“…These results indicate a synergistic effect resulting from the interpolyelectrolyte complexation between biopolymers leading to the strengthening of matrices based on CTS/XG blends. The obtained results are in agreement with previous works (Kharshoum and Aboutaleb, 2016, Fareez et al, 2015). Fig.…”
This paper addressed the application of deacetylated xanthan (XGDS) and chitosan (CTS) as a mixture blend forming hydrophilic matrices for Tramadol (TD) sustained release tablets. XGDSs derivatives were obtained by alkaline treatment of xanthan gum (XG) with various degrees of deacetylation (DD). The obtained products were characterized in terms of structural, thermal and physicochemical properties. Different tablet formulations containing CTS/XGDSs were prepared by direct compression method and compared to CTS/XG tablets. Flow properties of powder mixtures and pharmaceutical characteristics were evaluated. The dissolution test of TD was realized under simulated gastric and intestinal conditions to achieve drug release more than 24 h. All developed tablets were found conforming to standard evaluation tests. It was shown that CTS/XGDSs matrices ensure a slower release of TD in comparison with CTS/XG based formulations. Meanwhile, increasing DD resulted in a decrease of drug release. In addition, TD release from XGDS matrices was faster at pH (6.8) than at acidic pH (1.2). The matrix tablets based on CTS/XGDS4 (DD = 98.08%) were selected as the best candidates compared to the other systems in prolonging drug release. The optimal formulation was found to release 99.99% of TD after 24 h following a non-Fickian type.
“…These results indicate a synergistic effect resulting from the interpolyelectrolyte complexation between biopolymers leading to the strengthening of matrices based on CTS/XG blends. The obtained results are in agreement with previous works (Kharshoum and Aboutaleb, 2016, Fareez et al, 2015). Fig.…”
This paper addressed the application of deacetylated xanthan (XGDS) and chitosan (CTS) as a mixture blend forming hydrophilic matrices for Tramadol (TD) sustained release tablets. XGDSs derivatives were obtained by alkaline treatment of xanthan gum (XG) with various degrees of deacetylation (DD). The obtained products were characterized in terms of structural, thermal and physicochemical properties. Different tablet formulations containing CTS/XGDSs were prepared by direct compression method and compared to CTS/XG tablets. Flow properties of powder mixtures and pharmaceutical characteristics were evaluated. The dissolution test of TD was realized under simulated gastric and intestinal conditions to achieve drug release more than 24 h. All developed tablets were found conforming to standard evaluation tests. It was shown that CTS/XGDSs matrices ensure a slower release of TD in comparison with CTS/XG based formulations. Meanwhile, increasing DD resulted in a decrease of drug release. In addition, TD release from XGDS matrices was faster at pH (6.8) than at acidic pH (1.2). The matrix tablets based on CTS/XGDS4 (DD = 98.08%) were selected as the best candidates compared to the other systems in prolonging drug release. The optimal formulation was found to release 99.99% of TD after 24 h following a non-Fickian type.
