Abstract:
The aim of present investigation was to formulate and evaluate dry syrup of an anti
retroviral drug Nevirapine. As Nevirapine is BCS class II drug, to improve solubility
β-cyclodextrin was used. To investigate complexes phase solubility studies performed
in both 0.1 N HCL and 6.8 pH phsosphate buffer. Phase solubility studies indicating
that AL type curve obtained that means complexation follows K1:1. For complexation
of drug three methods used, among them kneading method given better results. By
using complexed drug dry syrup was prepared. In the dry syrup formulation
poloxamer-188, hydroxyl ethyl cellulose were used as wetting agent, stabilising agent,
dispersing agent. The concenstrations of 1%, 3%, 5% of poloxamer 188 and 1%, 1.5%
2% of HEC were selected. Dry syrup evaluated for flow properties like angle of
repose and Hausner’s ratio before reconstitution. Dry syrup evaluated after
reconstitution for the following parameters like drug content, Invitro dissolution
study, Dispersibility, Redispersibility, pH, Viscosity, Sedimentation volume and Time
taken to disappear bubbles. F2 batch containing poloxamer 3% and HEC 1% was
optimized. Accelerated stability studies conducted at 40±2°C/75±5% RH for one
month. After one month storage under accelerated conditions dry syrup was evaluated
before and after reconstitution. Assay and pH were evaluated periodically within a
week after reconstitution. From stability studies the prepared dry syrup found to be
stable.
