Domperidone

Domperidone is a time-tested and globally trusted medication used for the management of nausea, vomiting, bloating, and gastrointestinal motility disorders. It is a peripheral dopamine antagonist with excellent safety and efficacy in enhancing gastric emptying and reducing discomfort associated with dyspepsia and gastroparesis.

At BluepillExpress, we specialize in the third-party manufacturing of high-quality Domperidone formulations under stringent WHO-GMP, ISO, and regulatory-certified environments. As a contract manufacturing partner to leading pharmaceutical companies, hospitals, and government institutions, we provide Domperidone products tailored for both branded and institutional supply chains across global markets.

Product Overview

Generic Name: Domperidone
Therapeutic Category: Antiemetic / Prokinetic Agent
Pharmacological Class: Peripheral Dopamine D2 Receptor Antagonist

Available Dosage Forms:

• Oral Tablets
• Oral Suspension (especially for pediatric and geriatric use)
• Orodispersible Tablets (ODT) – on request
• Domperidone SR Capsules – for chronic therapy applications

Common Strengths Offered:

• Tablets: 10 mg
• Suspension: 1 mg/mL or 5 mg/5 mL
• Capsules (SR): 30 mg (Sustained Release)

Packaging Options:

• Tablets: Blister packs (10×10, 1×10) in Alu-Alu or PVC-Alu
• Suspension: HDPE or glass bottles (60 mL, 100 mL, 150 mL)
• Custom packaging in mono-cartons, bulk jars, or institutional strips
• Anti-counterfeit, QR-coded, and tamper-evident solutions available

Pharmacopoeial Compliance: IP / BP / USP / EP (As per client requirements)

Mechanism of Action

Domperidone functions as a selective peripheral dopamine D2 receptor antagonist. By blocking dopamine receptors in the chemoreceptor trigger zone (CTZ) and the gastrointestinal tract, it:

• Enhances the motility of the upper gastrointestinal tract
• Increases lower esophageal sphincter pressure
• Promotes gastric emptying
• Reduces sensations of nausea and vomiting

Unlike other dopamine antagonists, Domperidone does not readily cross the blood-brain barrier, which reduces central nervous system side effects such as sedation or extrapyramidal symptoms (EPS).

Indications

Domperidone is indicated for the management of:

• Nausea and vomiting of central or peripheral origin
• Gastroparesis and delayed gastric emptying
• Functional dyspepsia
• Bloating, early satiety, and postprandial fullness
• GERD-related symptoms (as adjunct therapy)
• Nausea associated with migraine and motion sickness
• Nausea during radiotherapy or drug therapy (e.g., Levodopa)

In pediatric patients, Domperidone suspension is often prescribed to manage gastrointestinal disturbances and vomiting.

Dosage and Administration

For Adults:

• Tablet (10 mg):
  • One tablet 15 to 30 minutes before meals and if needed before sleep
  • Maximum: 30 mg/day in divided doses
• Capsules (30 mg SR):
  • Once daily dose, typically in chronic gastrointestinal motility disorders

For Children:

• Suspension (1 mg/mL or 5 mg/5 mL):
  • Dosage based on body weight (0.25–0.5 mg/kg, up to 3 times daily)

Important Notes:

• Should be taken before meals for optimal absorption
• Dosage should be adjusted in hepatic or renal impairment
• Long-term use should be avoided unless clinically necessary due to QT interval considerations

Pharmacokinetics

• Absorption: Oral bioavailability ~15% due to first-pass metabolism
• Onset of Action: ~30–60 minutes
• Peak Plasma Concentration: Within 1 hour
• Half-Life: Approximately 7 hours
• Metabolism: Hepatic (CYP3A4); excreted in urine and feces

Domperidone’s pharmacokinetic profile supports both immediate and sustained-release formulations, catering to a wide range of clinical needs.

Advantages of Domperidone Therapy

• Peripheral selectivity ensures minimal CNS side effects
• Safe for use in a wide patient population including pediatrics
• Non-sedative, making it suitable for daily use
• Excellent efficacy in functional dyspepsia and nausea
• Can be combined with Proton Pump Inhibitors (PPIs) for GERD
• Customizable formulations for various markets and patient groups

Why Choose BluepillExpress for Domperidone Manufacturing?

