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Formulation Concern – Alum

Formulation Concern – Alum Does aluminum (alum) have a negative impact on patient health? Aluminum has been used as an adjuvant in numerous vaccines for over 70 years with no severe adverse effects reported. Despite suggestions, made decades ago, that alum may contribute to conditions such as Alzheimer’s disease or other neurological disorders, there has… read more

Diluents & Preservatives

Diluents & Preservatives When making dilutions from the concentrate vial, a number of diluents can be used. Normal Saline with Phenol (NSP) NSP is the same solution that is used to extract

Aqueous extract

s. It is a buffered solution of sodium chloride (0.9%) with phenol (0.4%) as a preservative. NSP offers limited stability protection for… read more

References

Home > References References General References Used Throughout Stability References Painful Injection From 50% Glycerin FDA Standardization Major Allergen And Standardization Regional Relevance Of Allergens Cross-Reactivity Management Of Anaphylaxis Coring & Syringe Technique Skin Testing USP 797 References – Beyond Use Date, Pharmacy Compounding Rules Allergen Information General References Used Throughout Cox, L, et al.… read more

Stability

The ability of an allergenic extract to retain its original properties and potency. Stability is reduced with extract dilution. read more

Reconstituted

Rehydrate freeze-dried (lyophilized) product with sterile diluent. read more

PNU

PNU, Protein Nitrogen Unit. A measurement of protein concentration, which is analyzed in all lots of aqueous, non-standardized extracts. PNU is derived from the nitrogen content of the extract solution. One milligram of nitrogen is equivalent to 100,000 PNU. read more

AU

A potency unit that expresses the relative biologic activity of an allergenic extract compared to an FDA-issued standard. House Dust Mite extracts are the only extracts that are standardized using AU. read more

Alum-precipitated

A process whereby an aqueous allergen extract is allowed to complex with an aluminum salt complex (e.g., aluminum hydroxide). Alum-precipitation functions as an adjuvant, which enables the extract to elicit an immunological response. In addition, the alum-allergen complex produces a depot effect, where the allergen is more slowly released into the body. This slow release… read more

Allergenic

A preparation obtained through the extraction of a raw biological source material with an appropriate extracting fluid. The four forms of allergenic extract commonly used are glycerinated, lyophilized, aqueous, and alum-precipitated. read more

Intradermal Dilutions

Intradermal Dilutions In early 2013, several allergen extract manufacturers decided to discontinue stock formulations of intradermal products. In place of this, it is recommended that you perform your own dilutions using the extract stock concentrations. Rationale for the discontinuation of intradermal strength products Allergen extracts that have been diluted to intradermal strength are known to… read more

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