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Vu Dang H, Tran Huu H, Nguyen HMT. Investigating the influence of excipient batch variation on the structure, consistency and physical stability of polysorbate 60-based topical vehicles. Int J Cosmet Sci. 2021;doi: 10.1111/ics.12747.
Vu Dang, H., Tran Huu, H., & Nguyen, H. M. T. (2021). Investigating the influence of excipient batch variation on the structure, consistency and physical stability of polysorbate 60-based topical vehicles. International journal of cosmetic science, . https://doi.org/10.1111/ics.12747
Vu Dang, Hoang, et al. "Investigating the influence of excipient batch variation on the structure, consistency and physical stability of polysorbate 60-based topical vehicles." International journal of cosmetic science vol. (2021). doi: https://doi.org/10.1111/ics.12747
Vu Dang H, Tran Huu H, Nguyen HMT. Investigating the influence of excipient batch variation on the structure, consistency and physical stability of polysorbate 60-based topical vehicles. Int J Cosmet Sci. 2021 Oct 29; doi: 10.1111/ics.12747. Epub 2021 Oct 29. PMID: 34714546.
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Int J Cosmet Sci. 2021 Oct 29; doi: 10.1111/ics.12747. Epub 2021 Oct 29.

Investigating the influence of excipient batch variation on the structure, consistency and physical stability of polysorbate 60-based topical vehicles.

International journal of cosmetic science

Hoang Vu Dang, Hung Tran Huu, Hue Minh Thi Nguyen

Affiliations

  1. Department of Analytical Chemistry and Toxicology, Hanoi University of Pharmacy, Hanoi, Vietnam.
  2. Faculty of Chemistry and Center for Computational Science, Hanoi National University of Education, Hanoi, Vietnam.

PMID: 34714546 DOI: 10.1111/ics.12747

Abstract

Fatty alcohol-polysorbate 60-water ternary systems were used as models to represent the continuous phases of the respective semisolid oil-in-water emulsions for topical delivery of cosmetic and medicinal agents. The influence of batch variation of polysorbate 60 and fatty alcohol on structure and consistency of these systems was investigated using microscopy, rheology, differential scanning calorimetry and X-ray scattering techniques. The polysorbate 60 : cetostearyl alcohol mixed emulsifying wax showed swelling in water, that is, the lamellar repeat distance continually augmented from 93 to 125 Å with water percentage 20-90%. Cetostearyl alcohol ternary systems were thicker than cetyl alcohol ones independently of polysorbate 60 batches used. All the ternary systems showed an initial increase in consistency over the first 2 weeks of storage, which was followed by slight changes in consistency (cetostearyl alcohol systems) due to the re-allocation of polysorbate 60 molecules in the gel network or significant breakdown of structure (cetyl alcohol systems) due to the transformation of swollen α-lamellar gel phase into β, γ crystals on 25°C storage. With all fatty alcohols, the consistency of polysorbate 60 ternary system was directly dependent upon interlamellar water thickness as governed by the length and distribution of polyoxyethylene groups within polysorbate 60 molecules. In relation with the composition of polysorbate 60 batches used, the consistency of ternary systems was higher when prepared with the polysorbate 60 batch containing a greater amount of sorbitan polyoxyethylene monoesters. It was proposed that the swollen α-crystalline gel phase could be better formed by sorbitan polyoxyethylene monoesters rather than sorbitan polyoxyethylene diesters.

© 2021 Society of Cosmetic Scientists and Societe Francaise de Cosmetologie.

Keywords: GC; LC-MS; X-ray scattering; batch variation; differential scanning calorimetry; fatty alcohol; microscopy; polyoxyethylene; polysorbate 60; reproducibility; rheology; ternary systems

