Milk of Magnesia + Liquid Paraffin + Sodium Picosulfate

Belonging to the Suspensions category within the Gastroenterology therapeutic segment, this three-molecule laxative combination is distinguished by its multi-mechanism approach. Unlike single-agent laxatives that target only one aspect of bowel function, this formulation simultaneously hydrates, stimulates, and lubricates — providing a comprehensive, comfortable laxative effect at doses that minimize the abdominal cramping associated with high-dose single-agent therapy.

The three actives represent fundamentally different pharmacological classes working synergistically. Milk of Magnesia (Magnesium Hydroxide) is the osmotic backbone of the formulation, drawing water into the intestinal lumen and softening stool to facilitate passage. Sodium Picosulfate is a locally acting stimulant laxative that accelerates colonic transit time and inhibits water reabsorption. Liquid Paraffin provides a mechanical lubricant effect, coating the stool and intestinal mucosa to facilitate easy defecation without straining.

For pharmaceutical marketing companies, this is a high-volume, repeat-prescription gastroenterology product with consistent demand across surgical recovery, cardiovascular care, geriatrics, and proctology — a broad prescriber base that provides year-round commercial stability. Saar Biotech manufactures it from our facility in Baddi in 170ml, 200ml, and 225ml sleeve-pack configurations.

At Saar Biotech, we manufacture Milk of Magnesia + Liquid Paraffin + Sodium Picosulfate Suspension using a controlled high-shear homogenization process that ensures the three distinct active phases — aqueous (Milk of Magnesia), oily (Liquid Paraffin), and dissolved (Sodium Picosulfate in Sorbitol base) — remain permanently, uniformly dispersed throughout each batch.

• Three-Phase Suspension Stability: The primary formulation challenge for this product is maintaining a stable emulsion between the aqueous Milk of Magnesia phase and the immiscible Liquid Paraffin phase. Our compounding process and emulsifying excipient selection ensure the Liquid Paraffin remains uniformly dispersed without coalescing into separate oil droplets over the 24-month shelf life.
• Uniform Re-Dispersibility: Despite controlled viscosity, Milk of Magnesia particles and any separated Liquid Paraffin must re-suspend rapidly on gentle shaking. Our suspending agent system is specifically optimized so that a single vigorous shake before dosing fully redistributes all three actives — ensuring dose-to-dose clinical consistency.
• Sorbitol Base Palatability: The Sorbitol base naturally imparts gentle sweetness and the characteristic smooth mouthfeel expected of a laxative suspension, while also contributing mild osmotic laxative activity that complements the primary actives.
• Large-Format Fill Precision: The 170ml, 200ml, and 225ml formats require precise, consistent fill volumes on automated lines. Our high-speed filling equipment maintains ±2% fill accuracy across all three pack sizes, minimizing wastage and ensuring every unit meets the labeled volume claim.

Manufactured and supplied by Saar Biotech from our third-party manufacturing facility in Himachal Pradesh, this suspension is indicated for:

• Piles (Haemorrhoids) & Anal Fissure: Constipation relief where straining is clinically contraindicated due to risk of worsening anorectal conditions.
• Pre- and Post-Operative Constipation: Bowel management before and after abdominal, colorectal, and anorectal surgical procedures.
• Cardiovascular Disorders: Patients post-myocardial infarction or cardiac surgery where straining at defecation elevates cardiac risk through Valsalva manoeuvre.
• Hernia Management: Prevention of intra-abdominal pressure elevation during defecation in hernia patients.
• Bowel Preparation: Pre-procedural cleansing for endoscopy, colonoscopy, and abdominal radioscopy.
• Elderly & Bedridden Patients: Management of immobility-related chronic constipation in geriatric care.

Triple-Component Laxative Mechanism

Milk of Magnesia (Magnesium Hydroxide) functions as an osmotic laxative. Being practically insoluble in water, it reacts with gastric hydrochloric acid to form magnesium chloride, which subsequently dissociates in the intestinal lumen. The resulting osmotic gradient draws water from the intestinal mucosa and surrounding tissues into the bowel lumen, increasing luminal fluid volume, softening stool consistency, and stimulating colonic peristalsis through bowel wall distension. The onset of osmotic action is typically 6–8 hours when taken at bedtime.

Sodium Picosulfate is a locally acting diphenylmethane stimulant laxative. In the colon, it is hydrolyzed by bacterial enzymes to its active bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) metabolite, which directly stimulates the enteric nervous system to increase propulsive colonic contractions. It simultaneously inhibits water and electrolyte reabsorption from the colonic lumen, increasing luminal water content and facilitating stool expulsion. This stimulant action complements Milk of Magnesia’s osmotic mechanism, providing a faster, more complete bowel clearance than either agent alone.

Liquid Paraffin acts as a mechanical lubricant. Its inert mineral oil nature means it is not absorbed from the GI tract. It penetrates and softens the stool mass from within, and simultaneously coats the colonic mucosa with a slippery film that reduces the friction between stool and intestinal wall, enabling defecation with minimal straining effort.

