JOURNAL ARTICLE

Analysis of wet granulation process with Plackett-Burman design—case study

Krzysztof Woyna-Orlewicz, Renata Jachowicz
Acta Poloniae Pharmaceutica 2011, 68 (5): 725-33
21928718
According to Process Analytical Technology perspective, drug product quality should be ensured by manufacturing process design. Initial step of the process analysis is investigation of critical process parameters (CPPs). It is generally accepted to type the CPPs based on project team knowledge and experience [5]. This paper describes the use of Design of Experiments tool for selection of the CPPs. Seven factors of wet granulation process were investigated for criticality. Low and high levels of each factor represented maximal and minimal settings of wide operational ranges. Granulates were produced in line with Plackett-Burman experimental matrix, blended with extra-granular excipients and compressed into tablets. Semi-products and final products were tested. Out of specification result of any critical quality attribute was treated as critical failure. The high-shear granulation factors, i.e. quantity of binding solution, rotational speed of impeller and wet massing time were considered of critical importance. Operational ranges of the parameters were optimized. The process performance was confirmed in qualification trials.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
21928718
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"