References

  1. Eccleston G. M. Functions of mixed emulsifiers and emulsifying waxes in dermatological lotions and creams. Colloids Surf A Physicochem Eng Asp. 1997;123-124:169-182. - PubMed
  2. Kónya M., Sorrenti M., Ferrari F., Rossi S., Csóka I., Caramella C. et al., Study of the microstructure of o/w creams with thermal and rheological methods. J Therm Anal Calorim. 2003;73(2):623-632. - PubMed
  3. Ribeiro H. M., Morais J. A., Eccleston G. M. Structure and rheology of semisolid o/w creams containing cetyl alcohol/non-ionic surfactant mixed emulsifier and different polymers. Int J Cosmet Sci. 2004;26(2):47-59. - PubMed
  4. Savic S., Vuleta G., Daniels R., Muller-Goymann C. C. Colloidal microstructure of binary systems and model creams stabilized with an alkylpolyglucoside non-ionic emulsifier. Colloid Polym Sci. 2004;283(4):439-451. - PubMed
  5. Masmoudi H., Piccerelle P., Le Dréau Y., Kister J. A rheological method to evaluate the physical stability of highly viscous pharmaceutical oil-in-water emulsions. Pharm Res. 2006;23(8):1937-1947. - PubMed
  6. Ballmann C., Mueller B. W. Stabilizing effect of cetostearyl alcohol and glyceryl monostearate as co-emulsifiers on hydrocarbon-free o/w glyceride creams. Pharm Dev Technol. 2008;13(5):433-445. - PubMed
  7. Savic S., Weber C., Tamburic S., Savic M., Müller-Goymann C. Topical vehicles based on natural surfactant/fatty alcohols mixed emulsifier: The influence of two polyols on the colloidal structure and in vitro/in vivo skin performance. J Pharm Sci. 2009;98(6):2073-2090. - PubMed
  8. Estanqueiro M., Conceição J., Amaral M. H., Sousa Lobo J. M. Characterization, sensorial evaluation and moisturizing efficacy of nanolipidgel formulations. Int J Cosmet Sci. 2014;36(2):159-166. - PubMed
  9. Olejnik A., Schroeder G., Nowak I. The tetrapeptide N-acetyl-Pro-Pro-Tyr-Leu in skin care formulations-Physicochemical and release studies. Int J Pharm. 2015;492(1-2):161-168. - PubMed
  10. Olejnik A., Kapuscinska A., Schroeder G., Nowak I. Physico-chemical characterization of formulations containing endomorphin-2 derivatives. Amino Acids. 2017;49(10):1719-1731. - PubMed
  11. Sankar V., Praveen C., Prasanth K. G., Srinivas C. R., Ruckmann K. Formulation and evaluation of a proniosome hydrocortisone gel in comparison with a commercial cream. Pharmazie. 2009;64(11):731-734. - PubMed
  12. Kang M. J., Eum J. Y., Jeong M. S., Choi S. E., Park S. H., Cho H. I. et al., Facilitated skin permeation of oregonin by elastic liposomal formulations and suppression of atopic dermatitis in NC/Nga mice. Biol Pharm Bull. 2010;33(1):100-106. - PubMed
  13. Farboud E. S., Nasrollahi S. A., Tabbakhi Z. Novel formulation and evaluation of a Q10-loaded solid lipid nanoparticle cream: in vitro and in vivo studies. Int J Nanomed. 2011;6:611-617. - PubMed
  14. Kang M. J., Eum J. Y., Jeong M. S., Park S. H., Moon K. Y., Kang M. H. et al., Tat peptide-admixed elastic liposomal formulation of hirsutenone for the treatment of atopic dermatitis in NC/Nga mice. Int J Nanomed. 2011;6:2459-2467. - PubMed
  15. Mahdi E. S., Noor A. M., Sakeena M. H., Abdullah G. Z., Abdulkarim M. F., Sattar M. A. Formulation and in vitro release evaluation of newly synthesized palm kernel oil esters-based nanoemulsion delivery system for 30% ethanolic dried extract derived from local Phyllanthus urinaria for skin antiaging. Int J Nanomed. 2011;6:2499-2512. - PubMed
  16. Sasivimolphan P., Lipipun V., Ritthidej G., Chitphet K., Yoshida Y., Daikoku T. et al., Microemulsion-based oxyresveratrol for topical treatment of herpes simplex virus (HSV) infection: physicochemical properties and efficacy in cutaneous HSV-1 infection in mice. AAPS PharmSciTech. 2012;13(4):1266-1275. - PubMed
  17. Khan B. A., Akhtar N., Khan H., Braga V. A. Development, characterization and antioxidant activity of polysorbate based o/w emulsion containing polyphenols derived from Hippophae rhamnoides and Cassia fistula. Braz J Pharm Sci. 2013;49(4):763-773. - PubMed
  18. Song S. H., Lee K. M., Kang J. B., Lee S. G., Kang M. J., Choi Y. W. Improved skin delivery of voriconazole with a nanostructured lipid carrier-based hydrogel formulation. Chem Pharm Bull. 2014;62(8):793-798. - PubMed
  19. Zainol N. A., Ming T. S., Darwis Y. Development and characterization of cinnamon leaf oil nanocream for topical application. Indian J Pharm Sci. 2015;77(4):422-433. - PubMed
  20. Goindi S., Narula M., Kalra A. Microemulsion-based topical hydrogels of tenoxicam for treatment of arthritis. AAPS PharmSciTech. 2016;17(3):597-606. - PubMed
  21. Sahoo S., Pani N. R., Sahoo S. K. Effect of microemulsion in topical sertaconazole hydrogel: in vitro and in vivo study. Drug Deliv. 2016;23(1):338-345. - PubMed
  22. Nimisha, Rizvi D., Fatima Z., Neema, Kaur C.. Antipsoriatic and anti-inflammatory studies of Berberis aristata extract loaded nanovesicular gels. Pharmacog Mag. 2017;13(Suppl 3):S587-S594. - PubMed
