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Capsicum oleoresin | CAS No: 8023-77-6 | GMP-certified suppliers
A medication that provides temporary relief of minor muscle and joint aches related to backache, arthritis, strains, and sprains through topical application of standardized Capsicum oleoresin.
Therapeutic categories
Primary indications
- Indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains
Product Snapshot
- Capsicum oleoresin is available in multiple formulation types including topical creams, gels, patches, ointments, liniments, sprays, and oral tablets
- It is primarily used for the temporary relief of minor musculoskeletal aches and pains such as those associated with backache, arthritis, strains, and sprains
- This API is approved for use in key regulatory markets including the United States and Canada
Clinical Overview
Clinically, capsicum oleoresin is indicated for the temporary relief of minor musculoskeletal aches and pains, such as those associated with simple backache, arthritis, strains, and sprains. It is commonly formulated as a topical agent in over-the-counter products. Additionally, capsicum oleoresin is contained in pepper sprays as an active lachrymatory agent, causing irritation, lacrimation, pain, and transient eye impairment.
Pharmacodynamically, the analgesic efficacy of capsicum oleoresin primarily derives from capsaicin, which acts on peripheral and central nervous system components. Capsaicin activates transient receptor potential vanilloid subfamily 1 (TRPV1) receptors located on afferent C and some Aδ fibers, inducing an influx of calcium ions and neuronal depolarization. This activation initially produces sensations of heat, stinging, or itching and triggers primary and secondary hyperalgesia. Prolonged receptor activation leads to desensitization, depletion of substance P—a neuropeptide involved in pain transmission—and decreased nociceptive signaling, resulting in analgesia. Clinical evidence supports efficacy in neuropathic pain models, including postherpetic neuralgia and diabetic neuropathy.
Key ADME parameters of capsicum oleoresin are influenced by its lipophilicity and complex mixture of phenolic compounds. Topical absorption enables localized effects with limited systemic exposure. Its fat-solubility facilitates penetration into skin and neuronal tissues but also demands careful formulation to balance efficacy and tolerability.
Safety considerations include localized irritation, burning sensation, and potential sensitization. Ocular exposure may cause significant pain and temporary blindness due to its lachrymatory properties. Systemic toxicity is uncommon with topical use but should be monitored in concentrated preparations.
From a regulatory perspective, capsicum oleoresin is classified under biological products, complex mixtures, and plant preparations, with approved status in various jurisdictions as a pharmaceutical preparation.
When sourcing capsicum oleoresin APIs, attention should be paid to the standardization of capsaicinoid content, solvent residuals, and purity profiles to ensure batch-to-batch consistency and compliance with pharmacopeial standards. Supplier certification, traceability of plant material origin, and adherence to good manufacturing practices (GMP) are critical for quality assurance in pharmaceutical applications.
