a seminar on gamma scintigraphy final

8/3/2019 A Seminar on Gamma Scintigraphy Final

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ASEMINAR ON GAMMA

SCINTIGRAPHY

Presented By Guided By

Baramade M. K. Mr. Kalyankar Sir


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WHAT IS GAMMASCINTIGRAPHY?

Gamma scintigraphy is a technique whereby thetransit of a dosage form through its intended siteof delivery can be non-invasively imaged in vivovia 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 drugabsorption.

Information such as the site of disintegration ordispersion can also be obtained.

Assistance in product development as well astesting of finished products for corporatesponsors are commonly performed.


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Gastrointestinal Transit


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FEATURES

Non-invasive

Human clinical or animal studies Oral and otherroutes 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


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WHY USE GAMMASCINTIGRAPHY?

Formulation development success depends on

defining the variables that affect the performance

of a drug delivery system.

Often, in vitro testing methods are not predictiveofin 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.


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RADIOLABELLING TECHNIQUES

Whole dose radiolabelling

Point radiolabelling

Surrogate markers

Neutron activation


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NEUTRON ACTIVATION

Standard radiolabeling techniques incorporate

the radioactive marker in a finished productshortly 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 aradioactive isotope appropriate for gamma

scintigraphy by a short exposure to a neutron

flux.


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NASAL ROUTE


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INTELISITE CAPSULE ..

The InteliSite capsule is a radiofrequencyactivated, non-disintegrating drug deliverydevice.

It is capable of non-invasive controlled delivery

of drug formulations to the gastrointestinal tractfor determining regional differences in drugabsorption and bioavailability.

Radiolabeling permits determination of thecapsule location within a specific region of the

gastrointestinal tract via gamma scintigraphy.When the capsule reaches the desired location in

the gastrointestinal tract, external activationopens a series of windows to the capsule drugreservoir.


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The release and degree of dispersion of the

solution or powder contents from the capsule can

be visualized. Scintipharma personnel wereinvolved in the evaluation and validation, in

animals and humans, of prototype capsules.


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ADVANTAGES

A rapid and effective method for determining the

rate and extent of drug absorption within specific

regions of the GI tract under pharmaceuticallyand physiologically relevant conditions

Saves time and avoids waste of resources during

the drug development process by definingformulation objectives


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InteliSite is a registered trademark of

Innovative Devices, LLC, Raleigh, NC

(919-781-6325)


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Thank you

a seminar on gamma scintigraphy final

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