People who are not familiar with the recent history of dissolution testing and QbD may find the following two links useful. These links are for the transcripts of two FDA meetings (held in 2005) on the topic. These are quite long documents and worth reading every word of it. I have noted some of the quotes which may be quite interesting (shocking!). I believe that the main or one of the main reasons for starting QbD was to determine and address the issues of drug dissolution testing, in a systematic way based on valid statistical design and analysis (aka QbD). I wonder what happened to that objective and where have we been lost!!!
http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4137T1.pdf
http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4187T1.pdf
Some comments from the speakers:
Dr. Helen Winkle:
“There is no evidence that the products out there on the market are bad products. There is no evidence that the agency has done a bad job in serving as a surrogate for ensuring good quality products for the consumer. And, there is no evidence that industry is not focused on quality as an important attribute to manufacturing products.”
“I think this meeting brings us a step closer to understanding quality-by-design, especially as it relates to dissolution. I think it is really important. I think the whole topic today will really help open the door to us to move ahead in the area of dissolution, and I think we have learned a lot through our past meetings here.”
“The meeting topics that we have for this particular meeting are that we are going to talk about quality-by-design and control of drug dissolution.”
Dr. Moheb Nasr:
“ … that there rate of drug release from solid oral dosage forms is a critical quality attribute.”
“ … that you approve of our approach of implementing quality-by-design in setting dissolution specification.”
Dr. Ajaz Hussain:
“It is noted that literally 50 percent of the batches are thrown out every year because of dissolution failures, …”
“I see our colleagues from Health Canada here who have been criticizing this [dissolution test] for a long time. Thank you for coming, sir.”