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Pharmaceutical suspension composition

a technology of pharmaceutical suspension and composition, applied in the direction of biocide, animal repellents, dispersed delivery, etc., can solve the problems of irreversible agglomeration of known systems, difficulty in swallowing tablets or capsules,

Inactive Publication Date: 2009-07-09
WYETH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention is about an oral liquid pharmaceutical composition that contains a suspending system. The suspending system is made up of a combination of xanthan gum and microcrystalline cellulose / carboxymethylcellulose sodium in an aqueous base. The pharmaceutical active ingredients are suspended in this system and a density adjusting agent is added to match the density of the suspended ingredients with the specific gravity of the aqueous medium. The pharmaceutical active ingredients can be insoluble in water and can include ibuprofen, naproxen, ketoprofen, or loratadine, among others. The composition can also contain a second pharmaceutical active ingredient that is soluble in the aqueous medium, such as pseudoephedrine, chlorpheniramine, dextromethorphan, brompheniramine, guaifenesin, or diphenhydramine. The method of preparing the composition involves preparing the suspending system and then suspending the pharmaceutical active ingredients in it. The resulting composition has improved stability and can be used to treat various medical conditions.

Problems solved by technology

Children, older persons and many other persons including disabled or incapacitated patients often have trouble swallowing tablets or capsules.
Although such suspensions are known, the known systems frequently manifest the undesirable properties of irreversible agglomeration and / or phase separation particularly if a pharmaceutical active with a limited solubility in water is used.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0052]The following Example discloses a pharmaceutical composition (which is a suspension) comprising ibuprofen as a substantially insoluble active and a process for manufacturing this composition. The composition of the suspension of Example 1 is provided in Table 1 below:

TABLE 1Componentg / 100 mLIbuprofen USP (40 micron particle size)2.00Pseudoephedrine HC1HCl USP0.300Chlorpheniramine Maleate USP0.0200Xanthan Gum NF (Rhodigel 80 Pharma Grade)0.200Microcrystalline Cellulose / Carboxymethylcellulose Sodium1.50NF (Avicel Type CL 611)Polysorbate 80 NF0.300Glycerin 96% USP30.0Sorbitol Solution USP 70%20.0Micronized Sucralose Powder NF0.200Sodium Citrate USP / FCC0.550Sodium Benzoate NF0.250Edetate Disodium USP0.0500Citric Acid Hydrous USP0.750Flavor0.360Color0.0025Purified Water USPQs 100 mL

[0053]As indicated in the header of Table 1, amounts are stated in grams per 100 milliliter aliquot of the final composition. Density matching was accomplished by first calculating theoretical amounts of...

example 2

[0061]The composition of Example 2 is provided in Table 2 below:

TABLE 2Componentg / 100 mLIbuprofen USP (40 micron particle size)2.00Pseudoephedrine HC1 USP0.300Dextromethorphan HBr USP0.150Xanthan Gum NF (Rhodigel 80 Pharma Grade)0.200Microcrystalline Cellulose / 1.50Carboxymethyl-cellulose SodiumNF (Avicel Type CL 611)Propyl Gallate NF (Progallin P-Drum)0.00500Polysorbate 80 NF0.300Glycerin 96% USP30.0Sorbitol Solution USP 70%20.0Micronized Sucralose Powder NF0.200Sodium Citrate USP / FCC0.550Sodium Benzoate NF0.250Edetate Disodium USP0.0500Citric Acid Hydrous USP0.750Flavor0.334Color0.0300Purified Water USPQs 100 mL

[0062]Example 2 is prepared in a manner similar to Example 1. The propyl gallate is dispersed in glycerin prior to addition of water, then combined with the soluble actives prior to addition to the main vessel. After the addition of the soluble actives and propyl gallate to the main vessel, flavor is then added followed by the adjustment of the final volume with water.

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Abstract

An aqueous oral liquid pharmaceutical composition system with reduced propensity for agglomeration and phase separation which is particularly amendable to the suspension of one or more pharmaceutical actives that are substantially insoluble in water. The oral liquid pharmaceutical composition may further comprise pharmaceutical actives that are soluble in water and dissolve in the aqueous medium. In the composition of the invention both suspended and any dissolved active agents are distributed homogeneously.

Description

[0001]This is a divisional application of copending application Ser. No. 10 / 852,946 filed on May 25, 2004 the entire disclosure of which is hereby incorporated by reference.FIELD OF INVENTIONBackground of Invention[0002]Orally administered pharmaceutical compositions are provided to patients in many dosage forms, including solid forms such as capsules, caplets or tablets and liquid forms such as solutions, emulsions or suspensions. Pharmaceutical compositions administered in solid form are usually intended to be swallowed whole. Children, older persons and many other persons including disabled or incapacitated patients often have trouble swallowing tablets or capsules. For many such patients, including pediatric and geriatric patients, a liquid dose form is preferable because of the ease with which it may be swallowed.[0003]Pharmaceutically acceptable liquid excipient suspension systems have been described in the literature. For example, in U.S. Pat. No. 5,759,579, Singh et al. desc...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/192A61K9/00A61K9/10A61K9/14A61K9/66A61K47/10A61K47/26
CPCA61K9/0095A61K9/10A61K31/00A61K45/06A61K47/36A61K47/26A61K47/38A61K31/192A61K47/10A61K31/137A61K31/4402A61K9/0053A61K47/12
Inventor DICKERSON, JAYMARK, WILLIAMTRIMMER, ANNABELLEJAEGER, DAVIDALLEY, AMANDA ROOP
Owner WYETH LLC
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