The influence of drug solubility on release behavior from polyethylene oxide matrices stored at 40oC (original) (raw)
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The aim of this study is to investigative the stability of poly(ethylene oxide) (PEO) matrix tablets containing diltiazem hydrochloride (DTZ) after five-year storage at room temperature. DTZ matrix tablets containing different molecular weights (MW) of PEO and electrolytes (sodium carbonate anhydrous Na2CO3, potassium chloride KCl and pentasodium tripolyphosphate anhydrous PSTPP) were prepared. The fresh and stored tablets were evaluated by DTZ content, in vitro drug release rates and kinetics as well as DSC. All the PEO’s matrix tablets showed no significant changes in release rate, kinetics and drug content. The release rates of DTZ following five-year storage were slightly increased as the MW of PEO increased from 900,000 to 8,000,000. Also, it was clear that the addition of electrolyte drastically slowed the release rates of DTZ from fresh and stored tablets. DSC thermograms and similarity factor (ƒ2) depicted good system stability for all stored tablets. This is the first five-year long-term stability study reported concerning DTZ/PEO matrix tablets with different MW, which proved its stability for several years. This study might throw light on the dramatic difference observed between this study and the reported data of accelerated stability testing under stress conditions found in the literature.
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A Novel Directly Compressible Co-Processed Excipient for Sustained Release Formulation
Journal of Applied Pharmaceutical Science
A novel directly compressible (DC) co-processed excipient with improved functionality and masking the undesirable properties of individual excipients was developed without any chemical modification by using simple laboratory technique. For the development of co-processed excipient, release retarding polymers such as Polyethylene oxide (Polyox® WSR 301) and hydroxyl propyl methyl cellulose (Methocel® K4M) were used. Co-processed excipient was prepared in polymers weight ratio of 1:9 to 9:1 by roller compaction technique. Co-processed excipient prepared from polymers ratio of 7:3 and 8:2 showed good physico-chemical properties. The developed DC grade co-processed excipient was characterized for DSC, FTIR, SEM, XRD which confirms the absence of any chemical changes during co-processing. Highly water soluble Metoprolol succinate and poorly water soluble anhydrous Theophylline was used as model drugs for Invitro release study. Formulations prepared using co-processed excipient showed sus...
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