Sodium Picosulphate

Constipation is a common gastrointestinal complaint affecting individuals across all age groups and geographies. It can arise due to diet, lifestyle, medications, or underlying health conditions. In more serious cases, especially those involving bowel preparation before diagnostic procedures such as colonoscopy, an effective and predictable laxative is essential. Sodium Picosulphate has proven to be one of the most reliable stimulant laxatives available, offering gentle yet powerful relief from constipation and effective colon cleansing before medical procedures.

BluepillExpress, a WHO-GMP certified pharmaceutical manufacturing partner, offers high-quality third-party manufacturing services for Sodium Picosulphate, tailored for global markets. We provide fully compliant, consistent, and scalable solutions for both domestic distribution and international export, supporting private-label brands, tender contracts, government supply, and over-the-counter (OTC) product portfolios.

What is Sodium Picosulphate?

Sodium Picosulphate is a locally acting stimulant laxative that works in the colon to increase peristalsis and bowel movement. Unlike osmotic laxatives that draw water into the intestines, Sodium Picosulphate is a prodrug that is activated in the colon by gut bacteria. Once activated, it stimulates the mucosal nerve plexus of the large intestine to initiate a bowel movement.

It is commonly used to treat short-term constipation and to empty the bowel before surgical or diagnostic procedures such as colonoscopy or barium enema. It is often available in tablet or oral solution/drops form and is known for its predictable action, minimal systemic absorption, and high patient tolerability.

Therapeutic Class

• Stimulant Laxative
• Contact Cathartic
• Bowel Evacuant

Key Benefits of Sodium Picosulphate

1. Gentle and Predictable Relief

Stimulates natural bowel movements typically within 6 to 12 hours of administration, offering overnight relief from constipation.

2. Effective Bowel Preparation

When used in higher or divided doses, it effectively clears the colon before endoscopic, radiologic, or surgical procedures.

3. No Systemic Absorption

Acts locally in the colon and is not systemically absorbed, reducing the risk of systemic side effects.

4. Convenient Dosage Forms

Available as drops, oral solution, and tablets, making it suitable for patients of all age groups including children and elderly.

5. Safe for Short-Term Use

Generally well-tolerated for short-term treatment with a low risk of dependency when used as directed.

Indications

Sodium Picosulphate is indicated for:

• Relief of occasional constipation
• Treatment of chronic functional constipation (short-term use)
• Pre-procedural bowel evacuation before colonoscopy or surgery
• Bowel cleansing before imaging procedures like barium enema or CT colonography
• Supportive therapy in irritable bowel syndrome where constipation is predominant

Available Dosage Forms and Strengths

BluepillExpress manufactures Sodium Picosulphate in multiple dosage forms and strengths to meet a variety of therapeutic needs and regulatory specifications.

Oral Drops / Solution

• Sodium Picosulphate 5 mg / 5 ml
• Sodium Picosulphate 7.5 mg / 5 ml
• Available in 10 ml, 15 ml, 30 ml, and 60 ml bottles
• Flavored, sugar-free, and pediatric-friendly versions available
• Supplied with dropper, calibrated cup, or measuring syringe

Tablets

• Sodium Picosulphate 5 mg
• Sodium Picosulphate 10 mg (on request)

Each dosage form is produced using high-purity raw materials, with excipients and preservatives compliant with USP/BP/IP standards.

Dosage and Administration

Constipation Relief (Adults):

• 5 to 10 mg orally at bedtime
• Onset of action: within 6–12 hours

Constipation Relief (Children):

• 2.5–5 mg depending on age and weight
• Pediatric drops recommended for children under 6 years

Bowel Preparation:

• As directed by the physician, often in combination with clear fluids
• Administered the night before and/or hours before the procedure

Note: Prolonged or high-dose use is not recommended. Always use under medical supervision when taken for more than 7 days or in pre-procedural settings.

Pharmacokinetics and Mechanism of Action

• Mechanism: Inactive prodrug; hydrolyzed by colonic bacteria into active bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM)
• Onset of Action: 6 to 12 hours post administration
• Absorption: Minimal systemic absorption
• Metabolism: Activated in the colon only
• Excretion: Via feces; minimal renal or hepatic load

The localized action ensures high efficacy and minimizes systemic side effects.

Manufacturing Capabilities

BluepillExpress leverages its robust infrastructure and technical know-how to deliver consistent, high-quality production of Sodium Picosulphate formulations.

