Stability study of homoeopathically potentised Arsenicum album in hydrolytic amber glass class II and high-density polyethylene terephthalate over twelve months

Authors

Marcia Pietroluongo, Laboratory of Experimental Pharmacotechnics, Department of Galenic Innovation, Vice-Directorate of Education, Research and Innovation, Institute of Technology in Pharmaceuticals - Farmanguinhos, Oswaldo Cruz Foundation - FIOCRUZ, Rio de Janeiro, BrazilFollow
Thiago Frances Giuimarães, Laboratory of Experimental Pharmacotechnics, Department of Galenic Innovation, Vice-Directorate of Education, Research and Innovation, Institute of Technology in Pharmaceuticals - Farmanguinhos, Oswaldo Cruz Foundation - FIOCRUZ, Rio de Janeiro, BrazilFollow
Thais de Barros Fernandes, Multidisciplinary Laboratory of Pharmaceutical Sciences, Department of Drugs and Medications, Pharmacy College, Federal University of Rio de Janeiro - UFRJ, Rio de Janeiro, BrazilFollow
Ana Paula dos Santos Matos, Laboratory of Experimental Pharmacotechnics, Department of Galenic Innovation, Vice-Directorate of Education, Research and Innovation, Institute of Technology in Pharmaceuticals - Farmanguinhos, Oswaldo Cruz Foundation - FIOCRUZ, Rio de Janeiro, BrazilFollow
Fortune Homsani, Multidisciplinary Laboratory of Pharmaceutical Sciences, Department of Drugs and Medications, Pharmacy College, Federal University of Rio de Janeiro - UFRJ, Rio de Janeiro, BrazilFollow
Adriana Passos Oliveira, Multidisciplinary Laboratory of Pharmaceutical Sciences, Department of Drugs and Medications, Pharmacy College, Federal University of Rio de Janeiro - UFRJ, Rio de Janeiro, BrazilFollow
Alessandra Lifsitch Viçosa, Laboratory of Experimental Pharmacotechnics, Department of Galenic Innovation, Vice-Directorate of Education, Research and Innovation, Institute of Technology in Pharmaceuticals - Farmanguinhos, Oswaldo Cruz Foundation - FIOCRUZ, Rio de Janeiro, BrazilFollow
Carla Holandino Quaresma, Multidisciplinary Laboratory of Pharmaceutical Sciences, Department of Drugs and Medications, Pharmacy College, Federal University of Rio de Janeiro - UFRJ, Rio de Janeiro, BrazilFollow

Author ORCID Identifier(s)

https://orcid.org/0000-0002-3944-6486

https://orcid.org/0000-0002-4534-6414

https://orcid.org/0000-0002-2691-5335

https://orcid.org/0000-0001-8511-0003

https://orcid.org/0000-0002-6441-7281

https://orcid.org/0000-0003-2005-579X

https://orcid.org/0000-0001-6968-4269

https://orcid.org/0000-0001-5086-5676

Corresponding Author

Carla Holandino Quaresma

Keywords

Amber glass flasks, Arsenicum album, Polyethylene terephthalate primary container, Stability study

Article Type

Original Article

Abstract

Background: The Brazilian Homoeopathic Pharmacopoeia (BHP) recommends using glass amber Type I, II, or III as a primary container for storing homoeopathic liquid medicines. Although the glass has advantages, there are some disadvantages, such as fragility, weight, and the presence of silicate particles, which have been described as critical components involved with the generation of silicon microparticles detected in homoeopathic solutions. Objectives: The present study aimed to investigate the stability of hydroalcoholic solutions of Arsenicum album dynamised in two different vials: class II hydrolytic amber glass and amber high-density polyethylene terephthalate (PET). Materials and Methods: Two potencies of the Arsenicum album, 6C and 30C, were prepared according to BHP. The solutions were stored in glass and PET amber flasks. The stability study was carried out in a climatic chamber according to the conditions described in the Brazilian official compendium for twelve months. During the study, samples were evaluated by density, pH, refractometry, and conductivity. Microbiological purity was evaluated at the beginning and the end of stability study. Results: No statistical differences were observed in the density of samples in both conditions and packages. The pH of all samples remained around 6, and refractometry around 1.363, suggesting their chemical stability. The microbiological assays showed no pathogenic microorganisms after twelve months of storing all samples. Conclusion: The results showed that Arsenicum album 6C and 30C are stable preparations. It can also be concluded that glass bottles are suitable for storing dynamised solutions of Arsenicum album. PET bottles maintained the physicochemical and microbiological stability of the solutions and can be a potential alternative to prepare or store homoeopathic matrices. However, further studies are required to confirm the suitability of PET vials in compounding and storing homoeopathic medicines.

Digital Object Identifier

10.53945/2320-7094.2003

Publisher

Central Council for Research in Homoeopathy

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.

How to cite this article

Pietroluongo M, Giuimarães TF, de Barros Fernandes T, Dos Santos Matos AP, Homsani F, Oliveira AP, et al. Stability study of homoeopathically potentised Arsenicum album in hydrolytic amber glass class II and high-density polyethylene terephthalate over twelve months. Indian J Res Homoeopathy 2024;18:172-179.