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joyjac ★ Philippines, 2012-01-12 10:45 (4869 d 09:16 ago) Posting: # 7911 Views: 9,046 |
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Hi colleagues, May I have your thoughts on this. How are effervescent tablet preparations administered in BE studies, that is, do we still need to give 200 mL of water following the dosing? Thanks. |
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MGR ★ India, 2012-01-12 13:14 (4869 d 06:47 ago) @ joyjac Posting: # 7913 Views: 8,143 |
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Hi Jojac, IMHO. Yes we still need to give water following the dosing. For Example please have a look of the below link: USFDA Recommendation of Individual product of Ranitidine — Regards, MGR |
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Helmut ★★★   Vienna, Austria, 2012-01-13 18:11 (4868 d 01:51 ago) @ MGR Posting: # 7933 Views: 8,051 |
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Dear MGR & Joy! One precaution: make sure that the API in solution is not absorbed at the walls of the beaker you are using. We once found absorption on disposable polystyrene beakers.  — 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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shyam_5p ☆ India, 2012-01-31 07:55 (4850 d 12:06 ago) @ MGR Posting: # 8021 Views: 7,865 |
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❝ IMHO. Yes we still need to give water following the dosing. For Example please have a look of the below link: ❝ USFDA Recommendation of Individual product of Ranitidine Gone through the Guideline for Ranitidine effervescent tablets, its state that "Wait until the tablet is completely dissolved before administering the solution.". My query is that as we are converting the tablet in solution, is it necessary to study the BE??.   |
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Ohlbe ★★★ France, 2012-01-31 18:55 (4850 d 01:06 ago) @ shyam_5p Posting: # 8029 Views: 7,921 |
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Dear Shyam, ❝ Gone through the Guideline for Ranitidine effervescent tablets, its state that ""Wait until the tablet is completely dissolved before administering the solution."". My query is that as we are converting the tablet in solution, is it necessary to study the BE??. "Dissolution" of an effervescent tablet does not mean dissolution of the active substance it contains, and you may actually get a suspension. If you read the ranitidine guidance further, it continues with "Subsequently, after swallowing the solution, any residue should be re-suspended in 240 mL of water and swallowed by the subjects". Regards Ohlbe — Regards Ohlbe |
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shyam_5p ☆ India, 2012-02-01 05:01 (4849 d 15:01 ago) @ Ohlbe Posting: # 8035 Views: 7,883 |
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❝ "Dissolution" of an effervescent tablet does not mean dissolution of the active substance it contains, and you may actually get a suspension. If you read the ranitidine guidance further, it continues with "Subsequently, after swallowing the solution, any residue should be re-suspended in 240 mL of water and swallowed by the subjects". Dear Dr. Ohlbe and Dr.S.Gunasakaran, Thanks for your reply. if we read the dosage and administration of Ranitidine Effervescent Tablets, it states - Preparation of ZANTAC 25 EFFERdose Tablets: Tablets should not be chewed, swallowed whole, or dissolved on the tongue. Dissolve 1 tablet in no less than 5 mL (1 teaspoonful) of water in an appropriate measuring cup. Wait until the tablet is completely dissolved before administering the solution to the infant/child. The solution may be administered to infants by medicine dropper or oral syringe. If we take the example of only ranitidine, we know that Ranitidine is soluble in water and we will get drug solution before we administered the dosage. Still I am not convince for BE study of Ranitidine Effevescent Tablets. when posology of formulation states that " can be swallowed as such" (e.g. Prednisolon Soluble tablets 5 mg- EU SPC)then I agree that we need to perform BE study on worst case situation. Please comment on the same also. (whether my assumption is correct???). |
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drgunasakaran1 ★★  2012-01-31 19:01 (4850 d 01:00 ago) @ shyam_5p Posting: # 8030 Views: 8,000 |
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Dear Mr.Shyam, If you gone through the FDA recommendation for Ranitidine Effervescent tablets it states that "The following passage is reproduced from the Dosage and Administration section of the labeling": Tablets should not be chewed, swallowed whole, or dissolved on the tongue. Dissolve 1 tablet in no less than 5 mL (1 teaspoonful) of water in an appropriate measuring cup. Wait until the tablet is completely dissolved before administering the solution. Subsequently, after swallowing the solution, any residue should be re-suspended in 240 mL of water and swallowed by the subjects. Kindly be informed that the dosing of Effervescent tablets in BE study will be based on the mode of drug administration provided in the Patient Information Leaflet or Prescribing Information of the Reference product you are going to compare with your formulation. The text given in the Guidance "Wait until the tablet is completely dissolved before administering the solution" is only to emphasis that the effervescent tablet need to get dissolved completely before administration to the subjects. Don't get confused with the BE waiver given for Oral solution. It is normally recommended to do BE study with Effervescent tablets. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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shyam_5p ☆ India, 2012-02-08 12:24 (4842 d 07:38 ago) @ drgunasakaran1 Posting: # 8073 Views: 7,752 |
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Dear Dr. Ohlbe and Dr.S.Gunasakaran, Thanks for your reply. if we read the dosage and administration of Ranitidine Effervescent Tablets, it states - Preparation of ZANTAC 25 EFFERdose Tablets: Tablets should not be chewed, swallowed whole, or dissolved on the tongue. Dissolve 1 tablet in no less than 5 mL (1 teaspoonful) of water in an appropriate measuring cup. Wait until the tablet is completely dissolved before administering the solution to the infant/child. The solution may be administered to infants by medicine dropper or oral syringe. If we take the example of only ranitidine, we know that Ranitidine is soluble in water and we will get drug solution before we administered the dosage. Still I am not convince for BE study of Ranitidine Effevescent Tablets. when posology of formulation states that "can be swallowed as such" (e.g. Prednisolon Soluble tablets 5 mg- EU SPC) then I agree that we need to perform BE study on worst case situation. Please comment on the same also. (whether my assumption is correct???). |
Ing. Helmut Schütz