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Learning Centre

ALL NEW! Background Biorelevant media Analysis Filters Dissolution tips Guides and Calcs Dissolution

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Two stage biorelevant dissolution of Stugeron® (cinnarizine 15 mg)

This post describes the results of two stage biorelevant dissolution of cinnarizine tablets in a USP 2 dissolution apparatus

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Dissolution tips

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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Dissolution tips

pH reproducibility of two Stage biorelevant dissolution kit

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

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Filters for two stage dissolution testing

This post describes filters designed for two stage dissolution testing

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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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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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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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What is simulated intestinal fluid USP (with or without enzyme)?

This post describes simulated intestinal fluid USP (with and without enzyme)

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A comparison of USP-SIF (sp) with biorelevant FaSSIF medium

This post compares and contrasts USP SIF with FaSSIF medium

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What are Gastric fluid, simulated, TS (Test Solution) and USP-SGF (sp)?

This post explains what are Gastric fluid, simulated, TS and USP-SGF (sp).

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USP <1236>: Solubility Measurements Chapter

This post summarises USP Chapter <1236>

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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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What is supersaturation of a drug substance?

This post explains supersaturation of a drug substance

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What is the difference between a drug product and a drug substance?

If you're developing an NCE (new chemical entity) or generic drug it’s helpful to understand the difference between drug substance and drug product.

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Biorelevant media

Dissolution tips

How can biorelevant media be discriminatory?

When selected and used correctly, Biorelevant Media are perfect discriminatory dissolution tools for evaluating a Test formulation against the Originator.

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Dissolution tips

Biorelevant Dissolution Test Method

Our biorelevant dissolution test method uses standardized USP apparatus and works for most immediate release oral dosage forms (e.g. BCS Class 2 or 4 drugs).

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Biorelevant media

How Biorelevant Media can help develop generic drugs

In vitro dissolution profiles of a Test Formulation vs the Reference in Biorelevant Media will reveal how similar drug release and dissolution rates will be in vivo.

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Biorelevant media

How Biorelevant Media can help develop new drugs (NCEs)

Biorelevant tests provide important information on the amount of drug (solubility) and speed (dissolution) at which NCEs will dissolve within gastrointestinal fluids.

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Biorelevant media

The importance of using Biorelevant's Buffer Concentrates

Biorelevant’s Buffer Concentrates have been designed to be used with our powders to provide a simple and accurate way of preparing biorelevant dissolution media.

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Biorelevant media

pH reproducibility of FaSSIF/FeSSIF/FaSSGF made from 3F Powder + Buffer Concentrates

Maintaining a consistent pH is essential to achieve reproducible solubility and dissolution results of drugs that have different aqueous solubility in the physiological range of the human gut.

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Biorelevant media

What is FaSSIF?

FaSSIF (Fasted State Simulated Intestinal Fluid) is a biorelevant test medium that replicates small intestinal fluid after drinking a glass of water.

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Biorelevant media

What is the composition of FaSSIF?

FaSSIF contains the same type and level of surfactants (bile salt and phospholipid) present in the gastrointestinal fluid it replicates.

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Biorelevant media

What is FeSSIF?

FeSSIF (Fed State Simulated Intestinal Fluid) is a biorelevant test medium that replicates biliary secretions present in small intestinal fluid after eating food.

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Biorelevant media

What is the composition of FeSSIF?

In response to eating a meal, the upper intestines secrete surfactants (bile salt and phospholipid) to help break the food down. FeSSIF contains the same types and levels of these surfactants.

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Biorelevant media

What is FaSSGF?

FaSSGF (Fasted State Simulated Gastric Fluid) is a biorelevant test medium that replicates gastric fluid after drinking a glass of water.

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Biorelevant media

What is the composition of FaSSGF?

In vivo gastric fluid in the fasted state contains low levels of surfactants refluxed back into the stomach from the upper section of the small intestine. FaSSGF contains the same type and low level of these surfactants (bile salt and phospholipid).