“…Kharshoum and Aboutaleb prepared Meclozine HCl microspheres using HPMC and compared its pharmacokinetics with marketed tablet Dramamine (25 mg). They reported C max 61.29 + 6.01 ng/ml and 70.34 + 2.265 ng/ml, T max 4.66 + 0.94 h and 2.17 + 0.48 h, AUC 0–t 787.25 + 89.14 ng/ml × h and 572.37 + 68.34 ng/ml × h and AUC 0 870.2867 + 97.23 ng/ml × h and 594.3509 + 73.14 ng/ml × h, MRT 10.9479 + 1.14 h, 7.7589 + 1.13 h and half-life 6.5438 + 0.64 h and 4.8833 + 0.51 h for Meclizine HCl microspheres and Dramamine tablets respectively 13 . Sher et al developed the HPLC method for the simultaneous determination of Meclizine in formulations and human serum and also determined the pharmacokinetic application of the newly developed method.…”
Section: Resultsmentioning
confidence: 96%
“…Each part comprised of 12 volunteers (n = 12). Since Meclizine HCl is not available in ER dosage form, comparative pharmacokinetic of newly developed ER Meclizine HCl pellets (60 mg) was carried out with IR core 13 . Sher et al developed the HPLC method for the simultaneous determination of Meclizine in formulations and human serum and also determined the pharmacokinetic application of the newly developed method.…”
Section: Development and Validation Of The Bioanalytical Method Devementioning
This study is based on the QbD development of extended-release (ER) extruded-spheronized pellets of Meclizine HCl and its comparative pharmacokinetic evaluation with immediate-release (IR) pellets. HPLC-fluorescence method was developed and validated for plasma drug analysis. IR drug cores were prepared from lactose, MCC, and PVP using water as granulating fluid. Three-level, three-factor CCRD was applied for modeling and optimization to study the influence of Eudragit (RL100-RS100), TEC, and talc on drug release and sphericity of coated pellets. HPLC-fluorescence method was sensitive with LLOQ 1 ng/ml and linearity between 10 and 200 ng/ml with R2 > 0.999. Pharmacokinetic parameters were obtained by non-compartmental analysis and results were statistically compared using logarithmically transformed data, where p > 0.05 was considered as non-significant with a 90% CI limit of 0.8–1.25. The AUC0–t and AUC0–∞ of ER pellets were not significantly different with geometric mean ratio 1.0096 and 1.0093, respectively. The Cmax of IR pellets (98.051 ng/ml) was higher than the ER pellets (84.052 ng/ml) and the Tmax of ER pellets (5.116 h) was higher than the IR pellets (3.029 h). No significant food effect was observed on key pharmacokinetic parameters of ER pellets. Eudragit RL100 (6%) coated Meclizine HCl pellets have a potential therapeutic effect for an extended time period.
“…Moreover, post-hoc test performed to ascertain the source of differences between generic brands and comparator product (N9) found that except for generic brand N2, there was a mean tablet weight difference between comparator and all generic brands. Correspondingly, various excipients like diluents, binders, disintegrants, lubricants, glidant, and others used in solid dosage forms may alter weight uniformity, hardness, friability, and other quality control parameters of tablets sourced from different manufacturers 28,29. Hence, the reason for the relative difference in a mean norfloxacin tablets’ weight between comparator and all brands may have been related to pharmaceutical manufacturer’s formulation conditions such as mixing, granulation methods, and amount of excipients added 30…”
Background
Pharmaceuticals play a pivotal role in maintaining human health and promoting well-being. However, safety, efficacy, and quality of the drugs should be ascertained to provide a desired pharmacological effect.
Aim
The aim of the present study was to determine the quality as well as the physicochemical equivalence of nine brands of norfloxacin tablets marketed in Jimma, Ethiopia.
Methods
Nine norfloxacin brands were subjected to in vitro tests associated with quality of tablet dosage form, and the tests were conducted according to procedures described in the United States Pharmacopeia (USP).
Results
This study indicated that all brands of norfloxacin complied with the USP for uniformity of weight, friability, hardness, and assay of active ingredient. However, two of the nine brands evaluated failed to release 80% of their drug contents within 30 minutes as outlined in the USP. Correspondingly, all of the brands studied were within the specification for hardness test. Furthermore, different dissolution profile comparison methods have proven the similarity in dissolution profile of Negaflox and Norcin with the comparator product (Trizolin). Mathematical models-dependent approaches have shown that the drug release data fit well to the Weibull release model.
Conclusion
The physicochemical evaluation showed that all the norfloxacin brands met the quality specification with respect to uniformity of weight, hardness, friability, and assay. With regard to dissolution test, two brands of norfloxacin were found to be out of the specified pharmacopeial requirement. The study also revealed the similarity in the dissolution profile of two brands of norfloxacin with the comparator product.
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