IDENTIFICATION OF CRITICAL
FORMULATION VARIABLES FOR OBTAINING
METOPROLOL TARTRATE MINI-TABLETS.
MIRELA BODEA1*, IOAN TOMUŢĂ2, SORIN LEUCUŢA2
1 S.C. Terapia-Ranbaxy, Cluj Napoca, Romania
2Department of Pharmaceutical Technology and Biopharmaceutics,
Faculty of Pharmacy, “Iuliu Hatieganu” University, Cluj-Napoca,
400023, Romania
*corresponding author: mirela.bodea@ranbaxy.com
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Abstract:
The aim of this experimental work was the obtaining of mini-tablets with 3 mm diameter containing metoprolol tartrate as active ingredient. They can be used either as pediatric medication or adult medication after further coatings, in order to obtain modified release mini-tablets.
The mini-tablets were prepared using an eccentric tabletting machine after a fluid bed granulation of the components. The dosage form with proper pharmaceutical and physico-chemical properties: no sticking, uniformity of weight and content uniformity in required limits, as well as desired immediate release of the drug was obtained. The formulation with these properties contained: 20% of the active drug, lactose as filler for fluid bed granulation, Cellactose 80 as extra granular diluent, as well as magnesium stearate and Compritol as lubricants.
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