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Methylcellulose | CAS No: 9004-67-5 | GMP-certified suppliers
A medication that supports relief from constipation, diverticulosis, hemorrhoids, and dry eyes or mouth by substituting natural fluids and promoting gastrointestinal health.
Therapeutic categories
Primary indications
- Solutions containing methyl cellulose are used as substitute for tears or saliva if the natural production of these fluids is disturbed
- It is also used or constipation, diverticulosis, hemorrhoids and irritable bowel syndrome
- Used in the manufacture of capsules in nutritional supplements
- Its edible and nontoxic properties provide a vegetarian alternative to the use of gelatin
Product Snapshot
- Methylcellulose is available primarily as oral powders and tablets, and ophthalmic solutions suitable for formulations such as ocular drops
- It is used mainly as a substitute for tears or saliva, and for gastrointestinal indications including constipation, diverticulosis, hemorrhoids, and irritable bowel syndrome, as well as an excipient in capsule manufacturing
- Methylcellulose is approved for use in the US and Canadian markets
Clinical Overview
Clinically, methylcellulose is utilized primarily as a bulk-forming laxative and as a substitute for tears or saliva in cases where natural secretion is compromised. It is indicated for conditions such as constipation, diverticulosis, hemorrhoids, and irritable bowel syndrome. Additionally, methylcellulose serves a functional role in the manufacture of vegetarian capsules for nutritional supplements due to its edibility, non-toxicity, and lack of allergenic potential.
Pharmacodynamically, methylcellulose increases stool bulk by absorbing water in the gastrointestinal lumen. This action promotes intestinal distension and stimulates peristaltic activity, facilitating bowel movements. By increasing water content, methylcellulose also softens stools, enhancing ease of passage. Its water-absorbing properties further contribute to normalizing stool consistency, providing benefit in managing diarrhea.
From an ADME perspective, methylcellulose is not absorbed systemically owing to its polymeric nature and lack of enzymatic digestibility. It remains within the gastrointestinal tract and is excreted unchanged in the feces.
Safety profiles for methylcellulose indicate minimal toxicity and no allergenic reactions, consistent with its inert cellulose backbone. It is generally well-tolerated, with adverse events rarely reported.
Methylcellulose is commercially available under multiple trade names and has established regulatory approvals in alimentary tract and metabolism applications. Its widespread pharmaceutical and industrial use underscores the need for rigorous quality control in API sourcing. Key considerations include ensuring consistent degree of substitution, polymer molecular weight distribution, absence of microbial contamination, and compliance with pharmacopeial standards to maintain performance and safety in finished formulations.
Identification & chemistry
| Generic name | Methylcellulose |
|---|---|
| Molecule type | Small molecule |
| CAS | 9004-67-5 |
| DrugBank ID | DB11228 |
Pharmacology
| Summary | Methylcellulose acts as a hydrophilic bulk-forming agent that absorbs water within the gastrointestinal lumen, increasing stool volume and promoting intestinal peristalsis. Its water-retaining properties also soften stool consistency, facilitating bowel movements and aiding in the management of constipation and related gastrointestinal disorders. Additionally, methylcellulose serves as an inert, non-toxic excipient in pharmaceutical and nutritional supplement formulations. |
|---|---|
| Mechanism of action | Methylcellulose absorbs water in the gastrointestinal lumen thereby increasing the bulk of the stool. This leads to distension and stimulation of peristalsis. The ability of methylcellulose to absorb water may contribute to its efficacy in the management of diarrhea by once again increasing the bulk and consistency of the stool. |
| Pharmacodynamics | It increases the bulk in your stool, an effect that helps to cause movement of the intestines. It also works by increasing the amount of water in the stool, making the stool softer and easier to pass. |
ADME / PK
| Absorption | Cellulose derivatives considered in this report are virtually unabsorbed and little or no degradation of absorbed and little or no degradation of absorbable products occurs in the human digestive tract. In humans, virtually 100 percent of orally ingested methyl cellulose can be recovered in the feces withihn four days, indicating that absorption does not occur. |
|---|---|
| Half-life | 4.2 minutes |
| Metabolism | Reported that when methylcellulose was given iv to dog and rabbit , aside from effect upon circulating blood, inability of body to degrade substance led to its retention & accumulation in liver, spleen, lymph nodes, kidney, and vascular walls. |
| Route of elimination | When swallowed they are not absorbed to any appreciable degree and appear unchanged in feces. |
| Volume of distribution | accumulation in liver, spleen, lymph nodes, kidney, and vascular walls. |
Formulation & handling
- Methylcellulose is a small molecule available in oral and ophthalmic formulations including powders, solutions, tablets, and chewing gum.
