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Esomeprazole and Domperidone Capsules Manufacturer - Esodel DSR

Esomeprazole and Domperidone Capsules Manufacturer

Delwis Healthcare manufactures Esomeprazole and Domperidone Capsules (Esomeprazole 40mg EC + Domperidone 30mg SR) — a dual-action gastroenterology formulation combining a proton pump inhibitor with a sustained-release prokinetic agent for effective management of GERD, acid reflux, functional dyspepsia, and related gastrointestinal disorders.

Composition

Esomeprazole 40mg + Domperidone 30 mg SR Cap.

Pack Size

10x10 Alu Alu

About Esomeprazole and Domperidone Capsules — Formulation & Mechanism

Esomeprazole and Domperidone Capsules is a fixed-dose combination gastroenterology formulation engineered using dual-release pellet technology — delivering two therapeutically complementary active ingredients through distinct controlled-release mechanisms within a single capsule.

Esomeprazole Magnesium 40mg (Enteric Coated)

Esomeprazole is the S-isomer of omeprazole and among the most potent proton pump inhibitors available. The enteric coating (EC) protects the pellets from gastric acid degradation, ensuring the drug reaches the small intestine for optimal absorption. Once absorbed, esomeprazole irreversibly inhibits the H+/K+ ATPase enzyme (the gastric proton pump) in parietal cells, producing sustained suppression of acid secretion and raising intragastric pH. This makes it highly effective for GERD treatment, erosive esophagitis, peptic ulcer healing, and heartburn medicine applications in India and globally.

Domperidone 30mg (Sustained Release)

Domperidone is a selective dopamine D2-receptor antagonist and prokinetic agent that enhances gastric motility without crossing the blood-brain barrier — reducing the central nervous system side effects seen with older prokinetics. The sustained-release (SR) granule formulation delivers domperidone steadily over an extended period, maintaining consistent gastric prokinetic activity throughout the dosing interval. This controls delayed gastric emptying, prevents food stagnation, reduces postprandial bloating, and addresses nausea associated with upper GI dysmotility.

Together, this enteric coated esomeprazole magnesium and domperidone SR capsule addresses both the acid component and the motility component of complex upper GI disorders — a therapeutic combination unavailable from either agent alone. For pharmaceutical companies seeking a DSR capsule contract manufacturer in India, this dual-technology formulation represents a technically demanding yet high-demand product in the gastroenterology segment.

Esomeprazole and Domperidone Capsules Uses — Indications & Therapeutic Applications

The esomeprazole and domperidone capsules uses span a broad range of upper gastrointestinal conditions where co-existing acid hypersecretion and impaired gastric motility are the underlying pathological drivers.

Gastroesophageal Reflux Disease (GERD)

GERD is the primary indication for this combination. Esomeprazole suppresses the acid that refluxes into the oesophagus, while domperidone strengthens lower oesophageal sphincter tone and accelerates gastric emptying — reducing the frequency and severity of reflux episodes. This dual approach makes it among the most effective formulations for GERD treatment in India.

Functional Dyspepsia

Functional dyspepsia treatment requires addressing both acid sensitivity and gastric motility impairment. The combination resolves the full symptomatic spectrum — postprandial fullness, early satiation, epigastric pain, and burning — making it a preferred prescriber choice for functional upper GI complaints.

Acid Reflux & Heartburn

For patients experiencing acid reflux after eating and persistent heartburn, esomeprazole's powerful acid suppression combined with domperidone's motility enhancement provides both immediate symptom relief and long-term mucosal protection — addressing root causes rather than symptoms alone.

Bloating and Acidity

The domperidone SR component directly targets bloating and acidity caused by sluggish gastric emptying and food accumulation — clearing gastric stasis and restoring normal upper GI transit, while esomeprazole controls the acid environment contributing to discomfort.

Peptic Ulcer Disease

As an adjunct in peptic ulcer treatment, esomeprazole reduces aggressive acid secretion to allow mucosal healing, while domperidone improves gastric emptying and reduces duodenogastric reflux — addressing both the causative acid environment and the motility dysfunction common in ulcer patients.

Nausea & Delayed Gastric Emptying

Nausea secondary to upper GI dysmotility, gastroparesis, and delayed gastric emptying responds well to domperidone's prokinetic action. This makes the combination particularly valuable in diabetic gastroparesis, post-surgical GI stasis, and chemotherapy-associated nausea management.

Zollinger-Ellison Syndrome

In hypersecretory conditions including Zollinger-Ellison syndrome, esomeprazole 40mg's potent and sustained acid suppression provides effective long-term control of pathological hypergastrinemia and its gastrointestinal consequences.

Dual-Release Technology — Enteric Coated EC + Sustained Release SR Capsule Manufacturing

The enteric coated esomeprazole magnesium and domperidone SR capsules manufactured by Delwis Healthcare utilise advanced multi-pellet capsule technology — a significantly more sophisticated formulation approach than standard single-release tablets.

