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Oral-based controlled release formulations using poly(acrylic acid) microgels.

Marie Wahlgren1, Karin Löwenstein Christensen, Erik Valentin Jørgensen

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Drug Development and Industrial Pharmacy
|May 27, 2009
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Tablet formulation impacts drug release. Wet granulation enhanced release, especially for hydrophobic diazepam from Pemulen excipients, showing near zero-order release. Hydrophilic midodrine-HCl release was similar with Carbopol and Pemulen.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Polymer Science

Background:

  • Excipients like Pemulen and Carbopol are crucial in tablet formulations.
  • Understanding drug release kinetics is vital for effective drug delivery.
  • Hydrophobic and hydrophilic drugs exhibit different release behaviors.

Purpose of the Study:

  • To investigate the release of hydrophobic (diazepam) and hydrophilic (midodrine-HCl) substances from tablets.
  • To compare drug release from formulations containing Pemulen versus Carbopol excipients.
  • To evaluate the impact of manufacturing methods (wet granulation vs. direct compression) on drug release.

Main Methods:

  • Dissolution studies of diazepam and midodrine-HCl from tablets with Carbopol 981 F or Pemulen.
  • Comparison of drug release in phosphate buffer (pH 6.8) and 0.1 M HCl.
  • Evaluation of tablets produced via wet granulation and direct compression.

Main Results:

  • Wet granulation significantly influenced drug release compared to direct compression.
  • Release of hydrophilic midodrine-HCl showed minimal differences between Carbopol and Pemulen.
  • Hydrophobic diazepam release varied significantly between Pemulen and Carbopol, with Pemulen showing slower release.
  • Reproducible release patterns were achieved with wet granulation.
  • Polymer differences in release were more pronounced at pH 6.8 than at low pH.

Conclusions:

  • Pemulen excipients resulted in very slow, near zero-order release of hydrophobic diazepam.
  • Manufacturing method (wet granulation) and polymer type (Pemulen vs. Carbopol) critically affect drug release profiles.
  • Formulation strategies need to consider drug hydrophobicity and polymer characteristics for optimal dissolution.