Compositions and methods for treating pathologies that necessitate suppression of gastric acid secretion
OwnerSabina Glozman, Ayelet David +1inventors
InventorsSabina Glozman, Ayelet David, Lada Paul
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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.
Claims29
An oral pharmaceutical composition comprising as active ingredients a pharmaceutically effective amount of:
- (i) a peptide comprising the amino acid sequence of SEQ ID NO:1, which activates parietal cells;
- (ii) an irreversible gastric H+/K+-ATPase proton pump inhibitor (PPI);
- and (iii) at least one preservation agent that preserves the availability of the peptide in gastric fluids.
22 The oral composition of claim 18, wherein the pH regulating agent is in amount sufficient to raise the pH of the stomach to a pH of at least 5.5.
An oral pharmaceutical kit comprising as active ingredients a pharmaceutically effective amount of:
- (i) a peptide comprising the amino acid sequence of SEQ ID NO:1;
- (ii) an irreversible gastric H+/K+-ATPase proton pump inhibitor (PPI);
- and (iii) at least one agent that preserves the availability of the peptide in the gastric fluids for at least 20 to 30 minutes, wherein the active ingredients are formulated in separate unit dosage forms.
A pharmaceutical kit for oral PPI treatment comprising:
- (a) an initial dose for the early stage of PPI treatment comprising a pharmaceutically effective amounts of a PPI combined with a peptide comprising the amino acid sequence of SEQ ID NO:1 and one or more pH regulating agents, wherein the pH regulating agents are in an amount sufficient to raise the pH in the stomach to a pH of at least 4.5, and
- (b) a continuance dose for the subsequent stage of PPI treatment comprising the effective amounts of the PPI and the peptide and one or more pH regulating agents in an amount less than the initial dose, but sufficient to raise the pH in the stomach to a pH of at least 4.5.
A method of reducing gastric acid secretion in a mammal, the method comprising orally administering to the mammal an effective amount of a pH regulating agent and a peptide comprising SEQ ID NO:1 in conjunction with an effective amount of a proton pump inhibitor (PPI), wherein the pH regulating agent is administered in an amount sufficient to raise the pH in the stomach to a pH greater than 4.5 for a sufficient time that the peptide enhances the inhibitory activity of PPI, thereby reducing the gastric acid secretion in the mammal.
Dependencies are inferred from the claim text.