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Controlled release analgesic suspensions

A medicament and liquid technology, applied in the field of controlled release pharmaceutical preparations, can solve the problems of increasing the overall cost and product production cycle, and being unable to provide immediate release dosage forms for users.

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, multiple coating steps not only increase the overall cost and product production cycle, but also the resulting dosage form cannot provide immediate release dosage form to the user

Method used

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  • Controlled release analgesic suspensions
  • Controlled release analgesic suspensions

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Experimental program
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preparation example Construction

[0054] The coated active ingredient granules can be prepared by any suitable method known in the art. Suitable granule formation and coating methods include: high shear granulation, fluidized bed granulation, e.g. drum granulation, fluidized bed coating, agglomeration, spray drying, spray coagulation, etc., and see for example Pharmaceutical DosageForms: Tablet Vol. 3, edited by Herbert A. Lieberman and Leon Lachman, Chapters 2, 3 and 4 (1982). In one embodiment, the particles coated with the controlled-release composition have an average particle size of about 20-400 microns, such as about 50-300 microns.

[0055] The medicaments of the invention may contain one or more active ingredients. Suitable active ingredients range widely and include, but are not limited to: pharmaceuticals, minerals, vitamins and other health products, oral care agents, fragrances, and mixtures thereof. Suitable medications include: analgesics, anti-inflammatories, anti-arthritics, narcotics, antih...

Embodiment 1

[0094] Embodiment 1: Preparation of controlled-release coating solution

[0095] Preparation of coating solution: methacrylate copolymer, "Eudragit L-100" from Rohm Parma, Inc., and cellulose acetate were dispersed in a solvent containing 98% acetone and 2 %water.

[0096] The resulting coating solution contained 7.6% cellulose acetate, 0.4% methacrylate copolymer, 90.2% acetone and 1.8% water, based on the total weight of the wet coating solution.

[0097] The corresponding solids levels were 95.00% cellulose acetate and 5.00% methacrylate copolymer, based on the total weight of the dry coating solution.

Embodiment 2

[0098] Example 2: Preparation of coated active ingredients

[0099] Preparation of Ibuprofen Premix: Mix Ibuprofen USP powder with colloidal silicon dioxide to form the following ibuprofen premix:

[0100] Content % by weight*

[0101] Colloidal silica 2.00%

[0102] Ibuprofen USP 98.00%

[0103] *Based on total weight of ibuprofen premix

[0104] Preparation of coated ibuprofen granules: use the wet controlled release coating solution prepared in Example 1 to coat the ibuprofen mixture prepared above, and 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 coated ibuprofen granules contain about 20% of the controlled-release coating based on the total dry weight of the ibuprofen granules plus the controlled-release coating.

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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

[0001] The present invention relates to a pharmaceutical preparation for controlled release, which is suitable for administering active ingredients (such as analgesics, etc.) in the form of liquid medicine. Background technique [0002] Therapeutic agents used to treat pain, inflammation and fever, including analgesics, anti-inflammatory drugs and antipyretics. Non-steroidal anti-inflammatory drugs (NSAIDs) are one such therapeutic agent. They include propionic acid derivatives, acetic acid derivatives, fenamic acid derivatives, biphenylcarboxylic acid derivatives, benzothiazines and cyclooxygenase 2 (COX-2) selective NSAIDs. [0003] Propionic acids include eg ibuprofen, naproxen and ketoprofen. In particular, ibuprofen is a widely used and common NSAID that can relieve pain and reduce fever. It has been available over-the-counter for many years. The chemical name of ibuprofen is 2-(4-isobutylphenyl)-propionic acid. [0004] Typical administration regimens for NSAIDs are ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/167A61K9/14A61K9/16A61K9/50A61K31/00A61K45/06
CPCA61K9/5084A61K31/167A61K9/5026A61K9/5036A61K45/06A61K9/0095A61P29/00A61K2300/00A61K9/10
Inventor D·W·怀恩G·麦克纳利N·帕里克
Owner MCNEIL PPC INC