Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Patent
1997-06-30
1999-12-14
Brouillette, D. Gabrielle
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
424426, 424488, A61F 1300
Patent
active
060013850
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to the use of starch for transdermal applications. The invention relates in particular to transdermal applications of solid products made from starch, such as implants. The invention relates more particularly to solid products produced by extruding and/or injection moulding raw materials based on starch and/or containing starch, which products are intended for transdermal applications. The invention further relates to the implants manufactured from starch, which may or may not be kinetic and may be hollow or solid.
Particular medicines, vaccines and the like may be introduced in the human or animal body in the form of implants. In order to administer implants (usually in solid form), ordinarily either a surgical incision is made through which the implant can be placed or a trocar is used, with or without mandrel.
In the first method (e.g. Endocons liquid-containing implant, as described in PCT/US93/04666), a local anaesthetic must first be given and one or more sutures made after the implant has been administered. This is a time-consuming and costly operation.
In the second method the trocar is pricked through the skin and the implant is pushed, optionally using the mandrel, into the tissues (subcutaneously/intramuscularly or in other organs). When an implant (for instance Crest-star.TM., Intervet, Netherlands) has to be arranged under the skin of the auricle of cattle., there is a danger of the cartilage present under the skin being damaged. Such damage increases the risk of inflammations and can adversely affect the release of the active substances. There is moreover a danger, when the animal makes an unexpected movement, of piercing right through the auricle with the trocar and even injuring the hand with which the auricle must be held. In the case a trocar with mandrel is used there is moreover a chance of damaging vulnerable implants (which contain antigens, hormones or other active substances and which are sold for instance in the form of pellets), so that the desired pattern of release is no longer certain.
In addition to by means of surgical incisions and trocars, it is also a known method to introduce implants into animals by means of ballistic biodegradable bullets such as for instance the commercially available "Biobullets" from Ballistivet or those described in U.S. Pat. No. 3,982,536, U.S. Pat. No. 3,616,758 and PCT/AU87/00091. The drawback of Ballistivet's Biobullets is their size (diameter 6.7 mm) and the fact that they contain up to 5% of the non-biologically degradable Hydroxy Propyl Cellulose (HPC). As a result, pieces of tissue have to be cut away during slaughter of the cattle treated therewith (the Biobullets are too coarse for use with other animal species or humans).
The object of the invention is to provide a transdermally applicable product, with which one or more active ingredients can be introduced into the human or animal body in simple and responsible manner.
Understood in this patent-application by "transdermal application" is any use wherein the relevant product (containing the active ingredient) is introduced into the body through the skin and/or mucous membranes. This does not therefore include uses wherein only the active ingredient enters the body. Subcutaneous, intramuscular, intrapleural, intraperitoneal and optionally intravenous administering can be envisaged here.
By "active ingredient" is meant in the broadest sense any material which must be introduced into the human or animal body. It not only comprises therapeutic, diagnostic of prophylactic compounds and compositions but also for instance identification chips and the like.
According to the invention it has now been found that products which are at least partly manufactured from substantially fully destructurized starch, particularly implants, are very suitable as vehicle for introducing active ingredients into the human or animal body in transdermal manner.
The term "substantially fully destructurized starch" means that the starch is practically fully released from the cells and gra
REFERENCES:
patent: 3616758 (1971-11-01), Komarov
patent: 4612009 (1986-09-01), Drobnik et al.
patent: 4673438 (1987-06-01), Wittwer
patent: 4900361 (1990-02-01), Sachetto
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