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Simethicone | CAS No: 8050-81-5 | GMP-certified suppliers
A medication that relieves bloating, abdominal pressure, and cramping from excess gas and supports bowel preparation needs for improved visualization during colonoscopy procedures.
Therapeutic categories
Primary indications
- Simethicone is indicated for the treatment of bloating, pressure, and cramps caused by gas
- Simethicone is also used as part of bowel preparation for colonoscopies
Product Snapshot
- Simethicone is supplied as oral and buccal non‑systemic antifoaming formulations across multiple solid and liquid dosage forms
- It is used for reducing gas-related bloating and pressure and as an adjunct in bowel‑preparation regimens
- It is approved for commercial use in Canada
Clinical Overview
Pharmacologically, simethicone acts locally in the gastrointestinal lumen to reduce the surface tension of dispersed gas bubbles. This antifoaming effect promotes coalescence of small bubbles into larger, more easily eliminated gas pockets. Its activity is purely physical rather than receptor mediated, and the therapeutic effect generally occurs shortly after ingestion when sufficient luminal concentrations are achieved.
Because simethicone is not absorbed across the gastrointestinal mucosa, classical systemic pharmacokinetic processes such as distribution, metabolism, and systemic clearance do not apply. The compound is excreted unchanged in the feces. The absence of systemic exposure contributes to a wide therapeutic index and supports administration on an as‑needed basis. No pharmacologically active metabolites or cytochrome P450 interactions have been identified.
Safety considerations focus on local tolerability. Adverse effects are uncommon and typically limited to mild gastrointestinal symptoms. Systemic toxicity is not expected due to negligible absorption. The material can be incorporated into oral suspensions, chewable tablets, softgels, and combination products. Well‑known over‑the‑counter formulations in global markets include antifoaming agents used for episodic gas relief and simethicone-containing solutions included in endoscopy preparation protocols.
For API procurement, suppliers should provide material that meets relevant pharmacopeial specifications for viscosity, purity, and absence of volatile siloxane impurities. Consistency in polymer chain length distribution and compliance with regional regulatory standards are important for formulation reproducibility and quality assurance.
Identification & chemistry
| Generic name | Simethicone |
|---|---|
| Molecule type | Small molecule |
| CAS | 8050-81-5 |
| DrugBank ID | DB09512 |
Pharmacology
| Summary | Simethicone acts as an inert surfactant that lowers the surface tension of gastrointestinal gas bubbles, promoting their coalescence and elimination. It is not systemically absorbed and exerts local effects in the gut with a wide therapeutic index. Its therapeutic intent is to relieve gas-related discomfort and to aid gastrointestinal gas clearance during bowel preparation procedures. |
|---|---|
| Mechanism of action | Simethicone is a surfactant that decreases the surface tension of gas bubbles in the gastrointestinal tract, more easily allowing gas to exit the body. |
| Pharmacodynamics | Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion.It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed. |
ADME / PK
| Absorption | Simethicone is not systemically absorbed and so these data are not readily available. |
|---|---|
| Half-life | Simethicone is not systemically absorbed and so these data are not readily available. |
| Protein binding | Simethicone is not systemically absorbed and so these data are not readily available. |
| Metabolism | Simethicone is not systemically absorbed and so it is not metabolised by the body. |
| Route of elimination | Simethicone is eliminated in the feces. |
| Volume of distribution | Simethicone is not systemically absorbed and so these data are not readily available. |
| Clearance | Simethicone is not systemically absorbed and so these data are not readily available. |
Formulation & handling
- Oral formulations rely on simethicone’s silicone‑oil nature; it is essentially insoluble in water and typically delivered as emulsions, suspensions, or liquid‑filled capsules.
- The API is chemically inert and stable, but uniform dispersion in aqueous systems requires appropriate surfactant/emulsifier systems and controlled mixing to prevent phase separation.
- Food has minimal impact on performance; handling focuses mainly on maintaining homogenous dispersions and preventing viscosity or droplet‑size drift during storage.
