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Mahesh M ★ India, 2016-01-08 11:56 (3362 d 17:00 ago) Posting: # 15803 Views: 5,973 |
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Dear All, My concern regarding multilayer tablet one API is IR and another is XR (combination of IR and XR) what is the exclusion criteria of subjects form PK analysis due to the emesis for FDA submission? Can we use different criteria for IR and XR as per FDA guidance or this combination product consider as modified release dosage form? Regards M |
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Mahesh M ★ India, 2016-01-13 13:46 (3357 d 15:10 ago) @ Mahesh M Posting: # 15823 Views: 4,553 |
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Please share your thoughts on that. Regards Edit: Please follow the Forum’s Policy. Five days ≠ two weeks. [Helmut] |
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jag009 ★★★ NJ, 2016-01-26 18:56 (3344 d 10:01 ago) @ Mahesh M Posting: # 15858 Views: 4,152 |
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❝ Please share your thoughts on that. I've done a few of those IR/XR or IR/ER bilayer tablets before and emesis was be based on IR. It's one tablet for administration. Why would you based on MR for emesis dropout criteria? John |
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Dr_Dan ★★ Germany, 2016-01-28 09:57 (3342 d 19:00 ago) @ jag009 Posting: # 15871 Views: 3,941 |
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Dear John Is there a possibility that tmax of the IR formulated drug is greater than tmax of the MR formulated? In this case you should based on MR for emesis dropout criteria, right? As you said, it's one tablet for administration... Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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jag009 ★★★ NJ, 2016-01-29 23:51 (3341 d 05:06 ago) @ Dr_Dan Posting: # 15898 Views: 3,865 |
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Hi Dr.Dan, ❝ Is there a possibility that tmax of the IR formulated drug is greater than tmax of the MR formulated? For MR product emesis criteria we would base on the dosing interval (ie, once daily then 24 hr) and not the Tmax. I assume the original post "XR" means MR product? Thanks John |
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Shuanghe ★★ Spain, 2016-01-28 14:00 (3342 d 14:56 ago) @ Mahesh M Posting: # 15877 Views: 3,920 |
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Dear All, I had a feeling that you guys were talking different things. e.g., asking about oranges and answered about apples.  ❝ My concern regarding multilayer tablet one API is IR and another is XR (combination of IR and XR) ... So I guess that means 1 APIs, compound A is IR and compound B is XR (that seems strange though). I believe John and Dan were talking about 1 API, compound A, which was formulated part as IR and part as XR so IR part can be released quickly to have quick initial effect and XR part released slowly to maintain the therapeutic effect, which is common for new pain killer formulation. Depending on which scenario I guess the answer should be different. — All the best, Shuanghe |
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jag009 ★★★ NJ, 2016-01-30 00:02 (3341 d 04:55 ago) @ Shuanghe Posting: # 15899 Views: 3,858 |
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Hi Shuanghe, But does it matter if it's IR/XR with a single API or IR with API A and XR with API B? The emesis criteria should be based on the IR Tmax. Okay, unless there is an IR product out there which has a really long Tmax such that it's actually longer than the dosing interval of the modified release. Thanks John |
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Shuanghe ★★ Spain, 2016-02-01 12:01 (3338 d 16:56 ago) @ jag009 Posting: # 15906 Views: 3,701 |
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Hi John, The difference is subtle. I would use IR Tmax as criteria if the product is of 1 API with 2 release components IR and ER. If the product is of 2 APIs, A (IR) and B (ER), then I would use separate criteria for each of them. e.g., if subject vomit during dosing interval, exclude for B but depending on when, this subject might (>2 x IR Tmax) or might not (<= 2xIR Tmax) be included for A. All scenarios should be described in detail in protocol of course. — All the best, Shuanghe |
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Mahesh M ★ India, 2016-02-01 14:14 (3338 d 14:43 ago) @ Shuanghe Posting: # 15908 Views: 3,624 |
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Hi, Shuanghe, I do agree with your thoughts but if we talk regarding bilayer or multilayer tablet it should consider as modified dosage form. And if the combination in capsule 1 API is IR tablet and 2 is modified release pallets then I would use separate criteria for each of them. e.g., if subject vomit during dosing interval, exclude for B but depending on when, this subject might (>2 x IR Tmax) or might not (<= 2xIR Tmax) be included for A. Regards |
Ing. Helmut Schütz