Technical Article - Crystal Pharmatech Co., Ltd.

Technical Article

Predicting Physical Stability of Amorphous Solid Dispersions (ASD)

01 IntroductionAt present, new drug compounds are becoming increasingly complex, and the proportion of poorly water-soluble drugs continues to rise. It is estimated that 40% of marketed oral drugs and...

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Technical Article

Crystal Pharmatech Viewpoint: Analysis of Crystal Form Patent Layouts for Small Molecule New Drugs Approved by the FDA in 2025

1. Overview of FDA New Drug Approvals in 2025In 2025, the U.S. Food and Drug Administration (FDA) approved a total of 46 new drugs [1], including 34 new molecular entities (NMEs). Among these, 30 are ...

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Technical Article

Determination and Control of Crystal Form in ASD Formulations: A Case Study on Everolimus Tablets

Amorphous solid dispersion (ASD) is a formulation strategy in which a drug is molecularly dispersed in a suitable polymer matrix, forming an amorphous solid solution or suspension that can markedly en...

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Technical Article

Holistic Polymorph Screening - Identify the Lead Crystal Form and Accelerate CMC Progress

From early developability to late-stage specifications—polymorph/salt-cocrystal strategy, SCXRD/MicroED solutions, solvent & pathway design, drug-product form control, ASD crystalline-form limits...

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Technical Article

Mol2Med™ Developability Assessment: Material-Sparing, Rapid Studies, and Developability Strategies

From early developability to late-stage specifications—polymorph/salt-cocrystal strategy, SCXRD/MicroED solutions, solvent & pathway design, drug-product form control, ASD crystalline-form limits...

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Technical Article

Solid-State, Crystallization, and CMC Control for Drug Development – A Crystal Pharmatech Case Study Series

From early developability to late-stage specifications—polymorph/salt-cocrystal strategy, SCXRD/MicroED solutions, solvent & pathway design, drug-product form control, ASD crystalline-form limits...

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Technical Article

Application of Compaction Simulation Technology in the Development of Oral Solid Dosage Forms

Characterization of powder mechanical properties and systematic study of powder compression are critical for guiding formulation and process development, enabling tableting scale-up across product lif...

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Technical Article

Enhancing Drug Product Performance Through Spray Drying Parameter Optimization

As amorphous solid dispersions (ASDs) and their formulations advance from lab-scale research to clinical trials and, ultimately, to commercial production, manufacturing scales increase from grams to k...

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Technical Article

Focus on PROTAC Compounds: Development Strategy

This series looks at the physicochemical challenges of PROTAC compounds. It explains how polymorph screening, salt/cocrystal optimization, and formulation and dosage-form development can improve solub...

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Technical Article

How to Mitigate Disproportionation of API Salts in Pharmaceutical Formulations

Salt formation is a well-established strategy for improving the physicochemical properties of active pharmaceutical ingredients (APIs) containing ionizable groups. This approach is particularly effect...

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Technical Article

Crystal's Perspective: Polymorph Patent Landscape of 28 FDA-Approved Small Molecule Drugs in 2024

Crystal’s Perspective: Polymorph Patent Landscape of 28 FDA-Approved Small Molecule Drugs in 2024 In 2024, the U.S. Food and Drug Administration (FDA) approved a total of 50 new drugs [1], including ...

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Technical Article

Concerned about mRNA -LNP Integrity during International Shipping?

Several batches of mRNA-LNP samples, shipped by CATUG (CDMO in China), were subjected to Quality Control-style testing performed at the receiving site (Crystal Bio, New Jersey, USA) to address the con...

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Technical Article

Optimizing Polymer Selection for Amorphous Solid Dispersion in Hot Melt Extrusion Processes

Hot melt extrusion (HME) technology is widely used in the development of amorphous solid dispersions, offering advantages such as a solvent-free preparation process, continuous operation, high automat...

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Technical Article

ADME Simulations: Insights into Bioavailability and Pharmacokinetics

How Crystal Pharmatech, a leading CRDMO, leverages GastroPlus® to guide small molecule development and manufacturing decisions.GastroPlus® BackgroundGastroPlus® is an advanced software tool used in...

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Technical Article

Characterization and Evaluation of Amorphous Solid Dispersion-Part 2

Amorphous solid dispersion (ASD) offers enhanced solubility over crystalline forms due to its elevated Gibbs free energy. Additionally, ASD is capable of maintaining high levels of supersaturation in ...

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Technical Article

Characterization and Evaluation of Amorphous Solid Dispersion (ASD) - Part 1

In previous articles, we have explored prevalent techniques for producing Amorphous Solid Dispersion (ASD), such as spray drying and hot melt extrusion, highlighting their respective benefits, limitat...

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Technical Article

Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions

In recent years, the utilization of Amorphous Solid Dispersions (ASD) has gained increasing interest, particularly for enhancing the solubility of drugs with inherently low solubility. Within ASDs, dr...

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Technical Article

Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023

In 2023, the FDA's Center for Drug Evaluation and Research (CDER) approved a total of 55 new drugs, which included 38 new molecular entities, of which 30 were small molecule drugs. In terms of adm...

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Technical Article

Development and Production Application Cases of Amorphous Solid Dispersion Formulations (II) - Spray Drying

In the preceding article, we discussed the application of hot-melt extrusion technology in developing amorphous solid dispersions (ASD) for pharmaceutical formulations. The process involves dispersing...

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Technical Article

Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion

Hot-melt extrusion (HME) is recognized as an optimal and efficient technique for manufacturing amorphous solid dispersions, characterized by its continuous processing, increased production efficiency,...

