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A practical framework for comparing amorphous dispersions, nanocrystals, lipid systems, salts, and co-crystals based on how each approach changes the development profile for poorly soluble oral drugs.
This blog examines controlled-substance development from a CMC perspective, with emphasis on how solid form, containment, and supply assumptions can begin interacting earlier than many teams expect. F...
This practical CMC guide explains how apparent solubility, true thermodynamic solubility, and supersaturation differ, and why that distinction matters for solid form selection, dissolution method design, and formulation strategy.
This practical CMC guide shows how humidity and temperature together affect solid forms, influence stability and manufacturability, and support better study design, control strategies, and packaging decisions
Crystal Pharmatech’s integrated mini-tablet platform accelerates development from lab to commercial scale. We provide precision engineering, 505(b)(2) expertise, and high-precision filling for APIs.
A short half-life doesn't rule out QD dosing. By leveraging Modified Release (MR) to flatten PK curves and addressing pillars like absorption windows and solubility, developers can bridge the gap from IR to once-daily regimens, ensuring patient compliance and therapeutic differentiation.
We want to move fast to first-in-human. How quickly can formulation and clinical supply be ready for IND?In the high-stakes world of drug development, speed is the ultimate currency. But as the saying...
Peptide crystallization process development can transform peptide API stability, filtration, and downstream manufacturability. Learn high-throughput screening, salt and polymorph screening, seeding, a...
In the world of drug development, PROTACs (Proteolysis Targeting Chimeras) are notoriously difficult to crystallize. Their high molecular weight, inherent flexibility, and complex surface area often l...
When a compound is both solubility and permeability limited, the reflex is often to reach for ASD. But is that always the right move? We walk through the systematic framework our team uses to find the true bottleneck.
How early formulation decisions shape the entire drug development lifecycle and why getting it right the first time matters more than ever.
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