Biorelevant Media 101
How matching dissolution profiles in Biorelevant Media will help identify which Test Formulation will be bioequivalent to the Reference
Generating in vitro dissolution profiles of a Test Product and Reference in this Biorelevant Medium reveals the rates of drug release in vivo
FeSSIF (Fed State Simulated Intestinal Fluid) is a biorelevant test medium that replicates biliary secretions present in small intestinal fluid after eating food
Although drugs are not generally absorbed in the stomach, the interaction with stomach fluid can influence the solubility and dissolution of many drugs greatly and impact on the subsequent absorption
FEDGAS dissolution media contain the full level of fat of an FDA meal along with carbohydrates, water soluble fibre and the low level of bile salts that is present in actual fed state stomach fluid due to intestinal reflux
Biorelevant Media: Discriminatory Dissolution Tools
Interaction of formulations with physiological components of Biorelevant Media mimic wetting and dissolution processes that occur in vivo
How to analyse your drug in Biorelevant Media
After drug separation, the medium (containing dissolved drug) is best analysed by HPLC. HPLC avoids potential interference of the media and can identify possible drug instability
How to carry out Biorelevant Dissolution
The test is based around USP Chapter <1092> 'The Dissolution Procedure' but it's specifically designed for BCS Class 2 drugs in any Biorelevant Media
The BCS (Biopharmaceutical Classification System)
Understanding a drug’s BCS class can help guide formulation development and assess development risk and difficulty
An improved buffer concentrate for preparation of FaSSIF-V2
An improved buffer concentrate for preparation of FaSSIF-V2 has been developed to overcome the limitations of the previous maleic acid buffer system.
HPLC Parameters using FaSSIF-V2
Comparing HPLC profiles of FaSSIF-V2 made using Buffer Concentrate versus FaSSIF-V2 made using buffer from scratch
Dissolution profiles in FaSSIF-V2
Ibuprofen, Carbamazepine and Diclofenac dissolution profiles in FaSSIF-V2
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.
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.
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.
Composition and properties of FaSSIF, FeSSIF and FaSSGF Media prepared from 3F Powder and Buffer Concentrates
FaSSIF, FeSSIF and FaSSGF dissolution media are prepared by diluting FaSSIF, FeSSIF, FaSSGF Buffer Concentrates with water and adding the required amount of 3F Powder®.
pH reproducibility of FaSSIF, FeSSIF and FaSSGF prepared from 3F Powder® and corresponding Buffer Concentrates
Variable pH of a solubility or dissolution medium is one of the most common and significant reasons for irreproducible results which affects decision making and interpretation.
What is a diluent?
A diluent is a solvent which is added to standard solutions of a drug substance...
Why include Biorelevant Medium in working standard solutions (WSS)
It is important to include Biorelevant Medium when diluting secondary standard solutions (SSS) as it keeps the matrix...
Why Biorelevant Dissolution samples should be diluted for HPLC analysis
Without dilution, drugs which are poorly water soluble may precipitate from biorelevant medium at room temperature after sampling.
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.
How to calculate the theoretical maximum drug concentration for Primary Standard Solution (PSS)
Before making the PSS, calculate the theoretical maximum drug concentration required for analysis...
How to dilute and prepare standard solutions
There are three types of standard solutions that need to be prepared when analysing dissolution samples...
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.
How to prepare the working drug solution containing dosage form (e.g. drug and excipients) with biorelevant medium to check interference
Three steps are required to prepare the working drug solution containing dosage form...
Which solutions are required to check for interference
The following solutions should be tested to check for interference...