Скачать или смотреть Dissolution 21/62: High-Dose Drugs vs Low-Solubility Drugs — Dissolution Strategy Differences

High-Dose Drugs vs Low-Solubility Drugs — Dissolution Strategy Differences
How Dose Load & Solubility Shape Method Development

Not all dissolution problems are the same.
Some fail because the dose is too high, others because the drug won’t dissolve—and using the same strategy for both is a guaranteed method failure.

In this video, we clearly compare high-dose drugs vs low-solubility drugs, showing how dose load and solubility fundamentally change dissolution design, data interpretation, and regulatory expectations.

If you want to stop forcing methods to work and start designing them correctly, this video is for you.

📌 What You’ll Learn in This Video
🔹 Why This Comparison Matters

Why many dissolution methods fail during scale-up or validation

How misidentifying the real problem leads to wrong fixes

Science-first vs shortcut-based method development

🔹 Understanding the Core Challenge

Dose-limited vs solubility-limited dissolution

How saturation, precipitation, and boundary layer effects differ

Why sink conditions mean different things in each case

🔹 Regulatory Perspective (USP, FDA, ICH)

What USP expects in method justification

How FDA evaluates high-risk dissolution methods

ICH expectations for discrimination and robustness

Common regulatory misunderstandings clarified

🔹 High-Dose Drugs: Key Dissolution Challenges

Media saturation even with good solubility

Volume limitations

Dose dumping risk

High variability between vessels

🔹 Dissolution Strategies for High-Dose Drugs

Volume optimization logic

Controlled agitation (not aggressive RPM)

Media buffering and pH control

Preventing artificial sink conditions

🔹 Low-Solubility Drugs: Key Dissolution Challenges

Slow wetting and poor dispersion

Precipitation during testing

Non-reproducible profiles

Over-dependence on surfactants

🔹 Dissolution Strategies for Low-Solubility Drugs

pH-based solubility enhancement

Rational surfactant selection

Apparatus choice for better hydrodynamics

Avoiding over-solubilization

🔹 When High-Dose and Low-Solubility Overlap

Worst-case dissolution scenario

Why many BCS Class II & IV products fail

Advanced strategies to manage both risks together

🔹 Hydrodynamics Optimization

Boundary layer control explained simply

RPM selection logic for each case

Why one RPM cannot fit all products

🔹 Media Selection Summary Table

Side-by-side comparison for quick decisions

When to change pH, volume, or surfactant

How to document scientific rationale

🔹 Discriminatory Method Expectations

What “discriminatory” really means for each category

How to challenge the method correctly

What regulators actually look for in submissions

👩‍🔬 Who Should Watch This Video?

✔ Dissolution & QC analysts
✔ Formulation & ARD scientists
✔ Method development professionals
✔ Regulatory & ANDA teams
✔ Pharma students learning dissolution strategy