Preparation and In-Vitro Characterization of Crystallo-Co-Agglomerates of Cilnidipine
Abstract
The present invention was aimed to develop pharmaceutically equivalent, stable, cost effective and quality improved formulation of cilnidipine with enhanced dissolution rate and micromeritic properties by preparation of agglomerates using a novel crystallo-co-agglomeration technique using water and DCM as bad and good solvent respectively. The influence of various polymers and different experimental conditions on formation of crystallo-co-agglomertaes(CCA) was evaluated. To optimized the agglomerates of desired characteristics 32 factorial design was implemented. The crystallo-co-agglomerates obtained having improved dissolution rate and micromeritic properties than pure drug. The optimized batch of CCA containing cilnidipine was characterized by FTIR, DSC, SEM, XRD and GC-HS which illustrated that there is no interaction between drug and excipients and negligible amount of residual solvent. Hence at last we conclude that this technique may be applicable for producing solid oral dosage form of cilnidipine with improved dissolution rate and oral bioavailability. However in-vivo studies are required to confirm these results.
