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Titolo:
STABILITY OF SOMATROPIN STORED IN PLASTIC SYRINGES FOR 28 DAYS
Autore:
RAY LR; CHEN DA;
Indirizzi:
ELI LILLY & CO,LILLY CORP CTR,BIOPHARMACEUT PROD DEV,DROP CODE 3832 INDIANAPOLIS IN 46285
Titolo Testata:
American journal of health-system pharmacy
fascicolo: 14, volume: 55, anno: 1998,
pagine: 1508 - 1511
SICI:
1079-2082(1998)55:14<1508:SOSSIP>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Soggetto:
HUMAN GROWTH-HORMONE;
Keywords:
CONCENTRATION; HORMONES; INCOMPATIBILITIES; METACRESOL; PLASTICS; POLYPROPYLENE; PRECIPITATION; PRESERVATIVES; PROPYLENE ETHYLENE COPOLYMER; SOMATROPIN; STABILITY; STORAGE; SYRINGES; TURBIDITY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
5
Recensione:
Indirizzi per estratti:
Citazione:
L.R. Ray e D.A. Chen, "STABILITY OF SOMATROPIN STORED IN PLASTIC SYRINGES FOR 28 DAYS", American journal of health-system pharmacy, 55(14), 1998, pp. 1508-1511

Abstract

The stability of somatropin stored in two types of plastic syringes was studied. Reconstituted somatropin at high (3.33-mg/mL) and low (1.0-mg/mL) concentrations was stored in polypropylene and propylene-ethylene copolymer syringes at 2-8 degrees C for 28 days. The contents of all syringes were analyzed immediately and at 7, 14, 21, and 28 days byhigh-performance liquid chromatography for purity, potency, and preservative (m-cresol) content; pH, physical appearance, clarity, and preservative effectiveness were analyzed at the same times. Glass vials ofsomatropin reconstituted with diluent served as controls. Somatropin did not show significant losses in purity or potency during the 28-daystudy. m-Cresol concentrations decreased in both types of plastic syringes, more so in the polypropylene syringes, but remained in excess of the minimum required to pass the USP test of preservative effectiveness. On average, the contents of the propylene-ethylene copolymer syringes had greater turbidity than the contents of the polypropylene syringes and, after 21 days, had an unacceptable level of turbidity. No visible particulates were present except at 28 days in high-concentration samples stored in propylene-ethylene copolymer syringes. Somatropin 3.33 and 1.0 mg/mL was stable in polypropylene syringes for up to 28 days and in propylene-ethylene copolymer syringes for up to 14 days when stored at 2-8 degrees C.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 12/07/20 alle ore 07:36:28