Palupi, Rani Yulinar and apt. Tamara Gusti Ebtavanny, S.Farm., M.Farm and apt. Ema Pristi Yunita, S.Farm., M.Farm.Klin. (2023) Pengaruh Beyond Use Date pada Stabilitas Obat Non- Steril: Systematic Literature Review. Sarjana thesis, Universitas Brawijaya.
Abstract
Sediaan non-steril akan mengalami perubahan stabilitas selama masa penyimpanannya dan dapat memengaruhi fungsi obat sehingga efek terapeutik dari obat tersebut menjadi gagal atau dapat memberikan efek toksik. Masa beyond use date digunakan sebagai tanda peringatan yang menunjukkan waktu paling tepat dari penggunaan obat tersebut sebelum sediaan mengalami perubahan stabilitas secara fisika, kimia, dan mikrobologi. Penelitian ini bertujuan untuk mengetahui pengaruh beyond use date pada stabilitas obat non-steril. Metode yang digunakan untuk penelitian ini adalah Systematic Literature Review. Pencarian literatur dilakukan menggunakan aplikasi publish or perish pada beberapa database yaitu google scholar, pubmed, scopus, dan crossref. Kata kunci yang digunakan yaitu “beyond use date” AND stability AND pulvis OR pulveres OR capsules OR tablet OR suppositoria OR syrup OR oral solution OR elixir OR suspension OR emulsion OR cream OR gels OR ointment OR pasta. Seleksi artikel dilakukan sesuai dengan protokol PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses). Dari hasil pencarian artikel didapatkan 1.226 artikel dan terdapat 16 artikel yang sesuai dengan kriteria pemilihan penelitian. Hasil penelitian ini menyimpulkan bahwa beyond use date memengaruhi stabilitas fisika, kimia, dan mikrobiologi sediaan non-steril. Perubahan stabilitas fisika yang terjadi adalah perubahan warna, perubahan bau dan rasa, perubahan konsistensi, penurunan laju disolusi, penurunan viskositas, perubahan isi kapsul yaitu tidak free-flowing, dan peningkatan kadar air. Perubahan kimia yang terjadi adalah penurunan potensi zat aktif dalam rentang 14,36% hingga 92,5%. Sementara itu, perubahan stabilitas mikrobiologi yang terjadi adalah peningkatan jumlah ragi dan jamur hingga mencapai 320 cfu/g.
English Abstract
Non-sterile preparations will experience changes in stability during their storage period and can affect the function of the drug so that the therapeutic effect of the drug fails or can give toxic effects. The period beyond use date is used as a warning sign indicating the most appropriate time to use the drug before the preparation undergoes a change in physical, chemical and microbiological stability. This study aims to determine the effect beyond the date of use on the stability of non-sterile drugs. The method used for this research is Systematic Literature Review. A literature search was carried out using the publish or perish application on several databases, namely Google Scholar, PubMed, Scopus, and Crossref. The keywords used were “beyond use date” AND stability AND pulvis OR pulveres OR capsules OR tablets OR suppositories OR syrup OR oral solution OR elixir OR suspension OR emulsion OR cream OR gel OR ointment OR paste. Article selection was carried out according to the PRISMA (Preferred Reporting Items for Systematic review and Meta-Analyses) protocol. From the results of the article search, 1,226 articles were found and there were 16 articles that matched the research selection criteria. The results of this study concluded that beyond the date of use affects the physical, chemical and microbiological stability of non-sterile preparations. Changes in physical stability that occur are changes in color, change in smell and taste, change in consistency, decrease in dissolution rate, decrease in viscosity, change in capsule contents that is not free-flowing, and increase in water content. The chemical changes that occur are a decrease in the potency of the active substance in the range of 14.36% to 92.5%. Meanwhile, the change in microbiological stability that occurred was an increase in the amount of yeast and fungi up to 320 cfu/g.
| Item Type: | Thesis (Sarjana) |
|---|---|
| Identification Number: | 0523060152 |
| Uncontrolled Keywords: | Beyond Use Date, Stabilitas Fisika, Stabilitas Kimia, Stabilitas Mikrobiologi, Sediaan Non-Steril |
| Subjects: | 600 Technology (Applied sciences) > 615 Pharmacology and therapeutics > 615.1 Drugs (materia medica) |
| Divisions: | Fakultas Kedokteran > Farmasi |
| Depositing User: | Endang Susworini |
| Date Deposited: | 13 Dec 2023 07:13 |
| Last Modified: | 13 Dec 2023 07:13 |
| URI: | http://repository.ub.ac.id/id/eprint/205178 |
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