Multivariate calibration of the degree of crystallinity in intact pellets by X-ray powder diffraction
  • Metaadatok
Tartalom: http://real.mtak.hu/41347/
Archívum: MTA Könyvtár
Gyűjtemény: Status = Published


Type = Article
Cím:
Multivariate calibration of the degree of crystallinity in intact pellets by X-ray powder diffraction
Létrehozó:
Nikowitz, Krisztina
Domján, Attila
Pintye-Hódi, Klára
Regdon, GĂ©za
Kiadó:
Elsevier
Dátum:
2016-02-16
Téma:
QD Chemistry / kémia
RM Therapeutics. Pharmacology / terápia, gyógyszertan
Tartalmi leírás:
XRPD is the method of choice to determine crystalline content in an amorphous environment. While
several studies describe its use on powders, little information is available on its performance on
finished
products. The method’s use may be limited not only by the need of sample pretreatment and its
validation but also by the propensity of some materials to recrystallize when exposed to heat or
mechanical stress. In this work the authors describe an attempt at constructing a model based on the
XRPD measurement of intact layered pellets using univariate methods based on peak heights and PLS
regression. Results indicate that neither the goodness-of-fit (below 0.9 for all tested variables), nor the
RMSEC values (above 5 for all tested variables) of any model based on peak height were good enough to
consider them for everyday use. PLS regression however provided a model with improved characteristics
(R2 = 0.9581, RMSEC = 3.04) despite the low API content and individual loading characteristics also
reflected the validity of the model. PLS analysis also indicated that a specific sample may be different in
some formulation characteristic that did not register on other examinations. This further indicates the
method’s usefulness in the analysis of intact dosage forms.
Nyelv:
magyar
Típus:
Article
PeerReviewed
info:eu-repo/semantics/article
Formátum:
text
Azonosító:
Nikowitz, Krisztina and Domján, Attila and Pintye-Hódi, Klára and Regdon, Géza (2016) Multivariate calibration of the degree of crystallinity in intact pellets by X-ray powder diffraction. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 502 (1-2). pp. 107-116. ISSN 0378-5173
Kapcsolat:
doi:10.1016/j.ijpharm.2016.02.018