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Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone

A nanoparticle and release composition technology, applied in the direction of nanomedicine, nanotechnology, nanotechnology, etc., can solve problems such as addiction

Inactive Publication Date: 2009-07-15
ELAN PHRMA INT LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0045] The problem with using traditional hydrocodone formulations is that they can be addictive

Method used

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  • Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone
  • Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone
  • Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0264] The purpose of this example is to describe a multiparticulate modified release composition comprising hydrocodone that can be used in the binding composition of the present invention.

[0265] A multiparticulate modified release hydrocodone composition according to the invention having an immediate release component and a modified release component (with a modified release coating) was prepared according to the formulations shown in Tables 1 and 2.

[0266] Table 1

[0267] Immediate release ingredient hydrocodone solution

[0268]

[0269] Table 2

[0270] Modified release ingredient hydrocodone solution

[0271]

[0272] In these exemplary hydrocodone formulations, sugar spheres (30 / 35 mesh) are provided as inert cores which serve as carriers for the active ingredient and other excipients present in the formulation. The amount and size of the sugar spheres is chosen to reflect the requirement that the average diameter of the produced multiparticulates be in t...

Embodiment 2

[0298] The purpose of this example was to prepare meloxicam nanoparticle dispersions stabilized with various surface stabilizers.

[0299] An aqueous dispersion formed of 5 wt % meloxicam (Unichem Laboratories, Ltd.) and 1 wt % stabilizer (see Table 9 below) was added to a 10 cc batch chamber equipped in milling systems (Elan Drug Delivery, Inc., King of Prussia, PA; see, eg, US Patent No. 6,431,478 entitled "SmallScale Mill"). For all formulations the following Milling system parameters: milling speed = 5500 rpm; total milling time = 1 hour; type of polymeric milling media = PolyMill™ 200 (The Dow Chemical Co.); and media loading sufficient to carry out the above process.

[0300] The resulting milled dispersions were analyzed for particle size using a Horiba LA-910 Particle Size Analyzer (Horiba Instruments, Irvine, CA). The results obtained are shown in Table 9 below. In the table below, the D50 value is the particle size below which 50% of the active agent particles f...

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Abstract

The invention relates to a compositions comprising a nanoparticulate meloxicam composition in combination with a multiparticulate modified release hydrocodone composition that, upon administration to a patient, delivers a hydrocodone in a bimodal or multimodal manner. The multiparticulate modified release composition comprises a first component and at least one subsequent component; the first component comprising a first population of hydrocodone - comprising particles and the at least one subsequent component comprising a second population of hydrocodone-comprising particles, wherein the combination of the components exhibit a bimodal or multimodal release profile. The invention also relates to a solid oral dosage form comprising such a combination composition.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to Provisional Application No. 60 / 815,884, filed June 23, 2006, and is a continuation-in-part of Application No. 11 / 372,857, filed March 10, 2006, and 4, 2004 continuation-in-part of Application No. 10 / 827,689, filed January 19, which is a continuation-in-part of Application No. 10 / 354,483, filed January 30, 2003 (now U.S. Patent No. 6,793,936) Continuation of Application No. 10 / 354,483, continuation of Application No. 10 / 331,754, filed December 30, 2002 (now U.S. Patent No. 6,902,742), Application No. 10 / 331,754, May 2001 Application No. 09 / 850,425 (now U.S. Patent No. 6,730,325) filed on the 7th is a continuation of application No. 09 / 850,425 filed on May 8, 2000 (now U.S. Patent No. 09 / 566,636 No. 6,228,398), application No. 09 / 566,636 is a continuation of application No. PCT / US99 / 25632 filed on November 1, 1999, and application No. PCT / US99 / 25632 claims November 1998 Priority of Provi...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61K9/54B32B25/00
CPCA61K9/145A61K9/5078A61K9/5138A61K9/146A61K31/485A61K9/107A61K9/5026A61K9/5161A61K9/5084A61P11/00A61P25/04A61P29/00A61P29/02A61K9/48B82Y5/00
Inventor P·斯塔克J·德韦恩N·范宁G·里弗斯德格S·简金斯G·辛格-雷克伊
Owner ELAN PHRMA INT LTD
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