In what will be our 7th showing, we are bringing together 2 leading industry experts who will be covering topics around pre-formulation & characterisation strategies for poorly soluble drugs.
In this webinar, we will consider the role which material characterisation methods play in enabling the development of new oral solid dose products. We will introduce the typical workflow and regulatory frameworks associated oral solid dose development and the techniques which are available to support these. We will then present case studies which confirm how development of a detailed physicochemical understanding of an API can enable more rapid formulation development through highlighting the most likely successful formulation strategies.
Oral Solid Dose formulations remain the dominant delivery method for pharmaceutical products, accounting for over 60% of global pharmaceutical sales. Oral solid dosage forms such as tablets and capsules offer a cost-effective route of administration which also delivers high patient compliance. As a result, Oral Solid Dose formulations still accounted for over 50% of New Chemical Entity (NCE) applications lodged with the FDA in the past 5 years, with companies looking to access the advantages such formulations provide in terms of physical and chemical stability, and the possibility of product differentiation through developing controlled release capabilities.
Although the outlook for oral solid dose remains positive, there are significant challenges associated with product development, especially for NCEs which show low solubility or have a narrow therapeutic window. For these products, successful product development depends upon understanding and controlling the critical material attributes of the APIs and excipients. Here, physicochemical analysis has a key role to play in not only confirming the API form but also understanding its interaction with functional excipients within the formulation.
Free registration is now open, click here to find out more.
Team Leader – Advanced Materials (Malvern)
Chief Technical Officer (Concept Life Sciences)
Since launch in December 2014, the Concept webinar series has aimed to provide an informative, interactive seminar looking to explore key topics within the drug discovery industry.
Catch up on the series so far:
- Antibody Drug Conjugates
- Stable-Isotope Labelled Compounds: Synthesis and Applications
- Early Developments in Drug Discovery Science – Understanding Compound Liability/Toxicity in Early Discovery
- Solid Forms in Drug Discovery
- Modified Sugars to Stabilise Nucleic Acid Duplexes for Therapeutic Applications
- Sugar Modified Nucleosides and Nucleotides: The Synthesis of Anti-Viral Drugs