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Pertemuan 6
Eksipien dalam Sediaan Steril
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Principle
Parenteral drugs are formulated as solutions,
suspensions, emulsions, liposomes, microspheres,
nanosystems, and powders to be reconstituted as
solutions.
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Components of parenterals
• Active pharmaceutical ingredients
• Vehicle
• Added substances
• Primary container
• Closure
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Vehicle
• Aqueous
• Non aqueous (miscible and immiscible)
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Syarat Vehicle
• Mudah didapat harga murah
• Inert
• Dapat bercampur dengan cairan badan
• Tidak toksik
• Tidak mengiritasi
• Tidak bersifat pirogenik
• Stabil fisikokimiawi
• Tetap cair pada suhu tubuh
• Tidak dipengaruhi pH
• Efektik untuk melarutkan/menjadi pembawa zat aktif
dalam volume kecil
• Dapat disterilkan dengan autoklaf (lebih baik hasilnya)
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WFI
• Water for Injection can be prepared by
distillation or by membrane technologies (i.e.,
reverse osmosis or ultrafiltration). The EP
(European Pharmacopeia) only permits
distillation as the process for producing WFI.
The USP and JP (Japanese Pharmacopeia) allow
all these technologies to be applied.
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Still
Several factors must be considered in selecting a still to
produce WFI:
• The quality of the feed water will affect the quality of the
distillate
• The size of the evaporator will affect the efficiency
• The baffles (condensing surfaces) determine the
effectiveness of refluxing
• Redissolving volatile impurities in the distillate reduces
its purity.
• Contamination of the vapor and distillate from the metal
parts of the still can occur. Constructed of metal coated
with pure tin, 304 or 316 stainless-steel, or chemically
resistant glass
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Purity of WFI
• Total organic carbon (TOC), with a limit of 500
ppb (0.5 mg/L), and conductivity, with a limit of
1.3 μS/cm at 25°C or 1.1 μS/cm at 20°C.
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TERIMAKASIH