Simultaneous quantification of simvastatin and excipients in liposomes using near infrared spectroscopy and chemometry

Porfire, Alina; Achim, Marcela; Vlase, Laurian; Tomuță, Ioan

doi:10.1016/j.jpba.2014.12.013

Cited by 22 publications

(13 citation statements)

References 13 publications

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“…Within the control strategy, process analytical technology (PAT) has been evidenced lately as a significant tool for measuring parameters and attributes related to the active substance, the finished product as well as the processing conditions. Among the PAT tools, in the field of liposomes, near-infrared spectroscopy (NIRs) has been shown to be useful for the chemical characterization of liposomes in terms of the composition of the lipid membrane, as well as for the simultaneous quantification of excipients and active substance [79,80].…”

Section: The Investigated Propertymentioning

confidence: 99%

Pharmaceutical Development of Liposomes Using the QbD Approach

Porfire¹,

Achim²,

Barbălată³

et al. 2019

Liposomes - Advances and Perspectives

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Quality by Design (QbD) is a systematic, risk-based approach to pharmaceutical product and manufacturing development, which uses quality-improving scientific methods upstream in the research, development, and design phases, in order to assure that quality and safety are designed into product at as early stage as possible. This work focuses on the state-of-the-art applications of the QbD principles in the development of liposomes. The QbD approach has recently been proposed as a useful tool to obtain higher-quality liposomal products, as their development is a challenging task, involving intricate formulation and manufacturing processes. Thus, the current strategies to define the relationship between the critical material attributes or process parameters and product critical quality attributes and to establish the design space are overviewed. Additionally, the current characterization methodologies are described, as part of the control strategy required within the QbD paradigm.

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Section: The Investigated Propertymentioning

confidence: 99%

Pharmaceutical Development of Liposomes Using the QbD Approach

Porfire¹,

Achim²,

Barbălată³

et al. 2019

Liposomes - Advances and Perspectives

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“…Many methods or techniques such as micronization, solid dispersion, cyclodextrin complexation, microemulsion, liposomes, nanoparticles, phospholipid complex, and self-microemulsifying drug delivery system (SMEDDS), etc. have been tried to improve the solubility, dissolution rate and thus oral bioavailability of the drug (4)(5)(6)(7)(8)(9)(10)(11)(12).…”

mentioning

confidence: 99%

Preparation and characterization of simvastatin/DMβCD complex and its pharmacokinetics in rats

Ning

Fan

et al. 2018

Acta Pharmaceutica

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Simvastatin is poorly bioavailable because it is practically insoluble in water and shows dissolution rate-limited absorption. Solubilizing effects of several β-cyclodextrin (βCD) derivatives such as HPβCD, SBEβCD and DMβCD on simvastatin in aqueous solution were investigated using the phase solubility technique. The solubility diagram of simvastatin with each βCD derivative could be classified as AL-type, indicating soluble complex formation of 1:1 stoichiometry. Among the above βCD derivatives DMβCD was found to be the ideal complexing agent for improving drug solubility. The simvastatin complex with DMβCD was prepared using the co-evaporation method and was then characterized by differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FT-IR) and in vitro dissolution. Dissolution and pharmacokinetic studies indicated that the simvastatin/DMβCD complex exhibited an increased dissolution rate, rapid absorption, and improved bioavailability in rats compared to free drug. Maximum plasma concentration (cmax) and the time to reach it (tmax) were 21.86 μg mL-1 and 1.4 h for the drug complex, 8.25 μg mL-1 and 3.0 h for free drug, respectively. Main pharmacokinetic parameters such as tmax, cmax were significantly different (p < 0.01) between the simvastatin complex and free drug. Bioavailability of the simvastatin complex relative to free drug was up to 167.0 %.

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“…Mixture designs are well suited for formulation application, where the sum of all ingredients adds up to 100% and where factors cannot be manipulated independently one from another. Porfire et al used a D-optimal design with three variables and five levels to build a calibration set with 63 formulations with the purpose of quantifying encapsulated simvastatin and two functional excipients L-α-phosphatidylcholine and cholesterol from liposomes [34]. Saraguca et al developed an NIR method to simultaneously quantify paracetamol and three other excipients from powder blends using a calibration set constructed on a 40-run D-optimal mixture design [19].…”

Section: Design Of Experiments Strategymentioning

confidence: 99%

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

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Vibrational spectroscopy, namely near infrared (NIR) and Raman spectroscopy, is based on the interaction between the electromagnetic radiation and matter. The technique is sensitive to chemical and physical properties and delivers a wide range of information about the analyzed sample, but in order to extract the information, multivariate calibration of the spectral data is required. The main goal of this work will be to present in detail the available multivariate calibration strategy for development of NIR and Raman spectroscopic methods, which was successfully applied in pharmaceutics.

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Simultaneous quantification of simvastatin and excipients in liposomes using near infrared spectroscopy and chemometry

Cited by 22 publications

References 13 publications

Pharmaceutical Development of Liposomes Using the QbD Approach

Pharmaceutical Development of Liposomes Using the QbD Approach

Preparation and characterization of simvastatin/DMβCD complex and its pharmacokinetics in rats

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

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