Identification & chemistry
| Generic name | Capsicum oleoresin |
|---|---|
| Molecule type | Biotech |
| CAS | 8023-77-6 |
| UNII | UW86K581WY |
| DrugBank ID | DB11131 |
Pharmacology
| Summary | Capsaicin is a selective agonist of the transient receptor potential vanilloid 1 (TRPV1) receptor, predominantly expressed on nociceptive C and some Aδ fibers. Activation of TRPV1 by capsaicin leads to increased intracellular calcium influx and neuronal depolarization, producing initial pain and sensitization followed by desensitization and diminished nociceptive signaling. This mechanism underlies its therapeutic use for temporary relief of minor musculoskeletal pain through modulation of peripheral sensory neuron activity. |
|---|---|
| Mechanism of action | Capsaicin is the active ingredient in capsicum oleoresin that confers the molecule its biological actions. It induces central sensitization to cause pain and depolarizes nociceptors to increases their cytosolic free Ca2+ concentration . It is a highly selective agonist and activator at the transient receptor potential vanilloid subfamily member 1 (TRPV1) receptors expressed in afferent neuronal C fibers and some Aδ fibers . The aliphatic tail of capsaicin interacts with the channel via nonspecific Van der Waals forces, while hydrogen bonds between its vanillyl “head” and amide “neck” with residues of glutamic acid E571 and T551 of the channel, respectively, confers specificity for ligand binding . Binding and local activation of these receptors lead to increased influx of calcium ions and nerve depolarization. Signal propagation to the central nervous system causes local heat, stinging, and/or itching sensations . Prolonged activation of TRPV1 receptors results in loss of receptor functionality, causing impaired local nociception for extended periods due to desensitization and inactivation of sensory neurons. It is thought that the activation of TRPV1 receptors is the main mechanism of action of capsaicin. Capsaicin also induces a local depletion of substance P, which is a neuropeptide involved in visceral pain signalling ; however this effect in the relief of pain remains controversial . |
| Pharmacodynamics | Capsicum oleoresin is a topical analgesic and inflammatory agent. Capsaicin, an active ingredient in capsicum oleoresin, causes pain and sensitization of both peripheral and central nerves. It induces primary and secondary hyperalgesia and mimics the symptoms associated with neuropathic pain, such as allodynia, secondary hyperalgesia, referred pain area, and viscerovisceral hyperalgesia . In opposition, capsaicin also mediates analgesic actions via desensitization and withdrawal of epidermal nerve fibers . Systemic reviews of capsaicin-containing topical formulations demonstrate clinical effectiveness for pain reduction in postherpetic neuralgia, postsurgical neuropathies, and diabetic neuropathy, compared to placebo . |
Targets
| Target | Organism | Actions |
|---|---|---|
| Transient receptor potential cation channel subfamily V member 1 | Humans | agonist, activator |
ADME / PK
| Absorption | For pharmacokinetic properties of capsaicin, refer to the drug entry for [DB06774]. |
|---|---|
| Half-life | For pharmacokinetic properties of capsaicin, refer to the drug entry for [DB06774]. |
| Protein binding | For pharmacokinetic properties of capsaicin, refer to the drug entry for [DB06774]. |
| Metabolism | For pharmacokinetic properties of capsaicin, refer to the drug entry for [DB06774]. |
| Route of elimination | For pharmacokinetic properties of capsaicin, refer to the drug entry for [DB06774]. |
| Volume of distribution | For pharmacokinetic properties of capsaicin, refer to the drug entry for [DB06774]. |
| Clearance | For pharmacokinetic properties of capsaicin, refer to the drug entry for [DB06774]. |
Formulation & handling
- Capsicum oleoresin is primarily formulated for topical and transdermal applications, with some oral dosage forms also available.
- As a biotech liquid extract, it requires careful handling to maintain stability and potency in various semi-solid and liquid formulations.
- Formulation should consider potential skin irritation and ensure controlled release in patch or plaster forms to optimize dosing and tolerability.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patents have expired, allowing generic versions to be marketed in both Canada and the US. The product is in a mature market phase with established availability across these regions. |
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| Markets | Canada, US |
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Supply Chain
| Supply chain summary | The manufacturing landscape for Capsicum oleoresin involves multiple originator companies supplying branded products primarily in the US and Canadian markets. Several branded formulations are available, indicating established global presence within these regions. There is no explicit data on patent status, suggesting that generic competition may already exist or could emerge as patents expire. |
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Safety
