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Related Concept Videos

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

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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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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Proof-of-Concept in Developing a 45% Drug Loaded Amorphous Nanoparticle Formulation.

Hitesh S Purohit1, Deliang Zhou2, Mengqi Yu1

  • 1Small molecule CMC development, Drug Product Development, AbbVie Inc., North Chicago, IL, USA.

Journal of Pharmaceutical Sciences
|October 13, 2023
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Summary
This summary is machine-generated.

This study developed high drug loading amorphous nanoparticles (ANPs) for poorly soluble drugs, overcoming pill burden limitations. Trehalose-containing lyophilized ANPs showed comparable oral absorption to tablets in dogs under fasted conditions.

Keywords:
Amorphous solid dispersionBioavailabilityLyophilizationNanoparticleSpray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Amorphous solid dispersions (ASDs) enhance oral absorption of poorly soluble drugs by forming amorphous nanoparticles (ANPs).
  • Conventional ASDs often have low drug loadings (<20%), leading to high pill burden for high-dose medications.
  • Developing high drug loading ANP formulations is crucial for improving patient compliance and therapeutic efficacy.

Purpose of the Study:

  • To engineer high drug loading amorphous nanoparticles (ANPs) that release drug-rich nanoparticles in aqueous environments.
  • To develop a re-dispersible amorphous dosage form from these ANPs.
  • To evaluate the impact of processing variables on ANP formulation characteristics and in vivo performance.

Main Methods:

  • Nanoparticles were synthesized using solvent/anti-solvent precipitation.
  • Formulations were solidified into re-dispersible amorphous dosage forms via spray drying or lyophilization.
  • Characterization involved dynamic light scattering (DLS), scanning electron microscopy (SEM), HPLC, NMR, and DSC.
  • In vivo performance was assessed in a dog study comparing lyophilized formulations to a reference tablet.

Main Results:

  • Spray drying resulted in non-re-dispersible formulations.
  • Lyophilized cakes containing sucrose or trehalose were re-dispersible.
  • Trehalose-containing lyocakes demonstrated comparable performance to reference tablets in the fasted state.
  • A lower area under the curve (AUC) was observed in the fed state for trehalose-containing lyocakes.

Conclusions:

  • High drug loading ANPs can be successfully engineered using solvent/anti-solvent precipitation.
  • Lyophilization with specific excipients (sucrose, trehalose) enables the creation of re-dispersible amorphous dosage forms.
  • Trehalose-containing ANP formulations show promise for improving oral absorption of poorly soluble drugs, particularly under fasted conditions, warranting further investigation in the fed state.