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Dye-free pharmaceutical suspensions comprising sorbitol as a non-reducing sweetener and at least one active agent

一种山梨糖醇、悬浮液的技术，应用在无染料药物悬浮液领域，能够解决挑战复杂化等问题

Inactive Publication Date: 2007-10-31
MCNEIL PPC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

All of these requirements complicate the challenge of manufacturing an acceptable dye-free APAP suspension product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] processing method

[0072] 1. Add about 35-40% by weight of purified water to a tared vessel equipped with a high shear vacuum mixer to a volume suitable for mixing.

[0073] 2. Disperse about 0.5-1.0% microcrystalline cellulose and carboxymethylcellulose (co-processed) and about 0.1-0.2% xanthan gum and mix until hydrated.

[0074] 3. Add the sorbitol solution, then the glycerin and mix.

[0075] 4. Add the sucrose and mix until dissolved.

[0076] 5. Add citric acid anhydrous powder, then add propylparaben and butylparaben previously dissolved in propylene and mix until dissolved.

[0077] 6. Disperse the APAP, then the sucralose and flavor system and mix.

[0078] 7. Bring the suspension to final volume with purified water and mix under vacuum to degas.

[0079] The above process yielded a batch size of approximately 7570 liters or 2000 gallons of dye-free acetaminophen suspension (100 mg / 5 ml) at a pH of 5.5.

Embodiment 2

[0082] processing method

[0083] 1. To a tared vessel equipped with a high shear vacuum mixer, add approximately 35% by weight purified water and approximately 24% by weight sorbitol to a volume suitable for mixing.

[0084] 2. Disperse about 0.5-1.0% microcrystalline cellulose and carboxymethylcellulose (co-processed) and about 0.1-0.2% xanthan gum and mix until hydrated.

[0085] 3. Add the rest of the sorbitol solution, then the glycerin and mix.

[0086] 4. Add citric acid anhydrous powder, then add propylparaben and butylparaben previously dissolved in propylene and mix until dissolved.

[0087] 5. Add APAP, then sucralose and flavor system and mix to disperse.

[0088] 6. Bring the suspension to final volume with purified water and mix under vacuum to degas.

[0089] The above procedure yielded a batch size of 3785 liters of dye-free acetaminophen suspension drops (80 mg / 0.8 ml) with a pH of 5.5.

Embodiment 3

[0091] Element

[0092]The procedure of Example 2 was followed except adding dextromethorphan hydrobromide and mixing, dissolving between microcrystalline cellulose and carboxymethyl cellulose (co-processed) and xanthan gum hydration. Add the pseudoephedrine hydrochloride and mix, just before adding the acetaminophen to dissolve. Use anhydrous sodium citrate powder instead of anhydrous citric acid powder to adjust pH.

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PUM

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Abstract

A dye-free pharmaceutical suspension having a therapeutically effective amount of a first active agent consisting essentially of a first substantially water insoluble active agent having an average particle size of between 10 and 100 microns, an effective amount of non-reducing sweetener; an effective amount of water; and an effective amount of a suspending system; wherein the dye-free pharmaceutical suspension has a pH of from about 5 to about 6 and is substantially free of a reducing sugar and related methods.

Description

field of invention [0001] The present invention relates to liquid pharmaceutical compositions. More particularly, the present invention relates to dye-free pharmaceutical suspensions containing at least one substantially water-insoluble active agent, such as acetaminophen. Background of the invention [0002] Drugs or drugs can be administered orally to a patient in many forms, including solid forms such as capsules, caplets, gel caps, or tablets, and liquid forms such as solutions such as syrups and elixirs, emulsions, or suspensions . Drugs administered in solid form are usually intended to be swallowed whole, and therefore, the unpleasant taste of the active agent need not be considered during the formulation of the drug, other than to provide some means to prevent the taste from being too pronounced during the short residence time of the drug in the mouth. Such means may include providing a suitably thin and rapidly dissolving coating on the tablet or caplet or in gela...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K47/16A61K31/165
CPCA61K9/1652A61K47/14A61K47/38A61K31/165A61K47/26A61K47/10A61K47/36A61K9/10A61P11/00A61P11/14
Inventor G·K·比勒
Owner MCNEIL PPC INC
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