FORMIRANJE STERILNIH OBLIKA U FARMACEUTSKOJ INDUSTRIJI

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13. međunarodni simpozij o kvaliteti „KVALITETA I DRUŠTVENA ODGOVORNOST“, Solin, 15.-16.3.2012.

STERILE DOSAGE FORM IN PHARMACEUTICAL INDUSTRY FORMIRANJE STERILNIH OBLIKA U FARMACEUTSKOJ INDUSTRIJI

Dražen Kostelac JGL d.d., Pulac b.b., 51 000 Rijeka, Croatia E-mail: drazen.kostelac@jgl.hr Damir Požgaj Termo - plin projekt d.o.o. Osječka 26, 51 000 Rijeka, Croatia E-mail: damir.pozgaj2@inet.hr

UDK/UDC: 54.08:005.6 Prethodno priopćenje/Preliminary communication Primljeno: 10. siječnja, 2012./Received: January 10th, 2012 Prihvaćeno: 6. veljače, 2012./Accepted: February 6th 2012

Izvor: Zbornik radova 13. međunarodnog simpozija o kvaliteti Kvaliteta i društvena odgovornost, Hrvatsko društvo menadžera kvalitete, Zagreb, Solin, 2012, str. 135-147.

ABSTRACT In this article there will be presented the manufacturing of the fictious sterile parenteral solution. The special emphasis will be put on the sterilization method, which should be selected from all the available methods. Those methods will be compared and selection arguments will be stated. The selected method will be described in details, including all the required activities, premises and equipment, as well as the critical points.

Key words: pharmaceutical quality management, sterile products, sterilization methods.

1. PRE-FORMULATION DATA A new sterile product should be developed as parenteral solution with active ingredient concentration of 50 mg/ml.

1.1. Basic data During the pre-formulation studies the following data were discovered: • Active ingredient is water soluble, with solubility more than 200 mg/ml; • Melting point of the active ingredient is about 220 °C; • Aqueous solution undergoes decomposition of 4-5 % when stored 4 days at 80 °C; • Decomposition is independent of pH in range of 4-9.


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