Avtor/Urednik		Vrbinc, Miha; Kmetec, Vojko
Naslov		Fizikalna stabilnost in kompatibilnost trdnih snovi v predformulacijskih študijah trdnih farmacevtskih oblik
Prevedeni naslov		Physical stability and compatibility of solid-state substances in preformulation studies of solid dosage forms
Tip		članek
Vir		Farm Vestn
Vol. in št.		Letnik 53, št. 4
Leto izdaje		2002
Obseg		str. 367-76
Jezik		slo
Abstrakt		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.
Izvleček		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.
Deskriptorji		DRUG APPROVAL TECHNOLOGY, PHARMACEUTICAL DRUG STABILITY