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"Terdapat zat aktif yang kurang stabil dalam waktu lama jika dibuat dalam sediaan suspensi yang mengandung banyak air seperti rifampisin. Di Indonesia belum tersedia suatu pembawa sediaan suspensi yang dapat digunakan untuk mengatasi masalah kestabilan tersebut. Penelitian ini bertujuan untuk mengembangkan formula pembawa suspensi yang stabil secara fisik dan kimia setelah penambahan isi kapsul rifampisin sebagai zat aktif. Formulasi dibuat sebanyak 4 formula dengan variasi jenis dan konsentrasi bahan pensuspensi. Formula pembawa terbaik dari hasil evaluasi volume sedimentasi, redispersi, dan pH dipilih, lalu ditambahkan kapsul rifampisin dan dilakukan pengujian stabilitas. Uji stabilitas fisik pada suhu kamar 25˚± 2˚C, suhu dingin 4˚± 2˚C, dan suhu tinggi 40˚± 2˚C selama 28 hari meliputi pengujian terhadap organoleptis (bau, bentuk, warna) dan pH menunjukkan bahwa suspensi rifampisin mengalami perubahan warna menjadi merah agak kehitaman setelah 7 hari penyimpanan, bau seperti obat, peningkatan pH, serta perubahan konsistensi. Uji stabilitas kimia dilakukan pada kondisi suhu kamar dengan menetapkan kadar rifampisin dalam suspensi menggunakan KCKT. Kadar suspensi rifampisin mengalami penurunan hingga 0,82% selama masa penyimpanan 14 hari pada suhu kamar. Dalam penelitian ini, suspensi rifampisin stabil secara fisik selama 7 hari, namun sangat tidak stabil secara kimia.

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Active ingredients in suspending vehicles with high water content, such as rifampicin, can degrade over time due to their instability. In Indonesia, there is no available suspending vehicle that can effectively address this stability issue. This research aimed to develop a stable suspending vehicle after the addition of rifampicin capsule contents as the active ingredient. Four formulations were prepared with variations in the type and concentration of suspending agents. The best suspending vehicle based on the evaluation of sedimentation volume, redispersion, and pH was selected, and then rifampicin capsules were added and stability testing was performed. Physical stability testing conducted at room temperature of 25˚± 2˚C, refrigerated temperature of 4˚± 2˚C, and elevated temperature of 40˚± 2˚C for 28 days, including organoleptic (smell, form, and color) and pH testing, revealed a color change of the rifampicin suspension to a reddish-black color after 7 days of storage, along with a medicinal odor, increased pH, and consistency change. Chemical stability testing was conducted at room temperature conditions by determining the rifampicin content in the suspension using HPLC. The rifampicin suspension concentration decreased by up to 0,82% during the 14-day storage period at room temperature. In this research, the rifampicin suspension was found to be physically stable for 7 days, but chemically very unstable."

"Omeprazol merupakan obat golongan PPI untuk penyakit refluks gastroesofageal yang diresepkan untuk segala jenis pasien, khususnya anak-anak dan pasien yang dipasang NGT. Omeprazol hanya tersedia dalam bentuk kapsul dan serbuk injeksi steril. Saat ini pembuatan obat racikan omeprazol disuspensikan dalam larutan natrium bikarbonat 8,4% yang rasanya pahit. Oleh karena itu, perlu dibuat formula pembawa suspensi untuk pembuatan omeprazol racikan. Uji stabilitas dilakukan terhadap empat formula pada suhu kamar 28C selama 14 hari dan pada suhu rendah 4C selama 30 hari.Hasil penelitian menunjukkan bahwa suspensi omeprazol racikan mengalami perubahan warna menjadi putih kekuningan dan nilai pH yang dihasilkan relatif stabil selama masa penyimpanan pada suhu rendah. Pada kondisi penyimpanan suhu kamar, suspensi omeprazol racikan mengalami perubahan warna menjadi kuning kecokelatan. Uji stabilitas kimia dilakukan dengan menetapkan kadar omeprazol dalam suspensi menggunakan spektrofotometer UV-Vis. Kadar suspensi omeprazol racikan mengalami penurunan selama masa penyimpanan, baik pada suhu kamar maupun suhu rendah. Hasil penetapan kadarnya menunjukkan bahwa omeprazol dalam pembawa suspensi formula A memiliki stabilitas kadar yang relatif sama dengan omeprazol dalam larutan natrium bikarbonat, yaitu >90% selama 7 hari pada penyimpanan pada suhu kamar 28C dan selama 14 hari pada penyimpanan suhu rendah 4C.

