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Buminate 25% (Albumin) - Description and Clinical Pharmacology

 
 



DESCRIPTION

BUMINATE 25%, Albumin (Human), 25% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 25 g of albumin and is prepared from human venous plasma using the Cohn cold ethanol fractionation process. Source material for fractionation may be obtained from another U.S. licensed manufacturer. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with sodium acetyltryptophanate and sodium caprylate. The sodium content is 145 ± 15 mEq/L. This solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 25%, Albumin (Human), 25% Solution is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.

The likelihood of the presence of viable hepatitis viruses has been minimized by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1-3

CLINICAL PHARMACOLOGY

Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating the volume of circulating blood.4-6 Albumin is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6

BUMINATE 25%, Albumin (Human), 25% Solution is osmotically equivalent to approximately five times its volume of human plasma. When injected intravenously, 25% albumin will draw about 3.5 times its volume of additional fluid into the circulation within 15 minutes, except when the patient is markedly dehydrated. This extra fluid reduces hemoconcentration and blood viscosity. The degree and duration of volume expansion depends upon the initial blood volume. With patients treated for diminished blood volume, the effect of infused albumin may persist for many hours; however, in patients with normal volume, the duration will be shorter. 7,8

Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extracellular compartments; more than 60% is located in the extravascular fluid compartment. The half-life of albumin is 15 to 20 days with a turnover of approximately 15 g per day. 5

The minimum plasma albumin level necessary to prevent or reverse peripheral edema is unknown. Some investigators recommend that plasma albumin levels be maintained at approximately 2.5 g/dL. This concentration provides a plasma oncotic value of 20 mm Hg.4

BUMINATE 25%, Albumin (Human), 25% Solution is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 ± 0.5°C for 10-11 hours. This process accomplishes both purification of albumin and reduction of viruses.

In vitro studies, demonstrate that the manufacturing process for BUMINATE 25%, Albumin (Human), 25% Solution provides for significant viral reduction. These viral reduction studies, summarized in Table 1, demonstrate viral clearance during the manufacturing process for BUMINATE 25%, Albumin (Human), 25% Solution using human immunodeficiency virus, type 1 (HIV-1) both as a relevant virus in its own right and as model virus for HIV-2 and other enveloped RNA viruses; bovine viral diarrheal virus (BVD), a model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); porcine parvovirus (PPV), a model for non-lipid enveloped DNA viruses such as human parvovirus B19; hepatitis A virus (HAV), a relevant virus in its own right and a model for other non-lipid enveloped RNA viruses.

These studies indicate that specific steps in the manufacture of BUMINATE 25%, Albumin (Human), 25% Solution are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation at each step is different, the overall manufacturing process of BUMINATE 25%, Albumin (Human), 25% Solution is robust in reducing viral load.

Table 1 Summary of Viral Reduction Factor for Each Virus and Processing Step
Process Step Viral Reduction Factor (log10)
Lipid Enveloped Non-lipid Enveloped
BVD HIV-1 PRV HAV PPV
Step 1: Processing of cryo-poor plasma to
Fraction I+II+III centrifugate
1.2±0.0 5.8±0.0 4.6±0.5 1.9±0.8 1.4±0.1
Step 2: Processing of Fraction I+II+III
centrifugate to Fraction IV1 centrifugate
2.8±0.5 NCM 3.4±0.4 1.9±0.7 (1.2±0.3) *
Step 3: Processing of Fraction IV1
centrifugate to Fraction IV4
centrifugate/filter press filtrate **/*
>2.4±0.1/
>2.4±0.1
>/=4.4±0.5/
>/=4.5±0.5
>4.8±0.1/
>4.8±0.1
3.8±0.1/
2.9±0.2
2.2±0.3/
2.0±0.3
Step 4: Processing of Fraction IV4
centrifugate/filter press filtrate to
Fraction IV4 Cuno 70C filtrate #
>1.6±0.2/
>1.7±0.1
NCM >4.1±0.5/
>4.4±0.1
4.7±0.1/
4.6±0.1
2.3±0.3/
3.0±0.8
Step 5: Processing of Fraction V
suspension to Cuno 90LP filtrate
(0.2±0.2) * >/=5.0±0.5 >4.6±0.0 4.2±0.4 3.4±0.5
Step 6: Pasteurization >4.9±0.1 >5.1±0.3 >5.3±0.1 5.3±0.4 NT
Cumulative Reduction Factor **, log10 >12.9/13.0 >20.3/20.4 >26.8/27.1 21.8/20.8 9.3/9.8
NTNot tested.
NCMNo virus reduction claim made at this step.
*Since the reduction factor of =1.0 is within the variability limit of the assay, these values are not included in the computation of the cumulative reduction factor.
**/* Two reduction factors indicate the two liquid-solid separation options available at this step.
# Two reduction factors indicate the two starting materials at this step.
**Two cumulative reduction factors derived from the use of the two liquid-solid separation options available at Step 3.

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