6533b82bfe1ef96bd128cf1d
RESEARCH PRODUCT
Toward Mechanistic Design of Surrogate Buffers for Dissolution Testing of pH-Dependent Drug Delivery Systems
Jozef Al-gousousJozef Al-gousousAnnika Marielina PostinaChristoph WilhelmyMarcus GettoJohannes Andreas BlecharPeter Langguthsubject
HPMCPBicarbonatebiorelevantPharmaceutical Sciencelcsh:RS1-441dissolutionbicarbonatesurrogate bufferEudragitArticleDosage formlcsh:Pharmacy and materia medicachemistry.chemical_compoundmedicineDissolution testingenteric coatingcitrateDissolutionchemistry.chemical_classificationChromatographyHPMCASPolymersuccinateEnteric coatingchemistryIonic strengthDrug deliverymedicine.drugdescription
The in vivo dissolution of enteric-coated (EC) products is often overestimated by compendial in vitro dissolution experiments. It is of great interest to mimic the in vivo conditions as closely as possible in vitro in order to predict the in vivo behavior of EC dosage forms. The reason behind this is the overly high buffering capacity of the common compendial buffers compared to the intestinal bicarbonate buffer. However, a bicarbonate-based buffer is technically difficult to handle due to the need for continuous sparging of the media with CO2 to maintain the desired buffer pH. Therefore, bicarbonate buffers are not commonly used in routine practice and a non-volatile alternative is of interest. A mathematical mass transport modelling approach was previously found to enable accurate calculation of surrogate buffer molarities for small molecule compounds
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2020-12-10 | Pharmaceutics |