Pharmaceutical composition containing a fusible carrier and method for producing the same
First Claim
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1. A process for the manufacture of a sustained release extrudate comprising the steps of:
- (a) mechanically working in a high-shear mixer, a mixture of a particulate drug and a particulate fusible carrier having a melting point from 35 to 150°
C., the particulate fusible carrier selected from the group consisting of a hydrophobic fusible carrier, a hydrophilic fusible carrier and mixtures thereof, at a speed and energy input which allows said particulate fusible carrier to melt or soften whereby it forms agglomerates;
(b) extruding said agglomerates to form an extrudate.
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Abstract
A process for the manufacture of particles comprises mechanically working a mixture of a drug and a hydrophobic and/or hydrophilic fusible carrier in a high speed mixture so as to form agglomerates, breaking the agglomerates to give controlled release particles and optionally continuing the mechanical working with the optional addition of a low percentage of the carrier or diluent.
222 Citations
25 Claims
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1. A process for the manufacture of a sustained release extrudate comprising the steps of:
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(a) mechanically working in a high-shear mixer, a mixture of a particulate drug and a particulate fusible carrier having a melting point from 35 to 150°
C., the particulate fusible carrier selected from the group consisting of a hydrophobic fusible carrier, a hydrophilic fusible carrier and mixtures thereof, at a speed and energy input which allows said particulate fusible carrier to melt or soften whereby it forms agglomerates;(b) extruding said agglomerates to form an extrudate. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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Specification