The pharmaceutical quality of freeze-dried tablets containing therapeutic bacteriophages against Pseudomonas aeruginosa and Staphylococcus aureus
Jazyk angličtina Země Nizozemsko Médium print-electronic
Typ dokumentu časopisecké články
PubMed
39800006
DOI
10.1016/j.ijpharm.2025.125199
PII: S0378-5173(25)00035-3
Knihovny.cz E-zdroje
- Klíčová slova
- D-mannitol (PubChem CID: 6251), Disodium hydrogen phosphate (PubChem CID: 24203), Dosage form, Drug stability, Freeze-dried tablets, Kayvirus, Magnesium sulfate heptahydrate (PubChem CID: 24843), Maltodextrin (PubChem CID: 68229136), Pbunavirus, Phage therapy, Potassium chloride (PubChem CID: 4873), Potassium dihydrogen phosphate (PubChem CID: 516951), Sodium chloride (PubChem CID: 5234), Sodium deoxycholate (PubChem CID: 23668196), Tris hydrochloride (PubChem CID: 93573), Trisodium citrate (PubChem CID: 6224),
- MeSH
- bakteriofágy * MeSH
- fágová terapie metody MeSH
- lyofilizace metody MeSH
- mannitol chemie MeSH
- polysacharidy chemie MeSH
- příprava léků MeSH
- Pseudomonas aeruginosa * virologie účinky léků MeSH
- stabilita léku MeSH
- Staphylococcus aureus * virologie účinky léků MeSH
- tablety MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- maltodextrin MeSH Prohlížeč
- mannitol MeSH
- polysacharidy MeSH
- tablety MeSH
The preparation of a solid dosage form containing bacteriophages, which meets pharmaceutical requirements and ensures long-term stability of the phage effect, is significant for implementing phage therapy in practice. A commonly used method for processing phages into a solid form is freeze-drying into a so-called freeze-dried cake; however, to date there have been no studies examining the pharmacopeial parameters of freeze-dried tablets with bacteriophages. In this study, we describe the preparation and properties of freeze-dried tablets containing a cocktail of purified pseudomonal bacteriophage DSM 33593 from the genus Pbunavirus and staphylococcal bacteriophage DSM 33473 from the genus Kayvirus (108 PFU/tablet) as the active ingredient. Maltodextrin was used as a tablet filler, and D-mannitol was used as a cryoprotectant. The tablet preparation process resulted in a decrease in phage titer by no more than 1 log PFU/mL. For Pbunavirus, the titer values in tablet and liquid form were comparable. Kayvirus was more stable in tablet form than in liquid form after six months of storage at 25 °C (a decrease of 1.9 ± 0.8 log PFU/mL and 3.8 ± 0.7 log PFU/mL, respectively). The uniformity of mass of single-dose preparations, uniformity of content of single-dose preparations, and their disintegration complied with pharmacopeial requirements. The uniformity of dosage units of the tablets was maintained over three months. A microscopic examination of the internal part of the tablet revealed a heterogeneous structure, which does not affect the required pharmacopeial properties of the tablets. This study highlights the potential of freeze-dried tablets for long-term preservation of the phage effect at room temperature.
Central European Institute of Technology Brno University of Technology 612 00 Brno Czech Republic
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