Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil

Villar, Ana M. Sierra; Naveros, Beatriz Clarés; Campmany, Ana Cristina Calpena; Trenchs, Monserrat Aróztegui; Rocabert, Coloma Barbe; Bellowa, Lyda Halbaut

doi:10.1016/j.ijpharm.2012.04.001

Cited by 137 publications

(84 citation statements)

References 63 publications

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“…Subsequently, the grid was inverted and stained with one drop of 1% phosphor-tungstic acid (PTA) for 10s. Excess PTA was removed, and examination of the grid was done at 60-80 kV [25].…”

Section: Transmission Electron Microscopymentioning

confidence: 99%

Design, Optimization and in Vitro Characterization of Self Nano Emulsifying Drug Delivery System of Olmesartan Medoxomil

Sisinthy

Nalamolu

Sarah

2016

Int J Pharm Pharm Sci

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Objective: The objective of the present study was to design, optimise and characterise self nano emulsifying drug delivery systems (SNEDDS) for a poorly water soluble drug, olmesartan medoxomil (OLM) by Formulation by Design (FbD) approach with an aim to improve its solubility and dissolution. Methods:The SNEDDS were systematically optimised using three factor Box-Behnken Results: Following optimisation, the values of formulation variables were found to be 142.276 mg (Capryol P), 399.999 mg (Cremophor EL) and 598.871 mg (Transcutol P) which produced a globule size of 12.64 nm, percentage drug release of 93.34% and a turbidity of 0.02 FNU. TEM studies demonstrated spherical droplet morphology.design. Concentration of formulation variables, namely, the oil phaseX1 (Capryol 90), the surfactant X2 (Cremophor EL), and the co-surfactant X3 (Transcutol P), was optimized for its impact on mean globule size (Y1), percentage drug release in 20 min (Y2) and turbidity (Y3) of the formulation. Ternary phase diagrams were constructed to select the areas of nanoemulsion and the amounts of oil, surfactant and cosurfactants as critical formulation variables. The prepared SNEDDS were characterised for globule size, dissolution studies, turbidity, and transmission electron microscopy (TEM). Conclusion:Thus, the present studies reveal that the SNEDDS is a promising drug delivery system approach for the enhancement of solubility and dissolution rate of OLM.

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“…Subsequently, the grid was inverted and stained with one drop of 1% phosphor-tungstic acid (PTA) for 10s. Excess PTA was removed, and examination of the grid was done at 60-80 kV [25].…”

Section: Transmission Electron Microscopymentioning

confidence: 99%

Design, Optimization and in Vitro Characterization of Self Nano Emulsifying Drug Delivery System of Olmesartan Medoxomil

Sisinthy

Nalamolu

Sarah

2016

Int J Pharm Pharm Sci

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“…These parameters are very useful for comparing profiles types, as an evaluation of the dissolution characteristics of the formulations is not conditioned by the goodness of the fit to a theoretical model of our data (35). The DE(%) was calculated by means of the following equation:…”

Section: Dissolution Test (In Vitro Drug Release Studies)mentioning

confidence: 99%

Development, Physical-Chemical Stability, and Release Studies of Four Alcohol-Free Spironolactone Suspensions for Use in Pediatrics

Bernal¹,

Calpena²,

Mallandrich³

et al. 2014

Dissolution Technol.

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Dissolution studies have become of great significance because, in most cases, drug dissolution is the rate-limiting step in the absorption process. As occurs with solid oral dosage forms, heterogeneous dispersed systems (suspensions) could also have some problems with their in vitro dissolution.The objective of this study was to evaluate the influence of excipients on the release of spironolactone from four alcohol-free suspensions (pharmaceutical compounding) of spironolactone 5 mg/mL suitable for pediatric use.In addition, the comparison of the physical and chemical stability of the suspensions stored at 4, 25, and 40 °C over a 60-day period has been studied. Rheological behavior, particle size, a prediction of long-term physical stability, pH, and assay of spironolactone by HPLC were assessed at preset times. The dissolution profile of each suspension was determined and compared with that of the commercial tablets. A microbiological study of the best formula was also performed. Chemically, the four spironolactone suspensions were stable for 60 days stored at three temperatures; Suspension IV had optimum pH values and the highest recovery percentage. In terms of physical stability, sedimentation occurred in Suspension IV, and flotation of spironolactone occurred in Suspensions I, II, and III. Suspension III had the highest viscosity and the slowest drug release. Suspension IV was also microbiologically stable for 60 days. In conclusion, Suspension IV had the best properties. The least suitable form was Suspension III, as its high viscosity made it difficult to achieve homogeneous redispersion and it had the slowest dissolution profile.

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“…The composition of developed formulations is shown in Table 1. The method was based on previous studies of this research group [6]. Preparation of reference standard solutions for the calibration curve …”

Section: Sample Preparationmentioning

confidence: 99%

“…In our previous study [6], a self-nanoemulsifying drug delivery system (SNEDDS) was used to conquer the challenge of improving the rate and extent of absorption of Gem, in which the active was loaded in the oily phase. These Gem SNEDDS exhibited a lot of difficulties to be analysed through the most reported technique, high performance liquid chromatography (HPLC) with ultraviolet detection at 276 nm [7,8]due to the excipients included in the formulation.…”

Section: Introductionmentioning

confidence: 99%

Validated spectrofluorometric method for determination of gemfibrozil in self nanoemulsifying drug delivery systems (SNEDDS)

Villar

Calpena

Bellowa

et al. 2013

Spectrochimica Acta Part A: Molecular and Biomolecular Spectros

Self Cite

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HIGHLIGHTSA spectrofluorometric method has been developed for the determination of gemfibrozil.The method is based on the excitation and emission capacities of gemfibrozil.This method allows de determination of the drug in SNEDDS.Results showed linear relationships, low limits of LOD and LOQ with good robustness. GRAPHICAL ABSTRACTValidated spectofluorometric method for determination of gemfibrozil in self nanoemulsifying drug delivery systems (SNEDDS) Article history: ABSTRACT A spectrofluorometric method has been developed and validated for the determination of gemfibrozil. The method is based on the excitation and emission capacities of gemfibrozil with excitation and emission wavelengths of 276 and 304 nm respectively. This method allows de determination of the drug in a selfnanoemulsifying drug delivery system (SNEDDS) for improve its intestinal absorption. Results obtained showed linear relationships with good correlation coefficients (r 2 > 0.999) and low limits of detection and quantification (LOD of 0.075 μg mL −1 and LOQ of 0.226 μg mL −1 ) in the range of 0.2-5 μg mL −1 , equally this method showed a good robustness and stability. Thus the amounts of gemfibrozil released from SNEDDS contained in gastro resistant hard gelatine capsules were analysed, and release studies could be performed satisfactorily.

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Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil

Cited by 137 publications

References 63 publications

Design, Optimization and in Vitro Characterization of Self Nano Emulsifying Drug Delivery System of Olmesartan Medoxomil

Design, Optimization and in Vitro Characterization of Self Nano Emulsifying Drug Delivery System of Olmesartan Medoxomil

Development, Physical-Chemical Stability, and Release Studies of Four Alcohol-Free Spironolactone Suspensions for Use in Pediatrics

Validated spectrofluorometric method for determination of gemfibrozil in self nanoemulsifying drug delivery systems (SNEDDS)

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