http://rdf.ncbi.nlm.nih.gov/pubchem/patent/WO-2019053451-A2

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filingDate 2018-09-14-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_ddfe5b64a0a944dde9e8f92c22b346da
http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_c66d3224f1f833bffb035d08da66feb5
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publicationDate 2019-03-21-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber WO-2019053451-A2
titleOfInvention APPARATUS, BUFFER AND METHOD FOR CONTROLLING PH
abstract The present invention relates to an apparatus, buffer solutions and method for pH control of in vitro dissolution tests used to monitor the drug release rate from solid unit dosage forms to predict their effects in vivo or for the purpose of quality control. In particular, the present invention relates to a process for the preparation of a continuous condition and an aqueous solution based on bicarbonate ions for the in vitro dissolution test of pharmaceutical products comprising a) providing a solution (solution A ) to create a test condition b) exposing a solid unit of a test drug to solution A for a predetermined period of time c) adding one or more solutions to solution A for changing the test condition and obtaining a solution F, the solutions being selected from the following: i) an aqueous alkaline solution comprising a base that accepts protons from any proton donor and / or at least partially releases hydroxide ions in an aqueous environment (solution B); ii) an aqueous solution of one or more inorganic salts which at least partially dissociate into ions of phosphate, potassium, sodium, chloride, calcium and magnesium (solution C); iii) an aqueous solution comprising bicarbonate ions (solution D); iv) a solution comprising lipids and bile salts (solution E). In particular, the present invention also relates to an enclosure device (10, 110) for use in performing pH control and stabilization on a bicarbonate solution used in the dissolution test. in vitro comprising a plate (11) attached to an annular chamber (14) comprising a hollow cavity (16), the plate (11) comprising at least one opening (26) extending over the entire thickness of the plate, the at least one aperture (26) being configured to be connected at one end to at least one gas supply and at the other end to connect to the hollow cavity (16) of the annular chamber, and a plurality of orifices (20) extending from the hollow cavity (16) in the direction away from the plate (11) through the entire thickness of the annular chamber (14) .
priorityDate 2017-09-16-04:00^^<http://www.w3.org/2001/XMLSchema#date>
type http://data.epo.org/linked-data/def/patent/Publication

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