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Oxybutynin | CAS No: 5633-20-5 | GMP-certified suppliers
A medication that helps manage overactive bladder symptoms and detrusor overactivity linked to neurological conditions, and can also ease bladder spasms in specific clinical situations.
Therapeutic categories
Primary indications
- Oxybutynin is indicated for the symptomatic treatment of overactive bladder, which causes urge urinary incontinence and frequency, and urgency
- Oxybutynin may also be used for children aged 6 and above for the symptomatic management of detrusor muscle overactivity which has been found to be related to a neurological condition
- Spina bifida is an example of a neurological condition in which oxybutynin may be used to control urinary symptoms
- On occasion, oxybutynin may be used off-label to relieve bladder spasms associated with ureteral stents or urinary catheters
Product Snapshot
- Oxybutynin is an oral and transdermal small‑molecule antimuscarinic available in multiple immediate‑ and extended‑release forms, including topical gels and patches
- It is used for management of overactive bladder symptoms and detrusor overactivity associated with neurologic conditions
- It is approved in the US, EU, and Canada, with both approved and investigational statuses noted for specific presentations
Clinical Overview
The pharmacological effect of oxybutynin is mediated through inhibition of muscarinic receptors in bladder smooth muscle. By blocking the muscarinic action of acetylcholine, oxybutynin reduces involuntary detrusor contractions and increases bladder capacity. Its active metabolite, N‑desethyloxybutynin, contributes to overall activity through competitive antagonism at M1, M2, and M3 receptors.
Absorption is formulation dependent, and the drug undergoes extensive first‑pass metabolism. Oxybutynin is primarily metabolized via CYP3A pathways, resulting in formation of N‑desethyloxybutynin. Both the parent compound and metabolite display anticholinergic pharmacodynamic effects. Elimination occurs through hepatic metabolism with renal excretion of metabolites.
Safety considerations include anticholinergic adverse effects such as dry mouth, constipation, blurred vision, drowsiness, confusion, and agitation. Angioedema has been reported and requires immediate discontinuation and medical evaluation. Central nervous system effects may be more pronounced in older adults or at higher exposures. Drug interactions may occur with inhibitors or inducers of CYP3A, and caution is warranted in patients sensitive to anticholinergic burden.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemical purity, impurity profiles, and consistent particle size distribution, supported by regulatory documentation such as DMFs or CEPs when applicable.
Identification & chemistry
| Generic name | Oxybutynin |
|---|---|
| Molecule type | Small molecule |
| CAS | 5633-20-5 |
| UNII | K9P6MC7092 |
| DrugBank ID | DB01062 |
Pharmacology
| Summary | Oxybutynin is an antimuscarinic agent that relaxes bladder smooth muscle by competitively inhibiting M1, M2, and M3 muscarinic receptors. Its primary pharmacologic effect is reduced detrusor overactivity, leading to increased bladder capacity and decreased urgency and frequency. The active metabolite, N‑desethyloxybutynin, contributes to these antispasmodic actions. |
|---|---|
| Mechanism of action | Oxybutynin acts to relax the bladder by inhibiting the muscarinic action of acetylcholine on smooth muscle, and not skeletal muscle. The active of oxybutynin is metabolite is N-desethyloxybutynin. It competitively inhibits the postganglionic type 1, 2 and 3 muscarinic receptors. The above actions lead to increased urine capacity in the bladder, decreasing urinary urgency and frequency. In addition, oxybutynin delays the initial desire to void. |
| Pharmacodynamics | Oxybutynin exerts antispasmodic actions on the bladder, relieving the uncomfortable symptoms of overactive bladder, including urinary urgency and frequency. These actions occur through the inhibition of muscarinic receptors. **A note on angioedema and anticholinergic effects** Symptoms of angioedema may occur with oxybutynin therapy. If angioedema is suspected, discontinue oxybutynin immediately and provide appropriate medical treatment.In addition, anticholinergic effects may occur with the administration of this drug. Some symptoms may include hallucinations, confusion, agitation, and drowsiness. It is advisable to avoid operating heavy machinery before the response to oxybutynin has been monitored. Dose adjustments may be required. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Muscarinic acetylcholine receptor M3 | Humans | antagonist |
