Hi,
I was thinking of why should one prefer lyophilization over dry powder filling. All the APIs are manufactured in solid form and solid excipients like mannitol, trehalose, etc. Can the API and solid excipients not be filled into a vial, with carrier solvent and liquid excipients in another container? Reconstitution can be performed at the point of requirement, right?
PS: I am new to this area, so please apologise if the question sounds stupid!
Very good question. Dear all APIs are not in solid form. We get them in solid form after lyophilisation. Suppose we have got any antibiotics after fermentation , in liquid form the stability will be few days only. After lyophilisation the shelf life increases from months to years. I hope you have got the answer.
Thanks for the answer, Jagmohan Sharma. This solves for non-solid APIs. But what about APIs that are synthesized in solid form (as salts)? Why not prefer dry powder filling over lyophilization for solid form APIs?
Other factors like flow property of the powder may not be good to make it fillable via filling machine.
Liophilization is the choice process when a) the powder has flowability problems or adhesive properties that clog the dosage screw b) when the dose is critical (little difference between the toxic dose and the therapeutical dose).
The a) case is obvious, an aqueous liquid usually has little - if any - flowability problem and a solution overcomes these; the b) case, using a suitable dilution of the toxic API, overcomes the problem of a very small and very precise dosage of the API, since the dosage of a liquid can be precise at 0,1 microliter. Stability of the API can get a good boost too, since mannitol and glycine - the most common supports for liophilized API - act as stabilizer too.
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