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Sample Preparation for Analysis: Advanced Techniques01:08

Sample Preparation for Analysis: Advanced Techniques

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Airway management is essential in emergency and surgical medicine, ensuring ventilation and oxygenation in patients who cannot maintain their own airway. Clinicians use a range of techniques and devices to secure the airway, depending on the patient’s condition and the clinical context. Key methods include endotracheal intubation, rapid sequence intubation (RSI), supraglottic airway devices, and advanced visualization aids. In cases where these approaches fail, surgical airway...
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Functional groups are groups of atoms with specific chemical properties that occur within organic molecules and are sometimes denoted as “R”. Functional groups can “functionalize” a compound by enabling it to adopt different physical and chemical properties.
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Metal ions can be separated from one another by complexation with organic ligands–the chelating agent– to form uncharged chelates. Here, the chelating agent must contain hydrophobic groups and behave as a weak acid, losing a proton to bind with the metal. Since most organic ligands used in this process are insoluble or undergo oxidation in the aqueous phase, the chelating agent is initially added to the organic phase and extracted into the aqueous phase. The metal-ligand complex is...
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Pharmaceutical cocrystallization techniques. Advances and challenges.

Marisa Rodrigues1, Bárbara Baptista2, João Almeida Lopes2

  • 1LAQV/REQUIMTE, Departamento de Ciências Químicas, Faculdade de Farmácia, Universidade do Porto, Rua Jorge Viterbo Ferreira, 228, 4050-313 Porto, Portugal.

International Journal of Pharmaceutics
|June 12, 2018
PubMed
Summary

This review explores cocrystallization methods for improving pharmaceutical active ingredients (APIs). It identifies suitable techniques for screening to industrial production, addressing current industry limitations.

Keywords:
Cocrystallization methodsCocrystalsContinuous productionIndustrial productionProcess analytical technologyScreening methodsSolvent-basedSolvent-free

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Area of Science:

  • Crystallization science
  • Pharmaceutical technology
  • Materials science

Background:

  • Cocrystals are single-phase structures of multiple components bonded non-covalently.
  • They offer enhanced API properties like solubility, bioavailability, and stability.
  • Current limitations include the need for high-throughput screening and scalable production methods.

Purpose of the Study:

  • To provide a comprehensive overview of cocrystallization techniques.
  • To analyze the advantages and disadvantages of each method.
  • To identify suitable methods for different manufacturing stages, from screening to industrial scale.

Main Methods:

  • Review of solvent-based cocrystallization methods.
  • Review of solvent-free cocrystallization methods.
  • Analysis of continuous and scalable production approaches.

Main Results:

  • Categorization of cocrystallization methods into solvent-based and solvent-free.
  • Identification of techniques appropriate for pharmaceutical cocrystal screening and large-scale manufacturing.
  • Discussion on integrating Quality-by-Design (QbD) and Process Analytical Technology (PAT).

Conclusions:

  • Cocrystallization holds significant potential for pharmaceutical development.
  • Selecting appropriate methods is crucial for efficient cocrystal manufacturing.
  • Advancements in scalable techniques and QbD/PAT implementation are key for industrial adoption.