Overview
More than 70 percent of all small molecule new chemical entities (NCEs) are poorly soluble. Yet these molecules could be powerful therapeutics for a wide variety of diseases including cancer, cardiovascular disease, infectious diseases, and diabetes.
There are several formulation techniques currently used by pharmaceutical scientists that aim to tackle solubility challenges. However, existing manufacturing technologies cannot overcome all formulation hurdles. Many APIs are sensitive to very high temperature processing or mechanical stress, and NCEs commonly have melting points well above 200°C. The API solubility in organic solvents is often limited, which leads to low spray solution concentrations and long processing times when using standard spray dried dispersion (SDD) techniques. Furthermore, poor particle size and distribution control, as well as poor flowability of the final powder can require additional post-processing steps, resulting in increased manufacturing time and costs.
Emulsion-based microparticles have a long and successful history in pharmaceutical dosage forms for parenteral drug delivery. Several microparticle-based drug products have been developed and marketed over the past few decades. By leveraging science and established manufacturing principles, we have developed a new process technology using emulsion-based microparticles to convert poorly soluble drugs into soluble amorphous solid dispersions (ASDs) and overcome existing process hurdles.
In this webinar we present this new manufacturing technology and support services for particle-engineered free-flowing ASDs for oral drug delivery. Our speakers will walk you through the approach and outline the benefits, including how this process technology option can be easily integrated to reduce costs, improve drug quality and consistency. Through detailed discussions of case studies, we show how solubility and pharmacokinetic performance can be enhanced.
Learning objectives of this webinar will be:- Understand the challenges of solubility enhancement
- Gain an overview of how microparticle-based ASD technology can be integrated into the full drug product process from pre-selection, to clinic to commercial use
- Examine case study findings on solubility enhancement and pharmacokinetic performance
- Learn about the benefits of the newly launched technology, EUDRATEC® SoluFlow
Who will benefit most from this webinar:- Drug discovery scientists
- Pre-formulation and formulation scientists
- Senior management of pharmaceutical and biotechnology companies
- Professors and researchers in the fields of pharmaceutical sciences and drug delivery
- Regulatory professionals
