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Assessing Polymorphic Purity of Rifampicin in Double and Triple-Drug Fixed-Dose Combination Products.

Marina Antonio1, Mariano Raffaghelli2, Rubén M Maggio3

  • 1Área de Análisis de Medicamentos, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario and Instituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina.

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Summary

This study developed near-infrared spectroscopy methods to analyze Rifampicin polymorphism in fixed-dose combination tuberculosis drugs. The methods accurately assessed drug purity, ensuring the safety and efficacy of these essential medications.

Keywords:
Fixed-dose combination (FDC)Near infrared spectroscopy (NIR)Partial least squares (PLS)PolymorphismRifampicin (RIF)

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Spectroscopy

Background:

  • First-line anti-tuberculosis drugs are often combined into fixed-dose combinations (FDCs) to improve patient adherence.
  • Variable bioavailability in FDCs is a significant quality challenge, with Rifampicin (RIF) solid-state properties being a key factor.
  • Polymorphism of RIF can impact the performance and quality of RIF-containing FDCs.

Purpose of the Study:

  • To develop and validate analytical methodologies for assessing the impact of RIF polymorphism on FDC performance.
  • To evaluate commercial RIF-ISH and PZA-RIF-ISH FDC products using the developed methods.
  • To correlate RIF polymorphic form with drug product quality and bioavailability.

Main Methods:

  • Development and validation of two near-infrared (NIR) spectroscopy methods combined with partial least squares (PLS) regression.
  • Preparation of training and validation sets using mixtures of RIF Form I/Form II with other active pharmaceutical ingredients (APIs) and excipients.
  • Optimization of data pre-treatment (SNV-D') and PLS factors, followed by validation using commercial FDC products and X-ray powder diffraction.

Main Results:

  • Satisfactory recoveries (98.5±2.0% and 98.7±1.8%) were achieved for double- and triple-FDC products during validation.
  • The NIR-PLS model accurately estimated Form II polymorphic purity in RIF-ISH capsules (1.02 ± 0.02w/w).
  • A low Form II purity (0.800 ± 0.021w/w) was detected in triple FDC tablets, confirmed by X-ray powder diffraction, but dissolution remained high (99-102%).

Conclusions:

  • The developed NIR-PLS methods are effective for quantifying RIF polymorphic forms in complex FDC formulations.
  • An 80% Form II purity in triple FDC tablets did not negatively impact dissolution, suggesting maintained safety and efficacy.
  • NIR-spectroscopy offers a valuable tool for quality control of RIF-containing FDCs, addressing bioavailability concerns related to polymorphism.