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Biorelevant media

What is a High-Fat FDA meal?

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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Biorelevant media

How can food affect drugs in the fed stomach?

In patients with a healthy stomach, a high-fat meal can have multiple effects on the stomach and its fluids.

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Biorelevant media

What is FEDGAS?

FEDGAS (Fed Gastric Fluid) biorelevant media are analytical laboratory test solutions that simulate different types of stomach fluids after eating an FDA meal.

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Biorelevant media

What is the composition of FEDGAS?

FEDGAS in vitro test solutions simulate stomach fluids after consumption of a high-fat FDA meal. 900mL of FEDGAS medium contains the same amount of fat present in this meal.

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Biorelevant media

FeSSGF vs FEDGAS: a comparison

FeSSGF (Fed State Simulated Gastric Fluid) vs FEDGAS (from Biorelevant): comparing physical stability, reproducibility, fat content, filterability and usability.

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Biorelevant media

Which ingredients are in FaSSIF-V2 Powder?

Which ingredients are in FaSSIF-V2 Powder?

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Biorelevant media

Biorelevant's improved buffer for FaSSIF-V2

Biorelevant has developed an improved buffer concentrate for preparation of FaSSIF-V2 to overcome the limitations of the previous maleic acid buffer system.

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Dissolution tips

Dissolution profiles in FaSSIF-V2

Ibuprofen, Carbamazepine and Diclofenac dissolution profiles in FaSSIF-V2 made using FaSSIF-V2 Powder + Buffer Concentrate.

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HPLC parameters using FaSSIF-V2

To compare HPLC profiles of FaSSIF-V2 made with our Buffer Concentrate vs buffer from scratch, the following HPLC method has been used for the different experiments.

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Biorelevant media

Which ingredients are in FeSSIF-V2 Powder?

This post describes the ingredients in this fed state biorelevant intestinal medium and its preparation.

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Biorelevant media

An improved Buffer Concentrate for preparation of FeSSIF-V2

An improved Buffer Concentrate for preparation of FeSSIF-V2 has been developed to overcome the limitations of the previous maleic acid buffer system.

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Dissolution tips

Dissolution profiles in FeSSIF-V2

Dissolution runs, using USP Dissolution Apparatus 2, were carried out at 37°C with 900mL of the FeSSIF-V2 media.

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HPLC Parameters using FeSSIF-V2

To compare the HPLC profiles of FeSSIF-V2 prepared using a) FeSSIF-V2 Powder with FeSSIF-V2 Buffer Concentrate and b) FeSSIF-V2 Powder with buffer made from scratch, the following HPLC in-house method has been used throughout the different experiments.

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Biorelevant media

Dissolution tips

What is Canine FaSSIF and Canine FaSSGF?

Learn about the three types of canine biorelevant media

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The BCS (Biopharmaceutical Classification System)

The ‘BCS’ is a systematic way of classifying orally administered pharmaceutical drugs based on water solubility and drug permeability.

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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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What is filter compatibility and why is it so important?

There are two aspects of filter compatibility that the dissolution scientist should consider...

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Sample requirements for a drug filter adsorption study

To conduct a drug filter adsorption study, typically, a sample representing around 10% to 20% of drug release from the immediate-release dosage form in the dissolution vessel is needed.

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How to analyse your drug in Biorelevant Media

Analysing your drug in Biorelevant Media is quite simple; it is just like analysing drugs in other test solutions.

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What is a diluent?

A diluent is a solvent which is added to standard solutions of a drug substance...

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How to dilute and prepare standards

There are three types of standards that need to be prepared when analysing dissolution samples...

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Which dilution ratio to select for HPLC analysis

A suitable diluent ratio should not only keep the sample chemically and physically stable but should also allow the drug to be detected accurately and precisely by HPLC.

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Why Biorelevant Dissolution samples should be diluted for HPLC analysis

Immediately diluting biorelevant dissolution samples with an appropriate organic diluent prevents drug precipitation.