Manufacturing Integrity

• Emulsion Stability: Liquid Paraffin requires careful emulsification within the aqueous suspension matrix. Our validated excipient system prevents phase separation during storage while maintaining the specific viscosity needed for accurate dosing from a measuring cap.
• Sodium Picosulfate Stability: Being an active at low concentration (3.33mg/5ml), Sodium Picosulfate must be uniformly distributed throughout the entire batch volume. Our compounding sequence ensures the dissolved drug is incorporated into the base before high-viscosity components are added, guaranteeing uniform distribution.

• Complementary Onset Profiles: Milk of Magnesia and Sodium Picosulfate both act within 6–12 hours, aligning to produce a single, coordinated laxative effect when the recommended bedtime dose is taken. Liquid Paraffin acts mechanically from the moment it contacts stool, smoothing passage throughout the episode. This synchronized multi-mechanism onset is a compelling clinical narrative for prescribers.
• Minimal Systemic Absorption: Liquid Paraffin is not absorbed systemically. Magnesium is minimally absorbed (less than 20%) in patients with intact renal function. Sodium Picosulfate’s systemic exposure is minimal after colonic bacterial activation. This low systemic burden makes the combination suitable for elderly patients on complex polypharmacy regimens — a key prescriber confidence point.
• Pack Size Commercial Logic: The 170ml pack provides approximately 11–17 doses at 10–15ml per dose — suited for acute short-course use. The 200ml and 225ml formats support repeat-use scenarios in geriatric and chronic constipation management, offering better per-dose value that encourages brand loyalty and repeat prescriptions.
• Sleeve-Pack Premium Positioning: The 225ml sleeve-pack format differentiates the brand visually at pharmacy level and positions the product in the premium laxative segment — where patients and caregivers associate quality packaging with product efficacy.

Saar Biotech offers comprehensive Contract Manufacturing (CMO) and Third-Party Manufacturing for Milk of Magnesia + Liquid Paraffin + Sodium Picosulfate Suspension from our oral liquid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Dedicated liquid manufacturing block with automated filling and capping lines for large-format suspension bottles (170ml to 225ml).
• Capacity: Scalable from 5,000-unit brand-entry batches to 2,00,000+ unit commercial runs; 64×170ml and 64×200ml shipper configurations for distributor-level dispatch.
• Quality Lab: In-house GLP-certified lab with HPLC assay, titrimetric analysis, viscometry, pH testing, MLT, and suspension uniformity checks.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 170ml, 200ml, 225ml; sticker label, metallic label, plain white cap, bell cap, measuring cap, sleeve-pack, with/without carton supply.
• MOQ: 5,000–10,000 units per SKU depending on pack size and presentation.

1. Warehouse Storage: Store sealed cartons below 30°C in a cool, dry location away from direct sunlight. Temperature excursions above 35°C can alter the viscosity of the Sorbitol base and potentially cause minor phase separation of the Liquid Paraffin emulsion.
2. No Freezing: Sub-zero temperatures cause irreversible separation of the Liquid Paraffin emulsion and permanent crystallization changes in the Sorbitol base. Cold-chain logistics are not required, but storage in uninsulated vehicles or warehouses during summer months must be managed.
3. Shake Well Before Use: This instruction must appear prominently on all labels. Milk of Magnesia particles settle during storage and Liquid Paraffin may partially separate — thorough shaking before each dose is essential for uniform dosing.
4. Measuring Cap: A calibrated measuring cap must accompany all pack sizes. Accurate 5ml or 10ml measurement ensures the patient receives the correct ratio of all three actives per dose.

Every batch of this laxative suspension is released from our GLP-certified quality control laboratories in Baddi only after the following analytical protocol is completed:

• Sodium Picosulfate Assay: HPLC quantification of Sodium Picosulfate at 3.33mg per 5ml against BP specifications — the critical low-concentration active in this formulation.
• Magnesium Hydroxide Assay: Titrimetric determination of Magnesium Hydroxide (Milk of Magnesia) content confirming 3.75ml per 5ml label claim accuracy.
• Liquid Paraffin Viscosity: Viscometric testing to confirm the Liquid Paraffin component meets IP viscosity specifications, verifying lubricant functionality.
• Suspension Uniformity: Multiple aliquots sampled throughout the fill volume confirm uniform distribution of all three active components from first dose to last.
• pH Testing: Verified within the physiologically compatible range to ensure patient comfort and active stability.
• Microbial Limit Testing (MLT): IP-compliant testing confirming absence of specified pathogens for oral suspension use.
• Certificate of Analysis (COA): Issued with every B2B batch for partner documentation and regulatory records.

This laxative suspension is generally well-tolerated at recommended doses for short-term use.

Common effects include mild abdominal cramping or bloating (from osmotic and stimulant activity), loose stools, and occasional mild nausea. Dose-related diarrhoea may occur if the dose is excessive — patients should be counselled to start with the lower end of the dosing range. Prolonged use may cause electrolyte imbalance due to chronic magnesium exposure and persistent stimulation of colonic water secretion.

Contraindicated in acute abdominal conditions, intestinal obstruction, undiagnosed abdominal pain, and pregnancy/lactation without physician guidance. Severe renal impairment requires physician evaluation due to magnesium accumulation risk.

For B2B manufacturing enquiries, third-party contracts, or to request pricing and packaging options for Milk of Magnesia + Liquid Paraffin + Sodium Picosulfate Suspension, please use the enquiry form below.