Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...
Patent
1996-03-18
1998-07-14
Caputa, Anthony C.
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
4241471, 4241501, 4241511, 4241591, 4241641, 4241691, 424809, 427 214, 427 216, A61K 39395, A61K 3942, B01J 1300, B05D 300
Patent
active
057800286
DESCRIPTION:
BRIEF SUMMARY
This application is a continuation of the national phase of PCT/AU94/00562, filed Sep. 20, 1994.
The present invention relates to a pharmaceutical composition, in particular a pharmaceutical composition including antibodies and to a method of preparing same.
BACKGROUND OF THE INVENTION
It is known that antibodies may be separated from human blood and used to treat various infectious diseases. In particular .gamma.-globulin fractionated from blood serum has been known to have effectiveness in treatment and prophylaxis of disease and was administered by injection in the treatment of measles and other infectious diseases. It was later found that in fact, .gamma.-globulin and part of the .beta.-globulin fraction were composed of five major constituents: IgG, IgA, IgM, IgD and IgE, each of which has its own physiological characteristics. However, such serum antibodies are difficult to collect, with the result that commercial production of large quantities of antibodies for medication is not economical. It was found that IgA was produced not only in blood serum but also in secretory organs such as the mammary gland. The IgA found in the secretory organs is in the form of a dimer consisting of two molecules of IgA, which are bridged with one molecule of a secretory component. This form of IgA is very stable against proteases and acidic conditions and is known as secretory IgA as distinguished from serum IgA. Unlike other immuno globulins, IgA present in the form of secretory IgA in the epithelial cells of mucous membranes attacks bacteria and viruses therein, thus playing an important role in local immunity. Because of this, oral administration of secretory IgA may be used to provide immunological protection to a patient, and it is known that this occurs naturally from the inferior resistance against infection exhibited by a bottle-fed infant as opposed to a breast-fed infant.
Secretory IgA is found in particularly high concentrations in colostrum. Colostrum is milk produced by mammals over a period extending from shortly before to shortly after giving birth. Colostrum contains on average 300 mg/dl secretory IgA, compared with 50 mg/dl for mature milk. It is recognized that by immunizing a mammal such as a cow with specific antigens, a colostrum containing specific antibodies may be harvested and used to treat infectious diseases, particularly intestinal diseases. For many applications, this has proved a preferable commercial alternative to isolating .gamma.-globulin from blood serum.
Although colostrum has proved a useful source of secretory IgA, difficulties have been experienced in the purification and storage of colostral antibodies. In particular, it has been found that colostral antibodies isolated by previously known methods may not be sufficiently stable to withstand some of the conditions found during the preparation and storage of pharmaceutical compositions, or the physiological conditions which may be encountered by a pharmaceutical composition prior to reaching the intended site of activation.
A further problem is found in the administration of colostral antibodies. Previously, colostral antibodies have been administered in compositions including a large percentage of pharmaceutically acceptable excipients. This in turn has resulted in impractical dosing due to the large quantities of pharmaceutical composition required to achieve desired levels of antibody administration. Prior art methods have included powders which may be dissolved or suspended in liquid for oral administration, or granulation and encapsulation of colostral antibodies, again for oral administration. Both of these methods require high dosage level regimes to ensure effective levels of antibodies are received.
Administration is also complicated by the origin of the antibodies. Since it is derived from milk products, quantities of lactose are often associated with the separated antibodies. This results in an increase in the overall volume of pharmaceutical compositions including the antibody, and makes the compositions unsuitable
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Anadis Ltd.
Caputa Anthony C.
Navarro Mark
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