Pharmaceutical gamma scintigraphy is a technique that has been adapted from clinical diagnostic applications to enable the in vivo fate of pharmaceutical dosage forms to be accurately determined in patient populations or healthy volunteers. It is the gold standard for deposition, retention and transit studies and has been used in many 100’s clinical trials since the 1970s. Glyn Taylor and Simon Warren at Scintigraphics show how evaluation of pharmaceutical dosage forms using clinical gamma scintigraphy in early phase clinical development can provide critical information on drug delivery to the site of action/absorption.

Extract:

‘Small-Scale Batch Production for Clinical Gamma Scintigraphy Studies of Pharmaceuticals’

Evaluation of pharmaceutical dosage forms using clinical gamma scintigraphy in early phase clinical development can provide critical information on drug delivery to the site of action/absorption and enables visualisation and quantitation of regional transit of drug and dosage forms.

Radiolabelling of dosage forms is accomplished by the association of a short lived gamma emitting radioisotope e.g. Technetium-99m (99mTc), with a carefully selected component of the formulation.

It is essential that the inclusion of the radioisotope does not appreciably alter the key pharmaceutical properties of the product, and that it acts as an accurate surrogate for the chosen formulation component.  This must be demonstrated by performing in vitro assessments, typically standard pharmacopoeial test methods, with additional analysis to quantify the radiolabel.

Following successful radiolabelling method development and process validation, a data package is generated including Master Batch Records (MBR) and information for the Investigational Medicinal Product Dossier (IMPD) which forms part of the Clinical Trial Authorisation (CTA) application.  A multi-disciplinary team with appropriate experience and expertise is essential in order to perform such studies.

Introduction

Pharmaceutical gamma scintigraphy is a technique which has been adapted from clinical diagnostic applications to enable the in vivo fate of pharmaceutical dosage forms to be accurately determined in patient populations, or healthy volunteers.  It is the gold standard for deposition, retention and transit studies and has been used in many 100’s of clinical trials since the 1970’s.  Its application to pharmaceutical products is dependent upon the physicochemical association of a radiolabel with the active pharmaceutical ingredient (API) or some other carefully selected excipient in the product (Taylor et al., 2018, Strugala et al., 2012).

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