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hiren379 ★ India, 2013-07-15 18:43 (4374 d 11:05 ago) Posting: # 10979 Views: 5,425 |
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Hello Friends,
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Dr_Dan ★★ Germany, 2013-07-16 14:18 (4373 d 15:29 ago) @ hiren379 Posting: # 10984 Views: 4,325 |
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Dear hiren379 Since the formulation of a drug could influence the extend of sublingual absorptions and as you pointed out in your last sentence sublingual absorption is not always 100% emesis could matter. Therefore in case of SL formulation the general exclusion criterion for IR formulation applies. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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hiren379 ★ India, 2013-07-17 09:00 (4372 d 20:47 ago) @ Dr_Dan Posting: # 10990 Views: 4,339 |
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Dear Dr Dan, ❝ Since the formulation of a drug could influence the extend of sublingual absorptions and as you pointed out in your last sentence sublingual absorption is not always 100% Agreed that SL absorption is not always 100%. But if we are in the debate of whether to consider emesis criteria for SL formulation, important thing is not SL absorption but oral bioavailability (e.g. Say we are administrating 100mg SL tablet of Drug X and 80mg is going into GIT (20mg enters into systemic circulation via SL route) but oral bioavailability is 1%, then amount of drug entering from GIT (except SL) in systemic circulation will be 0.8 mg which will hardly matter when compared to 20mg which is absorbed Sublingually. In this case emesis criteria will not help pharmacokinetically and lead to loss of data). I just wanted to confirm whether keeping emesis criteria for SL formulations solemly based on fraction of dose getting GI absorbed is scientifically correct and accepted by developed regulatories or not??? Regards, Hiren |
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Dr_Dan ★★ Germany, 2013-07-17 12:38 (4372 d 17:10 ago) @ hiren379 Posting: # 10992 Views: 4,313 |
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Dear Hiren I think in your example there is a misunderstanding: if you administer 100mg of Drug X and the bioavailability is 1% than according to your example 0.8mg went into the systemic circulation via GIT and 0.2mg are absorbed sublingually. In such a case emesis will definetly matter. BTW how do you exactly know how much of a drug is absorbed sublingually or in the GIT? This strongly depends on your formulation. All you see in the BE study is the systemic bioavailability. Oral bioavailability does not mean sublingual bioavalability! Oral bioavalability just defines the portion of a drug available after oral (including sublingual) administration in contrast to e.g. rectal or transdermal application. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz