Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
1997-09-15
2001-04-17
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S490000, C424S494000
Reexamination Certificate
active
06217902
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to suspensions of solid active agents for encapsulation in gelatin capsules. The invention also relates to gelatin capsules containing a suspension of a solid phase, i.e., particles or beads, in a liquid or semi-solid phase. It further relates to methods and apparatus for the production of soft gelatin capsules containing particulate material in a liquid or semi-solid phase.
DESCRIPTION OF THE RELATED ART
Soft elastic gelatin capsules containing particulate material are now well established as a means for providing a variety of liquid products such as drugs and dietary supplements in a readily ingestible form.
Known apparatus for producing filled gelatin capsules comprises either flat or rotary dies having recesses against which the capsule wall is shaped.
Conventional rotary die encapsulation apparatus can be used to produce soft elastic gelatin capsules containing suspensions of specific viscosities. These suspensions include suspensions of powders in liquids. To achieve trouble-free encapsulation of such suspensions, the suspension system must be pourable and pumpable and preferably homogeneous at a temperature suitable for encapsulation in a gelatin capsule. Furthermore, the particle size of the powders intended for encapsulation in such suspensions must be less than about 120 microns (&mgr;m).
Medicinal products and other active agents are frequently prepared in the form of microbeads. Such microbeads normally have diameters in excess of 180 microns. For example, typical sustained release pharmaceutical microbeads have a diameter of about 900 microns.
Encapsulation of microbeads in excess of about 180 microns using conventional state-of-the-art rotary die encapsulation apparatus produces capsules having many defects. Among the defects are non-uniform distribution of the microbeads in the gelatin capsules. Other more important problems are found during the encapsulation process itself. For example, suspensions of microbeads do not pass through the ports and tubes of the rotary die apparatus without significant and unsuitable levels of “clogging.” This is a result of the solid phase separating from the liquid phase. The present invention is designed to overcome the problems with encapsulation of suspensions of microbeads.
SUMMARY OF THE INVENTION
Although conventional rotary die encapsulation apparatus can be used to prepare soft gelatin capsules containing suspensions of solid particulate materials of mean diameters less than 180 &mgr;m, problems arise when the particles have diameters in excess of 180 &mgr;m. The present invention provides a solution to the problems associated with encapsulating microbeads or particles in suspensions.
In yet another aspect, the present invention provides suspensions of solid or particulate active agents, e.g., pharmaceutical agents, suitable for encapsulation in gelatin capsule. The suspensions of pharmaceutical agents may be encapsulated in gelatin capsules for subsequent oral administration. The invention also provides capsules suitable for a variety of non-oral uses.
Accordingly, a broad embodiment of the invention encompasses suspensions of active agents, the suspensions comprising a solid phase and a liquid phase capable of suspending the solid phase for at least a period of time sufficient to allow encapsulation into a gelatin capsule. The solid phase may comprise particles or beads having a mean diameter of at least about 149 &mgr;m. The solid phase may also comprise single or multi-component particles having mean diameters of at least about 149 &mgr;m. The inventive suspensions are pumpable at temperatures suitable for encapsulation into gelatin capsules. These suspensions, i.e., gelatin capsule fill materials, can be pumped without sedimentation or separation and without clogging of the various parts in a rotary die apparatus.
The invention further encompasses gelatin capsules comprising a fill material where the fill material is a suspension comprising a liquid phase and a solid phase.
The invention also encompasses methods and apparatus for preparing such gelatin capsules. The apparatus comprises a rotary die encapsulation machine modified to allow a suspension or slurry to be encapsulated without clogging of the various ports, tubes, and injection wedges. The apparatus alternatively may comprise a flat die encapsulation machine or a suitable liquid fill 2 piece hardshell encapsulation machine.
The invention thus provides gelatin capsules having particles or beads that may be visible within the capsule and readily discernable from the liquid phase.
The inventive gelatin capsules are also more tamper resistant since such capsules that have been tampered with or adulterated may be more readily distinguished.
The invention further provides gelatin capsules capable of releasing active agents at various predetermined times. For example, the liquid phase may comprise at least one active agent dissolved in the liquid phase available for immediate release while the solid phase may comprise a single agent or a plurality of different active agents formulated to have release profiles different from each other and from the agents in the liquid phase. Thus, the solid phase may comprise at least two different types of particles or beads, each containing a different active product.
REFERENCES:
patent: 4486412 (1984-12-01), Shah et al.
patent: 5002777 (1991-03-01), Cuca
patent: 5472712 (1995-12-01), Oshlack et al.
patent: 5672360 (1997-09-01), Sacklen et al.
patent: WO 94/08576 (1994-04-01), None
Cain John L.
Morton Frank S. S.
Pansari Brian R.
Schurig Gregory A.
Shelley Rickey S.
Fubara Blessing
Nickey Donald D.
Page Thurman K.
R. P. Scheier Company
Sarussi Steve
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