Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-09 12:50 (1536 d 16:52 ago) – Posting: # 21226
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Dear Ohlbe,

Many thanks for your detailed reply. Unfortunately, I'm bound by confidentiality clause. Hence my responses are guarded. Please find my responses below:

❝ First of all, if no product is registered yet with this FDC: you will have to demonstrate the rationale / therapeutic interest of combining the two active principles. Though patients who have an infection are usually also treated with an antipyretic, keeping the two separate gives more flexibility to choose the antipyretic and to adjust the dose and the dosing frequency. Also, having an injectable antipyretic combined only makes sense in patients who cannot swallow an oral formulation. Antipyretics in FDC increase the risk of overdose from different sources. FDCs are seen as improving the quality of life of patients and treatment observance by reducing the number of pills to swallow, but in the case of injectables it depends on the injection route. If IV route and the patients have a perfusion anyway, it makes no difference to them.

The FDC has potential as both the product are single dose treatment with comparable pharmacokinetics. Hence, the possibility of overdose is minimal. There won't be any potentiating effect of the products on each other but of course it will save an additional prick. Its I/M or S/C route of administration. So the benefit from perfusion can't be leveraged.

❝ Reading EMA's Guideline on clinical development of fixed combination medicinal products, I don't see much chances of registration of this combination in the EU. […]

Thanks for sharing the guideline. I will go through it. The dosing frequency for both the product is just one time treatment. This is the reason of our interest. When we have both the product similar in it's posology, why do we need two pricks? Won't it suffice as the rationale of FDC?

❝ ❝ Do we need to do any In-vivo study? If yes, what all do we need to do? Do we also need safety studies along with BA/BE? Do we need to do efficacy too?

❝ Well, I think more information is needed here. What is the injection route precisely, IM, IV, SC ? Is this a solution or a suspension at your pH ?

Can you kindly let me know the paths to be followed for both suspension and solution?

❝ Are the excipients (including your stabiliser) well known and in common use ? Are they known to potentially cause adverse events ?

I'm not sure. Can you let me know the path to be followed for both possible scenarios? Well known stabilizer and new stabilizer?

Thanks a ton.

Lets consider it as a solution with well established excipients without any known adverse event.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5. Merged with a later – now deleted – post. You can edit your posts for 24 hours. Please don’t shout[Helmut]

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