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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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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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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Dosage Regimens: Partial Pharmacokinetic Parameters01:01

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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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Related Experiment Video

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Tackling quantitative polymorphic analysis through fixed-dose combination tablets production. Pyrazinamide

Marina Antonio1, Mariano Raffaghelli2, Rubén M Maggio1

  • 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.

Journal of Pharmaceutical and Biomedical Analysis
|December 7, 2020
PubMed
Summary
This summary is machine-generated.

This study developed a new Near Infrared Spectroscopy (NIR) method to quantify pyrazinamide (PZA) Form α in tuberculosis drugs. The method accurately measures polymorphic purity in raw materials and fixed-dose combination tablets, ensuring drug quality.

Keywords:
Fixed-dose combination (FDC)Near infrared spectroscopy (NIR)Partial least squares (PLS)PolymorphismProcess analytical technology (PAT)Pyrazinamide (PZA)

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Spectroscopy

Background:

  • Tuberculosis treatment relies on fixed-dose combination (FDC) drugs like Pyrazinamide (PZA), Rifampicin (RIF), Isoniazid (ISH), and Ethambutol (ETB).
  • PZA has multiple polymorphs, but only Form α is suitable for pharmaceutical use due to stability and bioavailability.
  • Traditional methods for polymorph quantification face limitations with complex pharmaceutical formulations like FDC tablets.

Purpose of the Study:

  • To develop and validate a Near Infrared Spectroscopy (NIR) coupled with Partial Least Squares (PLS) regression strategy for quantifying PZA Form α.
  • To assess the method's accuracy in both PZA drug substance (raw material) and PZA/RIF/ISH-FDC tablets.
  • To provide a reliable analytical tool for ensuring PZA polymorphic purity throughout pharmaceutical manufacturing.

Main Methods:

  • Development of two PLS models: one for PZA drug substance (ternary mixture of polymorphs) and one for FDC tablets (including RIF, ISH, and excipients).
  • Optimization of NIR-PLS models using a radial optimization approach with specific pre-treatment methods (MSC-D' and SNV-D').
  • Validation of the models through assessment of bias, systematic errors, and recovery rates in both drug substance and FDC tablet samples.

Main Results:

  • Both NIR-PLS models demonstrated high accuracy and reliability, with satisfactory recoveries (102.5 ± 3.1% for drug substance, 98.7 ± 1.5% for FDC tablets).
  • The method accurately predicted PZA Form α content in commercial drug substance (0.98 ± 0.01 w/w) and in intact, sectioned, and powdered FDC tablets (e.g., 0.984 ± 0.003 w/w).
  • The methodology proved effective even when PZA Form α was analyzed in FDC formulations fortified with other PZA polymorphs.

Conclusions:

  • The developed NIR-PLS strategy offers an effective and accurate alternative for quantifying PZA Form α in pharmaceutical products.
  • This method is suitable for monitoring polymorphic purity across various stages of pharmaceutical manufacturing, from raw materials to finished FDC tablets.
  • The study highlights the potential of NIR spectroscopy as a powerful tool for quality control in complex drug formulations.