Stable benzimidazole formulation
AssigneeDexcel Pharma Technologies Ltd.
InventorsAdel Penhasi, Avi Avramoff, Maxim Gomberg, Valerie Azoulay
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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.
Claims13
An omeprazole delayed release tablet consisting of:
- a core consisting of omeprazole, lactose, sodium starch glycolate, sodium stearate, and sodium stearyl fumarate;
- and an enteric coating over the core consisting of hydroxypropyl methyl cellulose (HPMC) acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, monoethanol amine, a coloring agent and less than 500 ppm of residual ammonium hydroxide;
- wherein said monoethanol amine is prepared from an aqueous solution and is present in the coating in an amount of 1.195 weight %, 1.251 weight %, 1.28 weight %, 1.282 weight %, 1.325 weight %, 1.35 weight %, 1.360 weight %, 1.368 weight %, 1.388 weight %, 1.396 weight %, 1.44 weight %, 1.477 weight %, 1.59 weight %, or 1.75 weight % to reduce residual ammonium hydroxide in said tablet to a lower amount for toxicity/safety reasons.
An omeprazole delayed release tablet consisting of:
- a core and an enteric coating over the core,
- wherein the core consists 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 of hydroxypropyl methyl cellulose (HPMC) acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, monoethanol amine, a coloring agent and less than 500 ppm of residual ammonium hydroxide;
- wherein said monoethanol amine is prepared from an aqueous solution and is present in the coating in an amount of 1.195 weight %, 1.251 weight %, 1.28 weight %, 1.282 weight %, 1.325 weight %, 1.35 weight %, 1.360 weight %, 1.368 weight %, 1.388 weight %, 1.396 weight %, 1.44 weight %, 1.477 weight %, 1.59 weight %, or 1.75 weight % to reduce residual ammonium hydroxide in said tablet to a lower amount for toxicity/safety reasons.
An omeprazole delayed release tablet consisting of:
- a core and an enteric coating over the core,
- wherein the core consists 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 of hydroxypropyl methyl cellulose (HPMC) acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, monoethanol amine, a coloring agent and less than 500 ppm of residual ammonium hydroxide by weight percent of the enteric coating;
- wherein said monoethanol amine is prepared from an aqueous solution and is present in the coating in an amount of 1.195 weight %, 1.251 weight %, 1.28 weight %, 1.282 weight %, 1.325 weight %, 1.35 weight %, 1.360 weight %, 1.368 weight %, 1.388 weight %, 1.396 weight %, 1.44 weight %, 1.477 weight %, 1.59 weight %, or 1.75 weight % to reduce residual ammonium hydroxide in said tablet to a lower amount for toxicity/safety reasons.
Dependencies are inferred from the claim text.