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Controlled release analgesic suspensions

A technology of suspension and dosage form, applied in the field of controlled-release pharmaceutical preparations, can solve the problems of not being able to provide users with immediate drug release, increasing costs, and prolonging product production cycles, etc.

Inactive Publication Date: 2006-12-06
MCNEIL PPC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, not only the multi-step coating steps increase the cost and prolong the product production cycle, but also, the resulting dosage form cannot provide the user with immediate release of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] Embodiment 1: Preparation of controlled-release coating solution

[0094] Coating solution was prepared: Methacrylate copolymer, Rohm Parma, Inc.'s "Eudragit L-100" and cellulose acetate were dispersed in a solvent containing 98% acetone and 2 %water.

[0095] The resulting coating solution contained 7.6% cellulose acetate, 0.4% methacrylate copolymer, 90.2% acetone and 1.8% water, based on the total wet weight of the coating solution.

[0096] Based on the total weight of the dry coating solution, the relative amount of solids is 95.00% cellulose acetate and 5.00% methacrylate copolymer.

Embodiment 2

[0097] Example 2: Preparation of coated active ingredient

[0098] Preparation of ibuprofen premix: Mix ibuprofen USP powder with colloidal silicon dioxide to form the following ibuprofen premix:

[0099] Component Weight percent

[0100] Colloidal silicon dioxide 2.00%

[0101] Ibuprofen USP 98.00%

[0102] *Based on total weight of ibuprofen premix

[0103] Preparation of coated ibuprofen granules: wrap the ibuprofen mixture prepared above with the wet controlled release coating solution prepared in Example 1, the coating speed is about 20.0g / min, using Clatt-GPCG-5 / 9 Wurster fluidized bed coating equipment, the product temperature is about 29-32 ℃. The obtained ibuprofen coated fine granule contains, based on the total dry weight of the ibuprofen fine granule and the controlled release coating, about 20% of the controlled release coating.

Embodiment 3

[0104] Embodiment 3: the preparation of the suspension base material containing immediate release dose and controlled release dose

[0105] Preparation of the suspension base

[0106] Element

Product name

percentage (w / v)

mg / 5ml

pure water

50.0

2.

pregelatinized starch

Ultrasperse

1.5

0.

xanthan gum

Xantural

0.18

0.

Glycerin, USP

10.0

0.

Sucrose, NF

30.0

1.

polysorbate

(polysorbate-80K)

0.05

0.

citric acid

0.18

0.

sodium

0.20

0.

pure water

22.4

0.

total

114.5

5.0

[0107] As shown in Table A, add pure water USP into a mixing tank equipped with a Scott Turbo high shear agitator, and mix at a speed of about 500-1000 rpm to create a good vortex. The pregelatinized starch and xanthan gum were then added and mixed for 20 minutes. ...

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Abstract

A method of administering non-steroidal-anti-inflammatory drugs, in particular propionic acid derivatives such as ibuprofen, or acetaminophen via a liquid suspension is provided. This method provides improved therapeutic effect, in particular pain relief, over extended time periods.

Description

technical field [0001] The present invention relates to controlled release pharmaceutical formulations suitable for administration of active ingredients, such as analgesics, in liquid dosage form. technical background [0002] Medications for pain, inflammation, and fever include analgesics, anti-inflammatory drugs, and antipyretics. Nonsteroidal anti-inflammatory drugs (NSAIDs) are one such class. They include propionic acid derivatives, acetic acid derivatives, fenamic acid derivatives, biphenylcarbodylic, oxicams and cyclooxygenase-2 (COX-2) selective NSAIDs. [0003] Propionic acids include, for example, ibuprofen, naproxen and ketoprofen. Ibuprofen, in particular, is a widely used and well-known NSAID with analgesic and antipyretic properties. It has long been available over-the-counter and comes in many forms. The chemical name of ibuprofen is 2-(4-isobutylphenyl)propionic acid. [0004] NSAIDs are generally taken once to four times a day, with a daily dose of abo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/167A61K9/16A61K9/50
CPCA61K9/5084A61K31/167A61K9/5026A61K9/5036A61K9/0095A61P29/00A61K9/10A61K9/107
Inventor D·W·怀恩G·麦克纳利N·帕里克
Owner MCNEIL PPC INC