| Autor: |
E. V. Shilova, Irina Badygina, Alexander Chuchalin, Yuriy Kalinin, Tamerlan Balaev, Tatiana Molostova, Alexander Solovyev, Sofia Skachilova |
| Rok vydání: |
2015 |
| Předmět: |
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| Zdroj: |
5.1 Airway Pharmacology and Treatment. |
| Popis: |
The use of combined drugs in the treatment of diseases such as asthma and COPD improves adherence to treatment. The aim of the study was to investigate the biopharmaceutical and chemical compatibility of the new combination comprising an agonist β2 - adrenergic receptor - salbutamol hemisuccinate and a muscarinic antagonist - methatropium iodide. Experimental studies on the chemical and biopharmaceutical compatibility of the combined drug included: photolytic degradation, hydrolytic degradation and thermal studies. A test sample was studied by thin layer chromatography sorbent and different solvent systems and high performance liquid chromatography (HPLC) with detection by UV spectrophotometry. Samples of the drug components were tested in the form of a homogeneous mixture of dry powder and aqueous solutions in the following proportions: salbutamol hemisuccinate: methatropium iodide 20 mg: 10 mg; 50 mg: 20 mg; 100 mcg: 40 mcg. Photolytic research conducted by illuminating the specimen within 120 hours. Thermal and hydrolytic degradation was observed when the samples are heated to 100 ° C for 120 hours. It was established that all samples of the pharmaceutical compositions of matter found only 2 - salbutamol hemisuccinate and methatropium iodide. There is no chemical interaction between molecules and the degradation of salbutamol hemisuccinate and methatropium iodide impurities are not formed. Photolytic, hydrolytic, thermal studies show no degradation of the drug. [Figure 1] On the basis of data on the chemical and biopharmaceutical compatibility proposed to use a pharmaceutical composition in various dosage forms for inhalation. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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