United States Patent:  6,068,855

Assignee:  Euro-Celtique S. A. (Luxembourg, LU)

Filed:  August 18, 1997

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.

BACKGROUND AND SUMMARY OF THE INVENTION

The present invention relates generally to a method of manufacturing pharmaceutical dosage forms, for human or veterinary use, preferably sustained release particles, such particles having diameters ranging from 0.1 to 3.0 mm. Such particles may contain analgesics, such as morphine, or other active ingredients. The present invention also relates to dosage forms obtained by processing of the aforesaid particles, such as tablets, suppositories or pessaries.

In our co-pending British Patent Application No. 9404928.5 we describe a process for the manufacture of particles, preferably sustained release particles, which comprises

(a) mechanically working in a high-shear mixer, a mixture of a particulate drug and a particulate, hydrophobic and/or hydrophilic fusible carrier or diluent having a melting point from 35 to 150^oC. and optionally a release control component comprising a water-soluble fusible material or a particulate, soluble or insoluble organic or inorganic material, at a speed and energy input which allows the carrier or diluent to melt or soften whereby it forms agglomerates;

(b) breaking down the agglomerates to give controlled release particles; and optionally

(c) continuing mechanically working optionally with the addition of a low percentage of the carrier or diluent; and optionally

(d) repeating steps (c) and possibly (b) one or more times.

Claim 1 of 25 Claims

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^oC., 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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