Effects of granule particle size and lubricant concentration on tablet hardness containing large concentration of polymers

Chauhan Rajani,Dewangan Devendra Kumar,Jha Arvind Kumar,Dwivedi Jaya

doi:10.1590/s2175-97902017000300149

Chauhan Rajani, Dewangan Devendra Kumar + Show 2 more

Open Access

https://doi.org/10.1590/s2175-97902017000300149

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Abstract

ABSTRACT The objective of this research work is to demonstrate the impact of granule size and lubricant concentration on the hardness of tablets in formulations containing higher concentration of polymers and to resolve the hardness issue during compression process. The work involves optimization of a milling process for size reduction of granules and blending process to achieve tablets of good hardness on compression. To optimize the granule size, different sized co-mill screens were used. The different concentration of lubricant were studied on different sized granules to check the effect on hardness of tablets and to obtained the desired hardness of tablets. Compression of lubricated blend in various concentration was performed using the gravity feeder and force feeder separately to check the impact on the over lubrication effect. This ultimately leads to less hardness tablets. Lubricated blends were evaluated by performing the Bulk Density, Tapped Density, Hausner ratio and compressibility index tests. Tablets were evaluated for the physical characteristics like weight variation, hardness, thickness and dissolution. It has been conclude that on using the optimum granules size and lubricant concentration in formulation, all the downstream problems can be resolved and this in turn helps in compression of tablets and also provides the good hardness to the tablets.

Highlights

Granule sizes play an important role in obtaining the hardness of tablets
Granule size is very small, it leads to issues like sticking due to extra fine particles which enters in between the surface of punch and dies and form a thin film of it on inner surface of die
Nicergoline (Teva Pharmaceutical Industries), Lactose Monohydrate {Pharmatose 200M} (DFE Pharma, Netherlands), Microcrystalline cellulose {Avicel PH 101} (FMC Biopolymer, Philadelphia), Povidone {PVP K-30}(BASF Corporation, Germany), Xanthan Gum {Xanthural 75} (CP Kelco, Atalanta USA), Methocel K100 LVCR (Dow Chemicals, Michigan, United States), Lactose Monohydrate {Flowlac 100} (Molkerei Meggle Wasserburg Gmbh), Magnesium stearate (Peter Greven, Netherlands) used in the formulation are of Ph

Summary

INTRODUCTION

Granule sizes play an important role in obtaining the hardness of tablets. Generally, as granules size increased, tablets were found to show increased weight variation, decreased hardness and increased friability. Granule size is very small, it leads to issues like sticking due to extra fine particles which enters in between the surface of punch and dies and form a thin film of it on inner surface of die. This prevents the compressed tablets to come out of the die i.e. issue of tablet ejection from the die. The function of a lubricant in the product formulation is to prevent powder from sticking to the punches, dies and other metal components of the tablet press.

MATERIAL AND METHODS

Method

AND DISCUSSION

Findings

CONCLUSION