Enteric Coated (EC) Pellets — Esomeprazole

Esomeprazole pellets are coated with a pH-sensitive polymer that remains intact in the acidic stomach environment (pH < 5) and dissolves rapidly in the alkaline small intestine (pH > 5.5). This protects the PPI from gastric acid degradation, ensures complete absorption, and prevents premature drug release that would reduce efficacy.

Sustained Release (SR) Granules — Domperidone

Domperidone granules are formulated with rate-controlling polymer membranes that release the drug gradually over 8–12 hours. This extends the therapeutic window, maintains consistent prokinetic plasma levels throughout the dosing period, reduces peak-related side effects, and improves patient compliance versus immediate-release domperidone.

Multi-Pellet Capsule Assembly

Both EC pellets and SR granules are filled into a single hard gelatin or HPMC capsule — maintaining their individual release profiles while delivering combined therapeutic action from one dosage unit. This formulation complexity requires specialised pelletisation equipment, precision coating systems, and stringent dissolution testing — capabilities fully available at Delwis Healthcare's gastro capsule manufacturer facility in Gujarat.

Third Party Manufacturing & Contract Manufacturing — Esomeprazole Domperidone SR Capsules 

Delwis Healthcare is a WHO-GMP certified third party pharmaceutical manufacturer and CDMO partner for esomeprazole and domperidone capsules — serving pharmaceutical brands, hospital supply companies, and export distributors seeking a technically capable and quality-compliant gastroenterology manufacturing partner. 

Our Manufacturing Services

Third Party Manufacturing Manufacture esomeprazole magnesium and domperidone sustained release capsules under your brand with full GMP-compliant production, dissolution-validated quality testing, Alu-Alu blister packaging, and labeling support — with zero capital infrastructure investment from your side.

Contract Manufacturing (CDMO)

End-to-end contract development and manufacturing — from pellet formulation development, coating optimization, dissolution profile validation, scale-up, and commercial batch production to stability studies and regulatory documentation for your specific market requirements.

Private Label Manufacturing

Launch your own branded DSR capsule range with custom carton artwork, blister foil branding, and packaging formats designed for your target therapeutic segment and geographic market.

Custom Formulation Development

Modify polymer types, pellet ratios, capsule shell material (gelatin or HPMC/vegetarian), or dissolution release profiles to meet specific prescriber preferences or regulatory requirements.

Alu-Alu Blister Packaging

All capsules are packaged in 10×10 Alu-Alu blister format — the premium moisture and light barrier packaging standard for moisture-sensitive PPI and SR formulations. Custom strip, bottle, or institutional packaging formats are available on request.

Whether you are building a gastroenterology product portfolio, expanding into DSR capsule formats, or sourcing a gastro capsule manufacturer in Gujarat — Delwis Healthcare provides a ready, compliant, and scalable manufacturing partner.

Packaging — Esomeprazole Domperidone Capsules in Alu-Alu Blister 

Esomeprazole and Domperidone Capsules are packaged in 10×10 Alu-Alu blister — the pharmaceutical industry standard for moisture-sensitive, light-sensitive DSR and PPI formulations:

  • Dual aluminium construction provides a complete barrier against moisture, light, and oxygen — critical for protecting both the EC esomeprazole pellets and SR domperidone granules from degradation
  • Tamper-evidence for patient safety and retail compliance
  • Validated shelf life of 24 months under recommended storage conditions (store below 30°C, in a dry place, away from direct light)
  • Compatible with retail pharmacy, hospital formulary, institutional tender, and export distribution channels

Custom packaging formats — including branded cartons, unit-dose strips, and bulk pharmaceutical packs — are available for third party manufacturing buyers.

Quality Control — Esomeprazole Domperidone SR Capsule Manufacturing Standards

Every batch of esomeprazole and domperidone capsules manufactured at Delwis Healthcare undergoes a comprehensive, multi-stage quality control programme:

  • HPLC Analysis — Precise quantification of both esomeprazole magnesium and domperidone per batch
  • Dissolution Profile Testing — Separate EC release testing for esomeprazole (acid stage + buffer stage) and SR release kinetics for domperidone at specified time intervals
  • Content Uniformity — Per-capsule dose consistency verification across the batch
  • Disintegration Testing — Capsule shell dissolution confirmation
  • Microbial Limit Testing — Microbiological safety across all production batches
  • Stability Studies — Real-time and accelerated ICH-compliant stability data available for regulatory dossier submissions
  • Raw Material Testing — API and excipient verification including polymer characterisation before production commencement
  • QMS Alignment — Validated Quality Management System aligned with USP, BP, and EP standards

Why Choose Delwis Healthcare as Your Esomeprazole Domperidone Capsule Manufacturer 

Pharmaceutical brands and distributors partner with Delwis Healthcare for third party and contract manufacturing of esomeprazole and domperidone capsules because:

