Development of a novel dispersible
tablet formulation
This formulation was made by Rubicon
Research Pvt. Ltd. and the
purpose of this study was to develop a dispersible tablet which, upon
dispersion in water, forms a homogenous dispersion with reduced sedimentation
rate, thus ensuring uniformity of dosage.
Introduction
Dispersible tablets combine benefits of liquid
dosage forms with a solid dosage forms and are preferred for pediatric and
geriatric patients. The drug from conventional dispersible tablets, has
tendency to settle at the bottom or adhere to the sides of the containers upon
dispersion in water, leading to incomplete dosage.
Methods
Dispersible tablets were developed using
hydroxyethyl cellulose (HEC) as a viscolizer. The concentration of HEC and
other excipients was optimized to achieve desired sedimentation rate,
disintegration time and pleasant mouth feel. Oxcarbazepine, an antiepileptic drug, was studied as a model drug.
Dissolution of the developed formulation was studied (by Rubicon Research Pvt.
Ltd.) in water containing different amounts of cetrimide (used to enhance
solubility of the drug in the medium). A new method was developed to determine
sedimentation rate of the resultant suspension.
Results
These tablets were found to disperse rapidly in
water, despite the presence of the viscous polymer. During dispersion
formation, HEC dissolved, increasing the viscosity of the dispersion. This
ensured instant suspension formation with low sedimentation rate, typically
less than 30% of drug in 15 minutes, compared to more than 70% in the case of a
marketed conventional dispersible tablet formulation. Dissolution rate of
Oxcarbazepine dispersible tablet was found to be similar to that of the
marketed immediate release formulation.
Conclusion
A novel dispersible tablet technology was developed
to yield a low sedimentation rate of the formed dispersion and to ensure
uniformity of dose. Using this technology a stable oxcarbazepine dispersible
tablet formulation was developed. This technology can be used for different
categories of drugs, particularly antiepileptics and antibiotics.
By
Raj
Kishore
Deptt.
of Pharmaceutics
A.N.D.
college of Pharmacy
Babhnan,
Gonda