Amira
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Egypt,
2014-12-15 15:10
(3391 d 06:51 ago)

Posting: # 14072
Views: 5,737
 

 Surfactant in Biowaiver media [Dissolution / BCS / IVIVC]

When should surfactant be used in Biowaiver media as guidelines state that the 3 pH medias are done without surfactant?

Thanks,


Edit: Category changed. [Helmut]
Helmut
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Vienna, Austria,
2014-12-15 15:16
(3391 d 06:45 ago)

@ Amira
Posting: # 14073
Views: 4,734
 

 Surfactant in Biowaiver media

Hi Amira,

never!

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luvblooms
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India,
2014-12-16 06:29
(3390 d 15:32 ago)

@ Helmut
Posting: # 14075
Views: 4,698
 

 Surfactant in Biowaiver media

Hi Amira/Helmut

Which biowaiver we are talking about?
a) If BCS based biowaiver to be proposed then NEVER
b) If biowaiver for strengths other than bio strength: YES but need to provide sufficient justification/Data for usage of surfactant (especially in case of BCS class II/IV drugs, one have to add surfactant to show complete release)

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Helmut
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Vienna, Austria,
2014-12-16 15:00
(3390 d 07:01 ago)

@ luvblooms
Posting: # 14084
Views: 4,557
 

 Surfactant in Biowaiver media

Hi Luv & Amira

❝ Which biowaiver we are talking about?

❝ a) If BCS based biowaiver to be proposed then NEVER

❝ b) If biowaiver for strengths other than bio strength: YES


I assumed a) because Amira wrote

❝ ❝ as guidelines state that the 3 pH medias are done without surfactant


GLs sometimes leave space for interpretation (“should be”, “appropriate”, “if justified”, :blahblah:). However, “The use of any surfactant is not acceptable” is unambiguous.

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Amira
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Egypt,
2014-12-18 09:35
(3388 d 12:26 ago)

@ Helmut
Posting: # 14103
Views: 4,498
 

 Surfactant in Biowaiver media

Thanks all,

yes, I meant case a biowaiver.
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