Regulatory status
| Lifecycle | The U.S. patent expired in 2017, indicating the API is in a mature stage of its lifecycle with no remaining primary exclusivity. With current commercialization in Canada, the product is likely in an established market phase with potential generic availability. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | Simethicone is an established OTC active ingredient produced by multiple manufacturers, with no single dominant originator given its long history of use. Branded and store-brand formulations are widely available in Canada and broadly present in other major markets such as the US and EU. The listed US patent expired in 2017, indicating that generic competition is long‑standing and the supply base is well diversified. |
|---|
Safety
| Toxicity | Data regarding overdoses with simethicone are rare due to the fact that it is not systemically absorbed.. In the case of an overdose stop the drugand initiate symptomatic and supportive care. |
|---|
- Simethicone exhibits minimal systemic toxicity due to negligible absorption
- Overdose reports are rare and generally limited to localized gastrointestinal effects
- In overdose scenarios, management is limited to non‑specific supportive measures, as no systemic toxic sequelae are expected
Simethicone is a type of Antiflatulents
Antiflatulents are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are designed to alleviate symptoms related to excessive gas in the gastrointestinal tract. These medications target the uncomfortable and embarrassing condition known as flatulence, which is characterized by the accumulation of gas in the digestive system.
Antiflatulents work by reducing the production or facilitating the elimination of gas in the gastrointestinal tract. They can act through various mechanisms, such as breaking down large gas bubbles into smaller ones, promoting the absorption of gas into the bloodstream, or facilitating its expulsion through belching or passing gas.
Commonly used antiflatulents include simethicone, activated charcoal, and alpha-galactosidase. Simethicone is an effective antifoaming agent that helps reduce the surface tension of gas bubbles, allowing them to combine and be eliminated more easily. Activated charcoal has adsorbent properties, which means it can bind to gas molecules and toxins, reducing their presence in the digestive system. Alpha-galactosidase, on the other hand, breaks down complex carbohydrates, such as those found in certain foods, which can contribute to gas production.
Antiflatulents are available in various forms, including tablets, capsules, chewable tablets, and suspensions. They are typically taken orally after meals or as needed to relieve gas-related discomfort. These medications are generally well-tolerated with minimal side effects, making them a popular choice for individuals seeking relief from flatulence.
Overall, antiflatulents provide a targeted approach to manage the symptoms of excessive gas, offering comfort and relief for those experiencing discomfort associated with flatulence.
Simethicone (Antiflatulents), classified under Gastrointestinal Agents
Gastrointestinal Agents belong to the pharmaceutical API category that focuses on treating disorders and ailments related to the digestive system. These agents play a crucial role in addressing various gastrointestinal conditions, such as acid reflux, ulcers, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).
One of the key types of gastrointestinal agents is proton pump inhibitors (PPIs), which work by reducing the production of stomach acid. PPIs help in treating conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Another essential class of agents is antacids, which neutralize excessive stomach acid, providing relief from heartburn and indigestion.
Gastrointestinal agents also include antispasmodics that alleviate abdominal cramps and spasms associated with conditions like IBS. These drugs work by relaxing the smooth muscles of the digestive tract. Additionally, there are drugs categorized as laxatives that aid in relieving constipation by promoting bowel movements.
Moreover, certain gastrointestinal agents act as antiemetics, effectively reducing nausea and vomiting. These drugs are particularly useful for patients undergoing chemotherapy or experiencing motion sickness.
Pharmaceutical companies develop and manufacture a wide range of gastrointestinal agents in various forms, including tablets, capsules, suspensions, and injections. These agents are typically formulated using active pharmaceutical ingredients (APIs) and other excipients to ensure their efficacy and safety.
In conclusion, gastrointestinal agents form a vital category of pharmaceutical APIs, providing relief from digestive disorders and improving overall gastrointestinal health. The availability of diverse agents catering to different conditions ensures that patients can receive targeted treatment for their specific gastrointestinal needs.
Simethicone API manufacturers & distributors
Compare qualified Simethicone API suppliers worldwide. We currently have 8 companies offering Simethicone API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Basildon Chemical | Producer | United Kingdom | United Kingdom | CEP, CoA, FDA, GMP | 1 products |
| Chemizo Enterprise | Distributor | India | India | CoA | 19 products |
| Dow Corning Europe | Producer | Belgium | Belgium | CEP, CoA | 2 products |
| Eigenmann & Veronelli | Producer | Italy | Italy | CEP, CoA, GMP | 6 products |
| Nusil Technology | Producer | United States | United States | CEP, CoA, FDA, GMP | 1 products |
| Pharm Rx Chemical Corp | Distributor | United States | India | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Riocare India | Producer | India | India | CEP, CoA, FDA, USDMF, WC | 2 products |
| Wacker Chemie | Producer | Germany | Germany | CEP, CoA, FDA | 1 products |
When sending a request, specify which Simethicone 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 Simethicone 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 Simethicone API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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