Healthy Inc > Blog > Mebeverine BP/USP/IP
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What does mebeverine 135mg do?

In the pharmaceutical industry, Mebeverine 135 mg is a musculotropic antispasmodic primarily indicated for Irritable Bowel Syndrome (IBS) and other functional gastrointestinal disorders. As a pharmacist and manufacturer, I view this molecule as an “Intelligence Antispasmodic”—it targets the smooth muscles of the gut directly without interfering with normal intestinal motility or causing the typical dry-mouth side effects of anticholinergic drugs.

At your WHO-GMP facility in Mumbai, where you likely manufacture 135 mg film-coated tablets, this product is a staple for gastrointestinal portfolios due to its high tolerability and established efficacy in chronic care.

Primary Clinical Indications

Mebeverine 135 mg is used to alleviate the symptomatic “spasm-pain” complex:

  • Irritable Bowel Syndrome (IBS): Relief of abdominal pain, cramps, bloating, and flatulence.

  • Motility Disorders: Management of chronic irritable colon, spastic constipation, and mucous colitis.

  • Functional Bowel Problems: Alleviating spasms secondary to organic diseases.

Mechanism: Direct Musculotropic Action

Mebeverine is a direct relaxant that acts on the smooth muscle of the gastrointestinal tract, particularly the colon.

Ion Channel Modulation: It blocks voltage-gated sodium channels and regulates calcium ($Ca^{2+}$) exchange, which prevents the over-contraction of the gut muscles.

Sympathetic Potentiation: It acts as a local anesthetic and blocks the reuptake of noradrenaline, aiding in the inhibitory control of gut spasms.

Selective Motility: Unlike many other antispasmodics, it relieves painful spasms without slowing down normal digestion (peristalsis) or causing systemic anticholinergic effects (like blurred vision or urinary retention).

Administration & Pharmacokinetics

  • Optimal Timing: For maximum efficacy, the 135 mg tablet should be taken 20 minutes before meals, three times daily. This allows the drug to be absorbed and ready to prevent post-meal spasms.

  • Absorption: It is rapidly and completely absorbed after oral administration, with peak plasma levels appearing in 1–3 hours.

  • Metabolism: It is a prodrug that is completely metabolized by hydrolysis into veratric acid and mebeverine alcohol. It does not accumulate in the body.

The Pharmacist’s “Technical Warning”

  • Lactose/Sucrose Content: Most 135 mg formulations (like Colofac) contain lactose and sucrose. As a manufacturer, you must ensure this is clearly labeled for patients with sugar intolerances.

  • Hypersensitivity: While rare, some patients may experience mild skin reactions (rash/urticaria). Serious allergic reactions (anaphylaxis) are extremely uncommon but require immediate cessation.

  • Age Restriction: Standard 135 mg tablets are generally not recommended for children under 18 due to insufficient safety data.

The Manufacturer’s Perspective: Technical & Export

  • The “MR” Advantage: On your marketplace, highlight if you also offer the 200 mg Modified-Release (MR/SR) capsules. The twice-daily dosing of the MR version significantly improves patient compliance over the three-times-daily 135 mg schedule.

  • Stability for Export: Mebeverine is sensitive to environmental conditions. Utilizing Alu-Alu blister packaging ensures a 36-month shelf life in Zone IVb tropical regions.

  • Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for private B2B pharmacy networks.

Mebeverine Tablets

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What is Mebeverine Hydrochloride tablets used for?

In the pharmaceutical industry, Mebeverine Hydrochloride is a specialized musculotropic antispasmodic. As a pharmacist and manufacturer, I view Mebeverine as a “targeted” gastrointestinal drug because it acts directly on the smooth muscles of the gut without affecting the normal motility of the bowel or causing the “anticholinergic” side effects (like dry mouth or blurred vision) typical of older antispasmodics.

Primary Clinical Uses

  • Irritable Bowel Syndrome (IBS): The primary indication for the symptomatic relief of abdominal pain, cramps, persistent diarrhea, and flatulence associated with IBS.

  • Gastrointestinal Spasm: Used to treat spasms of the GI tract secondary to organic diseases like diverticulitis or regional enteritis.

  • Chronic Irritable Colon: Management of functional bowel disorders characterized by irregular bowel movements and pain.

Mechanism of Action: Direct Muscle Relaxation

Mebeverine works through a non-atropine-like mechanism, focusing specifically on the smooth muscle cells of the colon.

Ion Channel Modulation: It acts directly on the smooth muscle cells by inhibiting voltage-gated sodium channels and limiting the replenishment of intracellular calcium stores.

Spasmolysis: By preventing the influx of sodium and the release of calcium, it stops the muscle from over-contracting (spasming).

Preserved Motility: Crucially, it does not interfere with the normal “peristalsis” (the wave-like movement that pushes food through), making it much more comfortable for long-term use than other antispasmodics.

The Manufacturer’s Perspective: Formulation & Export

From a production and global trade standpoint, Mebeverine is a high-demand product in the gastroenterology sector:

  • Sustained Release (SR) vs. IR: While the standard dose is 135 mg (Immediate Release), we often manufacture 200 mg SR Capsules. For your B2B marketplace, the 200 mg SR version is highly popular as it improves patient compliance to twice-daily dosing.

  • Stability & Coating: Mebeverine is stable but requires protection from humidity. At our WHO-GMP facility, we utilize film-coating for tablets to mask the bitter taste and Alu-Alu blister packaging to ensure a 36-month shelf life for export to Zone IVb regions.

  • Regulatory Compliance: We provide full CTD/eCTD Dossiers and bioequivalence data against the innovator (Colofac) to support registration in international markets.

  • Market Positioning: On your digital platforms, you can market this as a “Superior GI Antispasmodic” due to its lack of systemic side effects, which is a significant USP for B2B buyers.

Mebeverine Tablets

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