Sterilization in the pharmaceutical and biotechnology industry

Armenante, Piero M.; Kirpekar, A. C.

doi:10.1007/978-94-009-1563-3_11

Cited by 5 publications

(8 citation statements)

References 14 publications

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“…The polymer chemistry can be designed to minimise chemical instability but also to incorporate novel functionality. In blending liposomes and polymersomes to create hybrid vesicles, the ambition is to combine advantageous properties of these materials while off-setting their weaknesses [35].For medicinal applications in particular, stringent regulatory requirements exist for the sterilisation and preservation during the transportation and storage of these formulations [36]. Vesicles need to exhibit good stability under appropriate processing conditions that maintain the encapsulation of active compounds and the colloidal stability of vesicle structures.Sterilisation is required to make the product safe for public use.…”

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confidence: 99%

“…For medicinal applications in particular, stringent regulatory requirements exist for the sterilisation and preservation during the transportation and storage of these formulations [36]. Vesicles need to exhibit good stability under appropriate processing conditions that maintain the encapsulation of active compounds and the colloidal stability of vesicle structures.…”

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confidence: 99%

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Hybrid Vesicle Stability under Sterilisation and Preservation Processes Used in the Manufacture of Medicinal Formulations

et al. 2020

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Sterilisation and preservation of vesicle formulations are important considerations for their viable manufacture for industry applications, particular those intended for medicinal use. Here, we undertake an initial investigation of the stability of hybrid lipid-block copolymer vesicles to common sterilisation and preservation processes, with particular interest in how the block copolymer component might tune vesicle stability.We investigate two sizes of polybutadiene-block-poly(ethylene oxide) polymers (PBd 12 -PEO 11 and PBd 22 -PEO 14 ) mixed with the phospholipid 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) considering the encapsulation stability of a fluorescent cargo and the colloidal stability of vesicle size distributions. We find that autoclaving and lyophilisation cause complete loss of encapsulation stability under the conditions studied here. Filtering through 200 nm pores appears to be viable for sterilisation for all vesicle compositions with comparatively low release of encapsulated cargo, even for vesicle size distributions which extend beyond the 200 nm filter pore size. Freeze-thaw of vesicles also shows promise for the preservation of hybrid vesicles with high block copolymer content. We discuss the process stability of hybrid vesicles in terms of the complex mechanical interplay between bending resistance, stretching elasticity and lysis strain of these membranes and propose strategies for future work to further enhance the process stability of these vesicle formulations.Polymers 2020, 12, 914 2 of 17 liposomes can have inherent instabilities. Their membranes are highly flexible under bending deformations, but weak under stretching deformations, with a lysis strain of less than 5% [28,29]. The labile fluidity of the membrane can lead to transient membrane defects that frustrates long term encapsulation stability and lipid peroxidation can cause chemical instabilities in these structures.Polymersomes, due to their synthetic nature, are often less biocompatible than their lipid counterparts but offer greater mechanical stability and a broader chemical parameter space [30]. Amphiphilic copolymers that form vesicles can have several different architectures, the most common being AB diblock (A = hydrophilic, B = hydrophobic) [6], ABA [31] and ABC tri-block polymers [32] where A and C are chemically different hydrophilic blocks and finally graft copolymers [33]. Formation of polymersomes depends on the amphiphilic co-polymers molecular weight, polydispersity and hydrophilic/hydrophobic block lengths ratio, which is ideally less than 1:3 to form vesicular structures [34]. Their membranes are often thicker than liposome membranes, which provides greater bending resistance and their enhanced elasticity under stretching makes them tough and durable [22]. The polymer chemistry can be designed to minimise chemical instability but also to incorporate novel functionality. In blending liposomes and polymersomes to create hybrid vesicles, the ambition is to combine advantageous properties of these m...

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Hybrid Vesicle Stability under Sterilisation and Preservation Processes Used in the Manufacture of Medicinal Formulations

et al. 2020

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“…[31] For medicinal applications in particular, stringent regulatory requirements exist for the sterilisation and preservation during transportation and storage of these formulations. [32] Vesicles need to exhibit good stability under appropriate processing conditions that maintain the encapsulation of active compounds and the colloidal stability of vesicle structures.…”

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“…Instead of an absolute measure of sterilisation, pharmaceutical industries use processes that reduces the probability of the survival of undesired organisms to a negligible level. Currently, pharmaceutical companies use thermal, filtration and irradiation techniques to sterilise their products [32,33]. Thermal sterilisation (Fig.…”

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“…Thermal sterilisation (Fig. 1a), by using an autoclave, is the most common and the most reliable as it achieves destruction of microorganisms by irreversible denaturation of enzymes [32] and it allows the sterilisation of larger objects more easily than filtration [34]. Filtration through a maximum of a 0.22 µ m membrane is usually used for sterilisation of thermally labile solutions while sterilisation of active ingredients or medical devices can be achieved by irradiation [33].…”

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Hybrid Vesicle Stability under Sterilisation and Preservation Processes Used in the Manufacture of Medicinal Formulations

Seneviratne¹,

Jeuken²,

Rappolt³

et al. 2020

Preprint

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Sterilisation and preservation of vesicle formulations are an important consideration for their viable manufacture for industry applications, particular those intended for medicinal use. Here we undertake an initial investigation of the stability of hybrid lipid -block copolymer vesicles to common sterilisation and preservation processes, with particular interest in how the block copolymer component might tune vesicle stability. We investigate two sizes of polybutadiene-blockpoly(ethylene oxide) polymers (PBd12-PEO11 and PBd22-PEO14) mixed with the phospholipid POPC considering the encapsulation stability of a fluorescent cargo and the colloidal stability of vesicle size distributions. We find that autoclaving and lyophilisation cause complete loss of encapsulation stability under the conditions studied here. Filtering through 200 nm pores appears to be viable for sterilisation for all vesicle compositions with comparatively low release of encapsulated cargo, even for vesicle size distributions which extend beyond the 200 nm filter pore size. Freeze-thaw of vesicles also shows promise for preservation of hybrid vesicles with high block copolymer content. We discuss the process stability of hybrid vesicles in terms of the complex mechanical interplay between bending resistance, stretching elasticity and lysis strain of these membranes and propose strategies for future work to further enhance the process stability of these vesicle formulations.

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Sterilization Processes in the Pharmaceutical Industry

Armenante

Akiti

2019

Chemical Engineering in the Pharmaceutical Industry

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Sterilization in the pharmaceutical and biotechnology industry

Cited by 5 publications

References 14 publications

Hybrid Vesicle Stability under Sterilisation and Preservation Processes Used in the Manufacture of Medicinal Formulations

Hybrid Vesicle Stability under Sterilisation and Preservation Processes Used in the Manufacture of Medicinal Formulations

Hybrid Vesicle Stability under Sterilisation and Preservation Processes Used in the Manufacture of Medicinal Formulations

Sterilization Processes in the Pharmaceutical Industry

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