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Stable pharmaceutical composition useful for treating gastrointestinal disorders

一种药物、混合物的技术，应用在治疗和/或预防胃肠疾病和/或紊乱领域，能够解决向上移动的悬浮液贮存期限口味不好、限制等问题

Inactive Publication Date: 2005-06-15
MCNEIL PPC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, at higher pH values, the shelf life of suspensions whose pH shows an upward shift is also limited by poor taste

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Two suspensions, SS1 and SS2, were prepared containing bismuth subsalicylate (1.746%), salicylic acid (0.122%) and sodium salicylate (0.4%) in % by weight. SS1 contained no magnesium aluminum silicate, while SS2 also contained 2.0% magnesium aluminum silicate. The suspensions were stored in a closed container under ambient conditions for 20 months, during which time samples were taken from each suspension for pH determination. The data are listed in Table 1.

[0047] suspension

[0048] These data show that the suspension with magnesium aluminum silicate has a higher initial pH and the pH increases over time compared to a similar suspension without magnesium aluminum silicate.

Embodiment 2

[0050] According to the following general method, nine suspensions S1-S9 were prepared, and the composition of each suspension is listed in Table 2. Purified water was weighed, placed in a container, and heated to 40°C. Salicylic acid (if present in suspension) was dissolved in water with stirring. With stirring, one or more preservatives, if any, and sucrose are added to the water. One or more suspending agents are dry mixed and then slowly added to water to form a suspension, which is then mixed for 10 minutes. Bismuth subsalicylate was added to the suspension with stirring. Flavors, colors and any other required excipients are added to the suspension and the suspension is stirred for 5 minutes to make it homogeneous. Add water as needed. Suspension S1 contained magnesium aluminum silicate as suspending agent. Suspensions S2-S9 contained no clay-derived suspending agent.

[0051] components

[0052] components

Embodiment 3

[0054] The suspensions S1-S9 of Example 2 were analyzed for pH shift during 10-12 months. The pH of each suspension was measured immediately after preparation and again after 10-19 months of storage at ambient conditions. The data are listed in Table 3.

[0055] suspension

[0056] Suspension S1, containing a clay-derived suspending agent, had a storage period of 10 months, compared to suspensions S2-S9 (which did not contain a clay-derived suspending agent), with a storage period of 11-12 months, exhibited a greater pH shift upwards. In addition, the pH of suspension S2 did not shift upward during the 12-month storage period, and the pH of suspensions S3 and S4 decreased during the 12- and 11-month storage periods. Finally, after 19 months of storage, the pH of the suspension S2 was 4.06 (data not shown in Table 3), an increase of only 0.04 in comparison to the pH measured immediately after preparation.

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PUM

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Abstract

The present invention provides a pharmaceutical composition comprising at least one pharmaceutically acceptable bismuth-containing compound, at least one pharmaceutically acceptable non-clay-derived suspending agent, and water. The suspension reduced the upward shift in pH compared to an otherwise similar suspension comprising a clay-derived suspending agent. Such compositions are useful in the prevention and treatment of gastrointestinal diseases and / or disorders.

Description

field of invention [0001] The present invention relates to bismuth-containing pharmaceutical compositions, processes for the preparation of these compositions, and the use of these compositions in the treatment and / or prevention of gastrointestinal diseases and / or disorders. Background of the invention [0002] Bismuth-containing pharmaceutical compositions, especially pharmaceutical suspensions, are known for the treatment of various gastrointestinal disorders, including nausea, heartache and diarrhoea. Examples of current and / or previous off-the-shelf bismuth-containing suspensions include Proctor & Gamble's Pepto-Bismol®, several similar retail bismuth-containing suspensions (illustratively including Walgreen's®, Rite-Aid®, Spartan®, and Meijer(R), and Rexall's Pabizol with analgesic action. Bismuth-containing compositions are summarized in Handbook of Nonprescription Drugs, 8th Edition, American Pharmaceutical Association, Washington D.C.; 1986, p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/28A61K31/29A61K31/60A61K33/24A61K47/36A61K47/38
CPCA61K9/0095A61K31/28A61K31/29A61K31/60A61K33/245A61K47/36A61K47/38A61P1/00A61P1/12
Inventor 洛兰·E·佩纳凡尼斯·L·赫齐克
Owner MCNEIL PPC INC
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