Apidra®

Apidra (Insulin Recombinant rapid- Engineered B3 asparagine Aventis 2004... 

Apidra (insulin glulisine) Yes 3-mL pen cartridge or OptiClik pen system... 

Injection 100 units/mL (insulin glulisine [rDNA]) Rx) Apidra (Aventis)... 

Apidra) [7,8] analogue studies 12 month (rat) 6 month (dog) chronic study was designed to investigate the carcinogenic potential of the compound battery EMEA-2004... 

Insulin Glulisine. Summary Basis for Approval, Pharmacology Review, 2004. http // www.fda.gov/cder/foi/nda/2004/21-629 Apidra.htm... 

II.R.l Competitive RIA of Apidra (Insulinanalogue) with Double Antibody Precipitation 647... 

PURPOSE AND RATIONALE Apidra (HMR 1964) is a synthetic short acting insulin (polypeptide) which is structurally very similar to human insulin and has an approximate molecular weight of 5800 Dalton. 

In the early development of Apidra a commercially available radioimmunoassay for the determination of rat insulin (Linco Research Inc. 14 Research RD, St. Charles, MO 6330, USA) was used for the analysis of Apidra in human serum because specific antibodies were not yet available. 

Several RIAs for insulin had been compared before aiming at 100% cross-reactivity with Apidra. The rat insulin RIA from Linco showed similar reactivity for Apidra and human insulin. Therefore, this assay was used with only slight modifications rat insulin standards were replaced by Apidra standards in an appropriate human serum matrix for calibration. 

Standards stock solution 20 ng/ml Apidra in insulin free human serum standard matrix insulin free human serum... 

Controls K1-K3 (low, medium, high) Apidra in human serum, concentration stated... 

Standards The stock solution of Apidra is prepared by dissolving about 500 xg (exact weight) Apidra in 5 ml of 0.1 M Tris/HCI buffer, pH 9. This solution (100 ig/ml) is further diluted in insulin free human serum to a concentration of 20.0 ng/ml (nominal value). The standards (10, 5, 2.5, 1.25, 0.63, 0.31, 0.16 ng/ml) are prepared by serial dilution of the stock solution in insulin free human serum matrix (e.g. WBAG Resources GmbH). 

Controls Control samples are prepared by spiking human sera (insulin content below 0.5 ng/ml) with Apidra stock solution to a concentration of about 0.5, 1.5, 5.0 ng/ml. 

Specificity No specific determination of Apidra (crossreactivity with human/rat/porc insulin is 80.2/106.9/102.2 %, respectively). 

CRITICAL ASSESSMENT OF THE METHOD The method described above could not differentiate Apidra from naturally occurring insulin/metabolites and precursors. This lack of specificity renders the characterisation of the pharmacokinetics difficult. Therefore, a specific assay for the determination of Apidra was required for its further development. 

This kit is very similar to the method described before with the exception that a highly specific antibody for Apidra (guinea pig anti-HMR 1964 antiserum prepared by Linco) is used. The antibody meets the specificity requirements (cross-reactivity e.g. to human insulin < 0.001 %) and the sensitivity requirements (< 0.2 ng/ml). 

A slightly modified method (MDS Pharma Services Switzerland AG, CH-8602 Wangen) was used in the development of Apidra (a synthetic short acting insulin). 

Scientific Discussion. Available at http //www.emea.europa.eu/humandocs/PDFs/EPAR/ apidra/121804en6.pdf. Accessed December 2007. 

Each milliliter of APIDRA (insulin glulisine injection) contains 100 lU (3.49 mg) of insulin glulisine,... 

Apidra (insulin glulisine) Aventis Yes cartridge Vial 28 days... 

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