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- Barbiturates
- Valerian
Valerian API Manufacturers & Suppliers
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Valerian | CAS No: 8057-49-6 | GMP-certified suppliers
A medication that provides sedative and anxiolytic benefits for managing sleep disorders, anxiety, and related central nervous system conditions, sourced from standardized Valerian root extracts.
Therapeutic categories
Product Snapshot
- Valerian is available in oral solid and liquid formulations as well as injectable and topical forms
- It is primarily utilized for therapeutic applications related to sedation and anxiolytic effects
- Valerian products hold approved and investigational statuses in the US and Canadian markets
Clinical Overview
Clinically, valerian has been traditionally employed for its sedative and anxiolytic effects. Reported uses encompass management of sleep disorders, anxiety, attention deficit-hyperactivity disorder (ADHD), and joint pain. However, the exact clinical indications and approval status vary between regions, with some applications considered investigational or experimental. Regulatory frameworks generally acknowledge valerian as a natural flavoring agent, permitting its direct addition to foods for human consumption.
The pharmacological profile of valerian is not fully characterized due to the complexity of its constituents. Its mechanism of action remains incompletely understood, with sedative and anxiolytic effects hypothesized to involve modulation of gamma-aminobutyric acid (GABA) receptors in the central nervous system, though definitive confirmation is lacking. Pharmacodynamic data specific to valerian extracts are limited, and standardization challenges arise from variable chemical composition.
Regarding absorption, distribution, metabolism, and excretion (ADME) parameters, detailed studies on valerian are sparse. The constituents are believed to be absorbed following oral administration, metabolized primarily via hepatic pathways, and excreted renally. These processes are influenced by the botanical source and extraction method, contributing to variability in clinical effects.
Safety and toxicity considerations include the generally favorable tolerability profile reported in traditional use. Nevertheless, there are potential risks of drug interactions, particularly with other central nervous system depressants, and contraindications during pregnancy and lactation. Hepatotoxicity, although rarely reported, remains a concern with prolonged or high-dose usage.
Valerian is incorporated in various pharmaceutically formulated preparations and is available under multiple brand names globally, often as dietary supplements or herbal medicinal products rather than conventional pharmaceuticals.
For API sourcing, quality control is critical due to the botanical origin and inherent variability. Good Agricultural and Collection Practices (GACP), validated extraction procedures, and stringent quality assurance measures including identification of active markers and contaminant testing are essential to ensure batch-to-batch consistency and regulatory compliance. Suppliers should provide comprehensive documentation covering origin, purity, and stability parameters to support pharmaceutical development and regulatory submissions.
Identification & chemistry
| Generic name | Valerian |
|---|---|
| Molecule type | Biotech |
| CAS | 8057-49-6 |
| UNII | JWF5YAW3QW |
| DrugBank ID | DB13196 |
Formulation & handling
- Valerian is primarily formulated for oral administration in various solid and liquid forms with additional intramuscular and cutaneous applications requiring sterile handling.
- As a biotech drug, it may require careful control of temperature and moisture to preserve its bioactivity during processing and storage.
- Due to multiple oral liquid and tincture forms, compatibility with excipients and potential food interactions should be assessed during formulation development.
Regulatory status
| Lifecycle | The API’s primary patents have expired in both the US and Canada, resulting in a mature market with multiple generic products available. Ongoing competition focuses on formulation variations and cost optimization. |
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| Markets | Canada, US |
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Supply Chain
| Supply chain summary | The manufacturing landscape for Valerian includes multiple originator companies producing branded formulations primarily in Canada and the US. These branded products have established presence in North American markets, with limited indication of penetration into EU or other regions. Patent expiry is not explicitly noted, suggesting that generic competition may not yet be prevalent but could emerge depending on intellectual property status. |
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Valerian is a type of Barbiturates
Barbiturates are a category of pharmaceutical active pharmaceutical ingredients (APIs) that have sedative, hypnotic, and anticonvulsant properties. They belong to the class of drugs called depressants, which slow down the central nervous system (CNS) activity. Barbiturates have been widely used in the medical field for their ability to induce sleep, reduce anxiety, and control seizures.
The mechanism of action of barbiturates involves enhancing the effects of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain. GABA inhibits the transmission of signals between nerve cells, leading to relaxation and sedation. Barbiturates bind to specific GABA receptors, increasing the inhibitory effects of GABA and resulting in a calming effect on the CNS.
In the past, barbiturates were commonly prescribed for insomnia, anxiety disorders, and epilepsy. However, their use has decreased significantly due to the emergence of safer and more effective alternatives with fewer side effects. Nonetheless, barbiturates are still utilized in certain medical situations, such as anesthesia induction, emergency seizure control, and in some cases of refractory epilepsy.
Despite their therapeutic benefits, barbiturates carry potential risks and side effects. They can cause drowsiness, impaired coordination, and dependence when used for extended periods. Overdose of barbiturates can be life-threatening, leading to respiratory depression and coma.
In conclusion, barbiturates are a class of API widely known for their sedative, hypnotic, and anticonvulsant properties. While their use has diminished over time, they remain important in specific medical contexts. Proper caution and medical supervision are crucial when using barbiturates to ensure safety and efficacy.
