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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

205
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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Metallic Solids02:37

Metallic Solids

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Metallic solids such as crystals of copper, aluminum, and iron are formed by metal atoms. The structure of metallic crystals is often described as a uniform distribution of atomic nuclei within a “sea” of delocalized electrons. The atoms within such a metallic solid are held together by a unique force known as metallic bonding that gives rise to many useful and varied bulk properties.
All metallic solids exhibit high thermal and electrical conductivity, metallic luster, and malleability....
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Structures of Solids02:22

Structures of Solids

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Solids in which the atoms, ions, or molecules are arranged in a definite repeating pattern are known as crystalline solids. Metals and ionic compounds typically form ordered, crystalline solids. A crystalline solid has a precise melting temperature because each atom or molecule of the same type is held in place with the same forces or energy. Amorphous solids or non-crystalline solids (or, sometimes, glasses) which lack an ordered internal structure and are randomly arranged. Substances that...
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Network Covalent Solids02:18

Network Covalent Solids

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Network covalent solids contain a three-dimensional network of covalently bonded atoms as found in the crystal structures of nonmetals like diamond, graphite, silicon, and some covalent compounds, such as silicon dioxide (sand) and silicon carbide (carborundum, the abrasive on sandpaper). Many minerals have networks of covalent bonds.
To break or to melt a covalent network solid, covalent bonds must be broken. Because covalent bonds are relatively strong, covalent network solids are typically...
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Molecular and Ionic Solids02:54

Molecular and Ionic Solids

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Crystalline solids are divided into four types: molecular, ionic, metallic, and covalent network based on the type of constituent units and their interparticle interactions.
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Molecular crystalline solids, such as ice, sucrose (table sugar), and iodine, are solids that are composed of neutral molecules as their constituent units. These molecules are held together by weak intermolecular forces such as London dispersion forces, dipole-dipole interactions, or hydrogen bonds, which...
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Quantifying Work02:30

Quantifying Work

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As a system undergoes a change, its internal energy can change, and energy can be transferred from the system to the surroundings, or from the surroundings to the system.
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Quantifying Disproportionation in Pharmaceutical Formulations with 35Cl Solid-State NMR.

David A Hirsh1, Yongchao Su2, Haichen Nie2

  • 1Department of Chemistry & Biochemistry , University of Windsor , Windsor , ON , N9B 3P4 , Canada.

Molecular Pharmaceutics
|July 18, 2018
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Summary

Ultra-wideline 35Cl solid-state NMR (SSNMR) accurately detects pioglitazone HCl disproportionation in drug formulations. This method quantifies changes in solid dosage forms, offering insights into drug stability.

Keywords:
chlorine-35disproportionationdosage formulationshydrochloride saltsprocessing-induced phase transitionsquantificationsolid-state NMR

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Area of Science:

  • Analytical Chemistry
  • Solid-State Chemistry
  • Pharmaceutical Analysis

Background:

  • Characterizing drug substances is vital for stability and bioavailability assessments in diverse formulations.
  • Drug formulations, especially ionic salts like pioglitazone HCl, can undergo disproportionation under stress conditions (heat, humidity), altering properties.
  • Solid dosage forms present challenges for analysis due to their complex heterogeneous mixtures of active pharmaceutical ingredients (APIs) and excipients.

Purpose of the Study:

  • To demonstrate the utility of ultra-wideline 35Cl solid-state NMR (UW 35Cl SSNMR) for characterizing the disproportionation of pioglitazone HCl (PiogHCl) in pharmaceutical formulations.
  • To quantitatively assess the degree of PiogHCl disproportionation in stressed solid dosage forms.
  • To highlight the advantages of 35Cl SSNMR in directly probing chloride anions without interference from excipients.

Main Methods:

  • Utilized ultra-wideline 35Cl solid-state NMR (UW 35Cl SSNMR) spectroscopy.
  • Prepared and stressed pioglitazone HCl (PiogHCl) mixtures with metallic stearate excipients under elevated temperature and humidity.
  • Quantitatively analyzed samples to determine the extent of PiogHCl disproportionation.

Main Results:

  • UW 35Cl SSNMR accurately quantified PiogHCl in mixed samples with a precision of ±1 wt %.
  • The method successfully measured the degree of PiogHCl disproportionation in formulation samples subjected to stress conditions.
  • 35Cl SSNMR directly detected all chlorine-containing species, including intact PiogHCl and disproportionation products, without interference from excipients.

Conclusions:

  • UW 35Cl SSNMR is a reliable and quantitative method for characterizing the disproportionation of pioglitazone HCl in solid dosage formulations.
  • This technique offers a direct and specific way to monitor chemical changes in complex pharmaceutical mixtures.
  • The findings demonstrate the potential of 35Cl SSNMR for drug stability studies and quality control in pharmaceutical development.