We are planning to scale up (lab-to-industry) lipid based nano injectable systems. Kindly suggest what sort of processing equipment/technology (Microfluidizer? or any other?) helps meets the criteria like reproducibility and bulk manufacturing? Thanks a ton.
The answer depends on you nanoparticles / liposomes properties: the 'softer' / more elastic the particle bilayer, the lower energy density input will suffice to create a reasonably uniform dispersion (see J Contr Rel 160: 135–146 (2012) for some representative data). A few practical suggestions: as bilayer elasticity decreases with the square of bilayer thickness, it is easier to prepare homogeneous vesicle dispersions from lipids with relatively short chains, identical polar region presuming; in turn, as elasticity increases with molecular area (see the cited paper), it is easier to disperse finely more polar / more hydrophilic lipids, the same chain-length presuming. Furthermore: as binding of amphipats (drugs / alcohols / preservatives, etc.) to bilayer surface tend sto expand, and thus soften, the resulting bilayers, such amphipats also generally facilitate vesicles preparation. Whether you will need a high-pressure homogeniser (for preparations with relatively little elastic bilayers) or just a, well shearing, mixer (for preparations with quite elastic bilayers) will hence depend on your prospective product composition - and thus properties. Further refinements / alternative methods are possible.
As an aside: you should seek to prepare uni- or at most oligolamellar vesicles rather than multivesicles, as the latter will inevitably be less well defined than the former - and consequently will have less reproducible loading/release characteristics. Furthermore, plan carefully and reserve enough time for proper characterisation of your final preparation - and its stability confirmation.
Thanks Dr. Gregor for very informative answer.
We are thinking of multivesicular liposomal systems for the reason that we wish to formulate a depot injection which releases the active for approx. 3 months. If not multivesicular systems, what other structures would you suggest to sustain the drug release for such a considerably long time. Thanks in advance.
Dear Vishnu,
Spray drying technology is very useful for large scale manufacturing of liposomes and niosomes. Please read the literature related to this.
We have technology which can produce low-polydispersity vesicles or nanodiscs. All these nanoparticles are self-assembled.
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