A fixed dose combination dissolution evaluation [Dissolution / BCS / IVIVC]

posted by mahonny – India, 2014-04-04 09:00  – Posting: # 12764
Views: 6,904

Dear Friends,

Many times i read topics in the forum and take advantage of your comments. Today i would like to ask a question for your evaluation.

We are working on a fixed dose combination product. Dissolution profiles of reference and test product are given below. API1 is BCS class I drug, whereas API2 is BCS class III.

Sampling points are 5-10-15-20-30-45 mins.

0.1 N HCl, 900 ml, 50 rpm, Pedal
API1
R

31.9
59.1
74.7
80.4
83.7
85.2

T
25.7
52.8
76.0
88.1
92.7
93.6

API2
R

42.2
77.1
91.6
95.2
95.7
94.8

T
30.5
60.3
84.2
95.3
97.2
97.7

pH 6.8, 900 ml, 50 rpm, Pedal
API1
R

21.1
48.5
72.1
83.2
88.9
92.3

T
23.0
45.2
72.1
92.3
102.8
102.4

API2
R

25.8
44.9
59.5
69.6
82.4
92.5

T
21.4
43.6
70.5
91.0
101.9
101.4

Do you think this formulation is eligible for BE study? For Class III drugs, drcampos has pointed that points earlier that 30 mins are negligible due to the fact that absorbtion is limiting step in BE study

http://forum.bebac.at/mix_entry.php?id=3314&page=0&category=0&

PS. API1 will be administed as one dose tablet whereas API2 will be of two doses in BE study. (Ref= A total of 3 tablets, Test= 1 tablet)

Looking for your kind comments.
Regards,
Mahonny

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