High Pressure Compaction For Pharmaceutical Formulations
First Claim
1. A method for producing a pharmaceutical preparation of pressure-fused particles comprising an active pharmaceutical ingredient, the method comprising:
- (a) providing a sample comprising said active pharmaceutical ingredient in crystalline or amorphous form;
(b) subjecting said sample to high pressure compaction at a pressure of between 0.1 GPa and 10 GPa to produce a compacted sample; and
(c) isolating pressure-fused particles from said compacted sample.
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Abstract
Methods for producing a pharmaceutical preparation of pressure-fused particles including an active pharmaceutical ingredient are disclosed. The methods include the application of a pressure of between 0.1 GPa and 10 GPa to produce a compacted sample. The pressure-fused particles of the invention are useful for parenteral administration, and particularly sustained-release formulations, due to dissolution kinetics which are superior to conventional crystalline or amorphous packed powder preparations of active pharmaceutical ingredients. Pharmaceutical preparations including such pressure-fused microparticles are also disclosed.
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Citations
28 Claims
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1. A method for producing a pharmaceutical preparation of pressure-fused particles comprising an active pharmaceutical ingredient, the method comprising:
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(a) providing a sample comprising said active pharmaceutical ingredient in crystalline or amorphous form;
(b) subjecting said sample to high pressure compaction at a pressure of between 0.1 GPa and 10 GPa to produce a compacted sample; and
(c) isolating pressure-fused particles from said compacted sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A pharmaceutical preparation of pressure-fused particles comprising an active pharmaceutical ingredient, the pressure-fused particles comprising:
an active pharmaceutical ingredient subjected to high pressure compaction at a pressure of between 0.1 GPa and 10 GPa - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28)
Specification