Classification and Quantitative Analysis of Azithromycin Tablets by Raman Spectroscopy and Chemometrics

Li, Yan; Du, Guotong; Cai, Wensheng; Shao, Xueguang

doi:10.4236/ajac.2011.22015

Cited by 16 publications

(9 citation statements)

References 40 publications

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“…At least 6 spectra of each formulation were used to develop the PLS model, regressing the CEL concentrations (Y) versus the corresponding Raman spectra (X). Validation and uncertainty estimation of the quantitative analytical procedure was performed calculating the following parameters(Li et al, 2011;Saerens et al, 2014):-Root mean square error of prediction:RMSEP ∑ -where I represent the number of samples, y i and ŷ i the reference and Raman predicted value for sample i, respectively.-Relative bias:…”

mentioning

confidence: 99%

Downstream processing from hot-melt extrusion towards tablets: A quality by design approach

Grymonpré

Bostijn

Herck

et al. 2017

International Journal of Pharmaceutics

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Since the concept of continuous processing is gaining momentum in pharmaceutical manufacturing, a thorough understanding on how process and formulation parameters can impact the critical quality attributes (CQA) of the end product is more than ever required. This study was designed to screen the influence of process parameters and drug load during HME on both extrudate properties and tableting behaviour of an amorphous solid dispersion formulation using a quality-by-design (QbD) approach. A full factorial experimental design with 19 experiments was used to evaluate the effect of several process variables (barrel temperature: 160-200°C, screw speed: 50-200rpm, throughput: 0.2-0.5kg/h) and drug load (0-20%) as formulation parameter on the hot-melt extrusion (HME) process, extrudate and tablet quality of Soluplus-Celecoxib amorphous solid dispersions. A prominent impact of the formulation parameter on the CQA of the extrudates (i.e. solid state properties, moisture content, particle size distribution) and tablets (i.e. tabletability, compactibility, fragmentary behaviour, elastic recovery) was discovered. The resistance of the polymer matrix to thermo-mechanical stress during HME was confirmed throughout the experimental design space. In addition, the suitability of Raman spectroscopy as verification method for the active pharmaceutical ingredient (API) concentration in solid dispersions was evaluated. Incorporation of the Raman spectroscopy data in a PLS model enabled API quantification in the extrudate powders with none of the DOE-experiments resulting in extrudates with a CEL content deviating>3% of the label claim. This research paper emphasized that HME is a robust process throughout the experimental design space for obtaining amorphous glassy solutions and for tabletting of such formulations since only minimal impact of the process parameters was detected on the extrudate and tablet properties. However, the quality of extrudates and tablets can be optimized by adjusting specific formulations parameters (e.g. drug load).

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confidence: 99%

Downstream processing from hot-melt extrusion towards tablets: A quality by design approach

Grymonpré

Bostijn

Herck

et al. 2017

International Journal of Pharmaceutics

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“…Azithromycin (C 38 H 72 N 2 O 12 ) is a macrolide antibiotic with a broad range of antibacterial activity. Since its discovery in 1980, it has been used worldwide as an effective treatment for many bacterial infections . It is on the World Health Organizationʼs List of Essential Medicines and, in 2011, it became the most commonly prescribed antibiotic in the United States .…”

Section: Introductionmentioning

confidence: 99%

Phase Transformations of Azithromycin Crystals Investigated by Thermal and Spectroscopic Analyses Combined with Ab Initio Calculations

Santana

Gomes

Santana

et al. 2021

Crystal Growth & Design

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In this research, we employed thermal analyses, X-ray diffraction, and Raman spectroscopy techniques to study the thermodynamic stability of the azithromycin dihydrate (AZM-DH) crystal and the vibrations under different temperature conditions. This study inferred that the crystal underwent two phase transformations. The first phase transformation was associated with a change from the orthorhombic symmetry to a new triclinic phase in the temperature interval of 388−395 K. The second phase transformation was characterized as a thermodynamically irreversible process from a triclinic phase to an amorphous phase, as observed for temperatures above 395 K. The new triclinic symmetry phase was accurately determined using the unit cell refinement by the Le Bail method, demonstrating that its structural system belongs to the P1̅ -space group. To the better of our knowledge, this new polymorphic phase has not been published until now. Moreover, a corrected assignment of Raman-and IR-active bands under room temperature was performed through vibrational analysis, using calculations based on density functional theory (DFT). Finally, chemical−physical properties of the AZM-DH crystal that had not been studied before are reported herein.

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“…Azithromycin is one of the antibiotic of macrolide group, due to the presence of large macrolide ring, which prevent the bacterial cells from synthesizing necessary protein for their survival and initially used against infections caused by respiratory pathogens (Al-Rimawi and Kharoaf, 2010). This 2 nd generation macrolide antibiotic drug is used broadly to cure infectious diseases caused by bacteria (Azithromycin, 2015;Firth and Prathapan, 2020) in respiratory tract, sexually transmitted diseases or soft tissue infections due to its excellent antibacterial activity and pharmacokinetics (Li et al, 2011). Piva, a pharmaceutical company discovered the drug in 1980, and it was approved in 1988 (Greenwood and David, 2008;Alapi and Fischer, 2006).…”

Section: Introductionmentioning

confidence: 99%

Assessment of Quality of Azithromycin, a Macrolide Antibiotic by NMR Spectroscopy

et al. 2021

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A total of forty-five pharmaceutical tablets containing 500 mg azithromycin from 9 (nine) different companies were collected from local pharmacies and evaluated the quality of the antibiotics with standard azithromycin by physical, chromatographic (HPLC), Fourier Transform Infrared (FT-IR), and 1H & 13C Nuclear Magnetic Resonance (NMR) spectroscopic studies. Weight variation of all tested tablets were within 0.1-1.8% which is in the allowed variation of 5%. Two prominent absorption bands were observed at 1723 and 1187 cm−1 in the FT-IR spectrum of all samples and standard for the presence of >C=O and -C-O groups, respectively due to the macrocyclic lactone ring. HPLC coupled with PDA detector (at 210 and 215 nm) gave reproducible results at retention time of 10.5 min for standard and samples. The 1H and 13C NMR spectral data of the standard azithromycin and test samples were found to be identical which led to the conclusion that 1H- and 13C-NMR experiments are feasible tools for qualitative determination of azithromycin in tablets. All the described methods determined the quality of analyzed tablets well. Bangladesh Pharmaceutical Journal 24(1): 37-44, 2021

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Classification and Quantitative Analysis of Azithromycin Tablets by Raman Spectroscopy and Chemometrics

Cited by 16 publications

References 40 publications

Downstream processing from hot-melt extrusion towards tablets: A quality by design approach

Downstream processing from hot-melt extrusion towards tablets: A quality by design approach

Phase Transformations of Azithromycin Crystals Investigated by Thermal and Spectroscopic Analyses Combined with Ab Initio Calculations

Assessment of Quality of Azithromycin, a Macrolide Antibiotic by NMR Spectroscopy

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