ABSTRACT

Resorcinol and 4-n-butyl resorcinol have been used to improve skin health. However, these two compounds were unstable due to the oxidation process. Lipid nanoparticle formulation strategies were reported as the solution to overcome the stability problem for both resorcinol and 4-n-butyl resorcinol. Nevertheless, it is important to determine the content of resorcinol and 4-n-butyl resorcinol in lipid nanoparticle formulation. Aiming to develop the analytical method for resorcinol and 4-n-butyl resorcinol determination, a response surface methodology (RSM) was applied in the HPLC optimization stage. An optimized HPLC condition was obtained by generating a Box-Behnken design followed by multiple response analysis. It was obtained that optimized HPLC conditions due to the predictive multiple response optimization were methanol percentage of 50.0%, acetonitrile percentage of 18.1%, and flow rate of 0.6 mL min–1. This optimized condition was successfully applied and met the requirements of the system suitability test. Quantitative estimation was performed and resulted that the resorcinol and 4-n-butyl resorcinol content in lipid nanoparticles were 70.37 ± 0.47 and 95.07 ± 0.80 µg mL–1, respectively.

Extemporaneous preparations are still widely prescribed for pediatric patients with special treatments of certain doses and/or combinations of drugs. Several problems related to extemporaneous preparations have been linked to the incidence of adverse events or a lack of therapeutic effectiveness. Developing nations are facing the challenges of compounding practices. The prevalence of compounded medication in developing nations must be explored to determine the urgency of compounding practices. Furthermore, the risks and challenges are described and explained through investigation and collection of numerous scientific articles from reputable databases, including Web of Science, Scopus, and PubMed. Pediatric patients need compounded medication related to the appropriate dosage form and dosage adjustment. Notably, it is important to observe extemporaneous preparations in order to provide patient-oriented medication.

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AbstrakInjeksi seftriakson merupakan antibiotik spektrum luas golongan sefalosporin generasi ketiga, yang dalam penggunaannya di rumah sakit memerlukan proses peracikan, yaitu rekonstitusi dan pengenceran. Sesuai dengan peraturan dan pedoman yang berlaku, peracikan sediaan steril harus dilakukan dengan fasilitas yang sesuai, proses peracikan yang aseptis, dan dilakukan oleh tenaga kefarmasian, sehingga diperoleh sediaan dengan kualitas dan stabilitas yang baik. Penelitian ini bertujuan mengamati proses peracikan dan sifat fisik hasil peracikan sediaan injeksi seftriakson yang dilakukan di salah satu rumah sakit swasta di Semarang dalam periode April-Mei 2017. Penelitian dilakukan secara observasional terhadap personel peracik, fasilitas dan proses peracikan sediaan injeksi seftriakson. Observasi dilakukan dengan bantuan check list yang disesuaikan dengan pedoman pencampuran obat suntik dan penanganan sitostatika. Sebanyak 60 proses peracikan injeksi seftriakson digunakan sebagai sampel. Hasil peracikan dengan kondisi proses paling tidak sesuai dengan pedoman diuji kualitas fisiknya meliputi pH, kejernihan dan sterilitas. Hasil penelitian menunjukkan bahwa peracikan sediaan injeksi seftriakson di rumah sakit tersebut belum memenuhi kriteria sesuai pedoman pencampuran obat suntik, terutama dari segi fasilitas dan personel peracik. Meskipun demikian, hasil uji kualitas yang dilakukan terhadap sediaan tersebut masih memenuhi kriteria bebas kuman, isohidris, dan jernih. AbstractCeftriaxone injection is a broad-spectrum antibiotic of third-generation cephalosporin. Its use in hospitals requires reconstitution and dilution to obtain the desired dose. Compounding of sterile preparations is supposed to be carried out with appropriate facilities, aseptic compounding process, and performed by a pharmacist, in accordance with regulations and guidelines, to obtain a good quality and stability of ceftriaxone injection. The aim of this study was to evaluate the compounding process of ceftriaxone injection preparation in one of a private hospital in Semarang at April-May 2017.The study was done by observing the compounding of ceftriaxone injection preparations involving the facility, process, and personnel. Observations were conducted using the checklist from Sterile Dispensing Guidelines. Sixty compounding of ceftriaxone injection were used as samples. Observation results were used to determine the process of compounding with the worst possible condition, and then pH, clarity, and sterility were tested to evaluate its physical quality. The results showed that compounding of ceftriaxone injection in the hospital do not conform the criteria according to the preparation of injectable guidelines, especially in terms of facilities and personnel. However, the results of quality tests performed still accord the criteria, i.e, free from microbe, isohydris and clear. dari segi warna, pH, kejernihan, dan bebas kuman. Perbaikan dan peningkatan saranaprasarana dan validasi proses peracikan perlu dilakukan untuk menjamin setiap sediaan inje...