Optimisation of Starch Glutamate as a New Modified Superdidintegrant in the Formulation of Ibuprofen Fast Dissolving Tablets

The chapter highlights about enhancement of the solubility and bioavaialibility of the ibuprofen by formulating it into fast dissolving tablets employing starch gutamate as a novel superdisintegrant. The concept of Fast Dissolving Drug Delivery Systems (FDDS) emerged from the desire to provide patient with conventional means of taking their medication. FDDS gaining popularity nowadays due to its improved patient compliance in pediatrics and geriatric patients who experience difficulties in swallowing. The esterification technique was used to create starch glutamate from native potato starch and glutamic acid. Ibuprofen fast-dissolving tablets were created using the direct compression method and a variety of superdisintegrants, including starch glutamate (a novel superdisintegrant). The prepared ibuprofen fast dissolvng tablets were evaluated for various pre & post compression parameters along with the in-vitro and in-vivo release characterisitics. Optimized formulation stability studies were performed at accelerated conditions for 6 months as per ICH & WHO guidelines. Fast dissolving tablets of ibuprofen were formulated by employing starch glutamate as a superdisintegrant showed good tablet properties and showed an increased dissolution efficiency of the drug. Hardness of the fast dissolving tablets of ibuprofen was found to be in between 3.7 ± 0.02 to 3.9 ± 0.02 Kg/cm2. Among all the formulations (F1 to F8), the formulation F4 which contain 5% starch glutamate and 5% croscarmellose sodium as superdisintegrants showed 99.7±0.34% drug dissolution within 5 minutes. From the results of the tablet evaluation tests, it was known that all the ibuprofen fast dissolving tablet formulations passing the official pharmacopoeial tablet evaluation tests. Pharmacokinetic parameters of the optimized ibuprofen fast dissolving tablet formulation F2 , attained peak plasma concentration in a short period of time and showed increased in an absorption rate with an increased relative bioavailability of the drug. Optimised formulation peak plasma concentration In accordance with ICH stability requirements, F2 was quickly attained, increased relative bioavailability, and was discovered to be stable during accelerated stability testing. Starch glutamate can be used as a superdisintegrant in the formulation of fast-dissolving tablets to increase the solubility and bioavailability of the poorly soluble drugs, according to studies on drug-excipient compatibility, disintegration time, in-vitro dissolution, and pharmacokinetics.