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US-2015328315-A1 · Nov 19, 2015 · US
Stabilized HME composition with small drug particles
US9504658B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9504658-B2 |
| Application number | US-71862005-A |
| Country | US |
| Kind code | B2 |
| Filing date | Nov 9, 2005 |
| Priority date | Nov 9, 2004 |
| Publication date | Nov 29, 2016 |
| Grant date | Nov 29, 2016 |
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Abstract
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A hot-melt extruded composition having finely divided drug-containing particles dispersed within a polymeric and/or lipophyllic carrier matrix is provided. The carrier softens or melts during hot-melt extrusion but it does not dissolve the drug-containing particles during extrusion. As a result, a majority or at least 90% wt. of the drug-containing particles in the extrudate are deaggregated during extrusion into essentially primary crystalline and/or amorphous particles. PEO is a suitable carrier material for drugs insoluble in the solid state in this carrier. Various functional excipients can be included in the carrier system to stabilize the particle size and physical state of the drug substance in either a crystalline and/or amorphous state. The carrier system is comprised of at least one thermal binder, and may also contain various functional excipients, such as: super-disintegrants, antioxidants, surfactants, wetting agents, stabilizing agents, retardants, or similar functional excipients. A hydrophilic polymer, such as hydroxypropyl methylcellulose (HPMC E15), polyvinyl alcohol (PVA), or poloxamer, and/or a surfactant, such as sodium lauryl sulfate (SLS), can be included in the composition. A process for preparing the extrudate is conducted at a temperature approximating or above the softening or melting temperature of the matrix and below the point of solubilization of drug-containing particles in the carrier system, and below the recrystallization point in the case of amorphous fine drug particles.
First claim
Opening claim text (preview).
What is claimed is: 1. A pharmaceutical composition comprising drug-containing particles dispersed in a hot-melt extruded stabilizing and non-solubilizing carrier, wherein said particles have a mean particle diameter of 100 microns or less and comprise one or more amorphous or crystalline therapeutic compounds dispersed in one or more adjunct stabilizers, and wherein said particles have been hot-melt extruded with a stabilizing and non-solubilizing carrier that does not solubilize,…
Assignees
Inventors
Classifications
Human Necessities · mapped topic
- A61K9/5138Primary
Human Necessities · mapped topic
Human Necessities · mapped topic
- A61K9/146Primary
Human Necessities · mapped topic
Human Necessities · mapped topic
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- What does patent US9504658B2 cover?
- A hot-melt extruded composition having finely divided drug-containing particles dispersed within a polymeric and/or lipophyllic carrier matrix is provided. The carrier softens or melts during hot-melt extrusion but it does not dissolve the drug-containing particles during extrusion. As a result, a majority or at least 90% wt. of the drug-containing particles in the extrudate are deaggregated du…
- Who is the assignee on this patent?
- Miller Dave A, Mcconville Jason T, Mcginity James W, and 2 more
- What technology area does this patent fall under?
- Primary CPC classification A61K9/5138. Mapped technology areas include Human Necessities.
- When was this patent published?
- Publication date Tue Nov 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
- What related patents are in patentsdb?
- We list 8 related publications on this page (citations in our corpus or others sharing the same primary CPC).