Preparation, Evaluation and Need of Spherical Crystallization in Case of High Speed Direct Tabletting
Suneel Pandey and Arun T. Patil
Affiliation: Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur-440 033, Maharashtra, India.
Keywords: Aceclofenac, Direct compression, High speed tabletting, Powder flowability and spherical crystallization.
In direct compression (DC), the significance of usual flow properties of powder from the hopper to the dies of
the tablet machine cannot be overstressed. Ensuring the free flow of powder presents a number of challenges to the pharmaceutical
formulator in case of high speed tabletting. This research work was conceived to obtain directly compressible
agglomerates by spherical crystallization technique and were comparatively evaluated for physicochemical properties as
well as tableting properties of agglomerates and unprocessed aceclofenac. Agglomerates of aceclofenac were developed
via spherical crystallization method by a solvent arrangement containing dichloromethane (DCM) as a good solvent, water
as a bad solvent and acetone as a bridging liquid. Hydroxypropyl cellulose (HPC) in variable quantity was implemented as
hydrophilic polymer. The agglomerates were evaluated for yield, solubility, drug content, FTIR spectroscopy, porosity,
particle size, micromeritic properties, differential scanning calorimetry (DSC), X-ray diffraction studies (XRD), scanning
electron microscopy (SEM), and dissolution studies. The agglomerates expressed improved micromeritic and dissolution
properties, in equivalence to pure drug. Formulation F3 (optimized agglomerates) exposed estimable rotundity, better drug
release, and easily compression into tablets by high speed DC Technique. The tablets showed acceptable physicochemical
properties and complied with the pharmacopoeial specifications. The dissolution rate of prepared tablets from agglomerates
was better than the tablets of pure drug. The F3 agglomerates show splendid physicochemical and micromeritic properties.
Agglomerated compression mix also showed good tableting properties as needed for high speed compression and
enough stability under accelerated conditions at least for 1 month.
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