Powder Blend Uniformity & UDU by Weight Variation

Dear @sunilrbudhkar,

May I know if the Uniformity of Dosage Unit of an OSD product is allowed to be determined by weight variation (uncoated tablet API > 25mg or 25% of tablet weight), does it mean we can omit doing powder Blend Uniformity Analysis as suggested in 'Results of Statistical Analysis of Blend and Dosage Unit Content Uniformity Data Obtained from the PQRI BUWG Data-Mining Effort?

Thank you in advance.

In any case you will have to comply the pharmacopoeial requirements of chapter 〈905〉 UNIFORMITY OF DOSAGE UNITS of USP in case of USP monograph products.

Thank you @sunilrbudhkar for your reply. Sorry but I am still confused. Yes we will comply with the requirements of chapter <905> UDU for USP monograph products, but if our product by the criteria set in this chapter can use weight variation instead of content uniformity to determine Uniformity of Dosage Unit, powder blend uniformity analysis is less critical for this product is it as compared to those products that require to do content uniformity to determine UDU?
I am trying to understand this sentence found in 'Results of Statistical Analysis of Blend and Dosage Unit Content Uniformity Data Obtained from the PQRI BUWG Data-Mining Effort, saying “This recommendation does not apply to those drug products where the determination of dosage form uniformity by weight variation is allowed…” I am wondering why the proposed recommendation doesn’t apply to these products by weight variation?

Hope you can help to enlighten me in this.

Thank you.

hi Mr. @sunilrbudhkar,

a gentle reminder, thank you.

Or anyone can help to explain why blend uniformity analysis is not required for those OSD products that their uniformity of dosage unit is by weight variation?

The proposals in the document which I had referred in my previous message was with an assumtion that an on-line, in-process measurement system is not currently available for demonstrating blend uniformity (e.g., on-line NIR measurement of in-process blend or dosage units). This proposal was made by the Final PQRI Blend Uniformity Working Group Recommendation to FDA in the year 2002.

This proposal was meant to address concerns raised following the issuance of the FDA document Guidance for Industry, ANDAs: Blend Uniformity Analysis, (August 3, 1999) as it was related to filing requirements and post-approval commitments.

The approach described in this document was proposed as a means to satisfy the cGMP requirement for in-process testing to demonstrate adequacy of mix, as well as USP compendial requirements for the content uniformity of finished dosage forms. Alternatively, traditionally employed methods (such as the direct sampling and analysis of powder blends, in conjunction with content uniformity testing of finished dosage forms) may continue to be used to satisfy cGMP and compendial testing requirements. Additionally, on-line measurement systems may also be used to demonstrate uniformity (e.g., NIR
measurement of in-process blend samples or dosage units).

Therefore, blend uniformity ca also be demonstrated through stratified sampling and analysis as proposed in this document even for those OSD products that their uniformity of dosage units is demonstrated by weight variation.

Thank you very much Mr. Sunil @sunilrbudhkar for your informative reply, as I was initially baffled as to why the PQRI BUWG Recommendation said that their recommendations are not applicable to those OSD products allowed to use Weight Variation to determine their Uniformity of Dosage Units, which I tried to understand their reasoning, probably they were trying to say that those products with API content more than 25% or above 25mg, don’t usually have blend uniformity issue.

Thanks for your reply. You are always welcome.

You are absolutely right. PQRI Blend Uniformity Working Group were trying to indicate that those products with API content more than 25% or above 25mg in OSD unit formulations, don’t usually have blend uniformity issue.

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