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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Irbesartan desmotropes: Solid-state characterization, thermodynamic study and dissolution properties.

Andrea Mariela Araya-Sibaja1,2,3, Carlos Eduardo Maduro de Campos4, Cinira Fandaruff5

  • 1Laboratorio Nacional de Nanotecnología LANOTEC-CeNAT-CONARE, 1174-1200, Pavas, San José, Costa Rica.

Journal of Pharmaceutical Analysis
|January 14, 2020
PubMed
Summary

Irbesartan (IBS) exists as desmotropes, not monotropically related polymorphs. Form A is more soluble than Form B, which shows instability under high humidity and temperature, highlighting the need for strict quality control.

Keywords:
Desmotropic formsIntrinsic dissolution rateIrbesartanSolid-state characterizationTautomerism

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Area of Science:

  • Pharmaceutical Chemistry
  • Solid-State Chemistry
  • Drug Development

Background:

  • Irbesartan (IBS) is an antihypertensive drug exhibiting tautomerism (1H- and 2H-tautomers).
  • Previous studies suggested IBS exists as a polymorphic system with monotropically related forms A (1H) and B (2H), with form B being more stable and less soluble.
  • This understanding impacts drug formulation and stability assessments.

Purpose of the Study:

  • To re-evaluate the solid-state characteristics and thermodynamic relationships of Irbesartan (IBS) forms A and B.
  • To investigate the desmotropic versus polymorphic nature of IBS and their interconversion.
  • To emphasize the critical need for stringent quality control of IBS raw materials.

Main Methods:

  • Solid-state characterization using powder X-ray diffraction (PXRD), Raman spectroscopy (RS), differential scanning calorimetry (DSC), hot stage microscopy (HSM), Fourier transform infrared (FT-IR), and scanning electron microscopy (SEM).
  • Thermodynamic and dissolution studies, including intrinsic dissolution rate (IDR).
  • Stability assessments under various conditions (25°C/98% RH and 40°C/98% RH).

Main Results:

  • IBS forms A and B are confirmed as desmotropes, not monotropically related polymorphs.
  • Form A exhibits approximately four-fold higher solubility compared to form B.
  • Form B demonstrated structural and/or chemical instability at 40°C and 98% RH, while both forms are stable at ambient conditions.

Conclusions:

  • Irbesartan (IBS) exists as a desmotropic system, challenging previous polymorphic classifications.
  • The distinct solubility and stability profiles of forms A and B necessitate careful consideration in pharmaceutical development.
  • Rigorous chemical and solid-state quality control of IBS is crucial to ensure drug product efficacy and safety.