TITLE:
Solubility Enhancement of Domperidone Fast Disintegrating Tablet Using Hydroxypropyl-β-Cyclodextrin by Inclusion Complexation Technique
AUTHORS:
Prakash Thapa, Ritu Thapa, Uttam Budhathoki, Panna Thapa
KEYWORDS:
Domperidone Maleate; Hydroxypropyl-β-Cyclodextrin; Inclusion Complexes
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.5 No.3,
March
13,
2014
ABSTRACT: Domperidone Maleate (DOM), an antiemetic drug,
has been used in treatment of adults and children. It has low aqueous
solubility and hence low bioavailability. In present study, an attempt has been
made to enhance the solubility of DOM by inclusion complexation with
Hydroxypropyl-β-Cyclodextrin (HP-β-CD) using kneading technique and
formulation of fast disintegrating tablets by using Sodium Starch Glycolate as
superdisintegrant. Solubility analysis of DOM in different concentrations of HP-β-CD was carried out. Design of experiment (DOE) is done by using
MINITAB 15.1 software to find out the variable for dissolution and
disintegration time. HP-β-CD and SSG were identified as the variable
for disintegration time and dissolution. For optimization of the concentration
of HP-β-CD and SSG, two factors at two levels design
through central composite design (CCD) were used which gave 13
formulations. All formulations are evaluated for characteristics such as weight
variation, hardness, friability, disintegration time and dissolution of drug. Solubility
of DOM increases linearly with increase in concentration of HP-β-CD. The optimum concentration of HP-β-CD is found to be in 1:2 molar ratios and SSG of
7%. The In-Vitro dissolution studies
of optimized
formulation and market sample were carried out in USP type II apparatus at different time intervals of 5, 10, 15 and 30 minutes
at 50 rpm in 0.1 N
HCl. The dissolution and disintegration time of optimized formulation is found
better than market sample.