| Muscarinic acetylcholine receptor M2 | Humans | antagonist |
| Muscarinic acetylcholine receptor M1 | Humans | antagonist |
ADME / PK
| Absorption | Oxybutynin should be swallowed whole with the help of liquids.A pharmacokinetic study revealed that oxybutynin was rapidly absorbed, and peak concentrations were reached within about 1 hour of administration, measured at 8.2 ngml-1 and AUC was 16 ngml-1.The biovailability of oxybutynin is about 6%, and the plasma concentration of the active metabolite, desethyloxybutynin is 5 to 12 times greater than that of oxybutynin.Bioavailability is increased in the elderly.Food has been shown to increase the exposure to controlled-release oxybutynin. |
|---|---|
| Half-life | The plasma elimination half-life is about 2 hours. In the elderly, the elimination half-life is prolonged up to 5 hours. |
| Protein binding | Oxybutynin enantiomers are more than 97% bound to plasma proteins, primarily to alpha-1 acid glycoprotein. |
| Metabolism | Oxybutynin is heavily metabolized by the CYP3A4 enzyme systemin both the liver and the wall of the intestine. It undergoes first-pass metabolism, and its resulting primary active metabolite, N-desethyloxybutynin circulates. It is active at the muscarinic receptors in both the bladder and the salivary gland.Hepatic biotransformation also produces its major inactive metabolite, phenylcyclohexylglycolic acid. |
| Route of elimination | Oxybutynin is heavily cleared by the liver.Under 0.1% of an administered dose is found as unchanged drug in the urine. Less than 0.1% of a single dose of oxybutynin is excreted as desethyloxybutynin. |
| Volume of distribution | Oxybutynin has a wide volume of distribution of 193 L.In rats, oxybutynin penetrates the central nervous system. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity favor solid oral formulations but may require solubilizers or controlled‑release matrices for consistent exposure.
- Suitable for transdermal and topical systems due to high LogP, with handling considerations for minimizing evaporation and ensuring uniform drug loading in gels or patches.
- Intravesical solutions require appropriate solubilization and pH control to maintain clarity and prevent precipitation during storage and administration.
Regulatory status
| Lifecycle | Most patent protections for the API have expired, with the last U.S. patents ending in 2020 and earlier expiration in Canada in 2016, indicating that the product is in a mature stage of its lifecycle. With availability across the US, Canada, and the EU, the market is likely characterized by established competition and limited exclusivity. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Oxybutynin originated from a small set of innovator companies, but the current supply landscape is dominated by numerous packagers and generic manufacturers, indicating that originator products now play a limited role. Branded formulations such as Ditropan and various national brand‑label versions have established presence in the US, Canada, and EU markets. Key patents in the US and Canada have expired, supporting the broad availability of generics and sustained multi‑supplier competition. |
|---|
Safety
| Toxicity | The acute oral LD50 in rats is 460 mg/kg. **Overdose information** An overdose with oxybutynin may manifest clinically as CNS overactivity, fever, palpitations, cardiac arrhythmias, urinary retention, respiratory failure, paralysis, in addition to coma.Provide supportive care immediately. Activated charcoal in addition to a cathartic agent should be administered. There have been 2 reports of an overdose with a 100 mg dose of oxybutynin. One case was a 13-year-old boy and another was a 34-year-old woman. Alcohol was also ingested simultaneously in both cases. The patients received supportive treatment and fully recovered. |
|---|
- Acute oral toxicity is moderate, with an LD50 of about 460 mg/kg in rats, indicating meaningful hazard potential on ingestion
- High‑level exposure has been associated with CNS excitation, autonomic instability, hyperthermia, cardiac arrhythmias, respiratory compromise, and, in severe cases, paralysis or coma
- Documented overdose cases demonstrate multi‑system involvement
Oxybutynin is a type of Anticholinergics/Parasympathemimetics
Anticholinergics/Parasympathomimetics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These compounds exhibit specific pharmacological actions by targeting the cholinergic system in the body.
