Krzysztof Woyna-Orlewicz, Renata Jachowicz

Ocena krytyczności parametrów sporządzania tabletek w analizie procesów technologicznych
2006-06-01

Criticality assessment of process parameters of tablet manufacturing in process analytical technology. Process operating parameters were studied for criticality assessment. Tablets containing BCS I class active ingredient and high molecular binder HPMC or Copovidone were manufactured within granulation, fluid bed drying, screening and compression steps. The process parameters were screened in line with Plackett-Burman experimental design. Amount of binding solution and impeller speed during massing are found critical for the HPMC formula. No one parameter looks critical for Copovidone based formula. Dissolution profiles were tested in various media. The formula containing HPMC demonstrates not adequate dissolution profile while tested in buffer solution of pH 6.8. The Copovidone based formula dissolves the active substance in similar manner to the reference drug within all tested media (of pH 1.2, 4.5 and 6.8).