Omeprazole Pellets / Micro-Pellets

Omeprazole commands a market size of $7 billion and is marketed as an enteric release formulation. Murli Krishna Pharma Pvt. Ltd. is a leading global Active Pharmaceutical Ingredients (API) manufacturer and supplier for Omeprazole API. The product is offered as a semi-finished formulation in a pelletized form. Omeprazole API is manufactured under a strict control with stringent specifications on the impurity profile as well as the particle size not to mention, the use of correct polymorphs also. The excipients used are specifically chosen and are non-infringing. The product can also be offered in a pellet size suitable for use in a suspension or for compression in tablets.

Registrations:
The DMF file for Omeprazole Pellets 8.5% is submitted to the USFDA and is awaiting review.
The EDMF file for Omeprazole Pellets 8.5% is submitted with the National Authorities is Greece and Romania and is awaiting review.
Omeprazole Pellets 8.5% BA/BE Studies have been successfully completed by the end users.

Omeprazole Micro pellets for Suspension

Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.

The active ingredient in PRILOSEC (omeprazole magnesium) for Delayed Release Oral Suspension, is 5-Methoxy-2-[[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H- benzimidazole, magnesium salt (2:1)

PRILOSEC (omeprazole) is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose, lactose, mannitol, sodium lauryl sulfate and other ingredients. The capsule shells have the following inactive ingredients: gelatin-NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD&C Blue #2, D&C Red #7 Calcium Lake, and, in addition, the 10 mg and 40 mg capsule shells also contain D&C Yellow #10.

Pellets have distinct advantages over single unit system such as multiple unit particles get distributed throughout the GI tract thereby avoiding localized accumulation. Pellets developed by aqueous technology have also advantage of avoiding the use of organic solvents. Omeprazole pellets are developed by Fluid Bed Coating process in which, the suspension of Omeprazole along with other ingredients like Hydroxy propyl methyl cellulose and Sodium Hydroxide which is sprayed on sugar spheres to get drug loaded pellets. On this pellets Enteric coating will be tried using Methacrylic acid copolymer Dispersion, Talc, Titanium Dioxide, PEG-6000, Polysorbate-80 and Sodium Hydroxide.

Administration: Take before eating. Mix contents of sachet in applesauce and take immediately; do not crush or chew granules; follow with water. Susp: mix 10mg packet with 15mL of water. Leave 2–3 mins to thicken, stir and drink within 30 mins.

Omeprazole is used for treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD). It may also be used for short-term treatment of ulcers of the stomach or small intestine. It may also be used with certain antibiotics to treat ulcers of the small intestine and to help prevent them from coming back. It may also be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Omeprazole delayed-release oral suspension is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.

Read more: Wikipedia