Supervisors info:
Ρέκκας Δημήτριος Αναπλ. Καθηγ.(Επιβλέπων), Δάλλας Παρασκευάς Επικ. Καθηγ., Βαλσαμή Γεωργία Επικ. Καθηγ.
Summary:
The objective of this study was the development and characterization of a lean,
environmentally friendly direct pelletization process for the production of
immediate release pellets with the use of effervescence as a disintegration
mechanism. The process was studied using a full factorial design with 9 runs.
Pellets were prepared with the tangential spray technique in rotor granulator
(Glatt GPCG3, Glatt GmbH, Dresden, Germany). Powder mixtures of Diclofenac
sodium (10%) and a mixture (90%) of effervescent mixture containing Sodium
Bicarbonate (SB) and Citric acid and Microcrystalline cellulose (MCC) in
various ratios. The results were evaluated with DoE techniques using Design
Expert® V. 8.0.1, Stat-ease Inc, Minneapolis. The responses of the experimental
design were the Geometric Mean Diameter (GMD), the Geometric Standard Deviation
(GSD), the sphericity factor eR, and their dissolution profile. It is possible
to produce pellets containing high quantity of MCC (>70%) and which
disintegrate and immediately release sodium Diclofenac with a one stage,
environmental friendly, safe and cost - effective process.
Keywords:
Pellets, Effervescent, Rotor Granulator, Experimental Design, Immediate Release
