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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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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Bioavailability Enhancement: Drug Solubility Enhancement01:16

Bioavailability Enhancement: Drug Solubility Enhancement

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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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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Oral Drug Delivery Systems: Introduction01:23

Oral Drug Delivery Systems: Introduction

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Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Amorphous Solid Dispersions: Utilization and Challenges in Drug Discovery and Development.

Yan He1, Chris Ho1

  • 1Pre-Development Sciences, LGCR, Waltham, Massachusetts, 02451.

Journal of Pharmaceutical Sciences
|July 16, 2015
PubMed
Summary
This summary is machine-generated.

Amorphous solid dispersion (ASD) enhances drug development by improving solubility and bioavailability. This technology aids in formulation, preclinical, and clinical stages, accelerating project timelines.

Keywords:
amorphous solid dispersion (ASD)bioavailabilitydissolutionformulationpolymerpoorly water soluble compoundsolubilityspray drying (SD)stabilitysupersaturation

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Area of Science:

  • Pharmaceutical Science
  • Materials Science

Background:

  • Amorphous solid dispersion (ASD) improves drug dissolution, solubility, and bioavailability.
  • Key properties for stable ASD formation include glass-forming ability and low crystallization tendency.

Purpose of the Study:

  • To review the application of ASD in pharmaceutical development.
  • To discuss methods for assessing ASD stability and polymer excipient screening.
  • To cover scalability and translation from preclinical to clinical studies.

Main Methods:

  • In silico miscibility prediction for polymer excipient screening.
  • Experimental screening techniques for ASD formulation.
  • Computational tools and experimental methods to assess physicochemical properties.

Main Results:

  • ASD facilitates dose escalation and provides adequate preclinical and clinical exposure.
  • Understanding polymer-drug interactions enhances amorphous phase stability.
  • ASD technology is scalable from bench to commercialization.

Conclusions:

  • ASD is a valuable tool for overcoming formulation challenges in drug development.
  • Further understanding of ASD mechanisms can optimize its application across research and development stages.
  • ASD integration spans discovery research through commercialization.