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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

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...
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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...
Raman Spectroscopy Instrumentation: Overview01:26

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A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
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The underlying principle of Raman spectroscopy is based on the interaction between light and matter, specifically molecules' inelastic scattering of photons. When a monochromatic beam of light, typically from a laser source, interacts with a sample, most scattered light has the same frequency as the incident light. This is known as Rayleigh scattering.
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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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Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution
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Bulk Raman analysis of pharmaceutical tablets.

P Matousek1, A W Parker

  • 1Central Laser Facility, CCLRC Rutherford Appleton Laboratory, Didcot, Oxfordshire, OX11 0QX, UK. P.Matousek@rl.ac.uk

Applied Spectroscopy
|January 16, 2007
PubMed
Summary

Transmission Raman spectroscopy effectively analyzes bulk pharmaceutical tablet composition, unlike surface-sensitive backscattering. This method offers a simple, sensitive approach for on-line quality control in pharmaceutical manufacturing.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis
  • Spectroscopy

Background:

  • Raman spectroscopy is a powerful tool for chemical analysis.
  • Monitoring bulk chemical composition in pharmaceutical tablets is crucial for quality control.
  • Turbid media present challenges for traditional spectroscopic methods.

Purpose of the Study:

  • To compare backscattering and transmission Raman collection geometries for analyzing turbid pharmaceutical samples.
  • To evaluate the suitability of each geometry for monitoring bulk chemical composition.
  • To determine the potential for on-line analysis in pharmaceutical applications.

Main Methods:

  • Experimental comparison of backscattering and transmission Raman spectroscopy.
  • Analysis of pharmaceutical tablets (turbid media).
  • Monte-Carlo simulations to support experimental findings.

Main Results:

  • Backscattering geometry showed a strong bias towards surface layers.
  • Transmission geometry demonstrated insensitivity to impurity depth, monitoring bulk composition.
  • Detectable Raman signals were observed even after light propagation through multiple tablets.
  • Transmission intensity was only 12 times lower than backscattering for a 3.9 mm tablet.

Conclusions:

  • Transmission Raman geometry is well-suited for bulk chemical composition analysis of pharmaceutical tablets.
  • The method is robust, showing minimal sensitivity to sample depth.
  • Instrumental simplicity and sensitivity make it ideal for on-line pharmaceutical quality control.