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Related Concept Videos

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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Microfluidic nanoparticle synthesis for oral solid dosage forms: A step toward clinical transition processes.

Lucia Morelli1, Evelyn Ochoa1, Lucia Salvioni1

  • 1University of Milano-Bicocca, Department of Biotechnology and Bioscience, Piazza della Scienza 2, 20126 Milano, Italy.

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This study developed stable oral solid dosage forms using nanoparticles (NPs) for enhanced drug delivery. Microfluidics enabled consistent NP production, paving the way for clinical translation of nanomedicines.

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ApplicationsClinical transitionsMicrofluidicsMulti-units dosage formsOral deliveryPolymeric nanoparticles

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Area of Science:

  • Nanomedicine and Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Nanoparticles (NPs) offer solutions for drug bioavailability, stability, and efficacy challenges.
  • Oral NPs enhance solubility and stability of active ingredients in the gastrointestinal tract.
  • Nanocarriers enable controlled drug release for local or systemic targeting, improving therapy efficiency.

Purpose of the Study:

  • To develop reliable oral solid dosage forms incorporating NPs.
  • To ensure consistent NP production for technology transfer and clinical use.
  • To demonstrate the feasibility of oral administration for NP-based drug delivery systems.

Main Methods:

  • Utilized microfluidics technology for automated, high-throughput NP synthesis.
  • Designed and developed innovative systems combining NPs with solid dosage formulations.
  • Manufactured oral dosage forms (pellets, minitablets) incorporating the developed NPs.
  • Assessed NP stability post-manufacturing and encapsulated drug protection.
  • Used indomethacin as a tracer to evaluate biopharmaceutical behavior.

Main Results:

  • Achieved stable oral solid dosage forms containing NPs.
  • Demonstrated the stability of NPs after incorporation into dosage forms.
  • Confirmed the protection of encapsulated drugs within the NPs.
  • Successfully tested the biopharmaceutical behavior using indomethacin as a tracer.
  • Validated the potential for oral administration of NP-loaded dosage forms.

Conclusions:

  • Developed a robust method for producing stable oral solid dosage forms with NPs.
  • The microfluidics-based approach ensures consistent NP production for clinical applications.
  • This advancement facilitates the oral administration of challenging drugs like anti-inflammatories and chemotherapeutics.
  • The findings support the progression of nanoproducts towards clinical trials and market approval.