacturing with minimal failures, and may be achieved by identifying and controlling critical physical properties of the active pharmaceutical ingredient.

The formulator carries out a design study in search of a formulation that meets criteria set for the stability, dissolution, tablet hardness, and bioavailability. The physical properties of the API (as well as the excipients) play a major role in meeting the aforementioned criteria. Lack of full characterization of the API may lead later to sudden problems in manufacturing, and failed batches. Those problems are frequently associated with undetected physical phenomena (batch-to-batch variations), and the stage at which problems occur, usually in production, is usually too late for any attempt to understand the underlying cause.

This short course will review the physical properties of API powders which have inpact on formulation requisites, with focus on understanding their dependence on structural properties of the particles/crystals. Analytical methodologies will be reviewed as well.

The course is targeted to:
Solid-state chemists/analysts and analytical chemists
API R&D researchers
Formulators
Pharma R&D researcher
RA, QA

ehudith 

Dr Judith Aronhime is a consultant in the field of pharmaceutical polymorphism and pharmaceutical solid state science. She has accumulated 27 years experience in her former position in Teva TAPI global R&D management as responsible for all the solid state aspects of the active pharmaceutical ingredients (APIs). In this key role she gained expertise in scientific analysis, characterization, development and research of polymorphism and all solid state attributes of API's, along with the scientific support provided to patent litigations, prosecutions and clearances.
She was a key contributor to TEVA worldwide leadership position in the intellectual property domain by searching new crystal forms of APIs. Part of those became API ingredients in the marketed TEVA products.
Author and contributor to more than 100 patents and current applications.