Omeprazole Pellets

OMEPRAZOLE PELLETS

Product Profile:

Omeprazole is delivered in enteric coated pellets form to protect from gastric fluids and releasing in intestine.

Features:

Acid resistance:
Our “STABICOAT Omeprazole Pellets” shows above 90% of gastric fluid resistance. This means that 90% of Omeprazole is protected in stomach, which ensures required quantity of drug is available for release in intestine.

Dissolution:
High GF resistance of our product is assisted by high dissolution in intestine fluid. Minimum 85% of the drug is dissolved within 45 minutes.

Loss on Drying:
LOD is another important parameter for Omeprazole pellets – less is better. Higher moisture content results in faster deterioration of the drug. Our product comes with less than 2% of LOD.

Hardness:
Our “Omeprazole Enteric Coated Granules” comes with good compressive strength, which minimizes the possibility of breakage. This makes handling of the granules during filling up of the capsules easy and trouble free.

Smoothness & shining:
High quality coating materials and advanced coating technology ensure smooth and shining surface of the granules. This makes the granules free flowing for easy operation of capsule filling. Shining helps in visual checking of the granules for its proper coating as well as in differentiating from uncoated granules.

Coating Materials:
Methacrylic acid polymer and HPMC Pthalate are the two most suitable enteric coating materials for Omeprazole. We use any of these two as per the specific requirement of the customer.

Specifications

We can provide the products as per customers’ specifications. However, our typical specifications are given below.

Test	Specifications
Description	White or off white colored spherical enteric coated granules (pellets)
Solubility	Soluble in methanol and in 0.1% NaOH
Identification of Omeprazole	UV light absorption
Loss on drying	Not more than 2.0% w/w
GF Resistance	Not less than 90% of drug to be retained in granules in gastric fluid after 2 hours
Dissolution in IF	Not less than 85% of the drug is released in intestine fluid after 45 minutes
Assay	Activity of Omeprazole 95% to 105% of label claim

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Stability And Storage

It is physically and chemically stable when stored in original packing in dry place at below 25° C protected from light.

Available as

7.5%, 8.5% and 10.5% or as per requirement

Packing

15 kg, 20 kg, 25 kg, 30 kg or multiple of 1 kg active equivalent