Special Expertise in Analyzing Inhalatives
Inhaled drugs have extremely low systemic abundance, intended or not.
Regardless of its purpose, quantification is necessary at the very least for regulatory requirement.
Extremely low concentrations of the systemic active ingredients, in ever declining sample volumes (plasma) call for increasingly sensitive methods. At the same time regulatory and ethical demands are rising.
pharm-analyt has been catering to this demand for more than a decade, analyzing orally inhaled and nasally administered Small Molecules and peptides in plasma.
Our most sensitive assays are in the range of femtogram/mL plasma.
Example:
Cyclesonide + M1 and Fluticasone Propionate
|
Common sensitivity can lead to loss of critical |
Increasing sensitivity by factor 10 discloses essential data especially on the terminal phase. |
Examples of Inhalative Substances and Determination Limits:
| Substance | Volume / Matrix | Calibration Range | Ionization | Equipment |
|---|---|---|---|---|
| Budesonide | 0.5 mL plasma | 5 - 1000 pg/mL | APCI neg | API 4000 |
| Ciclesonide + M1 | 1 mL serum | 10 - 2000 pg/mL | APCI neg | API 3000 |
| Fluticasone Propionate | 1 mL serum | 3 - 1000 pg/mL | APCI neg | API 3000 |
| Fluticasone Propionate | 0.25 mL serum | 3 - 1000 pg/mL | APCI pos | API 5000 |
| Fluticasone Propionate | 1 mL serum | 0.25 - 50 pg/mL | APCI pos | API 5000 |
| Formoterol | 0.5 mL plasma | 0.4 - 100 pg/mL | ESI pos | API 4000 |
| Salmeterol | 0.25 mL serum | 2 - 600 pg/mL | ESI pos | API 5000 |
Distinguishing Cortisol from Corticosteroids is critical and widely underestimated!
1000 ng prednisolone per mL plasma
fakes ca. 10 ng cortisol per mL plasma!
Administering Corticosteroids (oral, topical, inhalative) and analyzing them by immunoassays, there´s the danger of so called “cross-reactions” resulting in wrong (higher) levels. When suppressing cortisol by corticosteroids the levels of native cortisol will decrease and escalate the problem further.
Even using the highly selective HPLC-MS/MS systems, “cross-reactions” can occur! For example, by application of prednisone (attention: metabolite is prednisolone) or initially prednisolone, the disturbing peak of prednisolone in the chromatogram is likely to bias the cortisol results.
In general, on reversed phase columns (C8, C18) prednisolone (MW 360) is not separable from cortisol (MW 362) and consequently adds to the sensitive iontrack of cortisol a signal of identical fragmentation!
See Poster: “Where Your Cortisol Levels Measured Correctly?”