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- Indium In-111 pentetate
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Indium In-111 pentetate | CAS No: 135998-32-2 | GMP-certified suppliers
A medication that provides radioactive diagnostic imaging for central nervous system evaluation, primarily used in radionuclide cisternography to assess cerebrospinal fluid disorders.
Therapeutic categories
Primary indications
- Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography
Product Snapshot
- Indium In-111 pentetate is available as an intrathecal solution formulation
- It is primarily used for radionuclide cisternography procedures
- This product is approved for use in the US market
Clinical Overview
The radiopharmaceutical operates through the decay of Indium-111 via electron capture, emitting gamma photons detectable by a gamma camera. This imaging modality enables precise visualization of cerebrospinal fluid pathways, aiding in clinical assessment. The agent belongs to the central nervous system diagnostic radiopharmaceutical category, with specific approval for its use in radionuclide cisternography.
Pharmacodynamic data specific to the pentetate complex is not extensively detailed, but the clinical application relies on the distribution and kinetics of the radioactive tracer within cerebrospinal fluid. The radiolabeled compound typically exhibits properties consistent with hydrophilic chelates, allowing intrathecal administration and localization within the cerebrospinal fluid compartment without significant systemic absorption.
Regarding absorption, distribution, metabolism, and excretion (ADME), the primary route post-administration is intrathecal injection, with gradual clearance from cerebrospinal fluid and minimal systemic metabolism. The radioisotope’s half-life and emission profile dictate the imaging timepoints and radiation exposure considerations.
Safety and toxicity concerns focus on radiation exposure and potential adverse reactions related to intrathecal administration, such as headache or rare neurotoxic effects. Adherence to radiopharmaceutical handling protocols and dose optimization are essential to minimize risks.
Indium In-111 pentetate is marketed under various diagnostic brands worldwide and is utilized in nuclear medicine departments equipped for gamma camera imaging. For API procurement, stringent quality control measures must ensure radionuclidic purity, chemical stability, and sterility consistent with regulatory standards for injectable radiopharmaceuticals. Sourcing should prioritize suppliers with validated manufacturing processes and documentation supporting safety and efficacy in clinical diagnostic use.
Identification & chemistry
| Generic name | Indium In-111 pentetate |
|---|---|
| Molecule type | Small molecule |
| CAS | 135998-32-2 |
| UNII | 5K3UP561AX |
| DrugBank ID | DB09425 |
Pharmacology
| Summary | Pentetate Indium Disodium In 111 functions as a radiopharmaceutical agent used in diagnostic imaging. It emits gamma radiation detected by gamma cameras, enabling visualization of the brain and spinal column. The compound is primarily utilized for radionuclide cisternography to assess cerebrospinal fluid dynamics. |
|---|---|
| Mechanism of action | Decay of In-111 by electron capture allows for detection with a gamma camera for visualization of the brain and spinal column. |
ADME / PK
| Absorption | After intrathecal administration, the radiopharmaceutical is absorbed from the subarachnoid space as described below, and the remainder flows superiorly to the basal cisterns within 2 to 4 hours and subsequently will be apparent in the Sylvian cisterns, the interhemispheric cisterns, and over the cerebral convexities. In normal individuals, the radiopharmaceutical will have ascended to the parasagittal region within 24 hours with simultaneous partial or complete clearance of activity from the basal cisterns and Sylvian regions. In contrast to air, the radiopharmaceutical does not normally enter the cerebral ventricles. Although the primary absorption of cerebrospinal fluid (CSF) into the blood stream occurs at the arachnoid villi, there is some evidence that a significant fraction of CSF is also absorbed across both the cerebral and spinal leptomeninges. Lesser quantities may also be absorbed across the ventricular ependyma. It is also generally held that these alternate routes of CSF absorption may assume primary importance when the major routes of the flow are pathologically obstructed |
|---|---|
| Half-life | Indium 111 decays by electron capture with a physical half-life of 67.9 hours. |
| Route of elimination | Approximately 65% of the administered dose is excreted by the kidneys within 24 hours and this increases to 85% in 72 hours. |
Formulation & handling
- Indium In-111 pentetate is formulated for intrathecal administration, requiring sterile handling and precise dosing.
- The compound is a small molecule with high water solubility and low lipophilicity, indicating limited oral bioavailability and suitability for parenteral use.
- Stability considerations include protection from radiolytic degradation due to the radioactive indium component and maintenance of solution integrity.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) has patent protection expired in the US, allowing for generic competition and established market presence. Current products utilizing this API reflect a mature market phase with multiple authorized suppliers. |
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| Markets | US |
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Supply Chain
| Supply chain summary | The manufacturing landscape for Indium In-111 pentetate includes multiple originator companies producing branded products primarily for the US market. The presence of established brands such as In-111 DTPA indicates a notable role of patented formulations; however, the patent status suggests existing or imminent generic competition. There is limited information on branded product presence outside the US in EU or other regions. |
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Safety
| Toxicity | Pregnancy Category C Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography |
|---|
- Classified as Pregnancy Category C
- Use with caution in pregnant populations
- Rare occurrences of aseptic meningitis and pyrogenic reactions (‹0
Indium In-111 pentetate is a type of Other substances
The pharmaceutical industry encompasses a diverse range of active pharmaceutical ingredients (APIs) that are used in the production of various medications. One category of APIs is known as other substances. This category includes substances that do not fall under the conventional classifications such as antibiotics, analgesics, or antihypertensives.
Other substances in pharmaceutical APIs consist of a broad array of chemical compounds with unique properties and applications. These substances play a crucial role in the formulation and development of specialized medications, catering to specific therapeutic needs. The category encompasses various substances like excipients, solvents, stabilizers, and pH adjusters.
Excipients are inert substances that aid in the manufacturing process and enhance the stability, bioavailability, and patient acceptability of pharmaceutical formulations. Solvents are used to dissolve other ingredients and facilitate their incorporation into the final product. Stabilizers ensure the integrity and shelf life of medications by preventing degradation or chemical changes. pH adjusters help maintain the desired pH level of a formulation, which can influence the drug's efficacy and stability.
Pharmaceutical manufacturers carefully select and incorporate specific other substances into their formulations, adhering to regulatory guidelines and quality standards. These substances undergo rigorous testing and evaluation to ensure their safety, efficacy, and compatibility with the desired pharmaceutical product. By employing other substances in API formulations, pharmaceutical companies can optimize drug delivery, improve patient compliance, and enhance therapeutic outcomes.
In summary, the other substances category of pharmaceutical APIs comprises a diverse range of chemicals, including excipients, solvents, stabilizers, and pH adjusters. These substances contribute to the formulation, stability, and performance of medications, enabling pharmaceutical manufacturers to develop specialized products that meet specific therapeutic requirements.
