re: Ann: Phosphagenics Further Expands Pain P...
Perhaps Esra's mention of a "contained system" for topical oxycodone refers to the need to fully address a drug's container closure system design from as early as possible in a drug's development. The first excerpt below is from a drug delivery technology technical expert. The second is from draft Guidance on this same issue, which was only recently issued by the FDA.
The FDA Guidance for Industry, Container Closure Systems for Packaging Drugs and Biologicals recommends that each new drug application (NDA) or abbreviated new drug application (ANDA) contain enough information to demonstrate that a proposed package and its components are suitable for the intended use. In summary, the container-closure should adequately protect the dosage form, be composed of materials safe for use with the dosage form and route of administration, and function properly if it has a performance feature. Some questions that arise from the guidance include:
• Does the container-closure system protect the dosage form from environmental challenges (e.g., moisture, light, oxygen, shipping)? • Is the dosage form identified in the Guidance as a higher (e.g., ophthalmic solution, transdermal, or nasal) or highest (e.g., inhalation or injectable) risk for packaging concerns? • Does the container-closure system play a functional role in delivery of the drug product such as with inhalations and transdermals?
The more “yes” answers to questions such as these point to the need for earlier consideration/selection of the container-closure system during development. Current regulatory initiatives (e.g., quality by design, risk assessment) provides further urgency to an early initiation of container-closure consideration. Ultimate product quality is enhanced when the container-closure system is an integral part of early development studies. A better defined and robust design space for manufacturing will typically follow that may provide acceleration of the regulatory review process.
Safety Consideration for Product Design to Minimize Medication Errors
This guidance provides sponsors of investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs), and nonprescription drugs marketed without an approved application... with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. Improvements in a drug product’s design can enhance patient safety by reducing medication errors, adverse events, and patient harm resulting from such errors. The recommendations in this guidance document are intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. Many medication errors can be avoided by drawing upon lessons learned from other drug product errors and by evaluating the drug product using proactive risk assessments before marketing to reduce risks associated with a drug product’s overall design.
The FDA provides examples of mutiple factors for drug developers to consider, including
What characteristics might the end users have that could affect their ability to use the drug correctly (e.g., physical strength, stamina, dexterity, flexibility, coordination, vision, hearing, memory, disease state, mental clarity, ability to swallow, tolerance of medications that are unpalatable or difficult to swallow or ingest)?
Drug products should not be packaged in a container/closure system that... affords a route of administration other than the route intended
(20min delay)