title: Feasibility of amlodipine besylate, chloroquine phosphate, dapsone, phenytoin, pyridoxine hydrochloride, sulfadiazine, sulfasalazine, tetracycline hydrochloride, trimethoprim and zonisamide in SyrSpend(®) SF PH4 oral suspensions.
abstract: The objective of this study was to evaluate the feasibility of 10 commonly used active pharmaceutical ingredients (APIs) compounded in oral suspensions using an internationally used suspending vehicle (SyrSpend(®) SF PH4 liquid): (i) amlodipine, (as besylate) 1.0mg/mL; (ii) chloroquine phosphate,15.0 mg/mL; (iii) dapsone, 2.0 mg/mL; (iv) phenytoin, 15.0 mg/mL; (v) pyridoxine hydrochloride, 50.0 mg/mL; (vi) sulfadiazine, 100.0 mg/mL; (vii) sulfasalazine, 100.0 mg/mL; (viii) tetracycline hydrochloride, 25.0 mg/mL; (ix) trimethoprim, 10.0 mg/mL; and (x) zonisamide, 10.0 mg/mL. All suspensions were stored both at controlled refrigeration (2-8 °C) and controlled room temperature (20-25 °C). Feasibility was assessed by measuring the percent recovery at varying time points throughout a 90-day period. API quantification was performed by high-performance liquid chromatography (HPLC-UV), via a stability-indicating method. Given the percentage of recovery of the APIs within the suspensions, the expiration date of the final products (API+vehicle) was at least 90 days for all suspensions with regard to both the controlled temperatures. This suggests that the vehicle is stable for compounding APIs from different pharmacological classes.
authors.affiliation: Ortofarma-Quality Control Laboratories, Matias Barbosa, MG, Brazil; NUPICS-Núcleo de Pesquisa e Inovação em Ciências da Saúde, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.
authors.forename: Anderson O
authors.initials: AO
authors.lastname: Ferreira
authors.affiliation: Ortofarma-Quality Control Laboratories, Matias Barbosa, MG, Brazil; NUPICS-Núcleo de Pesquisa e Inovação em Ciências da Saúde, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.
authors.forename: Hudson C
authors.initials: HC
authors.lastname: Polonini
authors.affiliation: Ortofarma-Quality Control Laboratories, Matias Barbosa, MG, Brazil.
authors.forename: Sharlene L
authors.initials: SL
authors.lastname: Silva
authors.affiliation: Ortofarma-Quality Control Laboratories, Matias Barbosa, MG, Brazil.
authors.forename: Fernando B
authors.initials: FB
authors.lastname: Patrício
authors.affiliation: Ortofarma-Quality Control Laboratories, Matias Barbosa, MG, Brazil; NUPICS-Núcleo de Pesquisa e Inovação em Ciências da Saúde, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.
authors.forename: Marcos Antônio F
authors.initials: MAF
authors.lastname: Brandão
authors.affiliation: Ortofarma-Quality Control Laboratories, Matias Barbosa, MG, Brazil; NUPICS-Núcleo de Pesquisa e Inovação em Ciências da Saúde, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil. Electronic address: nadiacritt@gmail.com.
authors.forename: Nádia R B
authors.initials: NRB
authors.lastname: Raposo
mesh_terms: D000284:Administration, Oral; D017311:Amlodipine / Q000032:analysis / Q000592:standards; D002738:Chloroquine / Q000031:analogs & derivatives / Q000032:analysis / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003622:Dapsone / Q000032:analysis / Q000592:standards; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods* / Q000592:standards; D005240:Feasibility Studies; D006863:Hydrogen-Ion Concentration; D007555:Isoxazoles / Q000032:analysis / Q000592:standards; D010672:Phenytoin / Q000032:analysis / Q000592:standards; D011736:Pyridoxine / Q000032:analysis / Q000592:standards; D013411:Sulfadiazine / Q000032:analysis / Q000592:standards; D012460:Sulfasalazine / Q000032:analysis / Q000592:standards; D013535:Suspensions / Q000032:analysis* / Q000592:standards*; D013752:Tetracycline / Q000032:analysis / Q000592:standards; D014295:Trimethoprim / Q000032:analysis / Q000592:standards; D000078305:Zonisamide
chemical_list: D007555:Isoxazoles; D013535:Suspensions; D013411:Sulfadiazine; D017311:Amlodipine; D012460:Sulfasalazine; D000078305:Zonisamide; D010672:Phenytoin; C023676:chloroquine diphosphate; D002738:Chloroquine; D003622:Dapsone; D014295:Trimethoprim; D013752:Tetracycline; D011736:Pyridoxine
keywords: Compounding pharmacy; Feasibility; Stability; SyrSpend