1. WHO-GMP and ISO Certified Facilities

Our manufacturing plants operate under globally recognized standards with:

• Dedicated solid and liquid dosage manufacturing zones
• High-speed tablet compression and coating lines
• Oral liquid processing suites with automated filling and labeling
• Cleanroom environments with strict quality protocols

2. Full Formulation and Packaging Customization

We offer:

• Sugar-free or flavored suspensions (Orange, Mango, Raspberry)
• Orodispersible tablet versions for geriatric and pediatric use
• Sustained-release capsules for once-daily therapy
• Private-label and generic branding services
• Multilingual artwork and country-specific packaging

3. Regulatory and Documentation Support

We provide:

• COA, MOA, COPP, FSC, and GMP certificates
• CTD/ACTD dossier preparation
• Product stability data (real-time and accelerated)
• Assistance with MOH product registration and tenders
• Serialization and barcoding for traceability

4. Global Export Capability

BluepillExpress exports Domperidone formulations to over 40 countries, including:

• Africa: Nigeria, Ghana, Sudan, Kenya, Ethiopia
• Asia: Myanmar, Vietnam, Philippines, Cambodia
• Middle East: Iraq, Yemen, UAE, Jordan
• CIS & Latin America: Uzbekistan, Bolivia, Peru

Our logistics team ensures timely documentation, regulatory compliance, and shipment tracking.

Quality Control and Assurance

All formulations undergo strict quality control checks:

Tablet and Capsule Testing:

• Active Ingredient Assay (HPLC, UV Spectrophotometry)
• Disintegration and Dissolution Profile
• Hardness, Friability, and Content Uniformity
• Microbiological Testing

Suspension Testing:

• Viscosity, pH, Specific Gravity
• Microbial Limit Testing
• Stability and Homogeneity Testing

Stability Studies:

• ICH Guidelines for zones I-IV
• Accelerated and long-term real-time studies for global market readiness

Third-Party Manufacturing Process at BluepillExpress

Step 1: Product Discussion and Specification Finalization
Client and technical teams define dosage, packaging, and regulatory needs.

Step 2: Sampling and Documentation Preparation
Pilot samples and draft artwork are shared; COA, MOA, and pricing finalized.

Step 3: Batch Production and Quality Testing
WHO-GMP certified production begins with real-time quality assurance.

Step 4: Packaging and Dispatch
Final product is packaged, labeled, and dispatched with all export documentation.

Step 5: Regulatory and After-Sales Support
Assistance with product registration, post-approval changes, and batch variations.

Ideal Client Segments

• Pharmaceutical Marketing Companies
• Hospital Chains and Institutional Suppliers
• Government Health Program Suppliers
• NGOs and Public Health Organizations
• Distributors and Export Houses
• OTC Brands (where permitted by regulation)

Domperidone remains an essential product in both private and public sector markets due to its wide clinical application and cost-effectiveness.

Global Market Outlook

• The global antiemetics and prokinetics market is projected to grow at a CAGR of 6–8% due to increasing prevalence of functional gastrointestinal disorders.
• Domperidone continues to hold a significant market share in developing countries, especially where affordability and safety are critical.
• Generic brands, institutional contracts, and private-label offerings are driving demand in Africa, Asia, and Latin America.
• Domperidone’s role as a complementary therapy in PPI-based regimens further reinforces its demand.

BluepillExpress is well-positioned to meet this global demand with scalable production capacity, flexible packaging options, and regulatory expertise.

Conclusion

Domperidone is a safe, effective, and versatile gastrointestinal medication with proven efficacy across age groups. It continues to be a mainstay in the treatment of nausea, dyspepsia, and motility disorders. With its peripheral mode of action and favorable safety profile, it is widely accepted by clinicians worldwide.

At BluepillExpress, we bring together world-class infrastructure, regulatory compliance, and customer-centric solutions to offer end-to-end third-party manufacturing for Domperidone. Whether you require branded packaging, institutional supply, or regulatory dossier support, our team ensures timely, cost-effective, and high-quality delivery across international markets.