  • WHO-GMP & ISO Certified Facility — Globally compliant manufacturing infrastructure accepted for domestic and export markets
  • Dual-Release Pellet Expertise — In-house capability for EC and SR pellet manufacturing, coating, and multi-pellet capsule assembly
  • Alu-Alu Blister Packaging — Premium moisture barrier packaging standard for all PPI and DSR formulations
  • End-to-End CDMO Support — Formulation development through commercial production and regulatory documentation
  • Flexible MOQ — Scalable from development batches to large commercial runs
  • Regulatory Documentation Ready — Dissolution data, stability reports, batch records, and COA available for market submissions
  • Gastroenterology Segment Focus — Dedicated product portfolio and formulation expertise in the hyperacidity, reflux, and ulcer therapeutic category
  • Competitive Manufacturing Cost — Cost-efficient production from Gujarat, India with no compromise on quality

Frequently Asked Questions — Esomeprazole and Domperidone Capsules 

Q1: What are esomeprazole and domperidone capsules used for?

Esomeprazole and domperidone capsules uses include treatment of gastroesophageal reflux disease (GERD), functional dyspepsia, acid reflux, persistent heartburn, bloating associated with gastric dysmotility, peptic ulcer disease, nausea, and delayed gastric emptying. Esomeprazole suppresses stomach acid production while domperidone improves gastric motility — together addressing both the acid and the motility drivers of upper GI disorders.

Q2: What is a DSR capsule and how is it different from a regular capsule?

A DSR capsule contains two active ingredients in distinct controlled-release forms within one capsule — typically an enteric-coated (EC) PPI and a sustained-release (SR) prokinetic. Unlike a regular capsule that releases all its contents at once, the DSR format releases esomeprazole in the small intestine (protecting it from acid) and releases domperidone gradually over several hours — delivering superior therapeutic consistency and reduced side effects compared to standard immediate-release formulations.

Q3: Can esomeprazole and domperidone be taken together?

Yes. These two medicines are specifically formulated together as a fixed-dose combination DSR capsule precisely because they complement each other therapeutically. Esomeprazole reduces acid secretion while domperidone accelerates gastric emptying and improves GI motility — their combined action is more effective for complex upper GI disorders than either agent used alone. As with all prescription medicines, use should be under qualified medical supervision.

Q4: What is the difference between esomeprazole and omeprazole or pantoprazole?

Esomeprazole is the purified S-enantiomer of omeprazole. Due to reduced first-pass metabolism, it achieves higher and more consistent plasma levels than racemic omeprazole — delivering greater acid suppression at equivalent doses. Compared to pantoprazole, esomeprazole generally produces a faster onset of acid suppression and superior healing rates in erosive GERD. In the context of esomeprazole vs omeprazole vs pantoprazole, esomeprazole is widely considered the most potent clinically available oral PPI in India.

Q5: What are the side effects of esomeprazole and domperidone capsules?

Common side effects may include headache, diarrhoea, flatulence, stomach discomfort, and dry mouth — most of which are mild and transient. Prolonged PPI use requires periodic monitoring for magnesium levels, vitamin B12 status, and bone mineral density. Domperidone should be used cautiously in patients with cardiac conditions due to potential QT-interval effects at high doses. All use should be under qualified prescriber supervision.

Q6: Should esomeprazole and domperidone capsules be taken before or after food?

These capsules are typically prescribed to be taken before meals — ideally 30–60 minutes before eating. Taking esomeprazole pre-meal ensures it is absorbed and activates proton pumps before they are stimulated by food intake, maximising acid suppression. The SR domperidone component also works most effectively when taken before a meal, coordinating gastric motility with the arriving food bolus. Always follow the prescribing physician's specific instructions.

Q7: How long should esomeprazole and domperidone capsules be taken?

Duration depends on the clinical indication. For acute GERD or dyspepsia episodes, a course of 4–8 weeks is typical. For chronic GERD or peptic ulcer maintenance, longer treatment may be prescribed. Prolonged PPI therapy beyond 8 weeks should always be medically supervised and periodically reviewed. Prescribers determine duration based on symptom resolution, endoscopic findings, and individual patient response.

Q8: Do you offer third party manufacturing for esomeprazole domperidone SR capsules?

Yes. Delwis Healthcare is a WHO-GMP certified third party pharmaceutical manufacturer and CDMO partner offering complete contract manufacturing of esomeprazole magnesium and domperidone sustained release capsules under client brand names — including EC + SR pellet manufacturing, 10×10 Alu-Alu blister packaging, private labeling, and regulatory documentation support for Indian and export markets.

Q9: What certifications does your capsule manufacturing facility hold?

Our facility holds WHO-GMP, ISO 9001, and ISO 14001 certifications. Manufacturing processes are validated in compliance with USP, BP, and EP pharmacopoeial standards, with complete batch documentation and stability data maintained for domestic and international regulatory submissions.

Q10: What is the shelf life of esomeprazole domperidone capsules?

These capsules carry a validated shelf life of 24 months under recommended storage conditions — below 30°C, in a cool dry place, protected from direct light and moisture. The Alu-Alu blister packaging provides the superior moisture and light barrier necessary to maintain API integrity throughout this shelf life.

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