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Omeprazole is a PPI and used in the treatment of gastroesophageal reflux disease commonly prescribed in all patients, especially pediatric and patient with NGT. Omeprazole is only available in capsule form and sterile powder for injection. This has been accomplished by using 8.4% sodium bicarbonate solution as the vehicle which is bitter. For that reason, a suspending vehicle containing sweetening agent for omeprazole should be formulated. Stability test of four extemporaneous suspending formulation was carried out at room temperature (28C) for 14 days and at cold temperature (4C) for 30 days.The results showed that the extemporaneous suspension of omeprazole is changed to yellowish-white color and the resulting pH is relative stable during storage at cold temperature. At room temperature, the color is changed to brownish-yellow color. Chemical stability test was carried out using UV-Vis spectrophotometer. Concentration of omeprazole in the extemporaneous suspension decreased during storage. Based on stability data, it can be showed that omeprazole in the suspending vehicle of formula A has the same stability level with omeprazole in the sodium bicarbonate solution. The extemporaneous omeprazole suspension remained >90% during 7 days at room temperature and during 14 days at cold temperature."

"Di Australia, Eropa dan Amerika Serikat, pembawa suspensi untuk pembuatan obat racikan yang diberikan secara oral telah beredar di pasaran dan dikenal dengan nama dagang Ora-Plus. Namun, sediaan Ora-Plus ini belum beredar di Indonesia sehingga perlu dibuat formulasi pembawa sediaan suspensi untuk pembuatan obat racikan. Penelitian ini bertujuan untuk memperoleh formula pembawa sediaan suspensi yang stabil secara fisik dan kimia setelah penambahan zat aktif berupa tablet diltiazem hidroklorida sebagai model obat. Uji stabilitas dilakukan selama 30 hari pada formula pembawa suspensi terpilih, yaitu formula A dan E. Uji stabilitas fisik dilakukan pada suhu kamar dengan pengujian terhadap bau, warna serta pH sediaan. Hasil menunjukkan bahwa suspensi oral diltiazem hidroklorida berwarna putih dan memiliki bau seperti obat, serta pH yang dihasilkan mengalami penurunan yang tidak terlalu jauh selama masa penyimpanan. Uji stabilitas kimia dilakukan pada dua kondisi yang berbeda, yaitu suhu kamar dan suhu 4±2ºC untuk selanjutnya dilakukan penetapan kadar menggunakan spektrofotometer UV-Vis. Kadar suspensi oral diltiazem hidroklorida mengalami kenaikan dan penurunan selama masa penyimpanan sehingga dapat dikatakan bahwa suspensi oral diltiazem hidroklorida stabil secara fisik namun tidak stabil secara kimia.

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In Australia, Europe and the United States, suspending vehicle which is made by the manufactures for extemporaneous compounding in oral medications are known under the Ora-Plus trade name. However, Ora-Plus has not distributed in Indonesia, therefore a suspending vehicle formulation for extemporaneous oral liquid compounding should be formulated. The objective of this research was to obtain the optimum concentration of suspending vehicle and to obtain a physically and chemically stable formulation of diltiazem hydrochloride suspension. Stability test of suspension had been carried out for 30 days in the selected suspending vehicle formulas (Formula A and E). Physical stability test was performed at room temperature and physical properties (odor and color) and pH of suspension was evaluated. The results showed that the oral suspension of diltiazem hydrochloride possessed white and drug-like odor, and the resulting pH decreased less significantly during storage. Chemical stability test was carried out in two different conditions, at room temperature and at 4±2ºC for chemical stability test in suspension using spectrophotometer UV-Vis. Concentration of diltiazem hydrochloride in the oral suspension showed fluctuation during storage period. Based on those results, it can be concluded that the oral suspension of diltiazem hydrochloride was physically stable but not chemically stable during the storage period."

