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Novel controlled release delivery device for pharmaceutical agents incorporating microbial polysaccharide gum

a technology of microbial polysaccharide gum and delivery device, which is applied in the direction of biocide, heterocyclic compound active ingredients, drug compositions, etc., can solve the problems of complex manufacturing, no controlled or pulsatile delivery of pharmaceutical agents, and complex manufacturing

Inactive Publication Date: 2007-03-22
INTELLIPHARMACEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a controlled pharmaceutical release device that can deliver therapeutically effective amounts of pharmaceutically active agents in a controlled, continuous, or pulsatile manner for a predetermined period of time in mammals, including humans. The device comprises a combination of microbial polysaccharide and uncrosslinked linear polymer, which can be optionally further combined with crosslinked polymer, lipophillic polymer, or saturated polyglycolyzed glyceride. The invention also provides a pharmaceutical composition comprising the device and a method for making the controlled release formulation of pharmaceutically active agents. The composition can be manipulated to vary the type of release provided."

Problems solved by technology

However, it suffers from being very complex and is complicated to manufacture.
While these systems do provide for the delivery of a selected pharmaceutical agent, none of these provide a controlled or pulsatile delivery of the pharmaceutical agent in which drug release is modulated by combining a microbial polysaccharide and uncrosslinked polymer.
Furthermore, none of the prior art teaches a device comprising a microbial polysaccharide and uncrosslinked polymer and optionally a crosslinked polymer and / or lipophillic polymer and / or saturated polyglycolyzed glyceride.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Diltiazem Hydrochloride ER Tablets

[0048]

% compositionDiltiazem hydrochloride30Xanthan gum30Hydroxypropylmethyl cellulose K100M CR38Talc1Magnesium stearate1

[0049] Diltiazem hydrochloride was blended with xanthan gum and hydroxypropylmethyl cellulose in a high shear mixer until a homogeneous mixture was obtained. The mixture was granulated with isopropyl alcohol and dried in fluid bed dryer to a loss on drying of about <2.0%. The dried granules were passed through a sieve #14 mesh. The milled granules were blended with talc and magnesium stearate for 5 minutes in a V-blender. Finally, the treated granules were pressed into tablets using a rotary tablet press.

example 2

Diltiazem Hydrochloride ER Tablets

[0050]

% compositionDiltiazem hydrochloride30Microcrystalline cellulose10Xanthan gum25Hydroxypropylmethyl cellulose K100M CR33Talc1Magnesium stearate1

[0051] Diltiazem hydrochloride was blended with microcrystalline cellulose, xanthan gum and hydroxypropylmethyl cellulose in a light shear mixer until a homogeneous mixture was obtained. The mixture was granulated with isopropyl alcohol and dried in fluid bed dryer to a loss on drying of about <2.0%. The dried granules were passed through a sieve #14 mesh. The milled granules were blended with talc and magnesium stearate for 5 minutes in a V-blender. Finally, the treated granules were pressed into tablets using a rotary tablet press.

example 3

Glipizide ER Tablet

[0052]

% compositionGlipizide4Microcrystalline cellulose20Xanthan gum40Hydroxypropylmethyl cellulose K100M CR33Silicone dioxide1Talc1Magnesium stearate1

[0053] Glipizide was blended with silicone dioxide, microcrystalline cellulose, xanthan gum and hydroxypropylmethyl cellulose in a high shear mixer until a homogeneous mixture was obtained. The mixture was granulated with isopropyl alcohol and dried in fluid bed dryer to a loss on drying of about <2.0%. The dried granules were passed through a sieve #14 mesh. The milled granules were blended with talc and magnesium stearate for 5 minutes in a V-blender. Finally, the treated granules were pressed into tablets using a rotary tablet press.

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Abstract

The present invention provides a controlled release device for sustained or pulsatile delivery of pharmaceutically active substances for a predetermined period of time. This invention further provides such device in which sustained or pulsatile delivery is obtained by the unique blend and intimate mixture of pharmaceutically active substance with a microbial polysaccharide and uncrosslinked linear polymer and optionally a crosslinked polymer and / or lipophillic polymer and / or saturated polyglycolyzed glyceride. The invention also provides a process for the manufacture of such devices and pharmaceutical compositions containing the same.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a controlled release device which provides sustained or pulsatile delivery of pharmaceutically active substances for a predetermined period of time. This invention further relates to such device in which sustained or pulsatile delivery is obtained by the unique blend and intimate mixture of pharmaceutically active substances with a microbial polysaccharide and uncrosslinked linear polymer and optionally a crosslinked polymer and / or lipophillic polymer and / or saturated polyglycolyzed glyceride. The invention also relates to a process for the manufacture of such devices and pharmaceutical compositions containing the same. BACKGROUND OF THE INVENTION [0002] The prior art teaches many systems for the delivery of pharmaceutically beneficial agents. One such system operates by means of an osmotic pumping mechanism. However, it suffers from being very complex and is complicated to manufacture. A second type of pharmaceutical de...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/22A61K31/715A61K31/553A61K31/554A61K31/55A61K31/519A61K31/522A61K9/20
CPCA61K9/1611A61K9/1652A61K9/2013A61K9/2027A61K9/205A61K9/2054Y10S514/961A61K31/519A61K31/522A61K31/55A61K31/553A61K31/554A61K31/715A61K9/2077
Inventor ODIDI, ISAODIDI, AMINA
Owner INTELLIPHARMACEUTICS
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