Stable benzimidazole formulation
AssigneeDexcel Pharma Technologies Ltd.
InventorsAdel PENHASI, Avi Avramoff, Maxim Gomberg, Valerie Azoulay
Life of this patent
Estimating the term…
Abstract
An omeprazole delayed release tablet comprises a core and an enteric coating over the core. The core consists essentially of omeprazole, lactose, sodium starch glycolate, sodium stearate, and sodium stearyl fumarate. The enteric coating over the core consists essentially of hydroxypropyl methyl cellulose (HPMC) acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, monoethanol amine, and less than 500 ppm of residual ammonium hydroxide.
Claims3
An omeprazole delayed release tablet comprising:
- a core consisting essentially of omeprazole, lactose, sodium starch glycolate, sodium stearate, and sodium stearyl fumarate;
- and
- an enteric coating over the core consisting essentially of hydroxypropyl methyl cellulose (HPMC) acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, monoethanol amine, and less than 500 ppm of residual ammonium hydroxide.
An omeprazole delayed release tablet comprising:
- a core and an enteric coating over the core,
- wherein the core consists essentially of about:
- 20 mg omeprazole, 203 mg lactose monohydrate, 10 mg sodium starch glycolate, 10 mg sodium stearate, and 7 mg sodium stearyl fumarate,
- wherein the enteric coating consists essentially of about:
- 32 mg hydroxypropyl methyl cellulose (HPMC) acetate succinate, 4.5 mg triethyl citrate, 0.5 mg sodium lauryl sulfate, 8.1 mg talc, 1 mg monoethanol amine, and less than 500 ppm of residual ammonium hydroxide.
An omeprazole delayed release tablet comprising:
- a core and an enteric coating over the core,
- wherein the core consists essentially of about:
- 8 weight % omeprazole, 81.2 weight % lactose monohydrate, 4 weight % sodium starch glycolate, 4 weight % sodium stearate, and 2.8 weight % sodium stearyl fumarate by weight percent of the core,
- wherein the enteric coating consists essentially of about:
- 56.1 weight % hydroxypropyl methyl cellulose (HPMC) acetate succinate, 7.9 weight % triethyl citrate, 0.9 weight % sodium lauryl sulfate, 14.3 weight % talc, 1.8 weight % monoethanol amine, and less than 500 ppm of residual ammonium hydroxide by weight percent of the enteric coating.
Dependencies are inferred from the claim text.