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We need to find some literature data in order to get a bio waiver for Betahistine 16mg (to prove that it is BCS Class I).
Does such literature exist?
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Dear Maya Sabo,
The conditions for the suitability of biowaiver of betahistine have been discussed in CHMP taking into account: solubility, dissolution, and absorption/permeability. The CHMP finally concluded that Betahistine falls under the BCS category I based on the data submitted.
The results of solubility study showed a high solubility of the active substance of betahistine about a broad pH range.
Considering the dissolution test, both strengths of the test product can be classified as "very rapid dissolving tablets". The drug substance is completely and fast dissolved independent of the applied medium.
The evaluation of the permeability and the absorption of the active substance was derived from a bioequivalence and a mass balance study in vivo.
The BCS-studies of betahistine substance and formulations presented herein along with the properties of the drug substance (therapeutic index, safety and complete absorption) and the formulations (composition) provided robust support for waiving in vivo BE studies for Betavert N. Moreover, betahistine fulfils the regulatory requirements for granting a biowaver, being assigned to the group of compounds with high solubility and complete absorption - accordant with Class I of BCS.
The CHMP, considered these data, concluded that betahistine dihydrochloride can be assigned to the highly soluble class according to Biopharmaceutics Classification System, Class I.
For more details, refer the following weblink http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Be tavert_N_29/WC500006971.pdf
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