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Related Concept Videos

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

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Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
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Bioavailability Enhancement: Drug Solubility Enhancement01:16

Bioavailability Enhancement: Drug Solubility Enhancement

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Body:Bioavailability is a critical factor in determining a drug's effectiveness. It refers to the proportion of a drug that enters the circulation when introduced into the body and is, as a result, able to have an active effect. Enhancing bioavailability is essential for drugs with poor solubility, as it can significantly impact their therapeutic efficacy. Various methods are employed to increase the solubility of drugs, thereby enhancing their bioavailability.Micronization and nanonization are...
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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

169
Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Related Experiment Video

Updated: Dec 27, 2025

Flash NanoPrecipitation for the Encapsulation of Hydrophobic and Hydrophilic Compounds in Polymeric Nanoparticles
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Biorelevant test for supersaturable formulation.

Enxian Lu1, Shoufeng Li1, Zhongqin Wang1

  • 1Shanghai Aucta Pharmaceuticals Co., Ltd., No. 3377 Kangxin Road. SIMZ Pudong, Shanghai 201318, China.

Asian Journal of Pharmaceutical Sciences
|February 28, 2020
PubMed
Summary

Supersaturable formulations offer enhanced drug absorption but face precipitation challenges. Biorelevant in vitro dissolution methods combined with pharmacokinetic modeling improve prediction of in vivo performance for these advanced drug delivery systems.

Keywords:
BioavailabilityBiorelevantDissolutionFormulationSupersaturable

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Biopharmaceutics

Background:

  • Supersaturable formulations enhance drug dissolution and bioavailability.
  • Precipitation of supersaturated drug solutions before absorption hinders in vivo performance prediction.
  • Existing quality control methods lack predictive power for in vivo outcomes.

Purpose of the Study:

  • To review different types of supersaturable formulations.
  • To discuss in vitro dissolution methods for supersaturable formulations.
  • To highlight the need for predictive biorelevant testing.

Main Methods:

  • Review of supersaturable formulation types (amorphous dispersions, polymorphs, salts/co-crystals, weak bases, solubilized).
  • Analysis of various in vitro dissolution methods considering gastrointestinal physiology.
  • Discussion of limitations in predicting in vivo performance.

Main Results:

  • Various supersaturable formulation strategies exist.
  • Biorelevant in vitro methods offer improved prediction of in vivo performance.
  • In vitro methods cannot fully capture complex in vivo processes like transporters and metabolism.

Conclusions:

  • Combining in vitro biorelevant dissolution with physiologically-based pharmacokinetic modeling is crucial.
  • This integrated approach enhances product development for supersaturable formulations.
  • Accurate prediction of in vivo performance is essential for successful drug development.