"ABSTRAKPrevalensi hipertensi pada anak di Indonesia berkisar 1-2%. Sebagian besar obat hipertensitidak tersedia dalam bentuk sediaan cair danhanya tersediasecara komersialdalam bentuk tablet, seperti enalapril maleat yang hanya tersedia dengan kekuatan 5, 10,dan 20 mg, sehinggapenggunaan enalapril maleatpada anak membutuhkan peracikan extemporaneous.Sediaan extemporaneousmerupakan sediaan farmasetika yang diracik untuk pasien secara individual karena kebutuhan tertentu ketika bentuk sediaan yang dibutuhkan tidak tersedia secara komersial. Peracikan obat di Indonesia disediakan dalam bentuk puyerdengan permasalahanbobot dan kandungan puyer yang tidak seragam serta waktu penyiapan obatyang cukup lama. Untuk mengatasi hal tersebutpembawa sediaan suspensi extemporaneous komersial dapat digunakan untuk peracikan suspensi extemporaneous enalapril maleat. Akan tetapi, pembawa sediaan suspensi extemporaneouskomersial belum beredar di Indonesia.Dari tiga basis data (Science direct, Scopus, dan Pubmed) tiga artikel yangmenyajikan data stabilitas fisikadan kimiaenalapril maleat yang diracik dari bentuk tabletnyadalam pembawa sediaan suspensi extemporaneouskomersialyang berbeda, yaitu campuran Ora-PlusdanOra-Sweet(1:1), Ora-Plus danOra-Sweet SF(1:1), sertaproduk Oral Mixdiulas dalam artikel ini. Suspensi enalapril maleat yang diracik pada tiga pembawa sediaan extemporaneous komersial tersebut stabilsecara fisika dan kimiahingga 90 hari, baik disimpan pada suhu kulkas maupun suhu ruang. Faktor utama yang mempengaruhi stabilitasdari enalapril maleatdalam pembawa sediaan extmporaneous komersial adalah pH.Data stabilitas secara mikrobiologi tidak dapat ditemukan, sehingga dapat penelitian lebih lanjut diperlukan dalam bidang ini.

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ABSTRACT

Prevalence of pediatric hypertension in Indonesia are 1-2%. Most ofhypertension medication are unavailable in liquid form andonly commercially available in tablet dosage form, includeenalapril maleate which only available in 5, 10, and 20 mg dosage form, so that enalapril maleateuses in pediatric need to be extemporaneously compounded. Extemporaneous preparations are pharmaceutical preparations that compounded to meet the needs of a patient when a suitable commercially available product is not available. Extemporaneous compounded prescriptionsin Indonesiaare made into powder, which is called pulvereswith some problems likethe error of variations in the weight and content of pulveres and long preparation time. To solves that problems,tablets enalapril maleatecanbecompoundedinto extemporaneous oral suspension using commercially available suspending vehicle. Unfortunately,commercially available suspending vehicle are not available in Indonesia. Three databases were searched (Science direct, Scopus, and Pubmed) result three articles provide physical and chemical stability information of enalapril maleat suspensions that extemporaneously compounded in three different suspending vehicleproducts, which are the mixture of Ora-PlusandOra-Sweet(1:1), Ora-Plus and Ora-Sweet SF(1:1), and Oral Mix, were reviewed. Thestability of enalapril maleatethatextemporaneously compoundedincommercially available suspending vehicle are physically and chemically stable until 90day bothin refrigeratedand roomtemperature. The main factors of enalapril maleate stability is pH, and a little effect of temperature. Microbial studieswithin the data were lacking and further research can be undertaken in this area."