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.
ABSTRACTPrevalence 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. |
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