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Compositions for treating pathologies that necessitate suppression of gastric acid secretion

A composition and drug technology, applied to peptide/protein components, medical preparations containing active ingredients, pharmaceutical formulations, etc.

Inactive Publication Date: 2006-10-04
VECTA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the Phillips patent does not disclose or imply the use of PG that only has stimulatory activity and only binds to the CCK-B receptor, unlike the gastric parietal cell activator mentioned in the Phillips patent that will activate CCK-A and CCK-B receptors - including inhibition and stimulating effects

Method used

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  • Compositions for treating pathologies that necessitate suppression of gastric acid secretion
  • Compositions for treating pathologies that necessitate suppression of gastric acid secretion
  • Compositions for treating pathologies that necessitate suppression of gastric acid secretion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Example 1: NaHCO 3 Maintain the stability of PG in artificial gastric juice

[0093] In Vitro Determination of NaHCO Using Artificial Gastric Juice 3 Stability of PG in the presence of acidic pH. Artificial gastric juice was prepared according to page 235 of the United States Pharmacopoeia (USP) 2000 edition. To prepare 200 ml of gastric juice, 0.4 g of NaCl and 0.64 g of pepsin were dissolved in 16 ml of 1M HCl and 184 ml of water. The pH of gastric juice is 1.2. 10 or 20ml of 8.4% (1M) NaHCO 3 (3.72 mg / ml or 7.12 mg / ml final concentration, respectively) and 16 ml of 250 ppm PG solution (0.25 mg / ml) were added to the solution. The concentration of PG in the final solution was 16 ppm. When indicated, omeprazole granules were also added (solutions B and C). To determine the stability of PG in the final solution over time, HPLC analysis was performed on samples taken at the following time points after preparation: 0' (immediately after preparation), 5', 10', 20', 4...

Embodiment 2

[0096] Example 2: Compression-coated or bilayer tablet containing PG, non-enteric-coated-omeprazole, sodium bicarbonate and calcium carbonate

[0097] Omeprazole (powder)

[0098] Compression-coated or bi-layer tablets are prepared in a two-step process. For single tablets, 4 mg PG, 250 mg calcium carbonate and microcrystalline cellulose were mixed and pre-compressed into the first layer of the tablet. The PG containing layer was further coated with a thin layer of HPMC which allowed a delayed release of PG from the tablet for 10-15 minutes. For the second layer, 40 mg of non-enteric coated-omeprazole powder was combined with 500 mg of NaHCO 3 , 250mg CaCO 3 And a suitable adhesive is compressed onto the PG layer to form the second layer of the tablet. The second layer of the tablet breaks down immediately after degradation to release omeprazole rapidly. A schematic diagram of a bilayer tablet containing PG, non-enteric coated omeprazole, sodium bicarbonate and c...

Embodiment 3

[0099] Example 3: Rapidly Disintegrating Tablets Containing PG, Non-Enteric Coated-Omeprazole, Sodium Bicarbonate and Calcium Carbonate

[0100] Omeprazole (powder)

[0101] Mix non-enteric coated omeprazole (40mg), PG (4mg), NaHCO 3 , CaCO 3 , croscarmellose sodium, microcrystalline cellulose and magnesium stearate and the resulting mixture compressed into tablets using a standard tablet press to yield rapidly disintegrating tablets (intravescent).

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PUM

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Abstract

The present invention is related to novel oral compositions comprising an irreversible gastric H<+> / K<+>-ATPase proton pump inhibitor (PPI) as a gastric acid secretion inhibitor, pentagastrin (PG) or a PG analogue as an activator of parietal cells in the gastric lumen. In a preferred embodiment, the composition further comprises at least one agent that preserves the availability of PG in the gastric fluids, thus enabling PG to act locally in the stomach. Unexpectedly, the compositions of the present invention exhibit anti-acid activity locally in the stomach that is meal-independent, exhibit fast onset and prolonged inhibition of acid secretion.

Description

field of invention [0001] The present invention relates to novel oral compositions for the inhibition of gastric acid secretion, said compositions having a rapid action on gastric acid secretion, a prolonged inhibitory effect and independent of meals. Background of the invention [0002] A number of pathological conditions are characterized by the need to suppress gastric acid secretion. Such conditions include, but are not limited to, Zoller-Ellison syndrome (ZES), gastroesophageal reflux disease (GERD), peptic ulcer disease, duodenal ulcer, esophagitis, and the like. Conditions such as peptic ulcer can have serious complications and are some of the most prevalent diseases in industrialized countries. [0003] Currently, the mainstay of therapy for the treatment of GERD as well as peptic ulcer disease involves, for example, the use of histamine H 2 - Receptor antagonists or proton pump inhibitors (PPI's) drugs that reduce gastric acidity'. PPI’s act by inhibiting the H o...

Claims

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Application Information

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IPC IPC(8): A61K38/00A61K38/02A61K38/16
Inventor 阿叶列特·大卫萨比娜·格洛兹曼拉达·保罗
Owner VECTA
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