Surgery – Controlled release therapeutic device or system – Implanted dynamic device or system
Patent
1995-01-20
1996-09-10
Green, Randall L.
Surgery
Controlled release therapeutic device or system
Implanted dynamic device or system
6048921, 604 49, A61K 922
Patent
active
055541500
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a new method for the delivery of solutions containing a granulocyte-colony stimulating factor. In particular, this invention relates to a process for the delivery of aqueous G-CSF solutions.
The chemotherapy frequently used in the treatment of cancers causes the destruction of cancerous cells but also often has clinical side-effects related to this treatment. Thus, during these treatments, the existence is apparent of infectious diseases due to microorganisms which are resistant to any antibiotic therapy. In addition, during these chemotherapeutic treatments, part of the natural defences of living organisms is destroyed, which explains the appearance of infectious diseases in these organisms.
In order to avoid as far as possible the appearance of these infectious diseases related to chemotherapy, it has been proposed to use a substance which activates the natural defence abilities of the organism. In each organism, there exist defence systems which, in man, largely consist of leucocytes. These leucocytes provide for phagocytosis of the infectious agents or participate in their destruction and consequently prevent multiplication of harmful microorganisms within the sick organism. Granulocyte-colony stimulating factor has recently appeared among substances which promote proliferation or multiplication of leucocytes. This factor has been protected in the European patent application published for example under the number EP 237,545.
This granulocyte-colony stimulating factor is delivered to man or to animals at very low doses, of the order of 0.1 to 500 .mu.g for an adult man. The delivery of such low doses poses a problem of dilution of the active principle which had to be overcome. In fact, this active principle, which is a polypeptide, has the disadvantage of being adsorbed on the walls of the containers with which it has been brought into contact, whether syringes or perfusion bottles. The problem related to this adsorption was solved in the British patent application published under the number GB 2,193,631.
It is known, for example, according to this British patent application, that it is possible to stabilize the granulocyte-colony stimulating factor solution by addition to the aqueous solution of a protein which is competitive as regards adsorption on the walls of the container, which protein consists, for example, of albumin, and of a polysaccharide coupled to a non-ionic surfactant agent.
These solutions, when they are delivered to animals subcutaneously, cause, only two days after injection, an increase of five times the amount of polynucleate neutrophiles, but this increase is reduced to approximately two times the normal eight days after injection, all this being evaluated with respect to untreated controls.
A method of delivery using particles having a prolonged release was proposed in Patent Application EP 263,490. This method makes it possible, by virtue of the delivery of polymeric particles based on a poly-(lactic acid) polymer or on a copolymer of lactic acid and of glycolic acid containing the granulocyte-colony stimulating factor, to avoid the daily delivery of aqueous solutions of this said factor. These particles make it possible to obtain an effect virtually equivalent to that obtained with a daily subcutaneous injection of aqueous solutions of the said factor. The maximum effect is thus maintained throughout the period of release of the microparticles, which can reach two weeks.
It appeared, in an entirely surprising way, that when the aqueous stimulating factor solution was continuously introduced subcutaneously in animals or in man, the multiplier effect on the neutrophile content was greatly increased. In contrast, it appeared that the same dose injected cutaneously in a single daily injection, led to an increase six times less than that caused by the delivery of the same daily dose continuously. This entirely surprising effect has an entirely favourable consequence for the treatment using this type of active principle. It thus makes it possible, for
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Bousseau Anne
Frydman Armand
Plard Jean-Paul
Spenlehauer Gilles
Veillard Michel
Green Randall L.
Rhone-Poulenc Rorer S.A.
Van Over Perry E.
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