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Dear Mr.Kausal(loveladli), Marival (Bibilina),Walt Woltosz and Helmet(Bebac),
I seek your opinion in one of products - similarity factor f2 value of
dissolution study is not complying on comparison with originator products
moreover, our product gets rapidly dissolved more than 85 % within 15
mins.that's too in all 3 media whereas Innovator product hardly dissolved
15 -20 % within 30 mins and after 60 mins only crossing 85%.This products
was sent to one clinical Lab for BA/BE studies but they suggested don't
proceed further as not matching in dissolution stage itself only but my
strong opinion it suppose to be passed in BA/BE studies viewing rapid
dissolution pattern.
Since as per guidance of FDA (CDER) August 1997, The BCS suggests that in
some instances for high solubility ,low permeability drugs, 85% dissolution
in 0.1 N HCl in 15 minutes can ensure that the bioavailability of the drug
is not limited by dissolution, in these cases, the rate limiting step for
drug absorption is gastric emptying.The mean T50% gastric residence
(emptying) time is 15 - 20 minutes under fasting conditions.Based on this
information, a conservative conclusion is that a drug product undergoing
85% dissolution in 15minutes under mild dissolution conditions 0.1N HCl
behaves like a solution and generally should not have any bioavailability
problems.
What is your comments in this regard.
regards,
Dr. K.K.Chakraborty
R&D Manager
Mobile - 00966 - 551580172
E-mail - kkchakrabor.at.yahoo.com
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