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Questions and Answers
What does SUPAC stand for?
What does SUPAC stand for?
Which of these levels indicates a minor change according to SUPAC guidelines?
Which of these levels indicates a minor change according to SUPAC guidelines?
Level 3 changes are likely to have a significant impact.
Level 3 changes are likely to have a significant impact.
True
Match the cases to their corresponding dissolution requirements:
Match the cases to their corresponding dissolution requirements:
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What types of supplements are involved in filing according to SUPAC?
What types of supplements are involved in filing according to SUPAC?
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In case C, the dissolution profile should be performed in water, 0.1N HCl, and USP buffer media pH ___, 6.5, and 7.5.
In case C, the dissolution profile should be performed in water, 0.1N HCl, and USP buffer media pH ___, 6.5, and 7.5.
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What does SUPAC-MR refer to?
What does SUPAC-MR refer to?
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Study Notes
SUPAC Guidelines
- SUPAC (Scale Up and Post Approval Changes) represents the changes made after the approval of NDA or ANDA, mainly focuses on changes related to the manufacturing process, equipment, and batch sizes.
- The batch size usually increases along with the scale-up of drug development, and this is also covered by SUPAC guidelines.
- SUPAC guidelines defines three levels of change:
- Minor - Likely to have no detectable impact
- Moderate - Could have a significant impact
- Major - Likely to have a significant impact.
- The level of change will determine the type of test and filing needed, including:
- Testing - Application test, Compendial test, in-vitro dissolution, and in-vivo testing.
- Filing - Annual report, Changes being affected supplement, Prior Approval Supplement.
- Dissolution data is crucial for SUPAC and different cases are defined based on the drug's solubility and permeability:
- Case A (High permeability, high solubility): Dissolution of 85% drug in 15 minutes, in 900 mL of 0.1N HCl.
- Case B (Low permeability, high solubility): Multipoint dissolution profile in application or compendial medium at 15, 30, 45, 60, and 120 minutes.
- Case C (High permeability, low solubility): Multipoint dissolution profile in water, 0.1N HCl, USP buffer media pH 4.5, 6.5, 7.5 (total 5 separate dissolution profiles) at 15, 30, 45, 60, and 120 minutes until either 90% of the drug from the drug product is dissolved.
SUPAC Guidelines Recommendations
- SUPAC provides guidelines for post-approval changes in:
- The components or composition
- The site of manufacture
- The batch size
- The manufacturing (process and equipment)
SUPAC Guidelines: Post-Approval Changes to Drug Components or Composition
- Focuses on changes in excipients in the drug product.
- SUPAC-MR (Modified Release) - Excipient critical or non-critical to the Modified drug release, changes in both release and non-release controlling excipients.
- SUPAC-SS (Sustained release) - Changes in preservatives in semisolid formulations
- SUPAC-IR (Immediate release) - Changes for immediate-release solid oral dosage forms.
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Description
Test your knowledge on the SUPAC guidelines related to drug manufacturing changes. This quiz covers the levels of change, types of tests, and the importance of dissolution data in the scale-up process. Perfect for students and professionals in pharmaceutical sciences.
