Risedronate sodium
Sodium risedronate
CAS: 115436-72-1
Molecular Formula: C7H12NNaO7P2
Risedronate sodium - Names and Identifiers
| Name | Sodium risedronate |
| Synonyms | RISEDRONATE NA Risedronate sodium SODIUM RISEDRONATE RISEDRONATE SODIUM RISEDREMATE SODIUM Sodium risedronate RISEDRONIC ACID, SODIUM SALT (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-phosphonicacimonosodiumsalt sodium hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate [1-hydroxy-2-(3-pyridinyl)ethylidene]-bis[phosphonic acid] monosodium salt phosphonic acid, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-, monosodium salt |
| CAS | 115436-72-1 |
| EINECS | 1806241-263-5 |
| InChI | InChI=1/C7H11NO7P2.Na/c9-7(16(10,11)12,17(13,14)15)4-6-2-1-3-8-5-6;/h1-3,5,9H,4H2,(H2,10,11,12)(H2,13,14,15) |
Risedronate sodium - Physico-chemical Properties
| Molecular Formula | C7H12NNaO7P2 |
| Molar Mass | 307.11 |
| Melting Point | 252-262°C |
| Boling Point | 692.3°C at 760 mmHg |
| Flash Point | 372.5°C |
| Solubility | DMSO <1 mg/mL Water 2 mg/mL Ethanol <1 mg/mL |
| Vapor Presure | 4.03E-20mmHg at 25°C |
| Appearance | Fine white to off-white crystalline powder |
| Color | white to beige |
| Storage Condition | room temp |
| MDL | MFCD01706268 |
| Use | Is a total synthesis of anti-osteoporosis drugs |
Risedronate sodium - Risk and Safety
| Risk Codes | R62 - Possible risk of impaired fertility R64 - May cause harm to breast-fed babies |
| Safety Description | S20 - When using, do not eat or drink. S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. |
| WGK Germany | 3 |
| RTECS | SZ8567500 |
| HS Code | 29333990 |
Risedronate sodium - Reference Information
| bone resorption inhibitor | bisphosphonate (bisphosphonates) is a leading osteoporosis (OP) drug developed in the past 30 years and is currently the most important anti-bone resorption inhibitor. Its structure is similar to the endogenous bone metabolism regulator pyrophosphate. It replaces the P-O-P bond in pyrophosphate that is easily hydrolyzed or deactivated by pyrophosphatase in an acidic environment with a P-C-P structure, and its properties are stable in vivo. Diphosphonate is easily deposited in bone tissue, combined with calcium phosphonate in it, and then inhibits the dissolution, absorption, formation and growth of hydroxyapatite crystals and their amorphous precursors, and inhibits its absorption than inhibits its formation And the dose required for growth is lower, that is, at a low dose, it is enough to play the role of anti-bone resorption. According to the chemical structure, bisphosphonate drugs are divided into three generations. The representative drug of the first-generation bisphosphonates is etidronate; the second-generation bisphosphonates introduce nitrogen atoms in their side chains, and the representative drugs include clodronate and pamidronate; The third generation has a cyclic side chain, and the representative drugs are alendronate and risedronate. Risedronate sodium, as the third-generation bisphosphonate drug for anti-osteoporosis, was first developed by Procter & Gamble (Procter & Gamble, P & G) and Hoechst Marion Roussrl. It is a pyridine diphosphonate. Bone absorption inhibitor, chemical name: 1-hydroxy-2-(3-pyridyl) ethylene-diphosphonic acid monosodium salt. It was first marketed in the United States in 1998 and is clinically used to treat osteitis deforming. Risedronate sodium tablets were approved in Sweden in October 1999 and approved by FDA in 2004 for the prevention and treatment of osteoporosis in postmenopausal women. |
| pharmacokinetics | absorption: oral absorption is relatively fast (Tmax ~ 1 hour), the absorption process occurs in the whole digestive tract, the absorbed dose has nothing to do with the dose (from single dose 2.5~30mg, multiple doses 2.5~5mg), the drug is administered every day to reach steady state in 57 days, the average absolute bioavailability of oral 30mg tablets is 0.63%(90% Cl:0.54% ~ 0.75%). Taking risedronate sodium 0.5 hours before breakfast or 2 hours after dinner has the same absorption effect; risedronate sodium must be effective at least 30 minutes before breakfast. Distribution: The average steady-state distribution volume of human is 6.3L Kg-1, and the binding rate of human plasma protein is 24%. Preclinical studies in mice have shown that 14C-labeled risedronate sodium is administered in a single dose, the 60% is distributed to the bone, and the rest of the drug is excreted from the urine. Elimination: Nearly half of the absorbed dose is excreted in the urine within 24 hours, administered intravenously, and returned to normal in the urine on 28 days. The average renal clearance rate was 105ml · min-1(RSD = 34%) and the average total clearance rate was 122 ml · min-1(RSD = 19%). The renal clearance rate was not concentration-dependent, and there was a linear relationship between renal clearance and creatinine clearance rate. The unabsorbed drug is excreted from feces as a prototype. Once absorbed, the serum concentration-time graph is multiphase, with a half-life of 1.5 hours at the beginning. The terminal half-life is 480 hours, and the terminal half-life is believed to be the separation of risedronate sodium from the bone surface. |
| Synthetic route | Using nicotinic acid as raw material, risedronate sodium is obtained through esterification, Claisen condensation, Willgerodt-Kindler reaction, hydrolysis, acidification, etc. Fig. 1 shows the synthetic route of risedronate sodium |
| indications | for the treatment and prevention of osteoporosis in postmenopausal women; glucocorticoid-induced osteoporosis; osteitis deforming. (2016-03-18) |
| contraindications | hypocalcemia; Patients who are highly allergic to any component of this product; Patients who cannot maintain upright position for more than 30 minutes after administration. |
| precautions | risedronate sodium is easy to cause digestive tract dysfunction, such as dysphagia, digestive tract ulcer, etc. You must take the medicine 30 minutes before breakfast, take the medicine with a large amount of water, and do not lie down within 30 minutes after administration. If the food lacks calcium and vitamin D, calcium and vitamin D must be supplemented at the same time. Calcium, aluminum, magnesium and food can interfere with the absorption of risedronate sodium, so it must be administered at different times of the day. Use with caution in patients with severe renal insufficiency. When combined with glucocorticoid administration, the hormone level in the patient must be determined and appropriate replacement methods must be considered. |
| use | treatment of osteoporosis is a fully synthetic anti-osteoporosis drug anti-osteoporosis |
Last Update：2024-04-09 21:32:03
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