Formulation and process optimization of naproxen nanosuspensions stabilized by hydroxy propyl methyl cellulose

Mishra, Bibaswan; Sahoo, Jagannath; Dixit, Prasanna Kumar

doi:10.1016/j.carbpol.2015.03.077

Cited by 59 publications

(29 citation statements)

References 31 publications

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“…3. Absence of any other new peaks and also no differences in the positions of the absorption bands in the bilayer tablet F8 indicate the lack of significant interactions between etoricoxib and other excipients [19].…”

Section: Ftir Studymentioning

confidence: 93%

Once Daily Immediate-and Extended-Release Bilayer Tablets of Etoricoxib: A Study on the Release Kinetics

Mishra¹,

Mohanty²

2019

Int J App Pharm

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Objective: In the present work, the main objective was to develop bilayer extended release matrix tablets of etoricoxib by providing a loading dose followed by maintenance dose that expected to improve the therapeutic efficacy of the medication with less toxic effect. Methods: Bilayer tablets of etoricoxib was developed successfully with the meticulous proportion of release controlling Hydroxy propyl methyl cellulose K100 (HPMC K100) and lactose. The tablets were prepared by wet granulation technique. Granules for immediate layer and extended layer for different formulations were prepared separately. The formulations were developed and evaluations were performed to examine the parameters that affect the in vitro performance of the tablets. The drug-excipient compatibility was ensured by Fourier transform infrared spectroscopy (FTIR) study. Results: The values of physical parameters of all formulations were found within appreciable limit. Formulation containing HPMC K 100 and lactose in the proportion of 2:1 in the extended release layer was able to release 26.22% of drug in 15 min and shown a steady release of drug for an extended period of 12 h. The dissolution data was put in Korsemeyer–Peppas model in order to find out n value, which describes the drug release mechanism. The n-value of different formulations were found to be variable. The Fourier transform infrared spectroscopy (FTIR) study revealed absence of any other new peaks and also no differences in the positions of the absorption bands in the bilayer tablet F8 that indicate the lack of significant interactions between etoricoxib and other excipients. Conclusion: It had been concluded that once daily immediate-and extended release bilayer tablet of etoricoxib can be formulated with profound physical characteristics and dissolution properties. This resulted in reducing the daily dose and thus minimise the cardiovascular toxicity of etoricoxib.

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Section: Ftir Studymentioning

confidence: 93%

Once Daily Immediate-and Extended-Release Bilayer Tablets of Etoricoxib: A Study on the Release Kinetics

Mishra¹,

Mohanty²

2019

Int J App Pharm

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“…Samples were scanned for 2Ɵ from 10 to 80°. Diffraction pattern for pure Gem, physical mixture and NS were analyzed [29].…”

Section: Xrdmentioning

confidence: 99%

Formulation and Optimization of Nanosuspension for Improving Solubility and Dissolution of Gemfibrozil

Deshkar

Sonkamble

Mahore

2019

Asian J Pharm Clin Res

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Objective: The study aims at the formulation and optimization of gemfibrozil (Gem) nanosuspension (NS) for improving its solubility and dissolution rate.Method: Gem NS was prepared by precipitation-ultrasonication method using ethanol as solvent, water as anti-solvent, and polyvinyl alcohol (PVA) as a stabilizer. A Box–Behnken design was employed to study the effect of the independent variables, Gem concentration in the organic phase (X1), PVA concentration (X2) and sonication time (X3) on the dependent variable, drug release after 90 min (Y). The resulting data were statistically analyzed and subjected to 3D response surface methodology to study the influence of variables on the response. NS was evaluated for particle size, zeta potential, solubility and in vitro drug release and characterized using Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and X-ray diffractometry (XRD).Results: On the basis of the evaluation, NS4 formulation (with 80 mg/ml Gem, 0.5% PVA concentration, and 20 min of sonication time) demonstrated highest drug content with a particle size of 191.0 nm and zeta potential of −12.0 mV. Dissolution profiles of NS indicated 2.5-fold increase in drug release than pure drug. NS demonstrated 5- and 9-fold increase in solubility, in water, and phosphate buffer (pH 7.5), respectively, pure drug. DSC and XRD studies indicated changes in the crystallinity of Gem during NS formulation. No chemical change was evident in NS as indicated by FTIR.Conclusion: Gem NS formulation could serve as a promising approach for improving its solubility and dissolution rate.

