Abstract

SILDENAFIL-EXCIPIENT COMPATIBILITY STUDIES FOR PHARMACEUTICAL SUSPENSIONS ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

Abdalwali Ahmed Saif, Jalal H. Abdullah, Mahmoud Mahyoob Alburyhi*, Maged Alwan Noman and Sami Ahmed Saeed

Abstract

The main objective of the present study was to the preformulation studies were performed to know the physicochemical and mechanical properties of Sildenafil for formulation development of pharmaceutical suspensions ADDS. The drug-excipient compatibility studies were conducted to characterize the drug Sildenafil present in pharmaceutical suspensions ADDS. The safety, efficacy, quality and stability of a formulation are major concepts of any API development process. In API development process, a detailed characterization of the API and other formulation components is usually carried out during the preformulation stage. Preformulation, formulation and evaluation of Sildenafil to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability and pharmaceutical suspensions ADDS for manage pulmonary arterial hypertension in pediatric patients. In the present study that the compatibility was assessed by, FTIR spectroscopy, and melting point apparatus, preformulation parameters. Results showed that physical mixtures of Sildenafil and various excipients as xanthan gum, HPMC, CMC, citric acid, sodium benzoate, aspartame, sucralose, and sucrose were evaluated for preformulation studies parameters. It was concluded that the drug Sildenafil was found to be compatible with various excipients which were selected for the formulation development of the Sildenafil pharmaceutical suspensions ADDS for manage pulmonary arterial hypertension in pediatric patients. Formulation scientist from his experience and knowledge have to significantly in the preformulation study stage and is an important factor in the ADDS (Advanced Drug Delivery Systems) product development process.

Keywords: Sildenafil Citrate, Management of Pulmonary Arterial Hypertension, Pharmaceutical Suspensions ADDS, Compatibility, Excipients, Development, Preformulation, Advanced Drug Delivery Systems.