Self-Emulsifying Drug Delivery System of Simvastatin: Formulation Development, Optimization by Box- Behnken Design, In-Vitro and In-Situ Single-Pass Intestinal Perfusion (SPIP) Studies

Verma, Madhu; Nanda, Arun; Kumar, Yatendra

doi:10.2174/1872211312666181022150435

Cited by 3 publications

(2 citation statements)

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“…The most commonly-known dosage form of SIM in the market is the film-coated tablets used as a controlled release lipid-regulating drug 8 . Other formulations were described such as self-emulsifying drug delivery systems 9,10 , nanoparticles 7,[11][12][13] , buccal film of SIM 14 floating tablets 15 and dry powder inhaler 16 .…”

Section: Introductionmentioning

confidence: 99%

Validated green spectroscopic manipulation of area under the curve (AUC) for estimation of Simvastatin: Application to nano-structured lipid carriers and niosomal systems

MANNAA¹,

GAZAYERLY²,

ABDELBARY³

et al. 2023

jrp

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This work introduced a green spectrophotometric method based on the manipulation of the area under the curve named Area under the curve correction method (AUCCM). The method was applied for the characterization and evaluation the in-vitro release of two nanocarrier systems namely, nano-structured lipid carrier (NLC) and niosomal system of Simvastatin (SIM), through measuring free SIM in presence of the possible excipients/interferents (oleic acid and cholesterol) in a challenging matrix. The estimation of SIM was calculated using the area under the curve (AUC) in the wavelength range of (234.5 -245.5) nm which includes the λmax of SIM in the concentration range of (1-35 µg/mL). The method was validated in compliance with ICH guidelines. The greenness of the developed analytical method will be assessed and compared to other reported methods using the greenness assessment tools known as: National Environmental Methods Index (NEMI), Green Analytical Procedure Index (GAPI) and Eco-Scale. The method proved to be the best regrading greenness and and was successfully applied for the in-vitro release study of SIM from the two nano carrier systems.

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Section: Introductionmentioning

confidence: 99%

Validated green spectroscopic manipulation of area under the curve (AUC) for estimation of Simvastatin: Application to nano-structured lipid carriers and niosomal systems

MANNAA¹,

GAZAYERLY²,

ABDELBARY³

et al. 2023

jrp

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“…Simvastatin (SIM) is a white to off-white, non-hygroscopic, crystalline powder that exhibits extensive polymorphism (polymorphs I, II, and III have been reported, with form I being the more stable form) . It is categorized as a Biopharmaceutics Classification System (BCS) class II compound having very low aqueous solubility and high permeability, while the gastrointestinal dissolution is the rate-limiting step for its in vivo bioavailability. − In addition to the cholesterol-lowering properties, recent studies have also provided evidence that SIM (along with other statins) exhibits a significant therapeutic effect in the treatment of several other conditions such as cancer and skin diseases. , In this context, and despite its long clinical use, substantial efforts are still being made in order to develop new solid dosage forms for SIM with enhanced aqueous solubility and bioavailability after oral administration. − …”

Section: Introductionmentioning

confidence: 99%

Experimental, Thermodynamic, and Molecular Modeling Evaluation of Amorphous Simvastatin-Poly(vinylpyrrolidone) Solid Dispersions

et al. 2020

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A crucial step for the selection of proper amorphous solid dispersion (ASD) matrix carriers is the in-depth assessment of drug/polymer physicochemical properties. In this context, the present study extends the work of previously published attempts by evaluating the formation of simvastatin (SIM)–poly(vinylpyrrolidone) (PVP) ASDs with the aid of thermodynamic and molecular modeling. Specifically, the implementation of both Flory–Huggins lattice theory and molecular dynamics (MD) simulations was able to predict the miscibility between the two components (a finding that was experimentally verified via differential scanning calorimetry (DSC) and hot stage polarized microscopy), while a complete temperature-concentration phase-transition profile was constructed, leading to the identification of the thermodynamically metastable and unstable ASD zones. Furthermore, as in the case of previously published reports, the analysis of the ASDs via Fourier transform infrared spectroscopy did not clarify the type and extent of observed molecular interactions. Hence, in the present study, a computer-based MD simulation model was developed for the first time in order to gain an insight into the properties of the observed interactions. MD amorphous assemblies of SIM, PVP, and their mixtures were initially developed, and the calculated glass transition temperatures were in close agreement with experimentally obtained results, indicating that the developed models could be considered as realistic representations of the actual systems. Furthermore, molecular interactions evaluation via radial distribution function and radius of gyration analysis revealed that increasing SIM content results in a significant PVP chain shrinkage, which eventually leads to SIM–SIM amorphous intermolecular interactions, leading to the formation of amorphous drug zones. Finally, MD-based results were experimentally verified via DSC.

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Formulation strategy of nitrofurantoin: co-crystal or solid dispersion?

Teoh

Mahyuddin

Ahmad

et al. 2019

Pharmaceutical Development and Technology

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Self-Emulsifying Drug Delivery System of Simvastatin: Formulation Development, Optimization by Box- Behnken Design, In-Vitro and In-Situ Single-Pass Intestinal Perfusion (SPIP) Studies

Cited by 3 publications

References 0 publications

Validated green spectroscopic manipulation of area under the curve (AUC) for estimation of Simvastatin: Application to nano-structured lipid carriers and niosomal systems

Validated green spectroscopic manipulation of area under the curve (AUC) for estimation of Simvastatin: Application to nano-structured lipid carriers and niosomal systems

Experimental, Thermodynamic, and Molecular Modeling Evaluation of Amorphous Simvastatin-Poly(vinylpyrrolidone) Solid Dispersions

Formulation strategy of nitrofurantoin: co-crystal or solid dispersion?

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