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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).
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Heike Bley1, Bernd Fussnegger, Roland Bodmeier

  • 1College of Pharmacy, Freie Universität Berlin, Kelchstrasse 31, 12169 Berlin, Germany.

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This study enhanced drug dissolution rates using solid dispersions of carbamazepine and nifedipine with polyethylene glycol 1500 and various polymers. Certain polymer combinations improved drug stability and dissolution profiles, offering potential for improved pharmaceutical formulations.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Water-insoluble drugs like carbamazepine and nifedipine exhibit poor bioavailability.
  • Solid dispersions can enhance the dissolution rate and bioavailability of poorly soluble drugs.
  • Combining different polymers in solid dispersions aims to leverage their unique properties for improved drug formulation.

Purpose of the Study:

  • To prepare and characterize solid dispersions of carbamazepine and nifedipine using polyethylene glycol 1500 (PEG 1500) and various polymers.
  • To evaluate the impact of different polymer combinations on drug dissolution, crystallinity, and physical stability.
  • To assess the influence of storage conditions on the solid dispersion characteristics and drug release.

Main Methods:

  • Solid dispersions were prepared using the melting method with PEG 1500 and polymers like polyvinylpyrrolidone (PVP) and Eudragit EPO.
  • Characterization involved dissolution testing, powder X-ray diffractometry, and microscopy.
  • Stability was assessed after storage under different temperature and humidity conditions.

Main Results:

  • All solid dispersions showed over 80% drug release within 20 minutes.
  • Dissolution rates varied based on the PEG 1500/polymer composition, not solely on the drug's amorphous/crystalline state.
  • Polyvinylpyrrolidone-based solid dispersions demonstrated more stable dissolution profiles and drug stabilization compared to pure PEG 1500 dispersions after storage.
  • Phase separation occurred in some formulations under high humidity, influenced by polymer hygroscopicity.

Conclusions:

  • Solid dispersions with specific polymer blends, particularly those containing polyvinylpyrrolidone, can significantly improve and stabilize the dissolution profiles of water-insoluble drugs.
  • The choice of polymer carrier is critical for optimizing drug release and physical stability in solid dispersion formulations.
  • Further investigation into polymer interactions and hygroscopic properties is warranted for robust formulation development.