Author/Editor     Vrbinc, Miha; Kmetec, Vojko
Title     Fizikalna stabilnost in kompatibilnost trdnih snovi v predformulacijskih študijah trdnih farmacevtskih oblik
Translated title     Physical stability and compatibility of solid-state substances in preformulation studies of solid dosage forms
Type     članek
Source     Farm Vestn
Vol. and No.     Letnik 53, št. 4
Publication year     2002
Volume     str. 367-76
Language     slo
Abstract     Preformulation studies are very important in the development of new drug. They have influence on efficacy, safety and quality of medicinal product. Problems of preformulation studies must be solved from different points of view: analytics, stability and pharmaceutical technology. One of the main characteristics that should be solved is the study of crystallinity of solid-state substances, which are the source of different physical properties, e. g. solubility and dissolution rate. Compatibility studies of drug and (candidate) excipients are part of preformulation studies, too. The performance of compatibility studies is not strictly controlled by guidelines. Their extent and performance is mainly dictated by the preformulation group. Performance of preformulation studies can in major extent eliminate problems of instability during shelf-life period caused by the selection of unsuitable excipients.
Summary     Predformulacijske študije so zelo pomembne v razvoju učinkovitega, varnega in kakovostnega zdravila. Problematiko predformulacijskih študij je potrebno proučevati z različnih vidikov: analitike, stabilnosti in farmacevtske tehnologije: Eden ključnih vidikov je spremljanje kristalnega stanja snovi, iz česar izhajajo številne fizikalne lastnosti, npr. topnost in hitrost raztapljanja. Bistvena pa je tudi izvedba kompatibilnostnih študij zdravilne učinkovine s (potencialnimi) pomožnimi snovmi. Izvedba predformulacijskih študij ni podvržena strogo določenim smernicam, ampak sta njihov obseg in izvedba v veliki meri prepuščena izvajalcem le-teh. Z izvedbo predformulacijskih študij se lahko v veliki meri izognemo nestabilnosti, ki se pojavi zaradi izbora neustreznih pomožnih snovi.
Descriptors     DRUG APPROVAL
TECHNOLOGY, PHARMACEUTICAL
DRUG STABILITY