Blog - Crystal Pharmatech Co., Ltd.

Blog Technical Insight Case Study Whitepaper Presentation

Blog

Forced Degradation Studies for Candidate Selection: Protocol Design and Common Pitfalls

What a well-designed stress study looks like, how it differs from stability testing, and the design mistakes that undermine a filing.Forced degradation, also called stress testing, is the deliberate e...

05 Aug 2026



Blog

The Preformulation Package: A Section by Section Guide for Small Molecules

A section-by-section guide to the preformulation report: the data that de-risks a program, and how much depth each section needs at each stage. Real Question in Stable Form ScreeningUnderlying the com...

28 Jul 2026



Blog

Choosing a Solid Form Screening Strategy for Stable Crystalline Form Identification

How high-throughput and adaptive manual screening compare when the objective is to identify and confirm the thermodynamically stable form of an API. Real Question in Stable Form ScreeningUnderlying th...

06 Jul 2026



Blog

Salt Screening or Cocrystal Screening? A Decision Framework for Weakly Basic APIs

A practical framework for deciding between salt screening, cocrystal screening, or both when developing a weakly basic API.

22 Jun 2026



Blog

Spray Drying (SD) vs Hot Melt Extrusion (HME): A Detailed Comparison for Amorphous Solid Dispersion (ASD) Development

Amorphous solid dispersions (ASDs) have become one of the most widely adopted enabling oral formulation strategies for poorly soluble drug candidates. By converting crystalline APIs into high-energy amorphous systems, ASDs significantly improve dissolution and oral bioavailability.

22 May 2026



Blog

Polymorph Screening: A Phase-Appropriate Strategy Guide for Small Molecules

What a polymorph screen should cover at each development stage, what outputs to expect, and how to know if yours is thorough enough.

19 May 2026



Blog

Solid Form Changes That Reduce Solubility: Drug Substance and Formulation Risks in Drug Development

Solubility is not a fixed property of a drug. It depends on its physical form. This article examines how polymorphism, salt disproportionation, and amorphous recrystallization reduce solubility during development, manufacturing, and storage, and what each risk requires from the development team.

12 May 2026



Blog

Improving Bioavailability of Poorly Soluble Drugs: A Complete Guide

Poor aqueous solubility is one of the leading causes of failure in oral drug development. Approximately 40% of marketed drugs and up to 70–90% of drug candidates in development exhibit poor aqueous solubility, placing many compounds in Biopharmaceutics Classification System (BCS) Class II or IV categories where dissolution rate or solubility limits oral bioavailability.

08 May 2026



Blog

Why Strong In Vitro Supersaturation Does Not Always Improve Oral Exposure

What the dissolution curve does not show: the mechanisms that determine whether a supersaturating formulation actually delivers oral exposure for poorly soluble drugs. What Supersaturation Ratio Alone...

29 Apr 2026



Blog

What Is Amorphous Solid Dispersion (ASD)? Benefits, Applications, and When to Use It in Drug Development

IntroductionPoor aqueous solubility is one of the leading causes of failure in oral drug development. In fact, ~40% of marketed drugs and up to 70–90% of pipeline compounds exhibit poor water solubil...

28 Apr 2026



Blog

Solubility Enhancement Strategies for BCS Class II and IV Drugs: Which Levers Actually Change Developability

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.

14 Apr 2026



Blog

Developing Controlled Substances in CMC: Where Solid Form, Containment, and Supply Planning Intersect

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...

08 Apr 2026



Blog

Solubility vs. Supersaturation: Why Apparent Solubility Can Mislead Your Development Decisions

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.

02 Apr 2026



Blog

Predicting Solid-Form Change Under Real-World Humidity and Temperature Conditions

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

26 Mar 2026



Blog

Mini-Tablet, Major Impact: From Lab to Commercial Scale

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.

25 Mar 2026



Blog

Short Half-Life vs. Once-a-Day Dosing: Breaking the Barrier

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.

18 Mar 2026



Blog

The Race to FIH: How Fast Can You Reach the Clinic?

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...

12 Mar 2026



Blog

Peptide Crystallization Process Development: A Practical CMC Guide for Peptide APIs

Peptide crystallization process development can transform peptide API stability, filtration, and downstream manufacturability. Learn high-throughput screening, salt and polymorph screening, seeding, a...

11 Mar 2026



Blog

Conquering the “Uncrystallizable”: Advanced Strategies for PROTAC Solid-Form Development

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...

10 Mar 2026



Blog

The “Double-Limited” Challenge: Is ASD Always the Answer?

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.

05 Mar 2026

