Solid Forms of Tenofovir Disoproxil Fumarate, Their Mutual Conversion, and Stabilization of Form I in Formulation

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22310%2F16%3A43902372" target="_blank" >RIV/60461373:22310/16:43902372 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1016/j.xphs.2016.07.002" target="_blank" >http://dx.doi.org/10.1016/j.xphs.2016.07.002</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.xphs.2016.07.002" target="_blank" >10.1016/j.xphs.2016.07.002</a>

Result language
angličtina
Original language name
Solid Forms of Tenofovir Disoproxil Fumarate, Their Mutual Conversion, and Stabilization of Form I in Formulation
Original language description
Tenofovir disoproxil fumarate (TDF, form I) is an orally delivered pharmaceutical salt used for the treatment of HIV and chronic hepatitis, which acts as an inhibitor of nucleotide reverse transcriptase. There are many solid forms of TDF described in the literature; 2 of them were identified in the drug products: form I and form A. It seems that during formulation, the active pharmaceutical ingredient undergoes partial to total conversion of TDF form I to TDF form A. The goals of this study were to investigate when and why did the conversion occur and whether the conversion could be avoided and how. The influence of pH and possible interaction with excipients were studied. The conditions enabling using wet granulation in technology while preventing the undesired conversion were found. The stabilization was achieved either by replacement of used disintegrants or by acid addition to the current composition of formulation. ? 2016 American Pharmacists Association?
Czech name
—
Czech description
—

Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FR - Pharmacology and apothecary chemistry
OECD FORD branch
—

Project
<a href="/en/project/GA14-03636S" target="_blank" >GA14-03636S: Preparation and characterization of advanced multicomponent pharmaceutical solids with targeted physicochemical properties</a><br>
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Similar results(10)