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Nanoamorphous drug products - Design and development.

Rajan Jog1, Diane J Burgess1

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

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|October 26, 2018
PubMed
Summary

Developing stable nanoamorphous spironolactone formulations is crucial for labile drugs. This study used an integrated approach to design robust nanoamorphous spironolactone, achieving high yield and superior dissolution rates.

Keywords:
AmorphousDesign of experimentsIn vitro dissolution testingNanoparticlesQuality by designSolid-stateSonoprecipitationSpray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Many new drug compounds are labile, requiring robust oral formulations.
  • Existing oral drug products are primarily macroamorphous; no oral nanoamorphous products are FDA-approved.
  • Labile nanoamorphous drug formulations require controlled development strategies to ensure physicochemical stability.

Purpose of the Study:

  • To design and develop stable nanoamorphous spironolactone using a novel integrated critical process parameters and critical formulation parameters (iCPP-CFPs) Design of Experiments (DoE) approach.
  • To investigate and control polymorphic transitions during nanoamorphous particle manufacturing and storage.
  • To optimize critical quality attributes (CQAs) such as particle size and total product yield.

Main Methods:

  • Employed an integrated iCPP-CFPs DoE approach for nanoamorphous spironolactone development.
  • Utilized orthogonal solid-state characterization tools to monitor polymorphic transitions (amorphous-crystalline, anhydrous-hydrate).
  • Investigated the influence of significant iCPP-CFPs (solvent-to-antisolvent ratio, drug concentration, inlet temperature) on CQAs.

Main Results:

  • Identified solvent-to-antisolvent ratio and inlet temperature as significant iCPP-CFPs influencing particle size and total product yield.
  • Lab-scale spray drying yielded nanoamorphous spironolactone with high total product yield (82.4%) and uniform particle size (244.2 nm).
  • Nanoamorphous spironolactone exhibited significant polymorphic transitions at 40°C/75% RH but remained stable at 4°C.
  • Achieved a 10-fold increase in kinetic solubility/dissolution rate and longer supersaturation time (approx. 6h) compared to controls.

Conclusions:

  • The integrated iCPP-CFPs DoE approach successfully enabled the development of stable nanoamorphous spironolactone.
  • Controlled manufacturing and storage conditions are essential to prevent polymorphic instability in nanoamorphous formulations.
  • Developed nanoamorphous spironolactone demonstrates superior dissolution properties, offering potential for improved oral bioavailability.