Facilities Include:

• GMP-certified mixing, filling, and bottling lines for oral liquids
• High-speed tablet compression and blister packaging equipment
• Cleanrooms with Class 100,000 air quality for sensitive operations
• In-house microbiology and analytical testing labs
• Automated visual inspection and labeling systems

We support bulk production, private labeling, and custom formulation development, depending on client and market needs.

Packaging and Labeling

Our packaging ensures shelf-life stability, patient convenience, and regulatory compliance.

Oral Drops/Solutions:

• Amber or clear PET bottles
• Child-resistant caps (CRC)
• Dosing device (dropper/syringe) included
• Tamper-evident seal and measuring label

Tablets:

• Alu-Alu blister strips
• HDPE bottles with desiccants for moisture protection
• Available in 10×10, 10x1x10 formats or custom configurations

Secondary Packaging:

• Customizable mono cartons
• Multilingual labels and inserts (as per destination country)
• Barcode and serialization support (as required)

Quality Assurance and Regulatory Compliance

BluepillExpress maintains rigorous quality standards to ensure consistent safety, efficacy, and regulatory readiness.

Certifications:

• WHO-GMP
• ISO 22000:2018
• FSSAI (for liquid dosage forms)
• Indian FDA license
• Dossier support for semi-regulated and regulated markets

Quality Control Parameters:

• Assay and content uniformity
• Microbial load testing
• pH, specific gravity, and viscosity (for liquids)
• Stability testing under ICH Zone II and Zone IV
• Leachability and container compatibility tests

Every batch is supported by a Certificate of Analysis (CoA) and full Batch Manufacturing Record (BMR).

Regulatory Documentation Support

We assist clients with complete registration and export documentation, making the market-entry process smooth and compliant.

Documentation Includes:

• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• Product Dossier (CTD/ACTD)
• MSDS and Stability Data
• Product Artwork and Design Files
• GMP and Manufacturing License copies

Support is available for markets in Africa, Asia, Latin America, CIS, and the Middle East.

Export and Logistics

We offer full-service logistics coordination, supporting clients across the supply chain:

• Shipping modes: Sea, air, courier (bulk and retail-ready packs)
• Incoterms: EXW, FOB, CIF, DDP
• Tamper-proof and moisture-resistant export packaging
• Coordination with freight forwarders and customs brokers
• Consolidated shipments available on request

Our export team ensures that products are dispatched, documented, and delivered safely and efficiently to their destination.

Minimum Order Quantities and Lead Time

Product Type	MOQ	Lead Time
Oral Drops/Syrup	25,000 bottles	20–25 working days
Tablets	100,000 tablets	20–25 working days
Custom Formulations	50,000 units	25–30 working days
Sample Batches	20–50 units	7–10 working days

Production timelines may vary based on packaging, labeling, and documentation requirements.

Market Demand and Opportunity

The demand for Sodium Picosulphate continues to grow due to:

• Increasing prevalence of constipation and lifestyle-related GI issues
• Greater awareness and screening for colorectal diseases
• Inclusion in OTC and prescription gastro portfolios
• Use in public health systems, government supply chains, and NGO programs
• Preference over older, harsher laxatives due to its gentler action and tolerability

Its broad appeal across pediatric, adult, and geriatric segments makes it a high-volume product with year-round demand.

Ideal Partners

We collaborate with:

• OTC healthcare and pharmaceutical brands
• Generic and branded drug marketers
• Government and institutional suppliers
• Hospital procurement organizations
• E-commerce pharmacy platforms
• Exporters targeting regulated and semi-regulated markets

Whether you’re looking to launch a new digestive health brand or expand your global presence, BluepillExpress offers scalable and compliant manufacturing support.

Why Choose BluepillExpress?

• WHO-GMP certified infrastructure and export-ready formulations
• Competitive pricing and batch-size flexibility
• Expertise in gastroenterology and liquid formulation production
• Regulatory assistance from dossier to final delivery
• Consistent quality, technical support, and customer service
• Trusted by clients in 30+ international markets

Conclusion

Sodium Picosulphate remains one of the most trusted and clinically effective solutions for constipation relief and bowel preparation. Its predictable action, minimal systemic effects, and availability in multiple patient-friendly formats make it a valuable addition to any pharmaceutical product lineup.

BluepillExpress is your strategic third-party manufacturing partner, delivering high-quality, cost-effective, and compliant Sodium Picosulphate products for domestic and international markets. Let us help you meet your formulation needs with efficiency, transparency, and commitment to excellence.