Pellet Starters in Layering Technique Using Concentrated Drug Solution

Abstract

Characteristics of inert starters in drug solution layering are important for successful active pellet formation. Four types of starters composed of sucrose or microcrystalline cellulose (MCC) or lactose and MCC were compared in our study. The active pellets were prepared using Wurster type apparatus. Yield and pellet quality parameters were determined. The highest yield (85.66–89.41%) was obtained for cores composed of MCC due to their insolubility in water (the drug solvent) and good mechanical properties. On the contrary, soluble and brittle sucrose cores dissolved partially during the process forming undesirable agglomerates and giving lower yield (76.2%). All pellet samples showed good flow properties and drug content from 82.4 to 94.5% of the theoretical drug amount.

Keywords:

• pellets
• concentrated drug solution layering
• nonpareils
• sucrose
• microcrystalline cellulose

ACKNOWLEDGMENTS

This experimental work has been supported by the pharmaceutical company Zentiva a.s. Praha, Czech Republic. Cellets® 500 were kindly donated by Syntapharm GmbH, Germany.