VALIDATION OF THE LABORATORY – SCALE
TECHOLOGICAL PROCESS PREPARATION OF
A COLONIC RELEASE PHARMACEUTICAL
SYSTEM WITH PH AND TIME-CONTROL.
I. TOMUŢĂ*, S.E. LEUCUŢA
Department of Pharmaceutical Technology and Biopharmaceutics,
Faculty of Pharmacy, "Iuliu Hatieganu" University,
RO-400012, Cluj-Napoca, Romania
*coresponding author: tomutaioan@umfcluj.ro
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Abstract:

Validation of a manufacturing process is performed in order to ensure that the manufacturing process does what it purports to do. Pharmaceutical process validation guarantees the reliability and reproducibility of the manufacturing process.
The aim of this experimental work was to validate laboratory scale manufacturing process of a pharmaceutical system with pH and time-control colonic delivery system. The pharmaceutical system consists in minitablets with indomethacin as model drug and sodium starch glycolate, as swelling agent, coated with a retardation layer that contains: an inner polimeric film insoluble and permeable (Eudragit RS) and an exterior polimeric enteric layer soluble pH – dependent (Eudragit L 55). The following steps of the technological process were validated: blending, tabletting, coating with Eudragit RS and coating with Eudragit L 55. For each step of the pharmaceutical process the critical process parameters, responses with method of evaluation and acceptance criteria were established.
The results obtained on three laboratory scale batches performed in different days show that lab-scale technological processes are reliable and reproducible..

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