A SEMINAR ON GAMMA

SCINTIGRAPHY

Presented By Baramade M. K.

Guided By Mr. Kalyankar Sir

WHAT IS GAMMA SCINTIGRAPHY?

Gamma scintigraphy is a technique whereby the transit of a dosage form through its intended site of delivery can be non-invasively imaged in vivo via the judicious introduction of an appropriate short lived gamma emitting radioisotope. The observed transit of the dosage form can then be correlated with the rate and extent of drug absorption. Information such as the site of disintegration or dispersion can also be obtained. Assistance in product development as well as testing of finished products for corporate sponsors are commonly performed.

Gastrointestinal Transit

FEATURES

Non-invasive Human clinical or animal studies Oral and other routes of administration such as nasal, ocular, or inhalation Neutron activation and standard radiolabeling techniques Site specific delivery in the GI tract using the InteliSite Capsule Dosage form transit or site of release correlated with drug absorption Regulatory compliance Expert consultation Experience and innovation

WHY USE GAMMA SCINTIGRAPHY?

Formulation development success depends on defining the variables that affect the performance of a drug delivery system. Often, in vitro testing methods are not predictive of in vivo results. For oral dosage forms, altered gastrointestinal transit due to individual variation, physiologic or pharmacologic factors, or the presence of food, may influence bio-availability. Disintegration, erosion, or drug release may be premature or delayed in vivo.

RADIOLABELLING TECHNIQUES

Whole dose radiolabelling Point radiolabelling Surrogate markers Neutron activation

NEUTRON ACTIVATION Standard radiolabeling techniques incorporate the radioactive marker in a finished product shortly before dose administration. Alternatively, neutron activation is a technique where a small amount of stable isotope is incorporated in the dosage form at the time of manufacture. This allows the product to be produced in the sponsor's facility under normal manufacturing conditions. The stable isotope is then converted to a radioactive isotope appropriate for gamma scintigraphy by a short exposure to a neutron flux.

NASAL ROUTE

INTELISITE CAPSULE ..
The InteliSite capsule is a radiofrequency activated, non-disintegrating drug delivery device. It is capable of non-invasive controlled delivery of drug formulations to the gastrointestinal tract for determining regional differences in drug absorption and bioavailability. Radiolabeling permits determination of the capsule location within a specific region of the gastrointestinal tract via gamma scintigraphy. When the capsule reaches the desired location in the gastrointestinal tract, external activation opens a series of windows to the capsule drug reservoir.

The release and degree of dispersion of the solution or powder contents from the capsule can be visualized. Scintipharma personnel were involved in the evaluation and validation, in animals and humans, of prototype capsules.

ADVANTAGES

A rapid and effective method for determining the rate and extent of drug absorption within specific regions of the GI tract under pharmaceutically and physiologically relevant conditions Saves time and avoids waste of resources during the drug development process by defining formulation objectives

InteliSite is a registered trademark of Innovative Devices, LLC, Raleigh, NC (919-781-6325)

 Thank

you