Anticholinergics are drugs that block the action of acetylcholine, a neurotransmitter that regulates various bodily functions. By inhibiting the activity of acetylcholine, anticholinergics can have diverse therapeutic effects, including reducing muscle spasms, decreasing gastrointestinal motility, and alleviating symptoms associated with certain respiratory conditions.
On the other hand, parasympathomimetics, also known as cholinomimetics, mimic the action of acetylcholine by stimulating cholinergic receptors. These compounds enhance the parasympathetic nervous system, which is responsible for the "rest and digest" functions of the body. Parasympathomimetics are commonly used to treat conditions such as glaucoma, urinary retention, and Alzheimer's disease.
The use of anticholinergics/parasympathomimetics requires careful consideration and medical supervision due to their potential side effects, which can include dry mouth, blurred vision, urinary retention, constipation, and cognitive impairment. These medications are available in various forms, including tablets, capsules, patches, and inhalers, and their dosage is determined by the specific medical condition being treated.
Overall, anticholinergics/parasympathomimetics play a vital role in modern medicine, providing targeted therapeutic effects by modulating the cholinergic system. Their usage has significantly improved patient outcomes in various medical conditions and continues to be an important category of pharmaceutical APIs.
Oxybutynin (Anticholinergics/Parasympathemimetics), classified under Autonomic Nervous System Agents
Autonomic Nervous System Agents are a crucial category of pharmaceutical active ingredients (APIs) that target the autonomic nervous system (ANS). The ANS plays a vital role in regulating essential bodily functions such as heart rate, blood pressure, digestion, and respiratory rate. This category of pharmaceutical APIs encompasses a wide range of drugs designed to modulate the activity of the ANS.
One subcategory within Autonomic Nervous System Agents is the Sympathomimetic agents, which mimic the effects of the sympathetic nervous system. These drugs are often used to treat conditions such as asthma, nasal congestion, and hypotension by stimulating specific adrenergic receptors.
Conversely, Sympatholytic agents act to inhibit or block the sympathetic nervous system. They are employed to treat hypertension, anxiety, and certain cardiac conditions by reducing sympathetic activity.
Another subcategory is Parasympathomimetic agents, which mimic the effects of the parasympathetic nervous system. These drugs are commonly used to treat glaucoma, urinary retention, and certain gastrointestinal disorders by stimulating cholinergic receptors.
Parasympatholytic agents, on the other hand, act to block the parasympathetic nervous system. They find applications in the treatment of conditions such as overactive bladder and irritable bowel syndrome by inhibiting cholinergic receptors.
The Autonomic Nervous System Agents API category includes various drugs with distinct mechanisms of action that enable healthcare professionals to fine-tune the balance of the autonomic nervous system. By targeting specific receptors and pathways, these pharmaceutical APIs provide valuable therapeutic options for managing a wide range of medical conditions related to autonomic dysfunction.
Oxybutynin API manufacturers & distributors
Compare qualified Oxybutynin API suppliers worldwide. We currently have 10 companies offering Oxybutynin API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Corden Pharma | Producer | Germany | France | CoA, GMP, USDMF | 45 products |
| Duchefa Farma B.V. | Distributor | Netherlands | France | CoA, GMP, ISO9001, MSDS | 170 products |
| Harman Finochem | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 34 products |
| Mylan | Producer | India | India | CEP, CoA, WC | 201 products |
| PCAS | Producer | France | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 29 products |
| Piramal Healthcare | Producer | United Kingdom | India | CoA, GMP, WC | 31 products |
| Piramal Pharma Solutions | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 44 products |
| Resonance Labs. | Producer | India | India | CEP, CoA, GMP, WHO-GMP | 34 products |
| Synkem | Producer | France | France | CEP, CoA, FDA, GMP | 4 products |
When sending a request, specify which Oxybutynin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Oxybutynin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Oxybutynin API
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Regulatory
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