Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
نویسندگان
چکیده
The purpose of this study is to develop and improve oral liquids formulations of sildenafil citrate for paediatric use. Four different formulations were developed, which are as follows: two aqueous solutions of sildenafil citrate (2.5 mg/mL), with or without preservatives, and two other solutions of sildenafil in simple syrup (1.25 mg/mL), with or without preservatives. All of the formulations were physically, chemically and microbiologically stable for three months. The results of the stability studies allowed for the optimisation of formulations without preservatives due to their simplicity and their similar stable conditions when compared to the formulations containing antimicrobials. The shelf life of both formulations was three months; however, upon opening, aqueous solutions should be used within 10 days and kept refrigerated, and syrup solutions should be used within 14 days in a hospital setting.
منابع مشابه
Design and physicochemical stability studies of paediatric oral formulations of sildenafil.
Personalized medicine is a challenging research area in paediatric treatments. Elaborating new paediatric formulations when no commercial forms are available is a common practice in pharmacy laboratories; among these, oral liquid formulations are the most common. But due to the lack of specialized equipment, frequently studies to assure the efficiency and safety of the final medicine cannot be ...
متن کاملFabrication and Characterization of Sildenafil Citrate Loaded Transfersomes as a Carrier for Transdermal Drug Delivery
The aim of this study was to enhance the transdermal delivery of Sildenafil Citrate by encapsulation in nano sized ultra deformable vesicles, transfersomes. The thin film hydration and sonication technique was utilized in the preparation of Sildenafil Citrate loaded Transfersomes and both non ionic and ionic edge activators (anionic and cationic) were used in varying ratios to study their effec...
متن کاملFabrication, appraisal, and transdermal permeation of sildenafil citrate-loaded nanostructured lipid carriers versus solid lipid nanoparticles
Although sildenafil citrate (SC) is used extensively for erectile dysfunction, oral delivery of SC encounters many obstacles. Furthermore, the physicochemical characteristics of this amphoteric drug are challenging for delivery system formulation and transdermal permeation. This article concerns the assessment of the potential of nanomedicine for improving SC delivery and transdermal permeation...
متن کاملMethod Development and Validation of Stability Indicating Methods for Assay of Tadalafil and Sildenafil Citrate by Hplc
The simple, reliable and reproducible HPLC methods were developed for the analysis of Tadalafil and Sildednafil citrate(API). The column used was YMC-Pack ODS AQ (150 mm x 4.6 mm,i.d.).The mobile phase used was phosphate buffer (10mM,pH 3.0) acetonitrile gradient run at the flow rate of 1mL/min with UV (PDA) detector at 220nm at ambient temperature. Extraction of Tadalafil and Sildenafil citrat...
متن کاملValidated Methods for Determination of Sildenafil Citrate in The Presence of its Potential Impurities
Two simple, accurate, sensitive and reproducible methods have been developed and subsequent validated for the determination of Sildenafil citrate (SC) in presence of its impurities “1-methyl-4-nitro-3-n-propyl-5pyrozole Carboxamide (MNC), 4-amino-1-methyl-3-n-propyl-5-pyrazole Carboxamide (AMP), 4-(2-ethoxy benzoyl amino)-1-methyl-3-n-propyl-5-pyrazole Carboxamide (EMC) and 5-(2-ethoxyphenyl)-1...
متن کامل