Formulation and In-vitro Evaluation of Paracetamol and Ibuprofen Immediate Release Tablets by Solid Dispersion Technique

Abstract

Paracetamol (PARA) and Ibuprofen (IBU) comes under BCS class II drugs basing on its low solubility and high
permeability characteristics, these drugs having its oral bio availability is dissolution rate limited. The aim with an
objective of this study was to formulate immediate release (IR) tablets by direct compression method by using solid
dispersion technique to enhance dissolution rate of drugs (PARA and IBU). The IR tablets of PARA (500mg) and
IBU (200mg) was prepared by using super disintegrants like cross providone and SSG. Dissolution enhancers like
PVP K-30, PEG 4000, PVA, SLS, hydroxypropy β-cyclodextrin were used. Drug and excipients compatibility
studies were carried out through FTIR analysis. FTIR studies revealed that there is no incompatibility between the
drugs and different excipients used in the formulation of tables. All formulations were subjected to preformulation
and post formulation studies. The powder mass of the tablet is evaluated by assessing precompressional parameter
such as angle of repose (25.98-35.06θ), bulk density (0.254-0.318g/cc), tapped density (0.31-0.375g/cc), Hausner's
ratio (1.11-1.75%) and Carr’s compressibility index (6.1-15.5%). All the results are within the specifications and
indicated that all formulations have good flow properties. The post compressional parameters of the tablet like
hardness (3.3-4.9 kg/cm2
), friability (0.6-0.95%), Weight variation (894-906 mg), and thickness (3.96-4.88mm) are
within the acceptable limits. The IR tablet was designed in such a way to achieve complete release of the dose
within a 30 min. The drug content in all formulations was in the range 96.33-102.20% for PARA and 97.74-
101.92% for IBU within the disintegration time (2-11mins). In vitro release studies were carried out in USP II
paddle type dissolution apparatus for all formulations and the formulation F10 containing PARA (55.5%), IBU
(22.2%), SSG (3.8%), SLS (11.1%) and cross providone (3.8%)gives best release profile (PARA and IBU released
at the end of 5min is 80.6 & 72.6 respectively) due to their solubilizing capacity.