Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Patent
1997-09-12
2000-04-04
Kishore, Gollamudi S.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
424 943, 514 21, A61K 3843, A61K 908
Patent
active
060458097
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to novel pharmaceutical compositions which are particularly suitable for the oral administration of superoxide dismutase (SOD), ensuring that it has a good bioavailability and therapeutic efficacy.
Since their characterization in 1968 by McCord and Fridovich (J. Biol. Chem., 1969, 244, 6049-6055), superoxide dismutases have been studied in the treatment of numerous diseases; superoxide dismutase is in fact an enzyme which promotes removal of the superoxide radical (.O.sub.2.sup.-) by dismutation and therefore constitutes a system for providing protection from the deleterious effects of this radical, which is capable of forming in vivo from atmospheric oxygen. Consequently this enzyme plays a fundamental role in preventing the toxic effects which could result from exposure of the cells and the organism to an oxygenated atmosphere in which oxygen (a biradical) loses an unpaired electron (reduction).
As free radicals are involved in numerous diseases, the use of SOD in therapeutics has been recommended in different inflammatory processes (rheumatism and fibrosis in particular), viral processes (HIV infection in particular) and toxic conditions associated with the presence of substantial amounts of oxygen (central nervous system, ischemia, non-vascular gastrointestinal disorders, eye disorders or control of the undesirable effects of anticancer treatments) (Greenwald R. A., Free Radical Biol. Med., 1990, 8, 201-209).
The free forms of SOD which have been tested are Cu,Zn-SOD (vegetable origin or animal origin: bovine, rat or human), Mn-SOD (human, vegetable, algal origin), Fe-SOD and recombinant SODS.
The plasmatic half-lives of native SODs are very variable (of the order of a few minutes for Cu,Zn-SOD; of the order of several hours for Mn-SOD, for example).
Different modified forms for parenteral administration have been proposed for increasing the plasmatic half-life of these SODs; modified forms which may be mentioned are SODs conjugated with polyethylene glycol (SOD-PEG), SODs conjugated with heparin (SOD-heparin), SODs conjugated with albumin (SOD-albumin), SOD polymers or copolymers and liposomal SODs.
However, these different SODs have the major disadvantage of being very poorly absorbed when administered orally.
Consequently the Applicant set out to develop galenic forms capable of affording an effective absorption of SOD by oral administration, said mode of administration being particularly valuable for the majority of the above-mentioned diseases to be treated.
SUMMARY OF THE INVENTION
The present invention relates to pharmaceutical compositions which are characterized in that they essentially comprise a combination of a superoxide dismutase and at least one compound selected from the group consisting of lipids and proteins and optionally one or more pharmaceutically acceptable vehicles, said compositions being particularly suitable for oral administration.
In one advantageous embodiment of said compositions, said lipids are selected from plant lipids, preferably from the group consisting of ceramides, phospholipids, tylacoids and diacylglycerols.
In another advantageous embodiment of said compositions, said proteins are selected from plant proteins, preferably from the group consisting of prolamines and polymer films based on said prolamines.
Liposomes may be mentioned among the preferred vehicles which may be associated with the compositions.
In another advantageous embodiment of said composition, said ceramides (or N-acylsphingosines) are of synthetic, animal or vegetable origin, preferably of vegetable origin, and are N-acyl fatty acid derivatives of sphingosine of the formula ##STR1## in which n is between 5 and 15, preferably between 12 and 15,
Advantageously said ceramides of vegetable origin are preferably derived from cereals (flours), especially wheat, and have the following formula: ##STR2## in which R is a hydrogen atom or a glucose and
Such plant ceramides (glycosylated or non-glycosylated) can be obtained in particular by the process described in interna
REFERENCES:
patent: 5019400 (1991-05-01), Gombotz
patent: 5271961 (1993-12-01), Mathiowitz
patent: 5665778 (1997-09-01), Semenic
Brack Michel
Postaire Eric
Regnault Corinne
Rock-Arveiller Monique
Sauzieres Jacques
Institut de Recherches Franctales
Kishore Gollamudi S.
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