Physical-chemical Stability of Compounded Sildenafil 100-mg Rapid-dissolving Tablets
Abstract
Sildenafil citrate is a phosphodiesterase-5 inhibitor that is approved by the U.S. Food and Drug Administration for the treatment of erectile dysfunction. Rapid-dissolving tablets are relatively novel dosage forms that can be prepared by extemporaneous compounding and potentially provide unique advantages for medications like sildenafil. However, such preparations may present newer stability considerations previously unreported. Therefore, the purpose of this study was to assess the physical and chemical stability of sildenafil 100-mg rapid-dissolving tablets prepared by a commonly practiced molding method, using two different proprietary rapid-dissolving tablet bases (Medi-RDT or RDTPlus) immediately after preparation and over six months of storage at ambient room temperature. To prepare the rapid-dissolving tablets, the powder ingredients were homogeneously mixed, filled, and compressed into a 96-cavity metal mold. The formulation was then heated at 110°C for 10 minutes in the mold, released from the mold, and cooled at room temperature for 15 minutes. The prepared tablets were packaged in amber-colored blister packs with cold-adhesive backing seals and stored at ambient room temperature. At predetermined time points, rapid-dissolving tablets of each formulation were retrieved to perform stability analyses. These analyses included weight variation, breaking force, disintegration, friability, and potency via high-performance liquid chromatography following the United States…
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