- Oral formulations require administration with a full glass of water to ensure proper hydration and efficacy.
- Handling considerations include ensuring solutions are well-prepared to maintain homogeneity and prevent settling of the powder form.
Regulatory status
| Lifecycle | The API’s primary patents have expired in both the US and Canada, allowing for generic product entry and increased market competition. The lifecycle is in the mature phase with established presence across these markets. |
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| Markets | US, Canada |
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Supply Chain
| Supply chain summary | The manufacturing and supply landscape for methylcellulose includes several originator companies producing branded products primarily in the US and Canada markets. Established brands such as Citrucel have a notable presence, indicating a sustained market demand. Patent expirations in this category suggest the availability of generic competition, supporting broader access to methylcellulose-based therapies. |
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Safety
| Toxicity | Organism: Mouse Test type: LD50 Route : Intraperitoneal Reported Dose: 275gm/kg ( 275000mg/kg) Toxic Effect: Details of toxic effects not reported other than lethal dose value Organism: Mouse Test type: LDLo Route : Intravenous Reported Dose: 1gm/kg ( 1000mg/kg) Toxic Effect: Details of toxic effects not reported other than lethal dose value |
|---|
- Intraperitoneal LD50 in mice reported at 275,000 mg/kg
- Intravenous LDLo in mice reported at 1,000 mg/kg
- Lethal dose values indicate low acute toxicity via intraperitoneal route but higher toxicity potential intravenously
Methyl cellulose is a type of Laxatives
Laxatives are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are commonly used to promote bowel movements and alleviate constipation. These medications are designed to stimulate the digestive system, facilitating the passage of stool and providing relief to individuals experiencing irregular or infrequent bowel movements.
Laxatives work through various mechanisms, including increasing intestinal motility, softening stool consistency, or promoting water retention in the intestines. They are available in different forms, such as tablets, capsules, powders, or liquids, catering to diverse patient preferences and requirements.
There are several types of laxatives, each with its unique mode of action. Bulk-forming laxatives contain fiber or other indigestible substances that absorb water, adding bulk to the stool and promoting regular bowel movements. Stimulant laxatives, on the other hand, stimulate the intestinal muscles, accelerating the passage of stool through the intestines. Osmotic laxatives draw water into the intestines, softening the stool and facilitating its movement. Additionally, stool softeners and lubricant laxatives can help ease bowel movements by making the stool easier to pass.
Laxatives are commonly used for short-term relief from constipation or to prepare for certain medical procedures or surgeries. However, their long-term use should be done under the guidance of healthcare professionals to prevent dependency or potential adverse effects.
In conclusion, laxatives are a vital subcategory of pharmaceutical APIs that aid in managing constipation and improving bowel regularity. They are available in various formulations and function through different mechanisms to provide effective relief. However, it is crucial to use laxatives responsibly and seek professional advice when necessary.
Methyl cellulose (Laxatives), 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.
Methyl cellulose API manufacturers & distributors
Compare qualified Methyl cellulose API suppliers worldwide. We currently have 1 companies offering Methyl cellulose API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
When sending a request, specify which Methyl cellulose 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.).
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