Issue link: http://www.e-digitaleditions.com/i/525960
2 MEGGLE | Co-processed lactose CombiLac ® Product description The high-functionality excipient, CombiLac ® is an integrated, lactose-based, co-processed excipient, specifically designed to ease oral solid dosage form development and manufacture. It consists of 70 % alpha-lactose monohydrate, 20 % microcrystal- line cellulose (MCC) and 10 % white, native corn starch, each conforming with Ph.Eur., USP-NF, and JP compendial requirements. The three individual components are integrated into a monopar- ticulate structure, which is not separable by physical means. CombiLac ® shows improved compaction properties compared to an equivalent admixture of individual ingredients, providing robust tablets with minimal friability. It assures rapid, hardness- independent tablet disintegration for effective API release, and features powder flow characteristics necessary to enhance dosage form weight uniformity and throughput in DC. General information Direct compression (DC) tablet manufacture is a popular choice because it provides the least complex, most cost effective process to produce tablets compared to other tablet manufacturing approaches. Manufacturers can blend APIs with excipients and compress, making dosage forms simple to produce [1, 2]. DC technology and the use of modern tableting equipment require that excipients and APIs form a compactable mixture with excellent flowability and low particle segregation tendency [3]. In the pharmaceutical industry, lactose is one of the most commonly used excipients; however, like many other excipients, lactose may not be suitable for direct compression without modification due to insufficient powder flow or/and compress- ability properties (Figure 1). MEGGLE co-processed lactose grades for direct compression: CombiLac ® Figure 1: Powder blend compressability and flowability requirements for various tableting technologies (DC is direct compression, WG is wet granulation, DG is dry granulation) [3]. Lactose performance Flowability/compressability High Powder flow Low Powder compressability High WG DC WG DG