Meta title: Water Activity & Hydrates/Solvates in API Development Meta description: Learn how water activity (aw) drives hydrate/solvate form change in APIs—and how to control risk from crystallization to storage and specs.

Hydrates, Solvates, and Water Activity: Managing Moisture-Driven Solid-Form Change in Small-Molecule APIs

You don’t usually see moisture-driven solid-form change coming. A batch looks fine at release. The XRPD pattern matches, residual solvents pass, and water by Karl Fischer is low. Then a week later, after milling, after a liner change, after a stability pull… your API behaves differently. Flow shifts. Compaction changes. Dissolution surprises you. The uncomfortable […]

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Integrating Solid-State Chemistry into Your CMC Strategy 

Every solid form tells a story, one of stability gained or lost, solubility improved or compromised, and formulations that succeed or struggle. But sometimes, perhaps too often, the story begins too late. In many drug development programs, solid-state considerations are only addressed once a compound shows promise in formulation, by which point, key opportunities for

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How Early Formulation Decisions Impact Clinical Success 

Explore how early formulation choices can make or break clinical success. Learn how Solitek’s solid-state expertise helps pharma companies optimize their drug candidates.  Introduction  Did you know that nearly 40% of drug candidates fail due to poor solubility and bioavailability? These failures often stem from decisions made (or overlooked) during the earliest stages of formulation

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Common Misconceptions About Solid State Studies

In pharmaceutical development, solid-state analysis is often treated as a routine checkbox, but this misconception can cost millions. Misunderstanding polymorph behavior or skipping early solid form screening can derail scale-up and compromise drug efficacy. Despite its importance, solid-state analysis is frequently underestimated or misapplied, leading to costly setbacks in scale-up, stability, and regulatory approval.  At

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Critical Factors in the Stability of Pharmaceutical Solid Forms

Approximately 40% of marketed drugs and up to 90% of pipeline compounds are poorly water-soluble. Choosing and controlling the right solid form early—through screening, characterization, and process-ready crystallization—secures exposure and manufacturability while mitigating risks from phase changes and storage-related instability, preventing costly reformulations and keeping CMC timelines on track. At Solitek, we reduce this risk

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Applications of AI in Crystal Structure Prediction for Drug Development

How AI is Revolutionizing Crystal Structure Prediction in Drug Development 

In the fast-paced world of pharmaceutical development, the race to bring new drugs to market is fraught with challenges, one of which is Crystal Structure Prediction (CSP). The way a drug molecule crystallizes can determine its stability, solubility, and ultimately, its effectiveness in patients. A wrong crystal form can derail a drug, costing millions and

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Development of Crystallization Processes: Keys to Purity and Yield in the Pharmaceutical Industry

The development of the crystallization process for the active pharmaceutical ingredient (API) is crucial in the pharmaceutical industry, as it directly influences the purity, stability, bioavailability, and manufacturing of the drug. Optimizing this stage is fundamental to ensure the efficacy, safety, and viability of new medicines. Why Are Purity and Yield Critical in Pharmaceutical Crystallization?

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Screening and Selection of Solid Forms: Optimizing Drug Development

In the pharmaceutical industry, the development of a new drug is a long and meticulous process that requires critical decisions at every stage. One of the fundamental pillars, though sometimes overlooked, is the selection of the solid form of the active ingredient. This choice not only affects the efficacy and safety of the drug but

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Mark Chadwick appointed Solitek's strategic businees adviser

Solitek appoints Mark Chadwick as new Strategic Business Adviser

We’re excited to welcome Mark Chadwick as Strategic Business Adviser at Solitek – Solid Technologies SL! Mark brings a wealth of experience in the life sciences industry, with a proven track record of helping CROs and biotech companies scale and thrive. Over the years, he has successfully guided several organizations through high-growth phases, strategic repositioning,

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Characterization of Solids in the Pharmaceutical Industry: Why is it Crucial?

Imagine taking a tablet to relieve a headache. You trust that it will act quickly and without complications, but what ensures that this medication is safe, effective, and consistent every time you use it? The answer lies in an essential yet little-known scientific discipline outside laboratories: solid-state characterization. In the pharmaceutical industry, this process analyzes

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The Role of Particle Size Reduction in Early Drug Development

Introduction The development of new drugs has become an increasingly complex process, with modern pharmaceutical compounds often exhibiting poor solubility, leading to limited bioavailability and growing challenges in drug formulation. In fact, poor solubility is, probably, the main reason why many promising investigational new drugs (INDs) fail to progress through clinical trials. Thus, addressing solubility

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The 3D structure of the molecule of ritonavir next to the title of the article

Ritonavir: how the discovery of a new polymorph changed drug development forever

First published on Pharma Focus Europe on Oct 9th, 2024 Ritonavir is an antiretroviral drug discovered by Abbott Laboratories to treat acquired immunodeficiency syndrome (AIDS). It was approved by the Food and Drug Administration (FDA) in 1996, and was marketed in semi-solid capsule form under the brand name Norvir. Ritonavir works by inhibiting the growth

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Representatives of Solitek and XtalPi

Solid Technologies and XtalPi Enter into Partnership Agreement on Solid State and Computational Drug Development Services

FOR IMMEDIATE RELEASE Solid Technologies and XtalPi Enter into Partnership Agreement on Solid State and Computational Drug Development Services Barcelona, Spain, and Cambridge, MA – August 6, 2024 – Solid Technologies S.L. (Solitek), a leading provider of solid-state development services, has entered into a strategic agreement with XtalPi Inc., a leading global technology company in

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