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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

211
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,...
211
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

813
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...
813
Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

1.9K
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...
1.9K
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

703
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...
703
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

244
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
244

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Related Experiment Video

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Flash NanoPrecipitation for the Encapsulation of Hydrophobic and Hydrophilic Compounds in Polymeric Nanoparticles
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Pharmaceutical Amorphous Nanoparticles.

Rajan Jog1, Diane J Burgess1

  • 1Department of Pharmaceutical Sciences, University of Connecticut, Storrs, Connecticut 06269.

Journal of Pharmaceutical Sciences
|November 7, 2016
PubMed
Summary

Amorphous nanoparticles offer superior drug delivery by enhancing solubility and oral bioavailability. This review covers their formation, properties, and scalable manufacturing for improved nanomedicines.

Keywords:
X-ray diffractionamorphousbioavailabilitycalorimetrydissolutionnanocrystallinenanoparticlessolid statesolubilitystability

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Area of Science:

  • Nanotechnology
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Nanomedicines represent a significant advancement in drug delivery for diagnosis and therapy.
  • Nanoparticulate systems are crucial for improving the solubility and oral bioavailability of poorly soluble drug compounds.
  • Many new drug candidates face challenges with solubility and bioavailability.

Purpose of the Study:

  • To review the formation mechanisms and physicochemical properties of amorphous nanoparticles.
  • To highlight the advantages of amorphous nanoparticles over nanocrystalline materials for drug delivery.
  • To describe scalable manufacturing techniques for amorphous nanoparticles, exemplified by Nanomorph™ technology.

Main Methods:

  • Review of scientific literature on amorphous nanoparticles and nanomedicine.
  • Analysis of synergistic mechanisms for dissolution rate enhancement and supersaturation.
  • Description of manufacturing processes for amorphous nanoparticles.

Main Results:

  • Amorphous nanoparticles exhibit synergistic mechanisms (nanosize and amorphous nature) to enhance dissolution rates and supersaturation.
  • Nanomorph™ technology exemplifies amorphous nanoparticle precipitation for improved dissolution.
  • Scalable manufacturing techniques for amorphous nanoparticles are available.

Conclusions:

  • Amorphous nanoparticles present a promising strategy for overcoming solubility and bioavailability challenges in drug development.
  • The unique properties of amorphous nanoparticles offer significant advantages for advanced nanomedicine applications.
  • Further research and development in amorphous nanoparticle technology can lead to more effective therapeutics.