Abstract

FORMULATION AND EVALUATION OF SILDENAFIL CITRATE AS PHARMACEUTICAL RECONSTITUTABLE ORAL SUSPENSIONS ADVANCED DRUG DELIVERY SYSTEMS FOR MANAGEMENT OF PEDIATRIC PULMONARY ARTERIAL

Abdalwali Ahmed Saif, Mahmoud Mahyoob Alburyhi*, Maged Alwan Noman

ABSTRACT

Sildenafil citrate, a phosphodiesterase type 5 inhibitor, is a vasodilator used in the management of pulmonary arterial hypertension in both adults and children. Pulmonary arterial hypertension (PAH) in children requires precise, weight-based dosing, However the lack of suitable pediatric formulations often leads to unsafe practices like tablet splitting. This study aimed to develop a stable, palatable, and easily reconstitutable dry suspension of Sildenafil citrate tailored for pediatric use. Eleven formulations were prepared using wet granulation with xanthan gum, HPMC, and CMC as suspending agents, along with taste-masking excipients. Key results showed excellent stability (pH 3.3–3.6), rapid redispersibility. It was concluded that among the eleven formulations evaluated, F10 emerged as the most promising due to its rapid redispersibility, optimal drug dissolution within 5 minutes. F10 was the best formulation oral suspension as it showed a drug dissolution percentage 108% in 5minutes was within the acceptable limitas reconstitutable oral suspension of Sildenafil citrate formulations ADDS for management of pediatric pulmonary arterial hypertension (PAH).

Keywords: Sildenafil citrate, Formulation, Management of Pulmonary Arterial Hypertension, Pediatric Patients. ADDS.