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.
A pharmacoscintigraphic study of the relationship between tablet erosion and pharmacokinetics of oral semaglutide - ADA 2017
When administered orally, peptide-based drugs are susceptible to degradation in the stomach due to exposure to low pH and proteolytic enzymes.
Clinical Pharmacokinetics and Pharmacodynamics of ME-401 - AACR 2016
Clinical Pharmacokinetics and Pharmacodynamics of ME-401, an Oral, Potent and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ, Following Single Ascending Dose Administration to Healthy Volunteers
Rapid Formulation Development and Clinical Testing of Gastro-Retentive Controlled Release Technology to Enable Once-Daily Dosing
MK-X had demonstrated poor colonic absorption in dogs and conventional matrix based controlled release formulations failed to achieve adequate trough concentrations in a human pharmacokinetic (PK) study to support once daily dosing.
Accelerating the Developing of Orphan Drugs for Rare Diseases
A rare disease is defined as one affecting less than 200,000 people (in the US) or no more than five in 10,000 of the general EU population. There are approximately 7,000 rare diseases, affecting an estimated 30 million people in each of the US and EU. Worldwide there are over 300 million people living with one or more identified rare diseases representing 3.5% - 5.9% of the global population. The development of new treatments to address these unmet clinical needs clearly represents an important global health priority.