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Tablets & Capsules October 2019 47 nesium stearate and the superdis- integ rant croscarmellose sodium. A s in the pir ox ic a m s t ud y, the researchers used the dr y binders copovidone and Omyapharm 500- OG. The ingredients were mixed in a WAB Turbula T10F mixer and compr e ss ed into 2 0 0 -millig r a m tablets containing either 90 per- cent NCC and no dr y binder or 85 per cent NCC and 5 per cent dry binder. Again, the tablets were manufactured at 15,000 tablets per hour in a Fette 1200i rotary tablet press. The tablets were then mea- sured for hardness, friability, dis- integ ration time, and dissolution according to Ph. Eur. using a Phar- matron MultiTest 50, an Er weka TAR 102, Pharmatron DisiTest 50, and a Sotax AT7smart. Compactability, friability, and dis int eg rat ion t ime. Fig u r e 6 a shows how the addition of both dry binders significantly improved the compactabilit y of NCC DC a nd a llowed the u s e of highe r compression forces without cap- ping. Also, adding 5 percent copo- vidone or Omyaphar m 50 0 -OG decreased tablet friability consider- ably, resulting in mechanically sta- ble tablets at much lower compres- sion forces. Finally, the NCC DC tablets disintegrated rather quickly, independent of tablet hard ness. A d d i n g O m y a p h a r m 5 0 0 - O G , significantly reduced the disinte- gration time, particularly at lower compression forces. Copovidone increased to more than double the disintegration time along the entire range of compression forces tested. Study summary Table 2 summarizes the advan- t a g e s of u s in g d r y b in d e r s t o improve DC formulations contain- ing either 10 percent piroxicam or 90 percent NCC. As shown in the table, both copovidone and Omya- phar m 50 0 -OG can improve the tableting process and tablet prop- erties. However, the choice of the appropriate filler-binder and dr y binder combination will depend on the intended properties of the final may also be affected, which can be problematic in products where these properties are considered critical. Effect of dry binders in a high-dose DC formulation T he pir oxicam st udy showed that adding small amounts of dr y binder s to medium-dose MCC-, lactose-, or DCP-based DC for- mulations could improve tablet- ability. To determine the effects of dr y binders in high-dose tablets, researchers blended directly com- pressible natural calcium carbonate (NCC DC) with the lubricant mag- the three DC filler-binders, with and without the dry binders. Eighty percent of piroxicam was dissolved in less than 15 minutes for all for- mulations. Omyaphar m 50 0 -OG accelerated the dissolution for all three f iller-binder for mulations, while copovidone accelerated only that of the MCC-based formulation and delayed that of the DCP and lactose-based formulations. T h e s e r e s u l t s c l e a r l y i n d i - cate that even a small amount of API can have negative effects on the final dosage form's properties. A decrease in compactability leads to the use of higher compression for ce s to achieve me chanic ally stable tablets. In turn, high com- pression forces increase the risk of capping and cause strain on the tableting equipment. Additionally, the temperature of the tooling may increase, reducing the formulation's chemical stability. Negative effects on f riabilit y lead to tablets that are not mechanically stable, mak- ing them unsuitable for coating, if required, or transportation, unless special packaging is used, which may dramatically increase costs. Disintegration time and dissolution Figure 5 API dissolution rate of DC formulations containing 10% piroxicam with and without dry binders (Error bars represent the standard deviation of 6 tablets of equal hardness.) 140 120 100 80 60 40 20 0 Time (minutes) 0 10 20 30 40 50 60 70 DCP DC + piroxicam DCP DC + piroxicam + 5% Omyapharm 500-OG DCP DC + piroxicam + 5% copovidone Lactose DC + piroxicam Lactose DC + piroxicam + 5% Omyapharm 500-OG Lactose DC + piroxicam + 5% copovidone MCC DC + piroxicam MCC DC + piroxicam + 5% Omyapharm 500-OG MCC DC + piroxicam + 5% copovidone Dissolution (%) These results clearly indicate that even a small amount of API can have negative effects on the final dosage form's properties.