Poor aqueous solubility remains one of the most significant challenges in modern pharmaceutical development. With the majority of new chemical entities (NCEs) exhibiting low water solubility, ensuring sufficient drug absorption and therapeutic efficacy has become increasingly complex. Without effective solubility enhancement strategies, many promising molecules face clinical failure due to inadequate bioavailability.
At InnoTech BioPharm Solutions LLC, we specialize in overcoming these challenges through advanced formulation and manufacturing solutions. Solubility enhancement is not a one-size-fits-all approach; it requires a deep understanding of the API’s properties, selection of appropriate technologies, and careful consideration of scalability and regulatory compliance.
This white paper explores the comprehensive strategies we apply at InnoTech - including Amorphous Solid Dispersions (ASDs), nanocrystal technology, lipid-based formulations (SEDDS/SMEDDS), and cyclodextrin complexes. Through real-world case studies, analytical insights, and industrial-scale solutions, we demonstrate how our integrated CMC (Chemistry, Manufacturing, and Controls) services accelerate development, reduce risk, and enable the successful commercialization of poorly soluble APIs.
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