Characterization of physicochemical properties of hydroxypropyl methylcellulose (HPMC) type 2208 and their influence on prolonged drug release from matrix tablets
Devjak Novak, Sabina (Author), Šporar, Elena (Author), Baumgartner, Saša (Author), Vrečer, Franc (Author)

URLURL - Presentation file, Visit http://www.sciencedirect.com/science/article/pii/S0731708512001550 This link opens in a new window

The key physicochemical properties of functional excipients should be identified, and the influence of their variability on the properties of the final dosage form should be evaluated during the development phase. Excipients produced by different manufacturers and/or by differentb manufacturing processes should have comparable properties. Hydroxypropyl methylcellulose (HPMC) with a high molecular weight is a functional excipient often used in solid matrix systems with prolonged release of active pharmaceutical ingredients (API). This study investigates whether HPMC manufactured by two manufacturers using different chemical procedures differs in particle-size distribution, particle shape, particle morphology, chemical composition, and dissolution of diclofenac sodium as a model drug. NIR spectroscopy was introduced and calibration models were developed to detect physical differences among HPMC batches from two different origins. The physical differences between HPMC samples were additionally confirmed with scanning electron microscopy (SEM), gas chromatography (GC) measurements, and dissolution testing of hydrophilic matrix tablets. Our results prove that, even if HPMC polymers manufactured from two different sources comply with the pharmacopeial specification, they significantly differ in physicochemical properties and thus influence the properties of the formulated dosage forms.

Keywords:HPMC, sproščanje učinkovin, kalibracijski modeli, NIN, matrične tablete
Work type:Not categorized (r6)
Tipology:1.01 - Original Scientific Article
Organization:FFA - Faculty of Pharmacy
Number of pages:str. 136-143
Numbering:Vol. 66, july
ISSN on article:0731-7085
DOI:10.1016/j.jpba.2012.03.032 Link is opened in a new window
COBISS.SI-ID:3232625 Link is opened in a new window
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Record is a part of a journal

Title:Journal of pharmaceutical and biomedical analysis
Shortened title:J. pharm. biomed. anal.
Publisher:Pergamon Press
COBISS.SI-ID:6557447 This link opens in a new window

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