Abstract
Objective: To optimize aceclofenac fast dissolving tablets employing starch glutamate as novel superdisintegrant by 23factorial design to improve bioavailability and enhance patient compliance.
 Methods: Starch glutamate was prepared by the esterification process. Starch glutamate physical and micromeritics properties had been evaluated and the prepared starch glutamate was used as a superdisintegrant for the formulation of the fast dissolving tablets of aceclofenac by direct compression method and optimized by employing 23factorial design. The prepared aceclofenac fast dissolving tablets were evaluated for post compression parameters as well as in vitro and in vivo release characteristics. Optimized formulation stability studies were performed at accelerated conditions for 6 mo as per ICH and WHO guidelines.
 Results: The prepared starch glutamate was amorphous, insoluble in aqueous and organic solvents were tested. Fast dissolving tablets of aceclofenac were formulated by employing starch glutamate as a superdisintegrant showed good tablet properties and showed an increased dissolution efficiency of the drug. Among all the formulations (F1 to F8), the formulation F8 containing 5% concentration of starch glutamate, croscarmellose sodium and, crospovidone as a superdisintegrants showed 99.7±0.15% of drug release within 5 min. Whereas the formulation F2 containing 5% concentration of starch glutamate, drug release characters were comparable to the formulation F8. Optimized formulation F2 attained peak plasma concentration within a short period and showed increased relative bioavailability of the drug.
 Conclusion: From the physical properties, disintegration time, in vitro dissolution studies and pharmacokinetic studies, it was concluded that fast dissolving tablets of aceclofenac tablets formulated by employing starch glutamate as a superdisintegrant enhanced the dissolution efficiency and improved the bioavailability of the drug as compared to the pure drug and stable.
Highlights
Fast dissolving drug delivery system which consists of fast dissolving tablets gaining popularity nowadays [1]
HCl and Dimethyl sulfoxide, crospovidone, croscarmellose sodium, mannitol, microcrystalline cellulose were purchased from the SD fine chemicals, Hyderabad and aceclofenac pure drug purchased from Yarrow Chem, Mumbai
In the Fourier transform infrared spectroscopy (FTIR) spectrum of starch glutamate, a peak was observed at 1619.29 cm-1, characteristic of the ester group
Summary
Fast dissolving drug delivery system which consists of fast dissolving tablets gaining popularity nowadays [1]. Fast dissolving tablets can be administered without the aid of water and provides accurate dosing [4]. Fast dissolving tablets can provide the advantages of a liquid dosage form in the solid form [5]. Aceclofenac exhibits potent analgesic activity, effective in the treatment of painful inflammatory conditions, mostly administered orally. It is broadly prescribed for conditions rheumatoid arthritis, osteoarthritis, acute lumbago and dental pian [6]. The work aimed to formulate and characterize fast dissolving tablets of aceclofenac by utilizing optimization techniques for rapid dissolution of the drug and absorption employing a new superdisintegrant i.e., starch glutamate
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