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Sulpiride | CAS No: 15676-16-1 | GMP-certified suppliers
A medication that treats acute and chronic schizophrenia by targeting positive and negative symptoms with atypical antipsychotic efficacy, requiring quality-controlled API sourcing.
Therapeutic categories
Primary indications
- Sulpiride is indicated for the treatment of acute and chronic schizophrenia
Product Snapshot
- Sulpiride is available in multiple formulation types, including injectable solutions and oral dosage forms such as tablets, capsules, and syrups
- It is primarily indicated for the treatment of acute and chronic schizophrenia
- The product has both approved and investigational status in key regulatory markets
Clinical Overview
Pharmacodynamically, sulpiride acts as a selective antagonist at dopamine D2 and D3 receptors. Its mechanism of action involves binding to these receptors, with in silico studies identifying potential interactions at specific amino acid residues (Asp-119 and Phe-417). Effective therapeutic response correlates with approximately 65 to 80 percent D2 receptor occupancy, balancing efficacy and adverse effects. Sulpiride has a relatively short duration of action, necessitating twice-daily dosing. Notably, it possesses a wide therapeutic window, with documented survival following single intakes as high as 16 grams.
The absorption, distribution, metabolism, and excretion (ADME) profile includes substrate activity for various transporters such as BCRP/ABCG2, MATE 1 and 2, OCT1, OCT2, and P-glycoprotein, which may influence its pharmacokinetics and potential drug interactions. As a moderate risk QTc-prolonging agent, sulpiride requires careful cardiac monitoring in clinical settings. Safety considerations include the risk for extrapyramidal symptoms, increased motor agitation, and rare but serious neuroleptic malignant syndrome, warranting patient counseling and clinical vigilance.
Sulpiride is utilized under brand names in regional markets and is considered a second-generation antipsychotic within the broader class of psychotropic drugs. When sourcing sulpiride APIs, quality control must include verification of chemical purity, confirmation of its benzenesulfonamide structure, and screening for residual solvents or impurities. Given its interaction with multiple transporter proteins, consistent pharmacokinetic profiles should also be ensured to maintain therapeutic predictability and safety.
Identification & chemistry
| Generic name | Sulpiride |
|---|---|
| Molecule type | Small molecule |
| CAS | 15676-16-1 |
| UNII | 7MNE9M8287 |
| DrugBank ID | DB00391 |
Pharmacology
| Summary | Sulpiride is a selective antagonist of dopamine D2 and D3 receptors primarily used for the treatment of acute and chronic schizophrenia. Its pharmacodynamic effects are mediated through dopamine receptor blockade, which modulates dopaminergic neurotransmission implicated in psychotic symptoms. Additional receptor interactions include dopamine D4 and carbonic anhydrase isoenzymes, contributing to its pharmacological profile. |
|---|---|
| Mechanism of action | Sulpiride is a selective dopamine D2 and D3 receptor antagonist. _In silico_ studies show that sulpiride may interact with the Asp-119 and Phe-417 amino acid residues of these receptors. It is estimated that D2 receptors should be 65-80% occupied for optimal treatment and minimal adverse effects. |
| Pharmacodynamics | Sulpiride is a substituted benzamide derivative and a selective dopamine D2 antagonist indicated to treat acute and chronic schizophrenia. It has a short duration of action as it is given twice daily, and a wide therapeutic window as patients have survived single doses as high as 16g. Patients should be counselled regarding increased motor agitation, extrapyramidal reactions, and neuroleptic malignant syndrome. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D2 receptor | Humans | antagonist |
| Dopamine D3 receptor | Humans | antagonist |
| Carbonic anhydrase 2 | Humans | inhibitor |
ADME / PK
| Absorption | Sulpiride has an oral bioavailability of 27 ± 9%. A 100-108 mg dose of sulpiride reaches a C<sub>max</sub> of 232-403 ng/mL, with a T<sub>max</sub> of 8.3 h. In another study, the AUC of a 100mg oral dose of sulpiride is 1156 ± 522 h\*ng/mL and for an intravenous dose is 3981 ± 813 h\*ng/mL. |
|---|---|
| Half-life | Reports of the half life of sulpiride have only been performed with small numbers of subjects. Therefore, the average half life may be 7.15 hours to 8.3 hours. |
| Protein binding | Sulpiride is approximately 40% protein bound in plasma, particularly to albumin. |
| Metabolism | 95% of a dose of sulpiride is not metabolized. |
| Route of elimination | An intravenous dose of sulpiride is 70 ± 9% eliminated in the urine within 36 hours, while an oral dose is 27 ± 9% eliminated in urine. In both cases, the dose is recovered as the unchanged parent compound. |
| Volume of distribution | The average volume of distribution of sulpiride is 2.72 ± 0.66 L/kg. |
| Clearance | The total systemic clearance of sulpiride if 415 ± 84 mL/min, while the mean renal clearance was 310 ± 91 mL/min. |
Formulation & handling
- Sulpiride is a small molecule available for both oral and intramuscular injectable formulations, requiring consideration for route-specific formulation requirements.
