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Liquid oral pharmaceutical dosage form comprising a histamine h2-receptor antagonist and an antacid

A receptor antagonist, pharmaceutical dosage form technology, applied in the field of liquid oral pharmaceutical dosage forms, can solve the problems of unstable famotidine, no suspension guidance and examples are given, etc.

Active Publication Date: 2019-06-14
JOHNSON & JOHNSON COSTUMER INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no guidance and examples of how to prepare such suspensions are given in the patent application, and those skilled in the art realize that famotidine, which is unstable, would not have any guidance on how to prepare such formulations

Method used

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  • Liquid oral pharmaceutical dosage form comprising a histamine h2-receptor antagonist and an antacid
  • Liquid oral pharmaceutical dosage form comprising a histamine h2-receptor antagonist and an antacid
  • Liquid oral pharmaceutical dosage form comprising a histamine h2-receptor antagonist and an antacid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Material

[0054] All oils were obtained from Croda International.

[0055] Magnesium hydroxide and calcium carbonate were obtained from Magnesia GmbH.

[0056] Famotidine was obtained from Gedeon Richter, Hungary, and was internally film coated using conventional coating techniques well known to those skilled in the art.

[0057] preparation

[0058] Different kinds of formulations were prepared and shown in Table 1.

[0059] Famotidine was mixed in different kinds of solvents, including different oils, to investigate which oils were suitable for use with famotidine (Samples 1-11 and 22-25 in Table 1). The results show that famotidine is stable in all oils and is most stable in the presence of medium chain triglycerides (samples 8F1 / F2, 22C, 23A / B, 24A and 25B7).

[0060] Different kinds of antacid mixtures were investigated to determine which might be suitable (samples 12-21 in Table 1).

[0061] Two-compartment packaging

[0062] A two-compartment pack is...

Embodiment 2

[0065] Analysis of the stability of famotidine suspended in different oils.

[0066] Mix uncoated famotidine in one of the following oils: safflower oil (B1), soybean oil (B2), sesame oil (B3), corn oil (B4), cottonseed oil (B5), ultra Refined MCT (B6) and Standard MCT (B7). 3 samples were prepared per batch and the samples were incubated at 40 / 75°C, 50°C or 60°C. 10 mg of famotidine was mixed with 5 g of oil. Samples were taken after 14 days, 1 month, 2 months, and 3 months and famotidine stability was assessed.

[0067] For stability analysis, samples were prepared and analyzed using the following methods

[0068] solution

[0069]

[0070]

[0071] mobile phase

[0072]

[0073]

[0074] Famotidine Standard

[0075]

[0076] Famotidine: CAS Number: 76824-35-6, C 8 H 15 N 7 O 2 S 3 , MW: 337.45

[0077]

[0078]

[0079]

[0080]

[0081]

[0082] Sample Preparation

[0083] • Pour the sample vial into a 100ml volumetr...

Embodiment 3

[0102] Evaluate the viscosity and consistency of different antacid formulations.

[0103] Different amounts of Xanthan Gum 180 and Avicel CL 611 NF were used.

[0104]

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PUM

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Abstract

The invention relate to a liquid oral pharmaceutical dosage form, comprising a) pharmacologically effective amounts of at least one histamine H2-receptor antagonist in a hydrophobic / lipophilic liquidsubstantially free from water and b) pharmacologically effective amounts of at least one antacid, wherein a) and b) are physically separated from each other, a package comprising multiple liquid oraldosage forms as well as a method of treating a gastric disease or disorder by use of the liquid oral pharmaceutical dosage form.

Description

technical field [0001] The present invention relates to a liquid oral pharmaceutical dosage form comprising a) a pharmacologically effective amount of at least one histamine H2 receptor antagonist in a substantially water-free hydrophobic / lipophilic liquid, and b) a pharmacologically effective amount of at least one histamine H2 receptor antagonist Antacids, wherein a) and b) are physically separated from each other; a package comprising a plurality of liquid oral dosage forms; and a method of treating a stomach disease or disorder by using the liquid oral pharmaceutical dosage forms. Background technique [0002] Histamine H2 receptor antagonists, such as cimetidine, ranitidine, nicitidine, rositidine, and famotidine, reduce acid by acting directly on acid-secreting parietal cells in the gastric glands of the stomach lining secretion. [0003] While histamine H2 receptor antagonists are remarkably effective in the treatment of many gastric disorders, especially peptic and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/44A61K31/426A61K33/08A61K33/10A61P1/04
CPCA61K9/08A61K47/44A61K31/426A61K33/08A61K33/10A61K45/06A61K31/341A61K31/4164A61P1/04A61K2300/00A61K47/34
Inventor S·M·穆罕默德K·林德尔C·西弗森
Owner JOHNSON & JOHNSON COSTUMER INC
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