Drug – bio-affecting and body treating compositions – Lymphokine – Interferon
Reexamination Certificate
2001-12-18
2003-10-21
Kemmerer, Elizabeth (Department: 1646)
Drug, bio-affecting and body treating compositions
Lymphokine
Interferon
C424S085500, C424S085600, C424S085700, C424S078070
Reexamination Certificate
active
06635243
ABSTRACT:
CROSS REFERENCES TO RELATED APPLICATIONS
The present application claims the benefit of priority of PCT International Application No. PCT/RU99/00320, filed on Sep. 6, 1999, which claims priority from Russian Federation patent application No. 9910066, filed Mar. 16, 1999.
FIELD OF THE INVENTION
The present invention can be used in pharmacology specifically in the preparation of interferon-containing compositions, which are capable of conserving their biological activity and can be administrated intranasally, e.g. in the preparation of nasal drops.
BACKGROUND OF THE INVENTION
Medicines containing interferons (natural, recombinant or genetically engineered) are widely used. Interferon-containing preparations, in addition to antiviral effects, cause strong immunomodulatory effects that induce several positive homeostatic shifts, antitumour effects, etc. (RU, Application 940942742 Cl. A 61 K 38/21, 1997. RU, patent 20957544, Cl. A 61 K 38/21, 1996).
In Russia, natural human interferons derived from leukocytes have been widely used for the treatment and prevention of influenza and acute viral respiratory infections (AVRI) since the late 1960s. This interferon was manufactured from expensive donor blood leukocyte preparations (RU, Patent 2033180, Cl. A 61 K 38/21, 1995. SU, Inventor's Certificate 297296, Cl. A 61 K 36/21, 1977. RU, patent 2108804, Cl. A 61 K 38/21, 1996).
Medicines prepared from leukocytes or any other component of human blood are potentially hazardous and can transmit viral infection (hepatitis, herpes virus, cytomegalovirus, AIDS, slow infections etc.).
Because of this, recombinant and genetically engineered interferon preparations of the highest purification (up to 98% pure) are increasingly used for clinical purposes (FS 42-3279-96, VFS 42-2989-97, RU, Patent 2073522, Cl. A 61 38/21, 1997
. Ershov, F.I., Sistema interferona v norme i pri patologii
(The Interferon System under Normal and Pathological Conditions); Moscow: Medicina, 1966, p.216.
These preparations are effective in treating oncological diseases by parenteral administration of high doses (3-10 million IU or more per 24 h) in repeated long courses. However, such doses often cause side effects, such as disorders haemopoiesis, suppression of the immune system, formation of anti-interferon antibodies etc.
However, the recent experience with clinical administration of interferons suggests that their efficacy can be increased by using appropriate drug forms (with account taken of the specific pathogenetic features of the diseases) designed to deliver high concentrations of interferon to the focus of viral infection. After such an administration, interferon causes antiviral and immunomodulatory effects without cytostatic or other side effects. This makes it expedient to develop various drug forms containing interferons designed for topical administration (suppositories, ointments, drops, aerosols, etc.) The closest analogue of this invention, in terms of the nature of the drug and achieved result, is an antiviral drug form for intranasal administration containing human interferon, a biocompatible polymer (6% Polyglucin), and a buffer mixture with the following contents of ingredients per ml solution:
Interferon
(1-6.6) .10 IU
Biocompatible polymer (Polyglucin)
5-30
Buffer mixture
pH 7.0-7.6 in
solution
(RU. Patent 2095081, Cl. A 61 K 38/21, 1977).
However, intranasal drug forms containing recombinant or genetically engineered interferons have not been developed in Russia.
SUMMARY OF THE INVENTION
The main idea of this invention was to develop of an antiviral drug form (nasal drops) containing a genetically engineered interferon, which would allow a prolonged contact with nasal mucous, act topically at the site of primary invasion and reproduction of influenza and other respiratory viruses, be easily absorbable, and have an optimal viscosity permitting the drug to spread over the mucous and be retained on it for a long time.
To solver this problem, we developed an antiviral drug (nasal drops) containig a liquid interferon preparation (a genetically engineered alpha, beta or gamma interferon with viscosity of (1.1-30.0)*10 Pascal second). The antiviral drug contains a biocompatible polymer, antioxidant, and buffer mixture with the following contents of ingredients per ml buffer mixture:
Genetically engineered interferon
1000-50,000 IU
Biocompatible polymer
0.005-0.714 g
Antioxidant
0.0001-0.0008 g
TRILON B® (disodium salt of ethylenediaminetetraacetic acid (“EDTA”)) is used as an antioxidant, and polyvinylpyrrolidone and/or polyethylene oxide is used as a biocompatible polymer. The drug described here contains polyvinylpyrrolidone and polyethylene oxide at a ratio of 1:1-50.
REFERENCES:
patent: 4647454 (1987-03-01), Cymbalista
patent: 4710376 (1987-12-01), Evans et al.
patent: 4855238 (1989-08-01), Gray et al.
patent: 2020957 (1994-10-01), None
patent: 2022562 (1994-11-01), None
patent: 2033180 (1995-04-01), None
patent: 2057544 (1996-04-01), None
patent: 2073522 (1997-02-01), None
patent: 2077336 (1997-04-01), None
patent: 2095081 (1997-11-01), None
patent: 2097061 (1997-11-01), None
patent: 2108804 (1998-04-01), None
patent: 9321229 (1993-10-01), None
Ershov F.I.,Medicina, p. 216 (1996).
Gaponyuk Petr Jakovlevich
Markov Iliya Alexandrovich
Markova Elena Alexeevna
Kemmerer Elizabeth
Ladas & Parry
Li Ruixiang
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