Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2001-03-12
2004-08-03
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S451000, C424S453000, C424S454000, C424S461000, C424S463000
Reexamination Certificate
active
06770294
ABSTRACT:
FIELD OF THE INVENTION
The invention concerns gelatin compositions for the use in pharmaceutical, veterinary, food, cosmetic or other products like films for wrapping food, aspics or jellies, preferably for predosed formulations like soft or hard gelatin capsules wherein the gelatin used is of non-bovine and non-pig origin and preferably derived from fish, poultry or plant sources. Especially preferred are film compositions for hard gelatine capsules prepared from fish gelatin.
A second embodiment of the invention is the use of the film composition for the manufacturing of hard gelatin capsules by conventional dip moulding processes.
BACKGROUND OF THE INVENTION
The gelatin used for hard gelatin capsules is traditionally produced by extraction from collagen containing mammalian tissues, particularly such as pig skin and bovine bone. Gelatin from pig and bovine origin are preferably used for their gelling, film forming and surface-active properties. The manufacture of hard gelatin capsules by dip moulding process exploits fully its gelling and film forming abilities. Such capsules are manufactured by dipping mould pins into a hot solution of gelatin, removing the pins from the gelatin solution, allowing the gelatin solution attached on pins to set by cooling, drying and stripping the so-formed shells from the pins. The setting of the solution on the mould pins after dipping is the critical step to obtain an uniform thickness of the capsule shell.
Fish collagen is a further source of gelatin. However, it has long been known that gelatin derived from fish collagen lacks much of the gelling and setting ability of mammalian gelatins which limits the fish gelatin application. It is only applicable for products where a high viscosity of the solution without gel formation is desired, for example, in glue or food manufacturing. In the field of predosed pharmaceuticals, the fish gelatin can be used for micro-encapsulation (WO 9620612) or for the production of soft capsules where the gelling and setting ability is not a critical parameter in the manufacturing process.
A. N. Fraga et al. describe in J. Polym. Mater. 5 (1988) 49-55 the mechanical properties from fish Gelatins as a brittle behavior characteristic of a glassy material at normal temperatures. Such a brittleness is very undesired property for a gelatin capsule.
Norland Products Inc. describe in Research Disclosure 1987, 788 that water solutions of fish gelatin remain liquid down to 10° C., wheras water solutions of animal gelatin must be heated to temperatures over 30° C. to remain liquid. This behavior of fish gelatin will not allow the use in the conventional dip moulding process at conventional temperatures because of ist to low gelling temperature.
B. Leuenberger describes in Food Hydrocolloids 1991, 353-361 viscosity and gelation properties of different mammalian and fish gelatins with the conclusion that fish gelatin may be usefull in applications where high solution viscosity without gel formation is desired.
Surprisingly it has been found that fish gelatin can be used for the production of conventional Gelatins with conventional properties by adding a setting system to the aqueous fish gelatin solution.
SUMMARY OF THE INVENTION
The problem of the invention is therefore the provision of compositions for the production of Gelatins for the use in pharmaceutical, veterinary, food, cosmetic or other products like films for wrapping food, aspics or jellies, preferably for predosed formulations like soft or hard gelatin capsules wherein the gelatin used is of non-bovine and non-pig origin and preferably derived from fish, poultry or plant sources, and wherein a setting system is added to the aqueous gelatin solution. Especially preferred are film compositions for hard gelatine capsules prepared from fish gelatin.
Surprisingly this is achieved by the addition of a setting system and this allows the use of a wide range of gelatins from other sources than pigs or cattle for gelatin products for human consumption avoiding ethical and cultural problems.
REFERENCES:
patent: 4876105 (1989-10-01), Wolf et al.
patent: 4892766 (1990-01-01), Jones
patent: 5603952 (1997-02-01), Soper
patent: 5683717 (1997-11-01), Shen
patent: 5756123 (1998-05-01), Yamamoto et al.
patent: 6423346 (2002-07-01), Hansen et al.
Cadé Dominque
He Xiongwei
Scott Robert
Federman Evan J.
Lemke Kenneth G.
Sheikh Humera N.
Warner-Lambert Company LLC
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