Preparation Technology of Tamsulosin Hydrochloride Orally Disintegrating Tablets
- VernacularTitle:盐酸坦洛新口崩片的制备工艺研究
- Author:
Mei XUE
- Publication Type:Journal Article
- Keywords:
Tamsulosin hydrochloride;
Orally disintegrating tablets;
Orthogonal experiment;
Stability
- From:
China Pharmacy
2007;0(31):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To optimize the formulation of tamsulosin hydrochloride orally disintegrating tablets by orthogonal experiment and to determine its dissolution and stability.METHODS: The formulation of tablets was optimized by orthogonal experiment based on 3 factors: the proportions of microcrystalline cellulose(A),lactose(B),and the cross-link sodium starch glycolate(C) and 3 indexes: disintegrating time(td),the wet time(t) and the suspend stability(?A).The dissolution of the tablets was determined and its stability in different condition was followed for 24 months.RESULTS: To optimum preparation technical conditions for the tablets were as follows: the proportions of A,B,and C were 30%,15% and 10%,respectively.The tablets disintegrated completely within 30 s,with mean td at(20.1?4.2) s,t(24.2?2.1) s,and ?A 0.002 4.No obvious change was noted in appearance and content for the samples within 24 mouths.CONCLUSION: The tamsulosin hydrochloride orally disintegrating tablets were up to the standards of Chinese Pharmacopeia.
