Naslov
Stability study of losartan/hydrochlorothiazide tablets
(Stability study of losartan/hydrochlorotiazide tablets)

Autori
Lusina, Maja ; Cindrić, Tanja ; Tomaić, Jadranka ; Peko, Marijana ; Pozaić, Lidija ; Musulin, Nenad

Izvornik
International journal of pharmaceutics (0378-5173) 291 (2005), 1/2; 127-137

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
stability study ; losartan ; hydrochlorotiazide ; tablets

Sažetak
The purpose of stability testing is to investigate how the quality of a drug product changes with time under the influence of environmental factors, to establish a shelf life for the product and to recommend storage conditions. Stability study of losartan/hydrochlorothiazide tablets is presented in this paper. Losartan (angiotensin II receptor antagonist) and hydrochlorothiazide (diuretic) are successfully used in association in the treatment of hypertension. Stability study of losartan/hydrochlorothiazide tablets consisted of three steps: stress test (forced degradation study), preliminary testing (selection of packaging) and formal stability testing. The results of stress test suggested that losartan/hydrochlorothiazide tablets are sensitive to moisture. It was demonstrated that the developed analytical methods are stability indicating. Additional preliminary testing was performed in order to select appropriate packaging for losartan/hydrochlorothiazide tablets. OPA/Al/PVC//Al blisters were found to provide adequate protection for the product. Based on the first 12 months of the formal stability study, a shelf life of 24 months was proposed. Losartan/hydrochlorothiazide tablets in OPA/Al/PVC//Al blisters are demonstrated to be chemically, physically and microbiologically stable.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

Napomena
Rad je prezentiran na skupu 5th Central European
Symposium on Pharmaceutical Technology and
Biotechnology, održanom od 25.–27.09.2003.,
Ljubljana, Slovenija.

POVEZANOST RADA