Biomedical subjects

I Cagnazzo

Publications and source records attributed to I Cagnazzo.

4 recordsLinked to original sources

PubMed1993

Comparative study of progesterone plasma levels after nasal spray and intramuscular administration of natural progesterone in menopausal women.

11 mg natural progesterone (P) was administered to 20 healthy menopausal women by means of a nasal spray or intramuscular injection. Circulating P levels were calculated at various times after administration. The spray formulation yielded a CMax of 3.75 ng/ml at TMax = 60 min, the area under the curve (AUC)0-720 being 1,481.6 +/- 343. Intramuscular administration yielded a mean CMax of 4.137 ng/ml at TMax = 240 min, the AUC0-720 being 2,491.2 +/- 540. P absorption was faster through the nasal than through the intramuscular route, but intramuscular administration led to high serum levels for a much longer period.

Absorption↗

PubMed1992

Progesterone administration by nasal spray in menopausal women: comparison between two different spray formulations.

The aim of the study was to compare the bioavailability of progesterone dissolved in almond oil or dimethicone, and administered by nasal spray. Twenty healthy menopausal women were randomly allocated to treatment by four doses of intranasal spray either of a progesterone solution in almond oil, 2 mg/0.1 ml, corresponding to a total dose of approximately 11 mg of progesterone, or a progesterone solution in dimethicone 5 mg/0.1 ml corresponding to a total dose of approximately 28 mg of progesterone. Circulating progesterone levels were calculated at various time intervals following administration. The formulation with almond oil yielded a maximum progesterone concentration (Cmax of 3.75 ng/ml at Tmax = 60 min, and the area under the curve (AUC0-720) value was 1481.6 +/- 343. The formulation with dimethicone yielded a mean Cmax of 1.049 ng/ml at Tmax = 30 min; the AUC0-720 value was 302.06 +/- 37.5. Therefore, bioavailability of progesterone dissolved in almond oil proved to be largely superior compared to the solution in dimethicone. The crucial role of the carrier in the spray formulations is discussed; in addition to ensuring clinical safety, it must have good solubility for progesterone, be fluid enough to enable efficient 'spraying' and also must allow progesterone to be absorbed through the nasal mucosa.

Absorption↗

PubMed1991

Nasally-administered progesterone: comparison of ointment and spray formulations.

The aim of the study was to compare the bioavailability and clinical usefulness of progesterone (P) administered nasally in spray or ointment form. Twenty healthy post-menopausal women were randomly allocated to treatment by either intranasal spray (4 doses of an oil-based P solution at a concentration of 2 mg/0.1 ml, corresponding to a total dose of approximately 11 mg of P) or an ointment (quantity 0.1 ml, P concentration 20 mg/0.1 ml). Circulating P levels were calculated at various time intervals following administration. The spray formulation yielded a mean maximum concentration (CMax) of 3.75 ng/ml after 60 min (TMax) and the area under the curve (AUC) 0-720 min was 1481.6 +/- 343 ng.h/ml. The ointment yielded a mean CMax of 1.19 ng/ml at TMax = 30 min, the AUC 0-720 value being 404.35 +/- 148 ng.h/ml. The study findings confirmed that the intranasal route is a potentially useful alternative for the administration of natural sex steroid hormones, making it possible to avoid first-pass liver metabolism. P administered by spray showed greater bioavailability than it did when administered in ointment form, while both formulations seemed to be acceptable to patients and were probably clinically safe.

Administration, Intranasal↗

PubMed1991

Progesterone administration by nasal spray.

The bioavailability and the clinical usefulness of the P administered by nasal spray were investigated. Ten healthy menopausal women received an IN spray administration (4 doses of an oleic P solution 20 mg/mL, corresponding to nearly 11.2 mg of P) and the circulating P levels were calculated. Sixty minutes after administration, the maximum concentration (CMax, 3.75 +/- 0.214 ng/mL) was reached. High P levels (greater than 2 ng/mL) lasted until 360 minutes, and the AUC 0 to 720 was 1,481.6 +/- 343 ng.h/mL. Progesterone administration by spray formulation has proven to be effective in reaching therapeutic levels and to be acceptable to patients and, probably, clinically safe.

Absorption↗