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“…Polymers such as hydroxypropyl methylcellulose (HPMC), polyvinyl pyrrolidone (PVP), and hydroxypropyl cellulose (HPC) and surfactants such as dodecyl β-Dmaltoside (DM), sodium dodecyl sulfate (SDS), and polyethylene glycol (PEG) are frequently used in nanosuspension formulations intended for oral or parenteral drug administration as means to enhance the physical stability of nanosuspensions (1)(2)(3)(4)(5). It is well known that a significant number of new chemical entities exhibit poor water solubility, resulting in poor oral absorption and the need for bioavailability enhancement (6)(7)(8).…”

Section: Introductionmentioning

confidence: 99%

“…While this method has several benefits, there are also some limitations such as low selectivity, requirement for volatile mobile phase, nonlinear response, and also being destructive to the sample (25). This detection method has been applied effectively for at least the last two decades to quantify a wide spectrum of natural and synthetic compounds including pharmaceuticals (i.e., drug molecules and excipients including polymers, sugars, lipids, and surfactants) (4,24,(26)(27)(28)(29), natural products and biologics (30,31). foods, and beverages (32,33).…”

Section: Introductionmentioning

confidence: 99%

Development of a Robust Method for Simultaneous Quantification of Polymer (HPMC) and Surfactant (Dodecyl β-D-Maltoside) in Nanosuspensions

Patel

Bummer

2015

AAPS PharmSciTech

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Abstract. This report describes the development of a chromatographic method for the simultaneous quantification of a polymer, hydroxypropyl methylcellulose (HPMC), and a surfactant, dodecyl β-Dmaltoside (DM), that are commonly used in the physical stabilization of pharmaceutical formulations such as nanosuspensions and solid dispersions. These excipients are often challenging to quantify due to the lack of chromophores. A reverse phase size exclusion chromatography (SEC) with evaporative light scattering detector (ELSD) technique was utilized to develop an accurate and robust assay for the simultaneous quantification of HPMC and DM in a nanosuspension formulation. The statistical design of experiments was used to determine the influence of critical ELSD variables including temperature, pressure, and gain on accuracy, precision, and sensitivity of the assay. A robust design space was identified where it was determined that an increase in the temperature of the drift tube and gain of the instrument increased the accuracy and precision of the assay and a decrease in the nebulizer pressure value increased the sensitivity of the assay. In the optimized design space, response data showed that the assay could quantify HPMC and DM simultaneously with good accuracy, precision, and reproducibility. Overall, SEC-ELSD proved to be a powerful technique for the simultaneous quantification of HPMC and DM. This technique can be used to quantify the amount of HPMC and DM in nanosuspensions, which is critical to understanding their effects on the physical stability of nanosuspensions.KEY WORDS: design of experiments; dodecyl β-D-maltoside; evaporative light scattering detector; HPMC; nanosuspensions.

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Formulation and process optimization of naproxen nanosuspensions stabilized by hydroxy propyl methyl cellulose

Cited by 59 publications

References 31 publications

Once Daily Immediate-and Extended-Release Bilayer Tablets of Etoricoxib: A Study on the Release Kinetics

Once Daily Immediate-and Extended-Release Bilayer Tablets of Etoricoxib: A Study on the Release Kinetics

Formulation and Optimization of Nanosuspension for Improving Solubility and Dissolution of Gemfibrozil

Development of a Robust Method for Simultaneous Quantification of Polymer (HPMC) and Surfactant (Dodecyl β-D-Maltoside) in Nanosuspensions

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