Abstract

In this work, a fluidized bed agglomeration process was used to produce agglomerated lactose with good compressibility. In the fluidized bed agglomeration, large lactose crystals were used as the core materials, fine-milled lactose particles were bound to the surface of large lactose cores, and lactose solution was used as the binder. A suspension of lactose solution is sprayed onto the fluidized lactose particles, forming liquid bridges among the large and small lactose particles to form agglomerated lactose. Good hardness of 75-88 N was achieved for the agglomerated lactose. The particle size and bulk density can be controlled. The effects of agglomeration parameters, including solution concentration and temperature, atomizing pressure, peristalsis speed, and material temperature, were investigated for the agglomeration result and the characteristics of the agglomerated lactose. The result also shows that high solution temperature and high solution concentration can improve fluidized bed agglomeration efficiency.

Highlights

  • Excipients are inactive substances formulated with the active pharmaceutical ingredient (API) of a medication

  • Different kinds of excipients are frequently used together to achieve multiple properties for a medication; the ones that can improve the quality of pharmaceutical preparations or the production efficiency have attracted more and more attention [1, 2]

  • Solid dosage forms require different types of excipients to be added to the API in order to obtain the desired physicochemical properties, such as flowability, compressibility, disintegration, solubility, and stability [4,5,6,7,8], for the medication

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Summary

Introduction

Excipients are inactive substances formulated with the active pharmaceutical ingredient (API) of a medication. There have been several types of lactose excipient [3, 4], which have typical values of fluidity, viscosity, compressibility, particle size and particle size distribution, enteric disintegration performance, and so on. These values have great influence on the physical and chemical properties of pharmaceutical preparations, such as disintegration and dissolution and bioequivalence in vivo and in vitro. Solid dosage forms require different types of excipients to be added to the API in order to obtain the desired physicochemical properties, such as flowability, compressibility, disintegration, solubility, and stability [4,5,6,7,8], for the medication. The typical mixing and granulation techniques in the pharmaceutical industry include direct mixing, dry and wet granulation, spray drying, and freeze drying [9]

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