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Solifenacin | CAS No: 242478-37-1 | GMP-certified suppliers
A medication that treats overactive bladder by reducing urinary urgency, frequency, and incontinence, supporting symptom management in urological and benign prostatic hypertrophy conditions.
Therapeutic categories
Primary indications
- Solifenacin tablets are indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency
Product Snapshot
- Solifenacin is available primarily as an oral small molecule in various tablet formulations, including film-coated, orally disintegrating, extended-release, and delayed-release forms
- Its main therapeutic use is for managing overactive bladder symptoms such as urinary incontinence, urgency, and frequency
- Solifenacin has received regulatory approval for commercial use in the United States and Canada
Clinical Overview
Pharmacodynamically, solifenacin exhibits high affinity for muscarinic M3, M1, and M2 receptors, with clinical effects mainly mediated through antagonism of M2 and M3 receptors in the bladder. Approximately 80% of bladder muscarinic receptors are M2 subtype, and 20% are M3. By inhibiting M3 receptor activation, solifenacin reduces detrusor muscle contractions, thereby mitigating symptoms of urgency and frequency. Antagonism at M2 receptors may further decrease smooth muscle contractility within the bladder.
Key pharmacokinetic parameters include solifenacin’s metabolism via cytochrome P450 enzymes CYP3A4 and CYP2D6, which necessitates consideration of potential drug-drug interactions. Its absorption, distribution, metabolism, and elimination profiles support once-daily dosing. Solifenacin is categorized as a QTc-prolonging agent, which warrants caution especially in patients with underlying cardiac conditions or concomitant medications affecting cardiac repolarization.
Safety considerations include risk of common anticholinergic adverse effects such as dry mouth, constipation, and blurred vision. More serious but less frequent events include angioedema and anaphylaxis. Monitoring and patient education are advised, particularly in populations vulnerable to anticholinergic burden.
Solifenacin was approved by the U.S. Food and Drug Administration in November 2004 and is marketed under various brand names globally in formulations targeting urinary disorders. It is also utilized in managing symptoms associated with benign prostatic hypertrophy.
When sourcing solifenacin API, attention should be paid to compliance with pharmacopeial standards and verification of manufacturing under Good Manufacturing Practice (GMP) conditions. Ensuring consistent purity, polymorphic form, and absence of impurities is critical for formulation stability and regulatory acceptance. Reliable supply chains must address potential variability in cytochrome P450 metabolism affecting clinical performance.
Identification & chemistry
| Generic name | Solifenacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 242478-37-1 |
| UNII | A8910SQJ1U |
| DrugBank ID | DB01591 |
Pharmacology
| Summary | Solifenacin is a competitive antagonist of muscarinic acetylcholine receptors, with highest affinity for M3 and M2 subtypes predominantly found in bladder tissue. By inhibiting M3 receptor-mediated detrusor muscle contractions and M2 receptor activity, it reduces bladder overactivity associated with urinary urgency and incontinence. The compound exhibits prolonged pharmacodynamic effects suitable for once-daily administration. |
|---|---|
| Mechanism of action | Solifenacin is a competitive muscarinic receptor antagonist. It has the highest affinity for M3, M1, and M2 muscarinic receptors. 80% of the muscarinic receptors in the bladder are M2, while 20% are M3. Solifenacin's antagonism of the M3 receptor prevents contraction of the detrusor muscle, while antagonism of the M2 receptor may prevent contraction of smooth muscle in the bladder. |
| Pharmacodynamics | Solifenacin antagonizes the M2 and M3 muscarinic receptors in the bladder to treat an overactive bladder. It has a long duration of action as it is usually taken once daily. Patients taking solifenacin should be aware of the risks of angioedema and anaphylaxis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Muscarinic acetylcholine receptor M3 | Humans | antagonist |
| Muscarinic acetylcholine receptor M2 | Humans | antagonist |
| Muscarinic acetylcholine receptor M4 | Humans | antagonist |
ADME / PK
| Absorption | Solifenacin is well absorbed in the duodenum, jejunum, and ileum but not the stomach. Absorption occurs via passive diffusion and so no transporters are involved. The mean oral bioavailability of solifenacin is 88%. The T<sub>max</sub> of solifenacin is 3-8 hours with a C<sub>ss</sub> of 32.3ng/mL for a 5mg oral dose and 62.9ng/mL for a 10mg oral dose. |
|---|---|
| Half-life | The elimination half life of solifenacin ranges from 33-85 hours. |
| Protein binding | Solifenacin is 93-96% protein bound in plasma, mainly to alpha-1-acid glycoprotein. |
| Metabolism | Solifenacin undergoes N-oxidation at the quinuclidin ring by cytochrome P450, though the exact enzymes are not revealed in the literature. The tetrahydroisoquinolone ring is 4R-hydroxylated by CYP3A4, CYP1A1, and CYP2D6. A 4R-hydroxy N-oxide metabolite is also formed by CYP3A4. Finally, solifenacin can undergo direct glucuronidation. Only solifenacin and the 4R-hydroxy metabolite are pharmacologically active. |
| Route of elimination | 69.2±7.8% of a radiolabelled dose is recovered in the urine, 22.5±3.3% was recovered in feces, and 0.4±7.8% was recovered in exhaled air. 18% of solifenacin is eliminated as the N-oxide metabolite, 9% is eliminated as the 4R-hydroxy N-oxide metabolite, and 8% is eliminated as the 4R-hydroxy metabolite. |
| Volume of distribution | The volume of distribution of solifenacin is 600L. |
| Clearance | The clearance of solifenacin is 7-14L/h and a renal clearance of 0.67-1.51L/h. |
Formulation & handling
- Solifenacin is a small molecule API formulated primarily for oral administration in tablet and suspension forms.
