How To Use DMF Content To Support Your Application To The FDA
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?
WHITE PAPERS & CASE STUDIES
Product Development For An Oral Solid Dosage Using Continuous Manufacturing
A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.
Pediatric Dosage Form Considerations For Highly Potent Compounds
The development of pediatric medicine poses numerous challenges to pharmaceutical formulators, particularly products intended for infants and very young children. This white paper describes special considerations for selecting appropriate pediatric dosage forms and the benefits of choosing mini-tablets (e.g., orodispensible) for pediatric formulation, particularly for highly potent compounds.
Extrusion- Spheronization, Engineered For Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of both today’s and tomorrow’s complex OSD therapeutics.
Identifying Abrasive Wear Risks In Tableting Tooling For Nutraceutical Products
Tablet presses are used to manufacture a variety of products, such as pharmaceuticals, nutraceuticals, veterinarian products, confectionary, and industrial tablets. Each industry faces unique challenges due to the properties inherent to any particular formulation. A variety of steel types/coatings, tool design modifications/options, and tablet design recommendations can work together to increase tool life and improve tablet quality.
Overcoming Encapsulation Issues Caused By Sticky Formulations
This guide provides a best-practices approach to troubleshooting capsule-filling problems when handling a sticky product formulation.
Considerations When Cleaning Your Tablet Presses & Tablet Tooling
Implementing a cleaning procedure is essential to maintaining your tablet tooling and presses. Dirty tools cause tableting and product quality-related problems, such as sticking & picking. Keeping tools clean also decreases premature tool, turret and cam wear, and reduces the risk of product cross-contamination. While most cleaning methods can achieve similar results, utilizing an automated cleaning system, such as an ultrasonic wash with rinse and dryer, can ensure tooling is properly cleaned and dried consistently with limited handling and potential for damage. A warm air-drying process is ideal for preventing moisture and corrosion by pushing warm air through areas, such as key slots, punch cups, and die bores, that may not be dried properly with a traditional towel or cloth.