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Technical Article

Understand ASD Manufacturing Strategies, Choose the Optimal One

Preparation Method of Amorphous Solid DispersionsAlthough various techniques are currently available for preparing amorphous solid dispersions (ASD), the fundamental principles governing their formati...

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Technical Article

A Brief Introduction to Amorphous Solid Dispersion Technology

The swift advancements in pharmaceutical technology are consistently leading to significant breakthroughs in the realm of small molecule development. In this scenario, pharmaceutical formulations are ...

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Technical Article

Unlock Solubility Enhancement Methods for Poorly Soluble Oral Drugs

Oral solid drugs are widely used in the pharmaceutical industry due to good stability, cost-effectiveness, and convenient portability and administration. Oral drug absorption relies on dissolution as ...

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Technical Article

Applications of Dynamic Moisture Adsorption in Crystal Research

Content Overview1. Introduction2. Regulatory Requirements3. Application of Dynamic Vapor Sorption (DVS)3.1 Instrument Introduction3.2 Application 1 - Moisture Sorption Assessment3.3 Application 2 - Va...

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Technical Article

Shining Glory: Unveiling the “True Eye” behind the Veil of Drug Crystal Forms

Are you still troubled by the characterization of solid state?How to determine whether the prepared crystal form is the same?Compounds have polymorphism. Is it necessary to conduct impurity crystal fo...

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Technical Article

Application of Granularity Analysis in Crystal Typing Research

This article series is initiated and compiled by the Crystalline Cloud Solid-State Testing Center. Its aim is to create a platform for exchange and learning among industry peers. We intend to explore ...

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Technical Article

Polymorphs, Solvatomorphs and Hydrate of Dabrafenib

The solid-form screening and selection of active pharmaceutical ingredients (API) are crucial steps in the process of process development.

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Technical Article

Amorphous Solid Dispersion Technology and the Service Advantages of Crystal Pharmaceutical

With the rapid development of biopharmaceutical technology, the field of small molecule drug discovery continues to achieve significant breakthroughs. In this context, pharmaceutical formulations play...

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Technical Article

Development and Production Application Case Study of Amorphous Solid Dispersions: Spray Drying

In the previous article, we introduced the application of hot-melt extrusion technology in the development of amorphous solid dispersions in pharmaceutical formulation. Spray drying (SD) is another co...

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Technical Article

Case Study on Development and Production Applications of Amorphous Solid Dispersions - Hot Melt Extrusion

Hot melt extrusion (HME) is a common formulation technology for amorphous solid dispersions (ASD) with advantages such as continuity, high production efficiency, low energy consumption, and environmen...

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Technical Article

ASD Column | How to Select Polymers in Hot-melt Extrusion Process?

Hot melt extrusion (HME) technology is widely used in the development of amorphous solid dispersions (ASD) due to its advantages such as solvent-free processing, continuous manufacturing, high automat...

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Technical Article

ASD Column | Understanding the ASD Preparation Methods and Selecting the Optimal Method for Solution

In the previous article Mastering the Art of Stability, we revealed the key factors influencing the physical stability of amorphous solid dispersions (ASDs) and recognized that choosing th...

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Technical Article

ASD Column | Mastering Stable Art: Unveiling Key Factors Influencing Physical Stability of Amorphous Solid Dispersions

/ Formulation Rightthe First Time /In recent years, amorphous solid dispersions (ASD) have attracted attention due to their ability to significantly improve the solubility of poorly soluble drugs. Sin...

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Technical Article

Fun Sharing：The Story Between Ice Crystals and Frozen Foods (Part 3)

Our sincere suggestion—how to improve the quality of food affected by ice crystals Choose frozen food It is internationally recognized that when the central temperature of frozen food reaches -18℃ r...

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Technical Article

Fun Sharing: The Story of Ice Crystals and Frozen Foods (Part 2)

Ice crystals: Some times I really can't help myself, so let's hear it from me.The influence on food freezing: ice crystal behavior during fast/slow freezing and thawing of foodFor the growth o...

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Technical Article

Fun Sharing: The Relationship Between Ice Crystals and Frozen Foods (Part 1)

Development of Frozen Food It is hard to tell when various brands of frozen dumplings, glutinous rice balls, hand-grabbed pancakes, and frozen meats have filled up the freezer compartment of our refri...

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Technical Article

Fun Sharing: The Secret behind the Silky Smooth Enjoyment of Chocolate (Part 3)

How to Improve Chocolate ProcessingThe transformation from metastable crystal forms to stable crystal forms is inevitable, it's just a matter of time. Therefore, no piece of chocolate can escape f...

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Technical Article

Fun Sharing: The Secret Behind the Silky Smoothness of Chocolate (Part 2)

The story behind the perfect chocolateThe control of the crystal structure V's nucleation, growth, and stability in the polymorphic system, which is so close and easy to transform each other, has ...

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Technical Article

Fun Sharing: The Secret Behind the Silkiness of Chocolate (Part 1)

Origin of Chocolate HistoryFor some reason, chocolate seems to be inherently regarded as a symbol of romance, appearing in literary works and love connections between people. Its unique rich and silky...

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Technical Article

Learn about Drug Eutectic Screening

The selection of solid forms of drugs is an important factor to be considered in the study of drug preparations. The solid form of drugs mainly includes polycrystalline form, salt, hydrate or solvate,...

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Technical Article

Crystallization Process Method

Crystallization is the process by which a substance is precipitated in a crystalline state from a vapor, solution, or molten substance. When drugs crystallize, if different solvents and processes are ...

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