Q. When is it necessary to perform in-use stability studies on solid oral dosage forms such as tablets and capsules in multi-dose containers?
Ans. Data on the in-use stability of such products should be generated through a dedicated in-use stability study under long-term conditions when there is an indication from stability and/or stress studies that the drug product may be susceptible to deterioration. If there are no such indications, in-use stability studies do not need to be undertaken.
Q. If an in-use study is required, what length is appropriate?
Ans. 1.Dependence on Drug Use: In-use stability studies are tailored to the drug’s intended use, with an in-use shelf life set only if significant changes (per ICH Q1A (R2) or VICH GL3) are observed.
- Single Multi-Dose Container: For treatments requiring one container, studies should cover the treatment duration, considering the worst-case scenario for container size.
- Multiple Containers: For treatments exceeding one container, studies should cover the time to consume two containers, accounting for parallel use.
- Intermittent Use: For “when needed” treatments, studies should identify the failure point, potentially with less frequent container openings.
- Study Duration Limit: If no relevant changes occur within 6 months for products in immediate packaging, the study can cease, and no in-use shelf life is needed. Relevant changes refer to quality attributes trending toward out-of-specification results.
Q. Can an open dish stability study be used to assess in-use stability?
Ans. Yes. Storage without the immediate container is a worst-case scenario and can help assess the need for an in-use shelf life. This is relevant as oral solid dosage forms may be stored in compliance aids or multi-dose packages to improve adherence, reduce errors, and simplify medication management. If no significant changes occur after 3 months of open-dish storage, no in-use shelf life is needed. If changes are observed, standard in-use studies with repeated container opening and closing are required to establish a shelf life.
Open-dish studies should be controlled for comparability, with conditions like 25°C/60% RH deemed acceptable without further justification, as constant humidity exposure represents a worst-case scenario.
Read also:
- Frequently Asked Questions on Dissolution
- Common Interview Questions and Answers on Stability Testing
- What to Do When Accelerated Stability Tests Fail?
Resource Person: Vikas Bedi