IP Library › Patent Application 19227824
Patent Application
App. No. 19/227,824

SOFTGEL CAPSULE COMPRISING A H2 RECEPTOR ANTAGONIST

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Quick Facts
Patent No.
US None
App. No.
19/227,824
Abstract

The disclosure generally relates to soft gelatin oral dosage form. In particular the disclosure relates to an oral dosage form comprising a soft gelatin capsule and a liquid fill, where the liquid fill is a suspension of an H2 receptor antagonist in a hydrophobic/lipophilic excipient. The disclosure also relates to a method of treating a gastric disease or disorder by using said oral dosage form.

Claims (21)

1 . An oral dosage form comprising a soft gelatin capsule and a liquid fill contained within the soft gelatin capsule,

wherein the liquid fill comprises a suspension of an H2 receptor antagonist in a hydrophobic/lipophilic excipient substantially free from water, and

wherein at least 50%, in wt %, of the hydrophobic/lipophilic excipient consists of linoleic acid or linoleate moiety.

2 . The oral dosage form according to claim 1 , wherein the hydrophobic/lipophilic excipient has a HLB value below 3, preferably below 2, preferably at a maximum of 1.

3 . The oral dosage form according to claim 1 , wherein the hydrophobic/lipophilic excipient consists of glyceryl monolinoleate, corn oil, or combinations thereof.

4 . The oral dosage form according to claim 1 , wherein a solubility of the H2 receptor antagonist in the hydrophobic/lipophilic excipient is below 1 mg/g.

5 . The oral dosage form according to claim 1 , wherein the H2 receptor antagonist is selected from the group consisting of cimetidine, ranitidine, nizatidine, roxatidine and famotidine, and pharmaceutically acceptable salts thereof.

6 . The oral dosage form according to claim 5 , wherein the H2 receptor antagonist comprises famotidine.

7 . The oral dosage form according to claim 1 , wherein the H2 receptor antagonist comprises at least 15%, in wt %, of the liquid fill.

8 . The oral dosage form according to claim 1 , wherein the H2 receptor antagonist comprises at least 5 mg per oral dosage form preferably at least 10 mg.

9 . The oral dosage form according to claim 1 , wherein after 24 months at least 95% of the H2 receptor antagonist has not degraded.

10 . The oral dosage form according to claim 1 , comprising a soft gelatin capsule and a liquid fill contained within the soft gelatin capsule,

wherein the liquid fill consists of a suspension of famotidine in a hydrophobic/lipophilic excipient substantially free from water, and

wherein the hydrophobic/lipophilic excipient consists of glyceryl monolinoleate, corn oil or combinations thereof.

11 . The oral dosage form according to claim 10 , comprising a soft gelatin capsule and a liquid fill contained within the soft gelatin capsule,

wherein the liquid fill consists of a suspension of famotidine in a hydrophobic/lipophilic excipient substantially free from water, and

wherein the hydrophobic/lipophilic excipient consists of glyceryl monolinoleate.

12 . The oral dosage form according to claim 10 , comprising a soft gelatin capsule and a liquid fill contained within the soft gelatin capsule,

wherein the liquid fill consists of a suspension of famotidine in a hydrophobic/lipophilic excipient substantially free from water, and

wherein the hydrophobic/lipophilic excipient consists of corn oil.

13 . A method of treating a gastric disease or disorder by use of the oral dosage form according to claim 1 .