Chemistry: natural resins or derivatives; peptides or proteins; – Peptides of 3 to 100 amino acid residues – Insulin; related peptides
Patent
1998-04-20
1999-08-10
Tsang, Cecilia J.
Chemistry: natural resins or derivatives; peptides or proteins;
Peptides of 3 to 100 amino acid residues
Insulin; related peptides
530412, 530415, 530416, 530427, 210679, 210690, 210691, 604 27, 604 36, 604187, 604190, A61K 3700
Patent
active
059360615
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a new use of hydrophobic zeolites, i.e. to remove preservatives from (poly)peptide solutions. The invention further relates to a new product intended for injection solutions, more specifically a syringe intended for such solutions, which contains said hydrophobic zeolite for removing preservatives from the injection solution.
BACKGROUND OF THE INVENTION
Pharmaceutical preparations intended for injection are usually supplied as prepared injection solutions for immediate use. In many cases, such pharmaceutical preparations consist of proteins, the solutions of which cannot be heat sterilised. For this reason, effective preservatives are generally added to the solutions, which in turn means that the preservative is also injected into the patients. If this preservative could be removed, the patient would be spared toxic exposure, which must be considered particularly serious when the pharmaceutical preparation is used constantly. One example in this respect is diabetics injecting insulin, and the prevalent product on the market contains phenol as preservative. Another example is somatropin, where two dominating manufacturers use m-cresol as preservative and a third uses benzyl alcohol. It is also common for manufacturers of this type of drugs to supply special disposable syringes with dose indicator.
Especially for the last-mentioned reason, i.e. that the drugs are supplied in special disposable syringes, more or less complicated methods for removing the preservative cannot be applied. The present invention offers on the other hand a very simple but at the same time very effective method for removing preservatives from such solutions, the method being so simple that it can even be applied in connection with disposable syringes of the type involved. According to the present invention, it has thus been found that hydrophobic zeolites can be used for this purpose in a very simple, quick and effective manner. The fact that the invention is at the same time surprising is illustrated by the following.
The use of zeolites for adsorption of some specific types of organic compounds is per se known. Thus, e.g. U.S. Pat. No. 5,108,617 discloses the use of hydrophobic zeolites for adsorption of detergents from a solution containing the same, while PCT Application SE93/00582 discloses the use of hydrophobic zeolites for adsorption of hydrophobic proteins or peptides. However, none of these publications indicates that such hydrophobic zeolites could be usable for efficient removing of the type of compounds that is intended according to the present invention, viz. preservatives from (poly)peptide solutions, for instance solutions of pharmaceutical products. Moreover it is particularly surprising that the invention has been found to function extremely well for purifying solutions containing peptides or proteins, since, as mentioned above, hydrophobic zeolites have been used precisely to adsorb peptides or proteins.
DESCRIPTION OF THE INVENTION
A first aspect of the invention thus concerns a new use of hydrophobic zeolites, i.e. for removing preservatives from a (poly)peptide solution containing the same. In most cases, a water-based solution is involved, especially a solution of a pharmaceutical preparation, but also other types of solutions, for instance all sorts of biomedical solutions, containing similar preservatives are, of course, possible in connection with the use according to the invention.
As will be evident from the following, an extremely interesting embodiment of the invention is the use for a protein solution. However, the inventive idea should be applicable to all types of peptides, i.e. anything from peptides having a few amino acids bound to each other (e.g. oligopeptides having at most about 10 amino acids bound to each other) via polypeptides having up to about 100 amino acids, and up to polypeptides having more than about 100 amino acids, in which case the polypeptides usually change to be called proteins. The term (poly)peptide should thus, i
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Andersson Sten
Eriksson H.ang.kan
Larsson K.ang.re
Delacroix-Muirheid C.
Tsang Cecilia J.
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