Nitrosamine Guidance for Cream and Ophthalmic Solutions

Guidance, Documents, Resources
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Subject: Inquiry for Nitrosamine Guidance for Cream and Ophthalmic Solutions

Dear Members,

I hope this message finds you well. I am currently seeking guidance and insights regarding the detection and control of nitrosamines in cream and ophthalmic solutions within the pharmaceutical industry.

I believe that the forum’s collective expertise and experience can offer valuable insights into best practices, analytical techniques, and regulatory requirements for addressing nitrosamine-related challenges in these specific pharmaceutical formulations.

If you have any available resources, guidelines, or relevant information pertaining to the detection and control of nitrosamines in cream and ophthalmic solutions, we would greatly appreciate your willingness to share them with us.

Thank you for your time and consideration. look forward to receiving your valuable guidance and insights.

Best regards,
HK

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Dear Harshadkoshti,

Welcome to the forum
Current Guidelines do not make differences between route of administration, so the general regulation from each Health Authority apply exactly the same to dermal and ophthalmic products.

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How can we determine the maximum daily dose for creams and ointments to calculate AI?

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It should be stated in the SmPC, under 4.2 “Posology and method of administration”.
This is only an example: Ketoprofen 2.5% w/w Gel - Summary of Product Characteristics (SmPC) - (emc)
If it is not clearly stated in the SmPC, the definition of the MDD may become very complicated…

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Three “general” possibilities to potentially find the needed information:

  • SmPC (sometimes in Section 2, 4.2 or 5)
  • Public Assessment Report it is sometimes stated
  • Worst case: Via WHO ATC/DDD search WHOCC - ATC/DDD Index
    where DDD can potentially be used as a proxy value