Patent ID: 11912444
Assignee: AMCOR FLEXIBLES SINGEN GMBH
Field: Pharmaceuticals (Chemistry)
Classification: CPC B  A | IPC A  B

Claim 0:
1. A method for conditioning a hard gelatin capsule having any moisture content to a dry and non-brittle state when packed in a cavity of a blister base closed by a lid film, wherein the hard gelatin capsule is a hard starch capsule manufactured from collagen and the hard gelatin capsule contains pharmaceuticals and wherein the dry state of the hard gelatin capsule means a relative humidity of less than 50% at room temperature and the non-brittle state means that the hard gelatin capsule does not break when pressed out of the cavity of the blister base through the lid film, characterised in that the method includes the following process steps:
a) providing a lid film comprising an aluminium foil and if applicable a sealing layer made of a polyethylene and/or a moisture regulating buffer layer, further providing a blister base having at least one cavity, the lid film and/or the blister base comprising a moisture regulating buffer layer with a predefined humidity, wherein the moisture-regulating buffer layer consist of a polymer or polymer mixture containing 1 to 60 wt. % of an absorber material which is either a hygroscopic salt, a silica gel or a zeolite or a mixture of any of said absorber materials, wherein the moisture-regulating buffer layer, the lid film and/or the blister base comprising the buffer layer or a prelaminate for the lid film and/or the blister base comprising the buffer layer is exposed to a predefined moisture level, wherein the predefined moisture level of the buffer layer is such that it buffers the humidity in the space surrounding the hard gelatin capsule within the cavity closed by the lid film to lie in a range between 10 and 50% r.h.;
b) placing the hard gelatin capsule in a cavity of the blister base provided in step (a) and closing the cavity by laminating the lid film provided in step (a) to the blister base comprising the hard gelatin capsule;
c) storing the gelatin capsule for at least one week in the cavity closed by the lid film.