How to Achieve Different Release Profiles and Select Excipients for Formulation Development of Modified Release Oral Solid Dosage Forms
In pharmaceutical manufacturing, the formulation and manufacture of modified release oral solid dosage forms is highly specialized. To obtain the desired release profile(s), a holistic approach is necessary. This paper details numerous considerations for the planning and execution of a successful modified release oral solid dosage formulation.
Wurster processing is an extremely versatile pharmaceutical development and manufacturing technique for multiparticulates to be used in modified release (e.g., extended or controlled release) dosage forms. How do you know if it’s the right method for your modified release project?
It’s tempting to minimize or defer CMC activities while preparing for clinical milestones. Are you making decisions that may delay — rather than accelerate — development?
Steer clear of: “We have to start over.”
Do you want to develop an oral controlled release (OCR) product? If so, you’ll quickly realize there are a lot of questions to answer. What do you want the final dosage form to do? What formulation and process approach are you going to use? What traps and roadblocks might you encounter? Understanding the options and their ramifications is the first step toward devising a plan.
Today’s drug manufacturers must be agile and willing to adapt to wide-ranging and fast-changing requirements. Flexible, highly efficient manufacturing plants are in high demand. Many aspects of facility and equipment design can directly impact manufacturing performance in these complex operations.
When the Drug Supply Chain Security Act (DSCSA) was passed, it laid out requirements for manufacturers regarding transaction documentation, procedures for suspect product investigations, authorized trading partners and the use of a unique unit-level product identifier – a serial number – for each package and homogenous case of prescription drugs.
The FDA has postponed enforcement until November 2018, granting manufacturers one more year to complete implementation of a serialization program.
Are you serialization-ready? Failure to comply could result in penalties and the inability to sell your un-serialized products.