- The compound exhibits low water solubility and a moderate logP, indicating potential formulation challenges for bioavailability.
- It has no significant food sensitivity, allowing administration with or without food without affecting stability or efficacy.
Regulatory status
| Lifecycle | The API is marketed in Canada and the United States with patent protections that expired in Canada in 2015 and partially in the US in 2019, while a key US patent remains in force until 2031, indicating ongoing market exclusivity primarily in the US. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The solifenacin supply landscape features multiple packagers, indicating a mature manufacturing base with diverse sourcing options primarily serving the US and Canadian markets. Branded products are present predominantly in North America, with several brand variants available. Patent protection in the US extends until 2031, suggesting limited generic competition currently but potential for increased market entries after patent expiry. |
|---|
Safety
| Toxicity | The LD<sub>50</sub> of Solifenacin has yet to be determined. Signs of overdose include severe anticholinergic effects, mental status changes, and decreased consciousness. In case of overdose, treat patients with gastric lavage and supportive measures. Monitor patients with an ECG. |
|---|
- The LD₅₀ of Solifenacin has not been established
- Handle with caution to avoid accidental exposure
- Overdose may result in severe anticholinergic effects and altered mental status
Solifenacin is a type of Urological spasmolytics
Urological spasmolytics belong to the pharmaceutical API subcategory designed to address conditions related to urinary system spasms and discomfort. These medications work by relaxing the smooth muscles in the urinary tract, helping to alleviate symptoms such as bladder spasms and urinary urgency.
Urological spasmolytics are commonly prescribed for various urological disorders, including urinary incontinence, interstitial cystitis, and overactive bladder. The active ingredients in these APIs target specific receptors in the urinary system, blocking the signaling pathways that trigger muscle contractions.
By reducing muscle spasms and promoting relaxation, urological spasmolytics help relieve symptoms associated with these conditions. This includes reducing the frequency of urination, decreasing urinary urgency, and alleviating the discomfort caused by bladder spasms.
It is important to note that urological spasmolytics are typically available in different formulations, including oral tablets, extended-release capsules, and transdermal patches. The choice of formulation depends on the specific needs and preferences of the patient, as well as the severity of the condition being treated.
Before starting any urological spasmolytic medication, it is crucial to consult a healthcare professional. They will evaluate the individual's medical history, perform a thorough examination, and recommend the appropriate dosage and duration of treatment.
Overall, urological spasmolytics play a significant role in managing urological disorders characterized by muscle spasms in the urinary tract. These pharmaceutical APIs offer relief from symptoms and enhance the quality of life for individuals suffering from such conditions.
Solifenacin (Urological spasmolytics), classified under Genitourinary Agents
Genitourinary agents are a category of pharmaceutical active ingredients (APIs) that are specifically designed to target and treat disorders related to the genitourinary system. The genitourinary system encompasses the organs and structures involved in the production, storage, and elimination of urine, as well as the reproductive organs.
These APIs play a crucial role in the treatment of various genitourinary conditions, including urinary tract infections (UTIs), erectile dysfunction, urinary incontinence, benign prostatic hyperplasia (BPH), and other related disorders. They exert their therapeutic effects by interacting with specific receptors or enzymes in the genitourinary system, regulating physiological processes, and restoring normal function.
Some commonly used genitourinary agents include alpha-blockers, which relax the smooth muscles in the prostate and bladder neck, improving urine flow in patients with BPH. Additionally, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are widely prescribed for erectile dysfunction, as they enhance blood flow to the penile tissues, facilitating erection.
These APIs are typically formulated into various dosage forms, such as tablets, capsules, creams, gels, or injections, allowing for convenient administration to patients. The development and production of genitourinary agents involve stringent quality control measures and compliance with regulatory guidelines to ensure safety, efficacy, and consistent product performance.
In summary, genitourinary agents form a crucial category of pharmaceutical APIs used to treat a range of disorders affecting the genitourinary system. Their targeted mechanisms of action and diverse dosage forms make them valuable tools in improving genitourinary health and enhancing patients' quality of life.
Solifenacin API manufacturers & distributors
Compare qualified Solifenacin API suppliers worldwide. We currently have 19 companies offering Solifenacin API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 229 products |
| Cipla | Producer | India | India | CEP, CoA, GMP, USDMF | 164 products |
| Corden Pharma | Producer | Germany | Italy | CoA, GMP | 45 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, USDMF, WC | 98 products |
| Isochem | Producer | France | France | CoA, USDMF | 12 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 52 products |
| Micro Labs | Producer | India | India | CEP, CoA, GMP, USDMF | 38 products |
| Minakem | Producer | France | Canada | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 31 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 119 products |
| Polpharma | Producer | Poland | Poland | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 64 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CEP, CoA, ISO9001, MSDS, USDMF | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CoA, WC | 219 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, GMP, USDMF | 62 products |
| Weihai Disu Pharma | Producer | China | China | CoA, USDMF | 2 products |
When sending a request, specify which Solifenacin 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 Solifenacin 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.
