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Tina ★ India, 2013-10-03 14:45 (4646 d 12:26 ago) Posting: # 11595 Views: 4,377 |
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Dear forum members, We are planning to develop a product as an oily solution. The comparator are IR tablets. The comparator was approved in the EU in 1960s. Considering formulation related effects of oily solution vs tablets, will I be justified using the bibliographic approach? both are IR preparations. The oily solution has the same qualitative and quantitative composition of the active. Being a solution, dissolution wasnt done. Is there any possibility of applying the biowaiver/bibliograhic route considering the fact the invivo BE is unlikely to be shown (just hypothesis)? Has anyone done a BE study with oily solution vs IR tablets and have shown BE? Kind regards, Tina. |
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Helmut ★★★   Vienna, Austria, 2013-10-03 15:01 (4646 d 12:10 ago) @ Tina Posting: # 11596 Views: 3,841 |
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Hi Tina! ❝ […] Being a solution, dissolution wasnt done. Hhm, I don’t know whether regulators would accept that. For an example see
❝ Is there any possibility of applying the biowaiver/bibliograhic route… A biowaiver is based on an in vitro comparison, which you haven’t done. ❝ …considering the fact the invivo BE is unlikely to be shown (just hypothesis)? You have no in vitro similarity and hypothesize (!) that you will not have in vivo BE – why do you think you will get an approval? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Tina ★ India, 2013-10-03 15:16 (4646 d 11:56 ago) @ Helmut Posting: # 11597 Views: 3,836 |
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Dear Helmut, The test is an oily solution. How can dissolution tests be done with solution? The formulators couldnt make an acqueous solution considering the pharmaceutical properties of the API and stability of the acqueous solution. Kind regards, Tina |
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Helmut ★★★ Vienna, Austria, 2013-10-03 15:35 (4646 d 11:37 ago) @ Tina Posting: # 11598 Views: 3,824 |
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Hi Tina, ❝ The test is an oily solution. How can dissolution tests be done with solution? Sorry, my mistake. How is the formulation dosed? Do you have a metered dispenser? We once performed a comparative BA study (no BE!) of an oily solution (new formulation) vs. liquid filled capsules (US product) in the course of a European hybrid application. Too bad that the clinical study later on failed… See also the section “Oral Solutions” in the IR GL: In those cases where the test product is an oral solution which is intended to be bioequivalent to another immediate release oral dosage form, bioequivalence studies are required. Even if you walk the route of “well established use” I can’t imagine that European regulators accept the application based on simply claiming “Our product – if dosed properly – contains the same amount of API like the IR tablet”. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Tina ★ India, 2013-10-03 17:10 (4646 d 10:01 ago) @ Helmut Posting: # 11600 Views: 3,770 |
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Dear Helmut, Unlike comparison with solid oral dosage form, comparative bioavailability studies are a nightmare! We once did a study with liquid filled capsule vs tablets which failed (esp with Cmax)... no way we could design formulation which can have Cmax satisfying BE criteria especially between our tablets vs the liquid filled capsule and had to discontinue further development. Hybrid application though sounds different often has a BA/BE study difficult to achieve bioequivalence. As far as dosing the oily solution is concerned, adequate volume of solution will be given to match the quantity of active ingredient in the comparator tablets! Kind regards, Tina |
Ing. Helmut Schütz