Issue link: https://www.e-digitaleditions.com/i/1163217
Tablets & Capsules September 2019 41 eye on John Tillotson Abitec excipients This edition of Eye on Excipients dis- cusses direct-compression tableting and describes the benefits and limitations of two direct-compression lubricants. To form a durable compact in a direct-compression tableting process, you must physically compress, under relatively high pressure, a homoge- nized blend of powders, including any active pharmaceutical ingredi- ents (APIs) and any excipients necessary to the tablet's function or suitable manufacture. The term "compaction" describes the process of forming a solid tablet out of pow- der, while the term "compression" describes the powder's reduction in volume during compaction. The typical direct-compression tableting process consists of the following unit operations: screen- ing, weighing, blending, lubricant blending, and compaction, fol- lowed by testing to ensure the tab- let's robustness and intended func- tionality. The process is easy to explain conceptually, but in prac- tice it can be difficult to manufac- ture robust tablets that provide for all intended functionalities. In addition to the API(s) tablet manufacturers employ numerous excipients to help give the tablets the desired qualities. Excipients include but aren't limited to diluents, dry binders, sustained-release ingredi- ents, glidants, anti-adherents, pH modifiers, disintegrants, colors, sweeteners, flavors, delayed-release ingredients, preservatives, dissolution adjuvants, and lubricants. In practice, these ingredients can either contribute to or inhibit the for- mation of the physical bonding that occurs during the compaction event. Those excipients that contribute to physical bonding during compaction increase tablet hardness, while those ingredients that inhibit physical bonding during compaction reduce tablet hardness. Pharmaceutical man- ufacturers nearly universally recog- nize tablet lubricants as reducing the amount of bonding that occurs during compaction, which can lead to a loss in overall tablet hardness, thereby reducing tablet robustness. 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