Multi-dose vial: difference between revisions

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22	The requirement for a preservative in a multiple-dose container appears in the general requirements for injections, and the demonstration of effectiveness is by the antimicrobial effectiveness test in USP <51>. That test challenges the formulation with specified organisms — ''Staphylococcus aureus'', ''Pseudomonas aeruginosa'', ''Escherichia coli'', ''Candida albicans'' and ''Aspergillus brasiliensis'' — and requires defined log reductions at defined intervals over 28 days. For injectable products the criteria are the most demanding of the product categories the chapter defines.{{r\|usp51}}	22	The requirement for a preservative in a multiple-dose container appears in the general requirements for injections, and the demonstration of effectiveness is by the antimicrobial effectiveness test in USP <51>. That test challenges the formulation with specified organisms — ''Staphylococcus aureus'', ''Pseudomonas aeruginosa'', ''Escherichia coli'', ''Candida albicans'' and ''Aspergillus brasiliensis'' — and requires defined log reductions at defined intervals over 28 days. For injectable products the criteria are the most demanding of the product categories the chapter defines.{{r\|usp51}}
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+		24	== Antimicrobial preservatives ==
+		25	Preservatives used in injectable products are a small set, constrained by systemic toxicity at the concentrations required, by compatibility with peptides and proteins, and by the pH range over which they remain active.
+		26
+		27	\|+ Antimicrobial preservatives in injectable preparations
+		28	\| !Preservative \| Typical concentration \| Mechanism \| Notes on peptide compatibility \|
+		29	\|---\|---\|---\|---\|
+		30	\| Benzyl alcohol \| 0.9–2.0% w/v \| Membrane disruption \| The preservative in bacteriostatic water; has been reported to promote aggregation of some proteins \|
+		31	\| m-Cresol \| 0.15–0.32% w/v \| Membrane disruption; protein interaction \| Used in insulin formulations, where it also stabilises the hexameric assembly \|
+		32	\| Phenol \| 0.25–0.5% w/v \| Membrane disruption \| Used in insulin and in some peptide products; similar structural role to m-cresol \|
+		33	\| Methylparaben with propylparaben \| approximately 0.18% with 0.02% w/v \| Membrane and enzyme effects \| Common in older products; activity falls at higher pH \|
+		34	\| Thimerosal \| 0.003–0.01% w/v \| Organomercurial, thiol reactive \| Largely withdrawn; reacts with free cysteine \|
+		35	\| Chlorobutanol \| 0.5% w/v \| Membrane disruption \| Volatile; loses concentration on storage \|
+		36
+		37	Concentrations are those conventionally used in marketed injectable products; the effective concentration is formulation-specific and must be demonstrated for the product rather than assumed from the class.{{r\|usp51,brange1993}}
+		38
24	== References ==	39	== References ==
25	{{reflist}}	40	{{reflist}}
⋮		⋮
28	<ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref>	43	<ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref>
29	<ref name="cdc_injection">Centers for Disease Control and Prevention. ''Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care'', and associated injection-safety questions and answers on multi-dose vials.</ref>	44	<ref name="cdc_injection">Centers for Disease Control and Prevention. ''Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care'', and associated injection-safety questions and answers on multi-dose vials.</ref>
+		45	<ref name="brange1993">Brange J, Langkjaer L. "Insulin structure and stability." ''Pharmaceutical Biotechnology'' 5:315–350 (1993).</ref>
30		46
31	{{DEFAULTSORT:Multi-dose vial}}	47	{{DEFAULTSORT:Multi-dose vial}}