Package making – Methods – Enclosing contents within progressively formed web means
Reexamination Certificate
2000-09-12
2003-12-02
Gerrity, Stephen F. (Department: 3721)
Package making
Methods
Enclosing contents within progressively formed web means
C053S553000, C053S435000, C053S520000, C156S247000, C156S249000, C156S301000
Reexamination Certificate
active
06655112
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a primary packaging unit for film-like or wafer-like administration forms for oral application. The invention especially relates to a primary packaging unit which is formed out of the film-like or wafer-like administration form to be packaged, as well as an off-cut of an upper and a lower web of packaging material, respectively.
Film-like or wafer-like administration forms for oral application are known, for example, from the patents or applications U.S. Pat. No. 3,007,848, DE 24 32 925, DE 27 46 414 and EP 219 762. Such administration forms differ from conventional solid application forms, such as tablets or capsules, especially in their geometrical form and their production. They all have a thin, flat-shaped form, whereby differences with regard to flexibility, brittleness, smoothness or consistency can lead to either film- or sheet-like, paper-like, or wafer-like characteristics. For the production of said administration forms, the extrusion and coating processes applied in industrial film production were especially recommended.
Depending on the purpose of application, two basic types of embodiment suggest themselves. The first type comprises variations with rapid disintegration or rapid release for disintegration in the oral cavity immediately upon application under release of an active substance, whereby the term “rapid disintegration” in the sense of this invention relates to a disintegration time of several seconds up to a maximum of several minutes under influence of saliva. The other type comprises variations which disintegrate slowly or practically not at all, and are especially suited for slow and continuous active substance release and which, through addition of mucoadhesive materials, are able to adhere to the oral mucosa during the release of active substance. Both of these basic types can be embodied so that, depending on the incorporated active substance, they are suited for a local therapy of the oral mucosa or the systematic application of active substances.
The packaging of these administration forms in primary packaging units cannot simply be carried out with the usual processes, packaging means or machines commonly used for conventional pharmaceutical products such as capsules or tablets. A primary packaging unit for solid administration forms in individual doses, embodied from a modern point of view, should on the one hand protect the product from outer influences and on the other hand enable the deliberate and controllable removal of a single dosage unit at the desired time of intake, whereby the removal of the dosage unit from the primary packaging unit should be carried out in such a way that the administration form is not damaged.
Whereas tablets and capsules are often filled into glasses or boxes in larger amounts, which certainly would not suffice to fulfil the above requirements, it is in many cases customary to package dosage units in blister packages or deep-drawn packages. Such primary packaging units contain a plurality of dosage units which are each individually sealed in a cavity between two off-cuts of packaging material webs. The cavity is created through hot or cold forming of the lower web of packaging material with the help of an adequate tool before filling. After the cavities are filled, the upper web of packaging material is supplied and sealed together with the lower web of packaging material.
In modern blister packages, the dosage units are removed by exerting a pressure, with a finger, on the outer side of the deformed areas of the lower packaging material web and thus on the tablet or capsule contained in the cavity created through deformation, whereby the exerted pressure is sufficient to break through the upper web of packaging material and press out the dosage unit. This is, however, only possible if the material of the upper packaging material web does not exceed a certain strength.
This concept for primary packaging units has become widely known and used for conventional administration forms. For administration forms with film-like or wafer-like embodiments, however, it presents considerable disadvantages. In experiments carried out to this effect, two disadvantages have proved to be particularly serious, one of which concerns the production, and the other of which concerns the removal of dosage units from primary packaging units of this kind.
Film-like or wafer-like oral administration forms, especially the rapid release kinds, are generally very much lighter and less compact than conventional tablets or capsules. The recommended dimensions of film-like or wafer-like dosage units are approximately from 1 cm
2
(e.g. DE 27 46 414) to 3 cm
2
or more (e.g. DE 24 32 925), with a thickness of approximately 0.05 to 1 mm (e.g. DE 24 32 925). Using common pharmaceutical base materials, this then results in dosage units with a mass of approximately 5 to 100 mg, whereby the typical and preferred embodiments would tend to lie in the lower margin of this span. It has turned out, however, that enclosing such thin films or wafers in blisters is quite problematic. Especially in the case of higher machine speeds, air movement caused by moving machine parts and often also electrostatic charging of the packaging materials lead to the result that the dosage units cannot be correctly positioned in the blister or are wafted back out of the blister after being positioned therein. Although it is quite possible to produce deep-drawn primary packaging units with oral films or wafers, this is a complicated and inefficient packaging concept due to the problems mentioned above. The removal of film-like or wafer-like administration forms from blister packages which correspond to the conventional primary packaging for tablets and capsules is also problematic. A flat-shaped dosage unit lying in a cavity can hardly be pressed through the material of the upper web of packaging material; it has neither the necessary format nor the mechanical strength. The danger of damaging the dosage unit while pressing it out of the package is relatively large. Even if one first tries to break the material of the upper packaging material web in another way, e.g. using a fingernail, it is not easy to grip and remove a flat dosage unit in the exposed cavity, except when very large cavities are chosen, which is disadvantageous because of other reasons such as the enclosed air space, which is too large in relation the small mass of the administration form.
The use of conventional packaging means results in additional difficulties if the film-like or wafer-like administration forms are rather brittle and fragile. In this case, a dimensionally stable blister package can offer a certain amount of product protection during storage, but it makes the removal of the dosage units even more difficult.
In addition to these disadvantages of conventional blister packages for film-like or wafer-like administration form, the choice of adequate packaging materials for blister packages is limited; also, the available materials do not belong to the especially cheap packaging materials.
Several approaches for the creation of a primary packaging unit for film-like or wafer-like administration forms without the above described disadvantages of the state of the art are found in U.S. Pat. No. 3,007,848. The solutions presented in this document are partially of interest for all film-like and wafer-like administration forms although in U.S. Pat. No. 3,007,848, in contrast to the present invention, in the narrower sense refers to (1) wafers produced through extrusion or through printing of edible films, whereby (2) said wafers are not intended for application in the oral cavity, but rather for swallowing, and (3) are for this purpose optionally first sealed into film strips of an edible, smooth and easily swallowable film. The cited document does, however, teach the packaging of wafers by sealing the dosage units between two films which can in a general sense be understood as packaging materials. In addition, it teaches the only “light” se
Anhäuser Dieter
Bungarten Uwe
Cremer Karsten
Ludwig Karin
Schumann Klaus
Gerrity Stephen F.
Jordan and Hamburg LLP
LTS Lohmann Therapie-Systeme AG
Tran Louis
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