کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2505346 | 1557487 | 2008 | 12 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Moisture sorption, compressibility and caking of lactose polymorphs Moisture sorption, compressibility and caking of lactose polymorphs](/preview/png/2505346.png)
The aim of this study was to conduct storage studies on the moisture sorption and caking properties of lactose powder containing different polymorphs (i.e. α-monohydrate, α-anhydrous unstable, α-anhydrous stable, β-anhydrous) and spray-dried lactose. The dry sample was compacted using a texture analyzer in paper cylinders and stored at relative humidity (RH) of 33%, 43%, 57% and 75% (25 °C, for 3 months). The samples were monitored for weight gain, moisture content, α/β balance and hardness. A simple new method of powder compression for measuring the degree of hardness of caked lactose was developed using a texture analyzer. Clear distinctions were found in the storage behavior of the five different samples. Storage at various RHs caused severe caking to β-lactose anhydrous and spray-dried lactose. The β-lactose anhydrous was hygroscopic at 75% RH. The spray-dried lactose, which contained some amorphous lactose, was hygroscopic at all RHs studied. Its moisture sorption behavior differed from that of its major component, α-lactose monohydrate, by initially absorbing moisture then desorbing. α-Lactose monohydrate was less hygroscopic at 75% RH and it formed friable cakes. The α-lactose anhydrous stable was hygroscopic at 75% RH and initially formed hard cakes which became friable during storage. The unstable form of anhydrous α-lactose was hygroscopic at all levels of RH studied but did not cake.
Journal: International Journal of Pharmaceutics - Volume 359, Issues 1–2, 9 July 2008, Pages 123–134