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Formulating with highly insoluble, crystalline APIs
Q: What formulation options do I have for a highly insoluble, crystalline API that must be taken once daily for dose compliance?
Many highly potent active pharmaceutical ingredients (APIs) available today are crystalline in nature and exhibit poor solubility. In addition, payers and sponsors also insist on simplified, patient-centric, once daily (OD) dosing regimens to boost dose compliance and therapeutic performance.
A systematic literature search using the keywords "dosing frequency and medication adherence in chronic disease" concluded that patients with chronic diseases appear to be more adherent to OD dosing compared to other medication regimens .
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Sticky formulation buildup on die table
Q: What do you do when you have sticky formulation buildup on a tablet press die table?
Joseph Remington Wood, in his 1906 book Tablet Manufacture: Its History, Pharmacy, and Practice,
discusses sticking and picking of formulation to the punch face and die wall. To this day sticking remains a challenge to the industry. The following recommendations can help you prevent formulation from sticking to a tablet press die table.
Feeder scraper blade
The scraper blade on the tablet press feeder must move freely without binding in any position. When buildup occurs, evaluate the scraper blade's condition and ensure that it's adjusted properly and floats freely to follow the die table's runout. Most scraper blades have a bevel edge, which enhances the scraping performance.
In Tablets & Capsules magazine
Using a development and submission stage gate system to help improve drug product development outcomes
The regulatory concept of Quality by Design is a gateway to improved cost control and faster, bigger returns on investment. This article discusses how pharmaceutical manufacturers can unlock these benefits by using a system that integrates their product development and regulatory sciences and submissions teams, focusing on quality at every step.
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