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- Fluorodopa (18F)
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Fluorodopa (18F) | CAS No: 92812-82-3 | GMP-certified suppliers
A medication that enables PET imaging of dopaminergic nerve terminals to assist in the diagnosis and evaluation of adult patients with suspected Parkinsonian syndromes.
Therapeutic categories
Primary indications
- Fluorodopa F 18 is indicated for use with positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS)
Product Snapshot
- Fluorodopa (18F) is an injectable radiopharmaceutical solution formulated for intravenous administration
- It is primarily used for PET imaging to visualize dopaminergic nerve terminals in the evaluation of suspected Parkinsonian syndromes
- This product is approved for use in the US market with both approved and experimental status indications
Clinical Overview
Chemically, Fluorodopa (18F) belongs to the class of tyrosine derivatives, which consist of compounds derived from tyrosine by modification of amino or carboxy groups or replacement of hydrogen atoms. The radiolabeling with fluorine-18 enables PET detection, leveraging the compound’s structural similarity to levodopa to trace dopaminergic activity in the brain.
While detailed pharmacodynamics and mechanism of action data are not specified, the diagnostic capacity of Fluorodopa (18F) arises from its role as a substrate for aromatic L-amino acid decarboxylase. After administration, it is taken up by presynaptic dopaminergic neurons and undergoes conversion to fluorodopamine, enabling visualization of functional dopaminergic nerve terminals. Key pharmacokinetic parameters, including absorption, distribution, metabolism, and excretion, are influenced by the radiolabeled fluorine isotope, facilitating rapid imaging protocols within clinical PET workflows.
Safety considerations reflect those common to diagnostic radiopharmaceuticals, including exposure to ionizing radiation and potential hypersensitivity reactions. The agent’s short physical half-life (approximately 110 minutes for fluorine-18) supports its use within clinical imaging sessions while minimizing radiation dose.
Fluorodopa (18F) is commonly employed in specialized centers for neurodegenerative disease evaluation. Regulatory approval status varies by region, with both approved and experimental designations depending on local agencies.
For formulation scientists and procurement specialists, sourcing the Fluorodopa (18F) API requires adherence to stringent radiochemical purity specifications and compliance with regulatory requirements governing controlled radiopharmaceutical production. Stability, sterility, and consistent specific activity are critical quality attributes to ensure reliable imaging outcomes in clinical settings.
Identification & chemistry
| Generic name | Fluorodopa (18F) |
|---|---|
| Molecule type | Small molecule |
| CAS | 92812-82-3 |
| UNII | 2C598205QX |
| DrugBank ID | DB13848 |
ADME / PK
| Half-life | The plasma half-life following intravenous administration is approximately 1-3 hours. |
|---|---|
| Metabolism | Fluorodopa F 18 is decarboxylated by aromatic amino acid decarboxylase (AADC) in the striatum to fluorodopamine F 18. Fluorodopamine F 18 is then further metabolized by monoamine oxidase (MAO) to yield [18F] 6-fluoro-3,4-dihydroxyphenylacetic acid, then subsequently by COMT to yield [18F]6-fluorohomovanillic acid. |
| Route of elimination | Approximately 80% of the administered radioactivity is eliminated in the urine. |
| Clearance | The agent is cleared from blood and tissue within 24 hours following administration. |
Formulation & handling
- Fluorodopa (18F) is administered exclusively via parenteral routes, primarily intravenous injection.
- This small molecule requires fasting conditions prior to administration to avoid interference from food intake.
- Handling should consider its radioactive nature and stability as an injection solution concentrate.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in the US with patent protection recently expired, allowing for increased generic competition and established market availability. The product is in a mature phase of its lifecycle. |
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| Markets | US |
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Supply Chain
| Supply chain summary | Fluorodopa (18F) is primarily supplied by a limited number of originator companies with branded products available in the US market. The absence of mention of EU or other markets indicates a more regionally concentrated presence. Given the nature of radiopharmaceuticals and their regulatory environment, generic competition is generally limited, and there is no indication of imminent patent expiry leading to increased generic sourcing. |
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Fluorodopa (18F) 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.
