Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Elemental iodine or iodine compound
Patent
1996-10-17
1998-03-24
Pak, John
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Elemental iodine or iodine compound
424 7825, 514778, 514970, A61K 3318, A61K 3179
Patent
active
057310092
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/EP95/01299, filed on Apr. 8, 1995.
The present invention relates to an iodophore which has been improved in respect of properties and simplicity of preparation, where the carrier is composed of a mixture of dextrin with a poly-N-vinyllactam, namely poly-N-vinylpyrrolidone (PVP or polyvidone) or poly-N-vinylcaprolactam.
In the area of light-duty disinfectants, PVP-iodine is a long-established but cost-intensive product. Moreover, the preparation of saccharide-containing iodophores by polymerization of vinyl-pyrrolidone in the presence of the particular oligo- or polysac-charides is disclosed in EP-A 526 800. Although products of this type are less costly than PVP-iodine they do not meet the requirements of PVP-iodine. In addition, they have not hitherto received pharmacological acceptance.
EP-B 196 813 describes mixtures of PVP-iodine with sugar, EP-A 259 982 with sugar alcohols with and without sugar, EP-A 213 717 with sugar and a gelling polysaccharide. The preparation is complicated because it is necessary initially to prepare the PVP-iodine and then to mix it with the additive(s). Direct mixing of all the components is impossible. In addition, the products are unsuitable for pharmaceutical purposes because their available iodine content, the free iodine content and the iodine loss are, as a rule, outside the range permitted by the health authorities.
U.S. Pat. No. 4,719,106 describes mixtures of polydextrose-iodine and PVP-iodine. The preparation of polydextrose for this application is complicated and uneconomic: initially polysaccharides are decomposed to glucose, which is then polycondensed again in the presence of sorbitol and citric acid (cf. EP 380 248).
It is an object of the present invention to develop a simple and economic process for preparing an iodophore which meets the requirements of PVP-iodine in all respects.
We have found that this object is achieved by converting a mixture of PVP or poly-N-vinylcaprolactam and dextrin with a dextrose equivalent (DE) in the range from 2 to 40, preferably 10 to 30, into the iodine complex in a conventional way.
The dextrins are commercially available and can easily be obtained from starch by incomplete hydrolysis with dilute acid, by exposure to heat and by oxidative or enzymatic degradation with amylases.
Starch degradation products which can be obtained by hydrolysis in aqueous phase and have a weight average molecular weight of 2500 to 25,000 are normally called saccharified starches, to distinguish from the torrefaction dextrins, and are commercially obtainable as such.
Saccharified starches of this type differ chemically from the torrefaction dextrins inter alia by the fact that in a hydrolytic degradation in aqueous medium (normally suspensions or solutions), which is usually carried out at solids contents of 10-30% by weight and preferably with acid or enzyme catalysis, there is essentially no possibility of recombination and branching, which is also evident not least from the different molecular weight distributions.
The preparation of saccharified starches is generally known and described inter alia in Gunther Tegge, Starke und Starkederivate, Behr's Verlag, Hamburg 1984, pages 173 and 220 et seq. and in EP-A 441 197. The saccharified starches to be used according to the invention are preferably those whose weight average molecular weight M.sub.w is in the range from 4000 to 16,000, particularly preferably in the range from 6500 to 13,000.
The saccharified starches to be used according to the invention are normally completely soluble in water at room temperature, the solubility limit usually being above 50% by weight. Preferably 10-20% by weight solutions, particularly preferably 30-40% by weight solutions, are clear and not colloidal suspensions at room temperature.
It is furthermore advisable to use according to the invention those saccharified starches which have a dextrose equivalent DE of 2-40, preferably 10-30, and particularly preferably 10-20. The DE characterizes the reducing capacity based on the reduci
REFERENCES:
patent: 4719106 (1988-01-01), Shetty et al.
patent: 4844898 (1989-07-01), Komori et al.
patent: 5455042 (1995-10-01), Sakai et al.
Breitenbach Jorg
Sanner Axel
Thoma Dietrich
BASF - Aktiengesellschaft
Pak John
LandOfFree
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