title: Design and Optimization of Domperidone Fast Dissolving Tablet Using Central Composite Design.
abstract: The main aim present work was to optimize fast dissolving tablet (FDT) formulation using response surface approach. The variables studied were sodium bicarbonate (X1), citric acid (X2), and superdisintegrant, Ac-Di-Sol (X3). The main aspect of present work was to develop FDT of Domperidone which possesses fast disintegration and high mechanical strength. It was found that the response was affected by all the three factors studied. The statistical models were successfully used to prepare FDT of Domperidone with fast disintegration (31.08 seconds) and adequate hardness (4.1 kg/cm(2)). Pharmacokinetic studies in rats showed statistically insignificant difference (p>0.05) between Domperidone fast dissolving tablet (DFDT) and market product. This concluded that optimized FDT is bioequivalent with the marketed formulation. The values of Tmax were found to be 0.5 h and 0.75 h for DFDT and reference product, respectively. Conditioned place aversion study was performed on Swiss Albino mice and the study showed the better anti emetic potency of optimized FDT in nauseated condition over market product (p<0.05). Thus, the present investigation conclusively demonstrates the potential role in terms of rapid disintegration and high mechanical strength.
authors.affiliation: Mahrishi Arvind Institute of Pharmacy, Mansarovar, Jaipur-302020, Rajasthan, India. shailu.bhatt@gmail.com.
authors.forename: Bhatt
authors.initials: B
authors.lastname: Shailendra
authors.forename: Mandge
authors.initials: M
authors.lastname: Shailendra
authors.forename: Jaimini
authors.initials: J
authors.lastname: Manish
authors.forename: Tanwar Yuveraj
authors.initials: TY
authors.lastname: Singh
authors.forename: Trivedi
authors.initials: T
authors.lastname: Priti
mesh_terms: D000818:Animals; D000932:Antiemetics / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology; D002266:Carboxymethylcellulose Sodium / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D019343:Citric Acid / Q000737:chemistry; D004294:Domperidone / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology; D015195:Drug Design; D005079:Excipients / Q000737:chemistry; D006244:Hardness; D008297:Male; D051379:Mice; D015233:Models, Statistical; D009325:Nausea / Q000517:prevention & control*; D051381:Rats; D017208:Rats, Wistar; D017693:Sodium Bicarbonate / Q000737:chemistry; D012995:Solubility; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D000932:Antiemetics; D005079:Excipients; D013607:Tablets; D019343:Citric Acid; D004294:Domperidone; D017693:Sodium Bicarbonate; D002266:Carboxymethylcellulose Sodium