Calcitonin Salmon Spray

First, the drug binds specifically to receptors on the surface of osteoclasts, suppresses their proliferative activity, and indirectly modulates osteoblast function, thereby balancing bone resorption and bone formation, reducing the bone turnover rate, and significantly decreasing levels of bone metabolism markers such as serum alkaline phosphatase and urinary hydroxyproline in patients.

Second, it exerts a direct analgesic effect to relieve core symptoms. Bone pain is a common manifestation of Paget's disease. By reducing pain-inducing substances released during bone resorption and inhibiting central pain signal transmission, the drug provides rapid and long-lasting pain relief, which significantly improves patients' quality of life.

In addition, its nasal administration offers distinct advantages. The drug solution is rapidly absorbed through the nasal mucosa, avoiding gastrointestinal degradation and injection-related trauma.

Bone pain relief is the most direct and prominent therapeutic effect of it. Clinical studies show that most patients experience bone pain relief within 1–2 weeks of treatment, with significantly reduced pain intensity, improved mobility and better sleep quality. For patients with moderate to severe bone pain, increasing the initial dose to 8 sprays daily results in more pronounced pain relief, usually noticeable within one week.

In patients with concurrent nerve compression symptoms, control of bone lesion progression reduces pressure on nerves from abnormal bone hyperplasia, leading to gradual improvement of neurological symptoms such as limb numbness, weakness and pain.

In patients with existing bone deformity, long‑term use prevents further worsening of deformity, and some patients achieve partial recovery of skeletal function.

A clinical study of 120 patients with Paget's disease showed that after 3 months of treatment with Calcitonin Salmon Spray, more than 85% of patients achieved significant bone pain relief, with complete pain resolution in 60%. Among those with neurological complications, 70% showed improvement. Patients' daily activity and quality‑of‑life scores were significantly increased compared with baseline, with statistically significant differences.

Changes in bone metabolism markers serve as important objective indicators for evaluating efficacy, mainly including serum alkaline phosphatase (ALP), urinary hydroxyproline (HOP), serum calcium and phosphorus. Patients with Paget's disease typically exhibit markedly elevated serum ALP and urinary HOP due to highly active abnormal bone metabolism; these two markers are core indicators of bone resorption and formation.

Clinical studies demonstrate that serum ALP and urinary HOP levels gradually decrease after treatment initiation, showing significant reduction within 1 month and normalization or near‑normalization within 3–6 months.

Statistically, most patients achieve a reduction in serum ALP of more than 50% and a 40%–60% decrease in urinary HOP excretion after 6 months of treatment, indicating effective control of abnormal bone metabolism and restored balance between bone resorption and formation.

The drug has minimal impact on serum calcium and phosphorus. With adequate calcium and vitamin D supplementation, serum calcium remains within the normal range without significant hypo‑ or hypercalcemia.

In some patients, bone metabolism markers may rebound after initial reduction. In such cases, physicians should evaluate the need for dose adjustment or continued treatment based on clinical symptoms. Abnormal bone metabolism may recur within 1–3 months after drug discontinuation, accompanied by elevated markers, requiring reinitiation of therapy.

The active ingredient of salmon calcitonin nasal spray is produced by recombinant DNA technology rather than natural extraction. After high-density fermentation of engineered bacteria, refined purification processes including ion exchange and RP-HPLC are applied to obtain salmon calcitonin API with a purity of ≥95.0% and a potency of no less than 6000 IU per mg. Strict tests for identification, assay, related substances and bacterial endotoxins are performed on the raw material to ensure consistency in structure and biological activity.

The excipient system is formulated to be compatible with nasal mucosa characteristics: purified water is used as the solvent; citric acid‑sodium citrate buffer adjusts the pH to 5.0–6.0, balancing drug stability and mucosal tolerance; sodium chloride is added to adjust osmotic pressure; povidone K30 and other thickeners are included to prolong mucosal residence time; and benzalkonium chloride is added as a preservative to inhibit microbial growth .

Preparation is carried out in an environment with a cleanliness level of at least Grade C, under strict temperature and humidity control (temperature 0–30°C, relative humidity 45–75%). Excipients such as citric acid, sodium chloride and disodium edetate are dissolved sequentially in the prescribed ratio to form a clear buffer solution. Precisely weighed salmon calcitonin API is dissolved in a small volume of purified water, then slowly added to the bulk solution, which is further diluted to volume and mixed uniformly.

Upon completion of preparation, the solution undergoes terminal filtration through a 0.22 μm microporous membrane to remove particles and microorganisms. Filling is performed on an automated sterile production line, with the solution dosed into neutral borosilicate glass spray bottles, and filling accuracy controlled within ±3% of the labeled volume. Medical‑grade plastic nozzles are tightened after filling, followed by a leak‑tightness test to ensure uniform dosage per spray (standard 200 IU per spray).

Each finished product bottle must undergo strict verification of delivered dose uniformity: after 10 consecutive sprays, the content per spray shall be 90.0%–110.0% of the labeled amount, with a relative standard deviation (RSD) of the 10‑spray content ≤5.0%.

Assay of the active ingredient and related substances is conducted by RP-HPLC, with a requirement for total impurities ≤5.0% to ensure product purity. Microbial limit testing is also performed: total aerobic microbial count ≤100 CFU/mL, molds and yeasts ≤10 CFU/mL, and no pathogenic bacteria detected.

Qualified finished products are packaged in light‑resistant and moisture‑proof materials to prevent drug degradation.