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Gamma Scintigraphy Imaging

How do I design and conduct my scintigraphic studies?

Gamma scintigraphy is a proven imaging technique used to visualize the in vivo performance of pharmaceutical dosage forms. We have over 25 years’ experience in the design, conduct and reporting of scintigraphic studies, helping customers understand the impact of formulation composition, patient factors and human physiology on clinical outcomes.

Low levels of a gamma-emitting isotope are included in the formulation during product manufacture to allow real-time observation of clinical performance following dosing in human subjects.

Key applications include: oral and inhaled drug delivery.

Oral drug product performance;

  • Assessment and optimization of modified release dosage forms, including delayed, sustained, pulsatile and gastroretentive modalities
  • Quantification of the rate and anatomical sites of tablet erosion
  • Correlation of formulation performance with pharmacokinetic measurements
  • Formulation optimization for targeted GI drug delivery and local disease treatment
  • Understanding the impact of food on formulation performance
  • Evaluating formulation for local disease treatment

 

Inhaled drug product performance;

  • Assessment and optimization of nasal and pulmonary drug products
  • Understanding the impact of formulation, device and patient factors on in vivo deposition
  • Targeting drug delivery for local or systemic disease treatment
  • Comparing the clinical performance of different devices and products

 

Gamma scintigraphy is also used to study the pharmacodynamics of new chemical entities. 

Concomitant administration of radiolabelled food or placebo systems with clinical formulations can allow the observation and quantification of pharmacological effects.  Examples include:

  • Quantification of the rate of gastric emptying, and small intestinal and colon transit;
  • Assessment of gall bladder emptying;
  • Measurement of lung mucociliary clearance

Gamma scintigraphic assessments can be included with a standard Phase I clinical protocol, and combined with standard safety, pharmacokinetic and pharmacodynamic endpoints.

Statistics, Pharmacokinetics and Scintigraphics:

Our scintigraphic analysts provide expert review and interpretation of scintigraphic data, providing both qualitative and quantitative analysis of drug product performance and pharmacodynamic effects during a study. Quotient has designed, delivered and reported >100 scintigraphy studies across a range of drug products.

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