Spray drying active pharmaceutical ingredients (APIs) in solution to overcome solubility hurdles requires part craft and great attention to process variables. Today’s APIs are increasingly insoluble and that is presenting new problems for formulators looking to manage the bioavailability and dosing of their formulas. In this article, Javier Gurrea from Idifarma, explains how expertly applied spray drying technology offers drug innovators a faster route to higher-performing drugs.
Extract:
‘Formulation and Process Considerations for Optimising Spray-Dried Solid Dispersions’
Spray drying active pharmaceutical ingredients (APIs) in solution to overcome solubility hurdles requires part craft and great attention to process variables. In this article, Javier Gurrea, a spray drying manufacturing specialist from Idifarma, explains how expertly applied spray drying technology offers drug innovators a faster route to higher-performing drugs.
Although a technically challenging process, spray drying is a mature, well understood technique capable of transforming solutions or suspensions into solid particles. Although this process has been widely used in diverse industrial fields, it has become more and more demanded in pharmaceutical applications for the production of solid dispersions (SDSDs).
Pharma leveraging SDDs more than ever
Today’s APIs are increasingly insoluble and that is presenting new problems for formulators looking to manage the bioavailability and dosing of their formulas. As a result, a significant number of therapeutics gaining approval recently possessed poor biopharmaceutical properties that had to be managed through advanced processes and formulation strategies.
Improving the bioavailability of these new and existing drugs is turning out to be big business for contract development and manufacturing organizations (CDMOs) as pharma’s drug developers look to exploit both accelerated new chemical entity (NCE) and existing drug development pathways.
Several of the most popular drugs on the market today have had to manage poor solubility and low bioavailability. That trend isn’t slowing either. Pharma industry analysts estimate that as many as 40% of approved drugs and nearly 90% of the developmental pipeline drugs consist of poorly soluble molecules.
For developers, changing formula chemistries and identifying different routes of administration are just a few of the ways the industry is seeking to profit from accelerated drug development routes including 505(b) New Drug Applications (NDAs). The industry is finding that redeveloping existing formulations can quickly improve the therapeutic value of existing drugs to both payer and patient.
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