Pantoprazole Domperidone Pellets

Pantoprazole Domperidone Pellets Specification

Storage
Store in a cool, dry, and dark place below 25C, protected from moisture

Application
Pharmaceutical formulations for treatment of acid-related disorders and gastrointestinal motility disorders

Shape
Spherical pellets

Purity
NLT 99% (combined actives)

CAS No
Pantoprazole: 102625-70-7, Domperidone: 57808-66-9

Product Type
Active Pharmaceutical Ingredients

Shelf Life
24-36 months when properly stored

Ingredients
Pantoprazole Sodium, Domperidone, Excipients

EINECS No
Pantoprazole: 600-460-7, Domperidone: 260-967-7

Grade
Pharmaceutical Grade

Melting Point
Pantoprazole: 140-142C, Domperidone: 246-251C

Structural Formula
Refer to respective active pharmaceutical ingredient structures

Properties
Stable, free-flowing, gastro-resistant, enteric coated

Physical Form
Pellets

HS Code
3004

Appearance
White to off-white pellets

Solubility
Pantoprazole: Soluble in methanol, Domperidone: Practically insoluble in water

Ph Level
Neutral to slightly alkaline

Molecular Weight
Pantoprazole: 383.38 g/mol, Domperidone: 425.91 g/mol

Smell
Odourless

Poisonous
Non-poisonous when used as directed

Taste
Odourless or slightly bitter

Refractive Rate
Not applicable for solid pellets

Molecular Formula
Pantoprazole: C16H15F2N3O4S, Domperidone: C22H24ClN5O2

Usage
Used in gastro-resistant dosage forms and oral solid preparations

Density
1.3 Gram per cubic centimeter(g/cm3)

Regulatory Status
Complies with IP/USP/EP/BP specifications

Compatibility
Compatible with excipients used in oral solid dosage forms

Loss on Drying
Not more than 5%

Packaging
Double polyethylene bags in HDPE drums or as per client requirement

Particle Size
Typically 16-32 mesh or as specified

Assay
Pantoprazole Sodium: 95%-105% of label claim, Domperidone: 95%-105% of label claim

Coating Type
Enteric coated, moisture barrier coated

Heavy Metals
Within permissible limits

Microbial Limits
As per pharmacopoeial standards

About Pantoprazole Domperidone Pellets

Pantoprazole domperidone pellets are a pharmaceutical formulation of two drugs, pantoprazole and domperidone, used in the treatment of acid-related disorders such as gastroesophageal reflux disease (GERD) and peptic ulcer disease.

Pantoprazole is a proton pump inhibitor (PPI) that works by blocking the proton pumps in the stomach lining, which are responsible for producing acid. By reducing the amount of acid in the stomach, pantoprazole can alleviate symptoms such as heartburn, regurgitation, and stomach pain.

Domperidone is a dopamine antagonist that works by blocking the action of dopamine in the brain and the gut. It increases the contractions of the muscles in the stomach and intestines, which helps to move food through the digestive system more quickly. This can alleviate symptoms such as nausea, vomiting, and bloating.

The pellets are usually encapsulated in a capsule or a tablet to facilitate ingestion. The pellets are designed to release the drugs gradually, which allows for sustained blood levels and prolonged therapeutic effect.

Pantoprazole domperidone pellets are available in different strengths and formulations, and their use should be prescribed by a healthcare provider based on the patient's medical condition, age, and other factors.

Advanced Pellet Formulation for Acid and Motility Disorders

These Pantoprazole Domperidone Pellets provide dual active ingredient delivery for effective treatment of acid-related and gastrointestinal motility disorders. The enteric and moisture barrier coatings safeguard the actives until reaching the targeted absorption site, ensuring optimal therapeutic performance for pharmaceutical formulations.

Stringent Quality and Regulatory Compliance

Manufactured under strict guidelines, the pellets comply with all major pharmacopeial standards, including IP, USP, EP, and BP. Heavy metals and microbial counts remain within permissible ranges, ensuring patient safety and consistent pharmacological efficacy for global pharmaceutical applications.

Versatile Application in Oral Solid Dosage Forms

Due to their pelletized, free-flowing nature and compatibility with standard excipients, these pellets can be easily integrated into various oral solid dosage forms such as capsules or tablets. Their stable, gastro-resistant profile is ideal for products targeting controlled release and enhanced patient compliance.

FAQs of Pantoprazole Domperidone Pellets:

Q: How are Pantoprazole Domperidone Pellets typically used in pharmaceutical formulations?

A: These pellets serve as active ingredients in the production of oral solid dosage forms, such as capsules and tablets, formulated for the treatment of acid-related and gastrointestinal motility disorders. Their pelletized form offers controlled release and improved stability.

Q: What is the benefit of enteric and moisture barrier coatings on these pellets?

A: The dual coatings protect the active ingredients from degradation due to stomach acid and moisture, ensuring the drugs are released effectively at the intended site within the gastrointestinal tract, which increases therapeutic efficacy.

Q: When should these pellets be used in pharmaceutical manufacturing?

A: Pantoprazole Domperidone Pellets are best utilized when developing gastro-resistant, solid oral medications requiring precise dosing and reliable release profiles. They are ideal for products targeting conditions like gastric acidity and dysmotility disorders.

Q: Where does the product comply with regulatory standards?

A: The pellets meet specifications for pharmacopoeial compliance, including IP (Indian Pharmacopoeia), USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia), making them suitable for international markets.

Q: What is the recommended storage condition for maintaining product stability?

A: They should be stored below 25C in a cool, dry, and dark place, protected from moisture, as per recommended guidelines. Proper storage helps retain potency and quality for the entire 2436 month shelf life.

Q: How is product quality assessed during manufacturing and packaging?

A: Quality control involves assay checks (maintaining 95105% of label claim for actives), microbial testing, monitoring of heavy metals, and evaluation of loss on drying, particle size, and appearance. Packaging uses double polyethylene bags in HDPE drums to preserve integrity.

Q: What are the practical advantages for pharmaceutical exporters and suppliers?

A: The pellets compliant quality, stable profile, and versatile application in oral solid forms enhance marketability. They are easily handled, shipped in robust packaging, and suitable for import, export, supply, and trading within pharmaceutical industries worldwide.

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