Learning Centre

ALL NEW! Background Analysis Dissolution Filters Biorelevant media
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Dissolution
Biorelevant media

How food can affect drugs in the FED stomach

In patients with a healthy stomach, a high-fat meal can have multiple...
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Analysis

What is the difference between Drug Substance vs. Drug Product

Whether you're developing an NCE (new chemical entity) or the generic version of a marketed drug, it’s helpful to understand the difference between drug substance and drug product...
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Background

What is a high-fat meal and what is its purpose?

A high-fat FDA meal is a standardized meal that is orally administered along with a drug product to create fed state/condition in human clinical trials...
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Filters

Importance of filtration in dissolution sample preparation for HPLC analysis

Filtration is a crucial step in preparing a dissolution sample. It involves passing the sample through a filter to separate solid particles or undissolved materials...
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Filters

When is a filter adsorption study necessary?

Filter adsorption studies should always be conducted before dissolution studies are carried out when a) a new drug is being tested or b) a different biorelevant medium is being used.
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Filters

Key requirements for filters used in biorelevant dissolution testing

We recommend the use of glass filters with pre-filters built-in. These filters have excellent efficiency in removing particles and do not leach substances into the biorelevant media.
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Dissolution

Two stage biorelevant dissolution

This in vitro experiment simulates the in vivo process when fasted stomach fluid (FaSSGF) containing a drug product is converted to fasted intestinal fluid (FaSSIF).
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Analysis

How to apply a washing cycle when running an HPLC sequence

How to apply a washing cycle when running an HPLC sequence
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Analysis

Signs of column deterioration

Explains what the common indicators of HPLC column deterioration look like
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Analysis

How to store HPLC columns after using Biorelevant Media

How to store HPLC columns in the short, mid- and long term after using Biorelevant Media
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Dissolution

Coning of immediate release drug products in a USP 2

Coning of immediate release drug products is a problem
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Dissolution

What are the signs of coning

Signs and examples of coning in a USP 2 dissolution vessel
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Dissolution

PEAK (Apex) dissolution vessels

This post explains what PEAK (Apex) vessels
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Analysis

What are ghost peaks and why do they occur?

This post describes potential causes of ghost peaks when analysing a drug in biorelevant medium
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What is supersaturation of a drug substance?

This post explains supersaturation of a drug substance
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What is equilibrium solubility of a drug?

This post explains equilibrium solubility of a drug substance in a test medium
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USP <1236>: Solubility Measurements Chapter

This post summarises USP Chapter <1236>
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Filters

Filter design for two stage biorelevant dissolution testing

Filters design for two stage dissolution testing
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Filters

Single vs repeated use of filters for two stage biorelevant dissolution

This post describes best practice use of filters during two stage dissolution testing
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Dissolution

pH reproducibility of Two Stage Biorelevant Dissolution Kit

Learn about pH of FaSSGF and FaSSIF prepared from the Two Stage Biorelevant Dissolution Kit
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Dissolution
Biorelevant media

What is Canine FaSSIF and Canine FaSSGF?

Learn about the three types of canine biorelevant media