United States Patent:  6,024,980

Assignee:  McNeil-PPC, Inc. (Skillman, NJ)

Filed:  June 28, 1996

The present invention relates to a dosage form containing a common enclosure of polymeric material. The enclosure contains multiple phases of semi-solid fill materials containing active ingredients.

SUMMARY OF THE INVENTION

The present invention provides a dosage form having a common enclosure of a polymeric material. The enclosure contains first and second phases which are disposed in discreet regions of the enclosure and are in contact with each other at at least one interface. The first and second phases each contain a semi-solid fill material, with at least one phase containing an active ingredient. The first and second phases differ in composition and at least one of the phases has a turbidity less than 1300 NTU (Nephelometric Turbidity Unit).

In a further embodiment of the present invention, the common enclosure of polymeric material is a soft gelatin capsule containing a first phase which is substantially translucent and a second phase which opaque, which results in a dosage form having a distinct appearance.

In a further embodiment of the present invention, the semi-solids forming the first and second phases are sufficiently viscous so that they cannot be expelled at room temperature from the dosage form with a syringe, preferably having a 16 gauge or smaller needle.

Claim 1 of 25 Claims

1. A pharmaceutical dosage form, comprising:

a gelatin capsule shell;

a first phase comprising a first semi-solid containing a polyalkylene glycol having an average molecular weight of about 600 or less and a cellulose ether in an amount effective to thicken the polyalkylene glycol, a therapeutically effective amount of a first pharmaceutical dissolved or suspended in said first semi-solid and said first semi-solid having a turbidity less than about 1300 NTU;

a second phase comprising a second semi-solid fill containing a polyalkylene glycol having an average molecular weight of about 400 to about 20,000 and a therapeutically effective amount of a second pharmaceutical disposed in said semi-solid; and

said first and second phases each disposed in discrete regions of said shell and in contact with each other at at least one interface.

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