Description

Mebeverine Tablet

Mebeverine Hydrochloride Tablets IP / BP / USP (135 mg / 200 mg SR)

Direct-Acting Myotropic Antispasmodic & IBS Motility Regulator

Healthy Life Pharma Private Limited, alongside our specialized global export and marketing division Healthy Inc, is a leading Indian manufacturer, CDMO services provider, and wholesale exporter of advanced gastroenterology, metabolic, and functional gastrointestinal therapeutics. We manufacture ultra-high-purity, kinetically stable Mebeverine Hydrochloride Tablets within our state-of-the-art, WHO–GMP certified solid dosage manufacturing installations.

Serving as a premium targeted therapy for functional bowel disorders, this formulation represents a high-volume strategic export to gastroenterology clinic networks, state procurement distribution channels, retail pharmacy chains, and international digital B2B pharmaceutical marketplaces across the CIS region, Africa, LATAM, and South-East Asia.

Product Overview

This formulation operates as a “Direct Gastrointestinal Smooth Muscle Relaxant.” It ensures patient safety and gastrointestinal stabilization by normalizing localized hyper-peristalsis and painful spasms directly at the intestinal cell walls without depressing normal gut motility or inducing autonomic side effects.

• Mechanism 1 (Vascular Sodium Channel Blockade): Mebeverine physically targets and chemically blocks voltage-gated sodium channels on the membranes of intestinal smooth muscle cells. This direct action prevents the depolarization wave required for smooth muscle excitation.

• Mechanism 2 (Intracellular Calcium Influx Restraint): It chemically blocks the influx of extracellular calcium ions ($Ca^{2+}$) through L-type channels and prevents the depletion of intracellular calcium pools, arresting the mechanical actin-myosin cross-bridge formation to stop the spasm.

• Mechanism 3 (Dual-Channel Regulatory Effect): It chemically blocks potassium ($K^{+}$) channels to physically prevent local fluid depletion and smooth muscle hyper-relaxation. This prevents the development of secondary muscle hypotonia (rebound constipation or bowel laziness), making it a true bowel motility regulator.

Product Composition & Available Formats

We supply Mebeverine Hydrochloride in both rapid-acting immediate-release and advanced continuous-release configurations to accommodate customized patient compliance tracking.

Technical & Logistics Specifications

• HS Code: 3004.90.99 (Medicaments acting on the alimentary tract / Antispasmodics / Gastrointestinal Drugs)

• CAS Number: 2753-45-9 (Mebeverine Hydrochloride) / 3625-06-7 (Mebeverine Base)

• Dosage Form Options: Immediate-Release Film-Coated Tablets, or Sustained-Release (SR) Retard Matrix Tablets.

• Packaging Configurations: 10 or 15 Tablets per Blister Strip packed in high-barrier Alu-Alu (Cold-Form Foil) or thick moisture-shield PVC/PVDC strips. Our premium tropicalized packaging configurations completely isolate the active core from ambient atmospheric humidity and temperature cycles, guaranteeing a full 36-month shelf life in hot, humid Zone IVb export environments.

Sustained-Release Hydrogel Kinetics & Manufacturing Integrity

                 [ INGESTION OF MEBEVERINE 200mg SR ]
                                │
                                ▼
           [ HYDROPHILIC MATRIX HYDRATION IN GASTRIC FLUIDS ]
                                │
                                ▼
           [ FORMATION OF GAPPED VISCOUS DUAL-LAYER GELLAN SHIELD ]
                                │
         ┌──────────────────────┴──────────────────────┐
         ▼                                             ▼
 [ UNIFORM MOLECULAR DIFFUSION ]           [ CONSTANT PLASMA LEVEL SUSTENANCE ]
 Continuous 12-Hour Release Velocity       Eliminates Systemic Peak Toxicity

• Advanced Hydrophilic Sustained-Release Polymer Matrices: Our 200 mg SR formulations utilize a specialized Hydroxypropyl Methylcellulose (HPMC) and Gellan Gum Hydrogel Matrix. Upon entering the gastric cavity, the outer polymeric layer hydrates to form a dense, viscous gel boundary. The active Mebeverine molecules slowly diffuse through this physical barrier at a strictly calibrated kinetic rate over 12 hours, ensuring continuous antispasmodic action.

• High-Precision Content Uniformity Compression: Because Mebeverine Hydrochloride requires high mass accuracy across continuous manufacturing runs, we utilize automated compression suites equipped with Forced Feeder Die Systems and Online Multi-Point Hardness Testers, physically guaranteeing that every tablet core maintains structural and dissolution integrity.

• Zero Systemic Anticholinergic Bio-Calibration: Our formulations are strictly bio-validated to act locally on GI smooth muscles. Unlike dicyclomine matrices, it does not chemically block systemic acetylcholine receptors, physically ensuring zero cross-reactivity risks for patients presenting with glaucoma or prostatic hypertrophy.

Primary Indications

• Gastroenterology: Symptomatic treatment of Irritable Bowel Syndrome (IBS), chronic irritable colon, spastic constipation, mucous colitis, and functional cramping abdominal pain.

• Internal Medicine: Relieving secondary gastrointestinal spasms caused by organic inflammatory conditions such as diverticulitis, regional enteritis, or localized gallbladder dyskinesia.

Usage Instructions

• The Pre-Meal Administration Window: For immediate-release 135 mg configurations, the tablet must be taken physically 20 minutes before meals with a full glass of water. Taking the medication prior to ingestion chemically prepares the smooth muscle matrix to block postprandial hyper-reflexive spasms.

• The SR Integrity Mandate: For the 200 mg SR configuration, the tablet/capsule must be swallowed physically whole. Never chew, crush, or split the sustained-release matrix. Mechanically fracturing the core destroys the hydrophilic gel barrier, chemically causing immediate dumping of the entire high-dose payload (dose-dumping), increasing local mucosal toxicity.

• The Pediatric Age Restriction Rule: Standard adult formulations of Mebeverine Hydrochloride (135 mg / 200 mg SR) are optimized for adult and adolescent populations and are not recommended for pediatric patients under the age of 12 years.

Safety Warning: POTENT DIRECT MYOTROPIC ANTISPASMODIC. For Professional Gastroenterology & Medical Supervision Only. The Matrix Integrity Mandate: Do not chew or crush sustained-release configurations; chew-fracturing destroys delivery kinetics. Pregnancy Safety Note: Clinical safety data during pregnancy is limited; avoid administration during the first trimester unless strictly indicated. Contraindications: Absolute contraindications in patients presenting with paralytic ileus, mechanical intestinal obstruction, severe hepatic or renal impairment, or known hypersensitivity to mebeverine hydrochloride matrices.

Global CDMO Services & Wholesale Supply Chain

Healthy Life Pharma Private Limited and Healthy Inc provide complete, internationally validated Third-Party Contract Manufacturing (CDMO Services) and bulk private-label export supply for the entire Mebeverine Hydrochloride portfolio. Because this molecule faces zero controlled-substance dual-licensing regulatory hurdles, our high-capacity lines can rapidly manufacture, release, and ship multi-container shipping loads. We handle all mandatory documentation (WHO-GMP Certificate, Certificates of Pharmaceutical Product – COPP, Certificates of Analysis – COA, Stability Testing Matrix Sheets, and Complete CTD Format Dossier sets) for seamless entry registration.

Commercial & Bulk Procurement Inquiries:

• Corporate Head Office: Mumbai, Maharashtra, India

• Primary Manufacturing Base: Boisar, Maharashtra, India

• WhatsApp / Direct Call: +91 7710003340

• Corporate Email: info@healthyinc.co.in