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Related Concept Videos

X-ray Diffraction of Biological Samples01:10

X-ray Diffraction of Biological Samples

X-ray diffraction or XRD is an analytical tool that utilizes X-rays to study ordered structures such as crystalline organic and inorganic samples, polycrystalline materials, proteins, carbohydrates, and drugs.
According to Bragg's law, when X-rays strike the sample positioned on a stage, the rays are  scattered by the electron clouds around the sample atoms. The  X-ray diffraction or scattering is caused by constructive interference of the X-ray waves that reflect off the internal crystal...
Determination of Crystal Structures01:29

Determination of Crystal Structures

In the late 1800s, the revelation that light extended beyond visible wavelengths led to the discovery of X-rays by Wilhelm Roentgen. Recognized as high-energy electromagnetic radiation with short wavelengths, X-rays prompted exploration into their interaction with crystals. Max von Laue proposed in 1912 that the periodic arrangement of atoms, ions, or molecules in crystals would cause them to diffract X-rays, a hypothesis confirmed through experiments with copper sulfate and zinc sulfide...
X-ray Crystallography02:18

X-ray Crystallography

The size of the unit cell and the arrangement of atoms in a crystal may be determined from measurements of the diffraction of X-rays by the crystal, termed X-ray crystallography.
Diffraction
Diffraction is the change in the direction of travel experienced by an electromagnetic wave when it encounters a physical barrier whose dimensions are comparable to those of the wavelength of the light. X-rays are electromagnetic radiation with wavelengths about as long as the distance between neighboring...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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,...
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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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Microfluidic Chips for In Situ Crystal X-ray Diffraction and In Situ Dynamic Light Scattering for Serial Crystallography
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Quantitative analysis of crystalline pharmaceuticals in tablets by pattern-fitting procedure using X-ray diffraction

Rieko Takehira1, Yasunori Momose, Shigeo Yamamura

  • 1Faculty of Pharmaceutical Sciences, Josai International University, Togane, Chiba 283-8555, Japan.

International Journal of Pharmaceutics
|August 3, 2010
PubMed
Summary

A novel X-ray diffraction pattern-fitting method enables precise quantitative analysis of crystalline pharmaceutical mixtures in tablets. This technique accurately determines drug content and crystal characteristics without calibration curves.

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Area of Science:

  • Crystallography
  • Pharmaceutical analysis
  • Materials science

Background:

  • Accurate quantitative analysis of crystalline pharmaceutical mixtures is crucial for drug formulation and quality control.
  • Traditional methods for analyzing crystalline pharmaceuticals in tablets can be complex and require calibration curves.
  • X-ray diffraction (XRD) is a powerful technique for characterizing crystalline materials.

Purpose of the Study:

  • To develop and validate a pattern-fitting procedure for the quantitative analysis of binary crystalline pharmaceutical systems in tablets using XRD.
  • To assess the capability of the method for determining drug content and characterizing crystal properties simultaneously.
  • To establish a calibration-free method for quantitative phase analysis of crystalline pharmaceuticals.

Main Methods:

  • A pattern-fitting procedure was applied to X-ray diffraction patterns of binary mixtures of isoniazid (INH) and mannitol (MAN) in tablets.
  • Observed diffraction intensities were fitted to an analytic expression using a nonlinear least-squares procedure to separate contributions from INH and MAN crystals.
  • Optimized normalization constants and a correction parameter were used for quantitative analysis, enabling simultaneous determination of crystal characteristics.

Main Results:

  • The pattern-fitting procedure successfully quantified crystalline phases in the range of 10-90% (w/w) INH content.
  • The method allowed for the simultaneous determination of crystal characteristics, including preferred orientation, crystallite size, and lattice disorder.
  • Quantitative analysis was achieved without the need for a calibration curve, utilizing a correction parameter for experimental variables.

Conclusions:

  • The developed pattern-fitting procedure is a robust and efficient method for the quantitative phase analysis of crystalline pharmaceuticals in tablets.
  • This XRD-based approach offers a powerful tool for characterizing crystal properties within tablets and powders.
  • The method is adaptable for analyzing known crystalline compounds, enhancing pharmaceutical quality control and formulation development.