The Potential of Raman Spectroscopy as a Process Analytical Technique During Formulations of Topical Gels and Emulsions

Islam, Mohammad Tariqul; Rodrı́guez-Hornedo, Naı́r; Ciotti, Susan; Ackermann, Chrisita

doi:10.1023/b:pham.0000045238.39700.6c

Cited by 27 publications

(12 citation statements)

References 10 publications

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“…[18,34] In the Raman spectra of all the six excipients, δ(CH 2 ) and δ(CH 3 ) deformations are observed in the region between 1400 and 1500 cm −1 . [18,41,42] Some differences can be noted between the spectra of these excipients in the region between 1600 and 1800 cm −1 . Arachis oil (6a), for instance, has a distinct intense Raman band at 1653 cm −1 , which can be assigned to the ν(C C) stretching vibration due to the oleic acid present in the oil.…”

Section: Estersmentioning

confidence: 97%

“…[25,53] Macrogol 4000 (9b) is a PEG and its spectrum shows multiple strong Raman bands at 858 cm −1 , between 1050 and 1130 cm −1 and at 1444 cm −1 , which can be assigned to the symmetric ν(COC) stretch, the ν(CC) stretch and to δ(CH) deformations, respectively. [41] The distinct Raman band in the spectrum of polyvinyl pyrrolidone (9c) at ca 1660 cm −1 is characteristic for the ν(C O) stretching vibrations, while the bands in the area between 1400 and 1500 cm −1 can be assigned to ν(CC) stretching vibrations and ν(CN) in-plane vibrations. The ring vibration causes a very strong Raman band at 932 cm −1 with next to it two bands (850 and 892 cm −1 ) due to the ν(CNC) stretching modes.…”

Section: Inorganic Substancesmentioning

confidence: 99%

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Reference database of Raman spectra of pharmaceutical excipients

Veij

Vandenabeele

Beer

et al. 2008

J Raman Spectroscopy

197

101

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Raman spectroscopy has evolved into an important fast, direct and nondestructive technique in pharmaceutical analysis. Usually, the focus in this field is mainly on the active ingredients and not on the excipients present in the drugs. A collection of Raman spectra of widely used pharmaceutical excipients is presented in this article, which can serve as a reference for the interpretation of Raman spectra during drug analysis (including classical qualitative and quantitative pharmaceutical analysis, counterfeit tracing and process analytical technology (PAT) applications). The 43 analyzed excipients can be classified into seven categories: mono-and disaccharides (dextrose, lactitol, maltitol, lactose and sucrose), polysaccharides (microcrystalline cellulose, methylcellulose (MC), carboxymethylcellulose (CMC), hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), wheat starch, maltodextrin, primojel, tragacanth and pectin), polyalcohols (propylene glycol, erythritol, xylitol, mannitol and sorbitol), carboxylic acids and salts (alginic acid, glycine, magnesium stearate, sodium acetate and sodium benzoate), esters (arachis oil, lubritab, dibutyl sebacate, triacetin, Eudragit E100 and Eudragit RL100), inorganic compounds (calcium phosphate, talc, anatase and rutile (TiO 2 ), calcium carbonate, magnesium carbonate, sodium bicarbonate and calcium sulfate) and some unclassified products [gelatin, macrogol 4000 (polyethylene glycol (PEG), polyvinyl pyrrolidone and sodium lauryl sulfate].

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Section: Estersmentioning

confidence: 97%

Section: Inorganic Substancesmentioning

confidence: 99%

Reference database of Raman spectra of pharmaceutical excipients

Veij

Vandenabeele

Beer

et al. 2008

J Raman Spectroscopy

197

101

View full text Add to dashboard Cite

show abstract

“…[23,24] The IR study was conducted in this paper to gain clarity on the effect of the head group structure on interfacial interaction. From the publication, it is known that a surfactant interacts with the AN, which is reflected in the change in the NH peak in the IR spectrum.…”

Section: Ftir Analysismentioning

confidence: 99%

Effect of PIBSA-Based Surfactants on the Interfacial Interaction, Rheology, and Stability of Highly Concentrated Water-In-Oil Emulsion

Zhang

2014

Journal of Dispersion Science and Technology

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An investigation was performed into the effect of surfactants on the interfacial interaction of surfactants, rheological properties, and stability of highly concentrated water-in-oil emulsion (HCE). The surfactants were oligomers of the polyisobutylene succinic anhydride based on different head groups and hydrophobic chain lengths. The FTIR study revealed interaction between surfactant head groups and ammonium nitrate (AN) ions. The interactions were dependent on the polarity of the head group determined by their chemical structure. A certain amount of salt ratio in the head group can improve the interaction between surfactant and AN. It was also demonstrated that the nature of surfactants influences the rheological properties and stability of HCE. The viscoelasticity and yielding were correlated with interfacial interaction characteristics. The results of the increase of storage modulus with time show the increase of the solid-like properties of HCE.

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“…[3,4] Due to the wealth of chemical and physical information available in Raman spectroscopy, its applications have expanded to polymorph monitoring, [5,6] intermediate detection, [7] crystallization progression for drug substances, [8] content uniformity, [3,9] coating thickness, [10] and end-point determination for drug product processes. [11,12] As a rapid, non-invasive, non-destructive method of analysis, it is suitable for a variety of pharmaceutical dosage forms, such as solids, [12 -14] topical gels and emulsions, [15] dry powder inhalers [4] and suspensions. [16 -19] Water is a weak Raman scatter, which makes it an ideal PAT tool for aqueous-based products.…”

Section: Introductionmentioning

confidence: 99%

Real‐time monitoring of active ingredient dispersion in a pharmaceutical aqueous suspension using Raman spectroscopy

Medendorp

Yonzon

2011

J Raman Spectroscopy

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In a typical aqueous nasal suspension manufacturing process, the homogeneity of the active pharmaceutical ingredient (API) dispersion in a premix vessel is determined merely by visual observation. In this study, to better demonstrate in-process control, Raman spectroscopy was developed as a process analytical tool (PAT) to monitor the real-time API dispersion homogeneity in the active premix process. The end-point variations of the API dispersion as a function of the surfactant type, surfactant concentration, and agitation speed were evaluated by dispersive Raman spectroscopy in combination with multivariate analysis for both lab-scale and pilot-scale batches. The optimal surfactant concentration and type were determined to be 0.2% surfactant A for the active dispersion based on a quantitative end-point comparison. In addition, a chemometric model was developed successfully for the real-time prediction of API concentration in the active premix, with a root mean squared error of prediction (RMSEP) of 5.4%. In conclusion, Raman spectroscopy has proven to be a viable PAT tool to qualitatively and quantitatively assess the active premix homogeneity in an aqueous nasal suspension manufacturing process. In the future, this method can potentially be used in the commercial manufacturing process for in-process control of the dispersion homogeneity of the suspension.

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The Potential of Raman Spectroscopy as a Process Analytical Technique During Formulations of Topical Gels and Emulsions

Abstract: The findings from this work suggest that Raman spectroscopy can be a valuable process analytical technique for quality control of topical gel and cream formulations.

Cited by 27 publications

References 10 publications

Reference database of Raman spectra of pharmaceutical excipients

Reference database of Raman spectra of pharmaceutical excipients

Effect of PIBSA-Based Surfactants on the Interfacial Interaction, Rheology, and Stability of Highly Concentrated Water-In-Oil Emulsion

Real‐time monitoring of active ingredient dispersion in a pharmaceutical aqueous suspension using Raman spectroscopy

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