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"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."