  23. Radwan S. A. A., ElMeshad A. N., Shoukri R. A. Microemulsion loaded hydrogel as a promising vehicle for dermal delivery of the antifungal sertaconazole: design, optimization and ex vivo evaluation. Drug Dev Ind Pharm. 2017;43(8):1351-1365. - PubMed
  24. Kónya M., Dékány I., Erõs I. X-ray investigation of the role of the mixed emulsifier in the structure formation in o/w creams. Colloid Polym Sci. 2006;285(6):657-663. - PubMed
  25. Sepulveda E., Kildsig D. O., Ghaly E. S. Relationship between internal phase volume and emulsion stability: the cetyl alcohol/stearyl alcohol system. Pharm Dev Technol. 2003;8(3):263-275. - PubMed
  26. Commission, B.P. Cetostearyl alcohol monograph. London, UK: The Stationery Office. 2016. - PubMed
  27. Vu Dang H., Gray A. I., Watson D., Bates C. D., Scholes P., Eccleston G. M. Composition analysis of two batches of polysorbate 60 using MS and NMR techniques. J Pharm Biomed Anal. 2006;40(5):1155-1165. - PubMed
  28. Eirich F. R. Chapter 1: Viscoelasticity phenomena in amorphous high polymeric systems. In: Rheology: theory and applications. 1st edn. New York, USA: Academic Press; 1958. p. 1-61. - PubMed
  29. de Vringer T., Joosten J. G. H., Junginger H. E. A study of the gel structure in a nonionic O/W cream by differential scanning calorimetry. Colloid Polym Sci. 1986;264(8):691-700. - PubMed
  30. de Vringer T., Joosten J., Junginger H. Characterization of the gel structure in a nonionic ointment by small angle X-ray diffraction. Colloid Polym Sci. 1984;262(1):56-60. - PubMed
  31. de Vringer T., Joosten J. G. H., Junginger H. E. A study of the gel structure in a nonionic O/W cream by X-ray diffraction and microscopic methods. Colloid Polym Sci. 1987;265(2):167-179. - PubMed
  32. de Vringer T., Joosten J. G. H., Junginger H. E. A study of the ageing of the gel structure in a nonionic O/W cream by X-ray diffraction, differential scanning calorimetry and spin-lattice relaxation measurements. Colloid Polym Sci. 1987;265(5):448-457. - PubMed
  33. Barry B. W., Eccleston G. M. Oscillatory testing of o-w emulsions containing mixed emulsifiers of the surfactant-long chain alcohol type: influence of surfactant chain length. J Pharm Pharmacol. 1973;25(5):394-400. - PubMed
  34. Nakarapanich J., Barameesangpet T., Suksamranchit S., Sirivat A., Jamieson A. M. Rheological properties and structures of cationic surfactants and fatty alcohol emulsions: effect of surfactant chain length and concentration. Colloid Polym Sci. 2001;279(7):671-677. - PubMed
  35. Korhonen M., Lehtonen J., Hellen L., Hirvonen J., Yliruusi J. Rheological properties of three component creams containing sorbitan monoesters as surfactants. Int J Pharm. 2002;247:103-114. - PubMed
  36. Barry B. W., Eccleston G. M. Oscillatory testing of o-w emulsions containing mixed emulsifers of the surfactant-long chain alcohol type: self-bodying action. J Pharm Pharmacol. 1973;25(3):244-253. - PubMed
  37. Eccleston G. M., Behan-Martin M. K., Jones G. R., Towns-Andrews E. Synchrotron X-ray investigations into the lamellar gel phase formed in pharmaceutical creams prepared with cetrimide and fatty alcohols. Int J Pharm. 2000;203(1-2):127-139. - PubMed
  38. Goggin P. L., He R., Craig D. Q., Gregory D. P. An investigation into the supramolecular structure of ternary gel systems using oscillatory rheometry, microscopy, and low frequency dielectric spectroscopy. J Pharm Sci. 1999;88(7):661-669. - PubMed
  39. Fukushima S., Takahashi M., Yamaguchi M. Effect of cetostearyl alcohol on stabilization of oil-in-water emulsion. I. Difference in the effect by mixing cetyl alcol with stearyl alcol. J Colloid Interface Sci. 1976;57(2):201-206. - PubMed
  40. Fukushima S., Yamaguchi M., Harusawa F. Effect of cetostearyl alcohol on stabilization of oil-in-water emulsion. II. Relation between crystal form of the alcol and stability of the emulsion. J Colloid Interface Sci. 1977;59(1):159-165. - PubMed
  41. Eccleston G. M. Phase transitions in ternary systems and oil-in-water emulsions containing cetrimide and fatty alcohols. Int J Pharm. 1985;27(2):311-323. - PubMed
  42. Vu D. H., Tran H. H., Cong P. C., Nguyen T. M. H., Nguyen T. T. Investigating molecular mechanism for the stability of ternary systems containing cetrimide, fatty alcohol and water by using computer simulation. J Mol Graph Model. 2020;95:107500. - PubMed
  43. Hoang V. D., Cong C. P., Tran H. H., Nguyen H. M. T., Nguyen T. T. Influence of fatty alcohol mixing ratios on physicochemical properties of stearyl-cetyl-polysorbate 60-water ternary system: Insights from experiments and computer simulations. Colloid and Polymer Science. 2021. http://dx.doi.org/10.1007/s00396-021-04874-x - PubMed

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