Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1993-05-28
1994-12-13
Wityshyn, Michael G.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
215DIG3, 530362, 530363, 530364, 436 88, 435296, A61K 3700, B65D 2300
Patent
active
053729978
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
This invention relates to an albumin preparation and a method for preserving the same. More particularly, it relates to a liquid preparation of albumin of plasma origin and a method for preserving the same whereby an increase in the aluminum content of said preparation during storage is avoided.
TECHNICAL BACKGROUND
Serum albumin, the most abundant protein in plasma, contributes to the maintenance of osmotic pressure and binds to and transports nutrients and metabolites. Preparations containing the above-mentioned albumin have been used in the treatment of hypoalbuminemia and hemorrhagic shock due to a loss of albumin or in the ability to synthesize albumin.
Generally, albumin preparations are prepared from plasma via several purification stages. During detailed studies on contaminants of albumin preparations, the present inventors found that albumin preparations contain a significantly large amount of aluminum.
In recent years, attention has been directed to the correlation between aluminum and various diseases. For example, it is believed that bone diseases accompanied by serious pain, which are observed frequently in patients experiencing hemodialysis or prolonged instillation, are caused by aluminum contained in solutions employed in those treatments.
It is considered, furthermore, that dialysis dementia, bone diseases and hypochromic anemia observed in patients undergoing hemodialysis for treating chronic renal insufficiency are caused by the accumulation of aluminum in serum.
In addition, the correlation between aluminum in brain tissue and Alzheimer's disease (senile dementia) has attracted attention.
In view of those observations, attempts have been made world-wide to control the aluminum content of medical preparations.
There are a variety of hard glasses (borosilicate glass; falling within Class I in the Glass Classification of USP) and soft glasses (soda-lime glass, falling within Class II in the Glass Classification of USP) having a dealkalized surface which serve as materials of containers for injectable materials. Soft glass has a low melting point, can be easily molded and is less expensive than hard glass. These materials differ from each other in other physical properties, including chemical resistance. Thus different glasses have been used depending on the drugs to be contained. Hard glass containers are usable for preserving acidic, neutral or alkaline drug-containing solutions. On the other hand, soft glass containers are usable for preserving acidic and neutral drug-containing solutions, whereas the suitability for storing alkaline drug-containing solutions must be confirmed.
Hard glass containers which are excellent in chemical resistance have been employed conventionally and uniformly for preserving albumin preparations.
DISCLOSURE OF THE INVENTION
The present inventors have conducted extensive studies to reduce the aluminum content of an albumin preparation. As a result, the instant inventors found that a significantly high aluminum content of the final product is attributed to the contamination of the albumin preparation with aluminum during the production stage of the albumin preparation. Thus the present inventors have found that the aluminum content can be reduced by treating an albumin-containing aqueous solution with an anion exchanger during preparation.
It also has been found that when a liquid albumin preparation in which the aluminum content has been reduced by such a purification method is preserved in a conventional hard glass container, the aluminum content of the preparation increases during storage.
The present invention has been achieved to solve those problems. It is an object of the present invention to provide an albumin preparation, wherein an increase in the aluminum content thereof during preparation is minimized, and a method for preserving the same.
The present inventors further have studied methods for preserving an albumin preparation. As a result, they have found that the aluminum content of an albumin preparation can be maintained a
REFERENCES:
patent: 3598269 (1971-08-01), Carmen
patent: 3746196 (1973-07-01), Sako et al.
The Second Series of Pharmaceutical Research and Development, vol. 9, Package and Container Drugs, ed. by H. Sezaki, M. Sugihara, p. 351 Hirokawa Publishing Co. (1991).
Victor et al., "Aluminum contamination in albumin solutions . . . ", Transfusion, 28(3), pp. 290-291 (1988).
Furuta Kohichi
Ikariya Koei
Inoue Masahiro
Ito Hirokazu
Tomioka Shinji
Sayala C.
The Green Cross Corporation
Wityshyn Michael G.
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