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Information Journal Paper

Title

OPTIMIZATION OF ANTI-RH D IMMUNOGLOBULIN STABILITY IN THE LYOPHILIZATION PROCESSES

Pages

  55-61

Abstract

 Objective: ANTI-RH D IGG is used for the prevention of anti-D antibody production in Rh- individuals who have been exposed to Rh+ red blood cells. The stability of IgG preparations as a solution is low, with a shelf life of a year or more. FORMULATION of ANTI-RH D IGG as a lyophilized preparation would decrease its degradation rate and increases its shelf life. The objective of this study was to formulate the anti-Rh D as a lyophilized preparation using different FORMULATIONs and optimize the LYOPHILIZATION processes. Materials and Methods: The effect of various FORMULATIONs on the stability of anti-Rh D was evaluated using accelerated stability test.  In this method the amount of transmittance (T %) at 585 nm for the lyophilized preparations had inverse relationship with aggregation of anti-Rh D. To improve stability, the most stable FORMULATION was selected and different concentrations of sucrose in the presence of sodium-potassium phosphate buffer 25 mM pH 7.5. Then, the BIOACTIVITY was determined, using the ELAT test and also, the amount of moisture measured in this FORMULATION.Results; Among different FORMULATIONs, the one with anti-Rh D 5 mg/ml, tween 80 0.1%, glycine 0.15 M, manitol 7% and sucrose 60 mM in sodium-potassium phosphate buffer 25 mM pH 7.5 was the most stable FORMULATION (P<0.05). The result of biological test of ELAT showed that BIOACTIVITY of more than 93% meets the requirement set by British Pharmacopoeia. The amount of moisture measured in this FORMULATION was less than 3%.Conclusion:It was concluded that this FORMULATION could be introduced as a candidate for the FORMULATION of anti-Rh D in a lyophilized dosage form.

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    APA: Copy

    VARASTEH, A.A.R., HASHEMI, MARYAM, BARANZADEH, N., & JAFARI, M.R.. (2008). OPTIMIZATION OF ANTI-RH D IMMUNOGLOBULIN STABILITY IN THE LYOPHILIZATION PROCESSES. IRANIAN JOURNAL OF BASIC MEDICAL SCIENCES, 11(1 (37)), 55-61. SID. https://sid.ir/paper/563483/en

    Vancouver: Copy

    VARASTEH A.A.R., HASHEMI MARYAM, BARANZADEH N., JAFARI M.R.. OPTIMIZATION OF ANTI-RH D IMMUNOGLOBULIN STABILITY IN THE LYOPHILIZATION PROCESSES. IRANIAN JOURNAL OF BASIC MEDICAL SCIENCES[Internet]. 2008;11(1 (37)):55-61. Available from: https://sid.ir/paper/563483/en

    IEEE: Copy

    A.A.R. VARASTEH, MARYAM HASHEMI, N. BARANZADEH, and M.R. JAFARI, “OPTIMIZATION OF ANTI-RH D IMMUNOGLOBULIN STABILITY IN THE LYOPHILIZATION PROCESSES,” IRANIAN JOURNAL OF BASIC MEDICAL SCIENCES, vol. 11, no. 1 (37), pp. 55–61, 2008, [Online]. Available: https://sid.ir/paper/563483/en

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