Injection molding process for the preparation of an oral delivery device for a pharmaceutically active agent

1. A process for the preparation of a device comprising a core which includes a pharmaceutically active agent covered by an outer coating which includes at least one opening communicating from the exterior of the device to the core, in which the outer coating is applied by injection molding said coating around said core, the process comprising:

locating said core within a mold cavity surrounding the core, said mold cavity defining the required dimensions of the outer coating and also defining the required position, shape and dimensions of each said opening;

injecting a fluid moldable thermoplastic material into said mold cavity;

allowing the fluid moldable thermoplastic material to set, thereby forming the outer coating; and

separating the device, comprising the core, the outer coating, and said at least one opening, from the mold cavity,

in which the mold cavity has an interior surface, in which a space is provided between said interior surface of the mold cavity and the core, said space defining the required shape and dimensions of the coating, in which an internal member extends from the interior of the mold cavity, through each said opening during injection and setting of the fluid moldable thermoplastic material, to abut the said core and to define the shape and position of the opening through which the internal member extends, and in which part of said at least one said internal member is located outside the mold, and said at least one said internal member extends from the exterior of the mold into the mold cavity and is mounted for inward and outward movement relative to the mold cavity and resiliently biased against said core during injection and setting of the fluid moldable thermoplastic material.

2. A process according to claim 1 , in which said fluid moldable material is injected at a pressure less than 400-450 kg/cm 2 .

3. A process according to claim 1 , wherein said at least one internal member is resiliently moveable under a pressure of not more than 14 kg/cm 2 applied thereto.

4. A process according to claim 1 , wherein a reduced pressure is applied through a vacuum conduit extending through said at least one internal member from the inside to the outside of the mold, and said reduced pressure is applied to said core, while the core is in contact with said at least one internal member, to assist in retaining the core in place in the mold.

5. A process for the preparation of a device comprising a core which includes a pharmaceutically active agent covered by an outer coating which includes at least one opening communicating from the exterior of the device to the core, in which the outer coating is applied by injection molding said coating around said core, the process comprising:

locating said core within a mold cavity surrounding the core, said mold cavity defining the required dimensions of the outer coating and also defining the required position, shape and dimensions of each said opening;

injecting a fluid moldable thermoplastic material into said mold cavity;

allowing the material to set, thereby forming the outer coating; and

separating the device, comprising the core, the outer coating, and said at least one opening, from the mold cavity,

in which the mold cavity has an interior surface, in which a space is provided between said interior surface of the mold cavity and the core, said space defining the required shape and dimensions of the coating, in which an internal member extends from the interior of the mold cavity, through each said opening during injection and setting of the fluid moldable thermoplastic material, and has a convex end face comprising a substantially frusto-conical surface and an end face transverse to said frusto-conical surface, the internal member defining the shape and position of the opening through which the internal member extends,

in which a vacuum is drawn through a vacuum channel extending through at least one said internal member to an opening in said end face, and,

in which the core has a seating indentation comprising a concave frusto-conical surface receiving and fitting to the frusto-conical surface of said convex end face, and a transverse surface in abutment with said transverse end face so that, when the mold encloses the core, the internal member seats in the indentation.

6. A process according to claim 1 , in which said at least one internal member is resiliently biased against said core by the biasing action of a spring located outside the mold.