| Toxicity | Acute oral LD50, acute dermal LD50 and acute inhalation LD50 in rat are >3000mg/kg, >2500 mg/kg, and >10000 mg/m^3, respectively [MSDS]. Capsicum oleoresin is not considered to be a carcinogen. There has been no case reports or findings from studies indicating teratogenic potential of capsaicinoid . Capsicum oleoresin can cause serious irritation, conjunctivitis and lacrimation via contact with eyes. It induces a burning sensation and pain in case of contact with eyes and skin. As it is also irritating to the respiratory system, it causes lung irritation and coughing as well as bronchoconstriction. Other respiratory effects include laryngospasm, swelling of the larynx and lungs, chemical pneumonitis,respiratory arrest and central nervous system effects such as convulsions and excitement. In case of ingestion, gastrointestinal tract irritation may be observed along with a sensation of warmth or painful burning [MSDS]. Symptoms of systemic toxicity include disorientation, fear, loss of body motor control including diminished hand-eye coordination, hyperventilation, tachycardia, and pulmonary oedema . Careful early decontamination is recommended and medical intervention should be initiated for any life-threatening symptoms. In case of contact, individual must be removed from the source of exposure and the contacted skin and mucous membranes should be thoroughly washed with copious amounts of water . |
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- Capsicum oleoresin exhibits low acute toxicity with LD50 values ›3000 mg/kg (oral), ›2500 mg/kg (dermal), and ›10,000 mg/m³ (inhalation) in rats
- Exposure can cause severe eye and respiratory irritation, including conjunctivitis, lacrimation, bronchoconstriction, and potential respiratory distress
- Skin and mucous membrane contact may result in burning sensation and pain
Capsicum oleoresin is a type of Herbal remedies
Herbal remedies, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), refer to medicinal products derived from plants. These remedies have been used for centuries in traditional medicine systems across various cultures worldwide. Herbal remedies harness the therapeutic properties of plant materials such as roots, leaves, flowers, and bark to treat a wide range of health conditions.
Herbal remedies are rich in bioactive compounds, including alkaloids, flavonoids, terpenes, and phenolic acids. These compounds exhibit diverse pharmacological activities and can provide benefits for various ailments. They may possess antioxidant, anti-inflammatory, antimicrobial, antiviral, or immunomodulatory properties, among others.
Pharmaceutical companies extensively research and develop herbal remedies to ensure their safety, efficacy, and standardization. The extraction and purification processes involve techniques such as solvent extraction, steam distillation, and chromatography. Quality control measures are implemented to maintain consistency and potency across batches.
Herbal remedies offer a natural alternative to conventional pharmaceutical drugs and are often preferred by individuals seeking holistic or complementary treatment options. They are commonly available in various forms, including capsules, tablets, tinctures, and topical formulations.
It is essential to note that while herbal remedies are generally considered safe, they can still have interactions with other medications and may not be suitable for everyone. Consulting with healthcare professionals or herbalists before starting any herbal treatment is recommended to ensure proper usage and avoid potential adverse effects.
Overall, herbal remedies within the pharmaceutical API subcategory provide a valuable option for individuals seeking natural alternatives and contribute to the growing field of plant-based medicine.
Capsicum oleoresin (Herbal remedies), classified under Others
The others category refers to pharmaceutical APIs that do not fall under specific classifications such as antibiotics, antivirals, analgesics, or cardiovascular drugs. These APIs are diverse in nature and serve various therapeutic purposes, making them a crucial component of pharmaceutical formulations.
Pharmaceutical companies develop APIs in the others category to address specific medical conditions or target novel biological pathways. This category includes APIs used in oncology, neurology, immunology, and other specialized areas of medicine. The APIs in this category are often designed to interact with specific molecular targets or receptors, providing targeted therapeutic effects.
The development of APIs in the others category requires extensive research and testing to ensure their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers employ advanced techniques such as chemical synthesis, biotechnology, and genetic engineering to produce these APIs.
Due to the broad range of applications and therapeutic uses, APIs in the others category contribute significantly to the advancement of medical treatments. Pharmaceutical companies constantly strive to innovate and discover new APIs within this category to address unmet medical needs and improve patient outcomes.
In conclusion, the others category of pharmaceutical APIs encompasses a diverse range of active ingredients used in drug formulation. These APIs play a crucial role in developing innovative therapies across various therapeutic areas, contributing to advancements in healthcare and patient well-being.
Capsicum oleoresin API manufacturers & distributors
Compare qualified Capsicum oleoresin API suppliers worldwide. We currently have 2 companies offering Capsicum oleoresin API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Duchefa Farma B.V. | Distributor | Netherlands | United Kingdom | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
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