Scientific Considerations for Generic Synthetic Salmon Calcitonin Nasal Spray Products

Salmon calcitonin nasal spray in the prevention of corticosteroid-induced osteoporosis.

The objectives were to determine the efficacy and safety of nasal salmon calcitonin 200 IU daily in the prevention of corticosteroid-induced osteoporosis. A minimized, double-blind, placebo-controlled trial was carried out in corticosteroid-treated patients with polymyalgia rheumatica. The setting was a tertiary care university-affiliated hospital and a total of 31 patients were enrolled. The p...

Physical stability of salmon calcitonin spray-dried powders for inhalation.

The effects of excipient crystallinity and water content on the physical stability of salmon calcitonin (sCT) in a spray-dried powder for inhalation have been investigated. sCT was dissolved in water with and without mannitol and then spray dried using a Büchi 190 spray dryer. The spray dried powders were stored for 5 days at 0, 29, 51, 58, 69, and 84% relative humidity at ambient temperature. ...

Stability of PEGylated salmon calcitonin in nasal mucosa.

The purpose of this study was to evaluate the stabilization of salmon calcitonin (sCT) by PEGylation in nasal mucosa. Degradation of native sCT in the homogenates of rat nasal mucosa was investigated by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). The initial cleavage of sCT was due to tryptic-like endopeptidase activity, and the subsequent degrad...

Azelastine Hydrochloride 0.1% Nasal Spray Azelastine Hydrochloride 0.15% Nasal Spray

FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Allergic Rhinitis Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 6 years of age and older. 2 DOSAGE AND ADMINISTRATION 2.1 Seasonal Allergic Rhinitis In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride Na...

Summary of Chum Salmon Stock Identification Research Conducted by the Molecular Genetics Laboratory, Pacific Biological Station