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Related Concept Videos

Bioavailability Enhancement: Drug Solubility Enhancement01:16

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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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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 absorption...
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After oral administration, poor permeability often limits the rate at which drugs are absorbed through the intestinal epithelium. Enhancing drug permeability is crucial for effective therapy, and several strategies have been developed to overcome this challenge.One effective strategy involves the use of lipid-based formulations. These formulations enhance dissolution and solubility, targeting physiological mechanisms to increase drug absorption. This includes stimulating bile salt secretion,...
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Factors Influencing Drug Absorption: Drug Dissolution01:27

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Amorphous solid dispersions: a robust platform to address bioavailability challenges.

Ann Newman1, Karthik Nagapudi, Robert Wenslow

  • 1Crystal Pharmatech & Seventh Street Development Group, 615 S. 7th St. Lafayette, IN 47901, USA.

Therapeutic Delivery
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Summary
This summary is machine-generated.

Amorphous solid dispersions (ASDs) enhance drug solubility and stability for poorly soluble compounds. This review covers ASD preparation, characterization, stability prediction, and clinical development insights.

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Area of Science:

  • Pharmaceutical Science
  • Materials Science

Background:

  • Amorphous solid dispersions (ASDs) are increasingly vital for developing poorly soluble drugs.
  • ASDs stabilize amorphous active pharmaceutical ingredients (APIs) with polymers, enhancing physical and solution stability.
  • They are primarily used to improve the apparent solubility of APIs.

Purpose of the Study:

  • To review methods for preparing and characterizing ASDs.
  • To emphasize understanding and predicting the stability of ASDs.
  • To summarize preclinical and clinical development efforts, highlighting risks and pitfalls.

Main Methods:

  • Review of preparation techniques for ASDs.
  • Discussion of characterization methods for ASDs.
  • Analysis of stability prediction models and in vivo performance.

Main Results:

  • ASDs offer improved solubility and stability for challenging APIs.
  • Understanding supersaturation is key to predicting in vivo performance.
  • Development of ASDs involves specific risks and potential pitfalls.

Conclusions:

  • ASDs are a powerful tool for enhancing the bioavailability of poorly soluble drugs.
  • Predictive models and thorough characterization are crucial for successful ASD development.
  • Knowledge of clinical development challenges aids in mitigating risks.