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Biorelevant Media 101
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How matching dissolution profiles in Biorelevant Media will help identify which Test Formulation will be bioequivalent to the Reference
FaSSIF 101
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Generating in vitro dissolution profiles of a Test Product and Reference in this Biorelevant Medium reveals the rates of drug release in vivo
FeSSIF 101
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FeSSIF (Fed State Simulated Intestinal Fluid) is a biorelevant test medium that replicates biliary secretions present in small intestinal fluid after eating food
FaSSGF 101
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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 101
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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
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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
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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
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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)
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Understanding a drug’s BCS class can help guide formulation development and assess development risk and difficulty
Composition and physico-chemical properties of FaSSIF-V2
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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
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Comparing HPLC profiles of FaSSIF-V2 made using Buffer Concentrate versus FaSSIF-V2 made using buffer from scratch
Dissolution profiles in FaSSIF-V2
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Ibuprofen, Carbamazepine and Diclofenac dissolution profiles in FaSSIF-V2
Composition and physico-chemical properties of FeSSIF-V2
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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
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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
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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
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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
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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.