- The API has moderate water solubility and low lipophilicity (LogP 0.22), influencing its dissolution and absorption profiles in oral dosage forms.
- Avoid co-administration with alcohol due to enhanced sedative effects, which should be considered during patient counseling and formulation labeling.
Regulatory status
Safety
| Toxicity | Patients experiencing an overdose of sulpiride may present with hypotension, sinus tachycardia, arrhythmia, dystonia, CNS depression, hallucinations, vomiting, agitation, dysarthria, salivation, as well as increased muscle tone, hyperreflexia, and extensor plantar reflex. Patients should be treated with symptomatic and supportive treatment. |
|---|
- Handle sulpiride with care to avoid exposure, as overdose may induce central nervous system depression and cardiovascular effects
- Use appropriate personal protective equipment to minimize risk of sensitization and systemic toxicity
- Ensure proper containment and ventilation during manufacturing to prevent inhalation or dermal contact that could lead to neurological or autonomic adverse effects
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Sulpiride is a type of Antipsychotics
Antipsychotics belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category used to treat psychiatric disorders such as schizophrenia, bipolar disorder, and other related conditions. These medications play a crucial role in managing symptoms associated with psychosis, including hallucinations, delusions, and disorganized thinking.
Antipsychotics work by modulating the levels of neurotransmitters in the brain, particularly dopamine and serotonin. They can be categorized into two classes: first-generation (typical) antipsychotics and second-generation (atypical) antipsychotics. Typical antipsychotics primarily target dopamine receptors, while atypical antipsychotics also affect serotonin receptors.
The pharmaceutical API category of antipsychotics includes various well-known drugs, such as haloperidol, chlorpromazine, risperidone, quetiapine, and olanzapine. These APIs are often formulated into different dosage forms, including tablets, capsules, injections, and oral suspensions, to provide flexibility in administration and patient-specific needs.
Antipsychotics offer relief from psychotic symptoms by stabilizing the imbalanced neurotransmitter activity in the brain. However, they may also have certain side effects, such as sedation, weight gain, extrapyramidal symptoms, and metabolic disturbances. It is essential for healthcare professionals to carefully monitor patients receiving antipsychotic treatment to optimize therapeutic benefits while minimizing adverse effects.
In summary, antipsychotics are a vital category of pharmaceutical APIs used to manage psychiatric disorders by modulating neurotransmitter activity in the brain. Their effectiveness in treating psychosis has made them a cornerstone of mental health treatment, providing much-needed relief to individuals suffering from these conditions.
Sulpiride API manufacturers & distributors
Compare qualified Sulpiride API suppliers worldwide. We currently have 4 companies offering Sulpiride API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Duchefa Farma B.V. | Distributor | Netherlands | China | CoA, GMP, ISO9001, MSDS | 170 products |
| ICROM | Producer | Italy | Italy | CEP, CoA, FDA, GMP, KDMF | 19 products |
| LEBSA | Producer | Spain | Spain | BSE/TSE, CoA, Other, EDMF/ASMF, GMP, Other, Other, ISO9001, MSDS | 18 products |
When sending a request, specify which Sulpiride 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 Sulpiride 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.