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How to dilute your secondary standard (SS) and dissolution samples with 1:10 dilution ratio whilst keeping the same matrix

The dilution of standard containing biorelevant medium is slightly different from the biorelevant dissolution sample...

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How to examine compatibility and dilution ratio of diluent with Biorelevant Media

Before HPLC analysis of any biorelevant dissolution sample containing drug, it is important to have identified a compatible diluent for the biorelevant media that will be used.

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Why are specificity and precision required with biorelevant media?

Biorelevant dissolution media contain natural surfactants which can affect chromatographic properties leading to erroneous analytical results.

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When are specificity and precision required when testing drugs in biorelevant media using HPLC??

Specificity and precision when analysing drugs in biorelevant media by HPLC

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What is 'specificity'?

Specificity is an integral part of analytical method validation and must be performed by carrying out multiple injections to eliminate potential errors that can occur during experimental sequence.

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How to prepare working sample of dosage unit(e.g. drug and excipients) with biorelevant medium to check interference

Three steps are required to prepare the working sample of dosage unit...

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Which solutions are required to check for interference

The following solutions should be tested to check for interference...

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Why include Biorelevant Media in working standards (WS)

It is important to include a biorelevant medium when diluting the secondary standard (SS) as it keeps the matrix of working standard (WS) and biorelevant dissolution samples similar.

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Selecting the drug concentration range of linearity standards (LS)

The linearity of an analytical method enables (over the range of dissolution concentration) generation of test results...

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What is 'precision'?

The degree of deviation between a set of measurements obtained from multiple analysis of the same homogenous sample under the specified conditions expresses the precision of an analytical method.

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How many HPLC injections are needed when carrying out specificity and precision?

For specificity and precision tests, it is recommended to carry out a similar number of injections that cover the number of samples that will be analysed by HPLC.

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Checking interference by injecting the dosage form in biorelevant medium

Interference of non-drug peaks (originating for example from excipients) should also be evaluated via specificity and precision using a sample which contains the dosage form.

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What to do if the retention time of a drug is reduced during HPLC analysis

Reduced retention time during HPLC analysis

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Which factors can increase the retention time of an analyte during HPLC analysis

Which factors can increase the retention time of an analyte during HPLC analysis

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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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Signs of column deterioration

Explains what the common indicators of HPLC column deterioration look like

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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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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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Dissolution tips

Coning of immediate release drug products in a USP 2

Coning of immediate release drug products is a problem

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Dissolution tips

What are the signs of coning

Signs and examples of coning in a USP 2 dissolution vessel

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Dissolution tips

PEAK (Apex) dissolution vessels

This post explains what PEAK (Apex) vessels

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Guides and Calcs

HPLC mobile phase selection for biorelevant samples

This post describes selection of mobile phase for biorelevant samples analysed by HPLC

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Guides and Calcs

HPLC column selection for analysing samples containing biorelevant medium

This post explains HPLC column selection for analysing samples containing biorelevant medium

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Guides and Calcs

What is Maximum drug concentration calculator?

Before making PS, calculate theoretical maximum drug concentration required for analysis...

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Guides and Calcs

What is Primary standard target concentration calculator?

This calculator helps you to figure out what will be the concentration of primary standard according to the amount of drug in the dosage form

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Guides and Calcs

What is Primary standard (PS) calculator?

The purpose of the primary standard is to serve as a concentrated standard/stock for subsequent preparation of secondary standard, multiple standards or dilutions of known drug concentrations.

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Guides and Calcs

What is Secondary standard (SS) calculator?

Secondary standard is required to improve the accuracy of drug concentration and has an intermediate drug concentration. For the preparation of secondary standard, dilution of primary standard is carried out.

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Guides and Calcs

What is Highest (HD) and Lowest drug (LD) concentration standards calculator?

The highest and lowest drug concentration standards are used to check whether the analytical HPLC method can accurately and reliably quantify the drug at both extremes of concentration.