SPECIFIC FEATURES OF INHALATION FORMULATIONS USED IN PULMONOLOGY

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DOI: https://doi.org/None
Issue: 
3
Year: 
2016

Professor S.Ya. Skachilova (1), PhD; O.I. Teryoshkina (2), PhD; Professor E.V. Shilova (1), PhD; Professor I.P. Rudakova (2), PhD; T.A. Balaev (3); A.Yu. Solovyev (3); T.N. Molostova (4); Professor I.A. Samylina (2), PhD, Corresponding Member of the Russian Academy of Sciences 1 -All-Russian Research Center for Safety of Biologically Active Substances; 23, Kirov St., Staraya Kupavna, Moscow Region 142450; 2 -Research Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University; 8, Trubetskaya St., Build. 2, Moscow 119991 3 -Joint-Stock Company «Pharmaceutical Factory of Saint Petersburg»; 24a, Moiseenko St., Saint Petersburg 191144 4 -Research Institute of Pulmonology, Federal Biomedical Agency of Russia; 32, Eleventh Parkovaya St., Moscow 105077

The paper considers the specific features of inhalation formulations used in pulmonology, the benefits of their application and the efficiency of drug delivery systems to ensure the maximum possible dose of a drug to be delivered into the lung. The formulations are systematized by the types of inhaler devices and pharmacotherapeutic groups, indicating their excipients. The paper notes the specific features of excipients used to ensure the dose of the active ingredient and the flow rate of formulations as powders, to provide stability and osmolarity of solutions and suspensions for use in nebulizer therapy. It also analyzes medical undesirable adverse reactions caused by some excipients (lactose, benzalkonium chloride, edetate disodium, etc.).
Keywords: 
inhalation formulations
delivery systems
excipients
References: 
  1. Gosudarstvennyy reestr lekarstvennyh sredstv. http://grls.rosminzdrav. ru/grls.aspx (data obrashheniya11.05.2015). [The state register of medicines http://grls.rosminzdrav.ru/grls.aspx (date 11.05.2015)] (in Russian).
  2. Gosudarstvennaya farmakopeya SSSR XI izd., vyp. 2. 1998; 136. [The State Pharmacopoeia of the USSR XI, vol. 2.1998; 136] (in Russian).
  3. Teryoshkina O.I., Pavlov V.M., Rudakova I.P., Samylina I.A., Bagirova V.L Razrabotka proekta obshhey farmakopeynoy stat`i «Ae`rozoli». Farmaciya. 2005; 5: 3–7. [Tereshkina O.I., Pavlov V.M., Rudakova I.P., Samylina I.A., Bagirova V.L. Development of the draft General monograph «Aerosol». Farmatcyia. 2005; 5: 3–7] (in Russian).
  4. Teryoshkina O.I., Pavlov V.M., Rudakova I.P., Samylina I.A. Sprei: opredelenie ponyatiya. Farmaciya. 2006; 5: 41–43. [Tereshkina O.I., Pavlov V.M., Rudakova I.P., Samulina I.A. Spray: definitions. Farmatcyia.2006; 5: 41–43] (in Russian).
  5. USP30 –NF 25 (e-book), 2007.
  6. Farmakopeya SShA. Nacional`nyy formulyar: izbrannye obnovleniya i vse novye materialy s USP 29-NF 24 po USP 33-NF 28 vklyuchitel`no:[per.c angl.]. M.: GEOTAR-Media, 2012; 888. [United States Pharmacopoeia. National formulary: selected updates and all new materials of USP 29- NF 24 to the USP 33- NF 28 inclusive: Moscow: GEOTAR-Media, 2012; 888] (in Russian).
  7. European Pharmacopoeia 6.0, 2008.
  8. Evropeyskaya farmakopeya na russkom yazyke, 8-e izdanie, t.1; 2014. [Publication European Pharmacopoeia in Russian 8-ed., t.1; 2014] (in Russian).
  9. Chuchalin A.G. Bronhial`naya astma. M., 1997; t.1: 434. t.2: 395. [Chuchalin A.G. Bronchial asthma. Moscow:1997; t.1: 434. t.2: 395] (in Russian).
  10. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, Revised 2014, http://www.ginasthma. org/local/uploads/files/GINA_Report_2014_Aug12.pdf
  11. Global initiative for Obstructive Lung Disease (GOLD)/ 2009.
  12. Federal`noe rukovodstvo po ispol`zovaniyu lekarstvennyh sredstv (pod red. A.G. Chuchalina). 2015; v XVI: 959–963. [Federal guidelines on the use of medicines. (ed. by Chuchalin A.G.). 2015; in XVI: 959– 963] (in Russian).
  13. Maggi L., Bruni R., Conte U. Influence of the moisture on the performance of a new dry powder inhaler. Int. J. Pharm., 1999; vol. 177(1): 83–91.
  14. Pobedin O.A. Issledovanie ae`rodinamicheskih svoystv ingalyacionnyh lekarstvennyh form. Dis. kand. farm. nauk, M., 2010. [Pobedin O.A. The study of aerodynamic properties of inhaled formulations. Dissertation candidate pharmaceutical sciences, Moscow: 2010] (in Russian).
  15. Avdeev S.N., Brodskaya R.N. Steri-Neby – novye vozmozhnosti nebulayzernoy terapii obstruktivnyh zabolevaniy legkih. Nauchnoe obozrenie respiratornoy mediciny, 2011; 3: 18–23. [Avdeev S.N., Brodsky R.N.. Steri-Nebs – new possibilities of nebulised therapy of obstructive lung disease. Scientific review of respiratory medicine, 2011; 3: 18–23] (in Russian).
  16. Avdeev S.N. Nebulayzernaya terapiya obstruktivnyh zabolevaniy legkih. Consilium Medicum, 2011; 13. (3): 30–42. [Avdeev S.N., Nebulised therapy of obstructive lung disease. Consilium Medicum, 2011; 13. (3): 30–42] (in Russian).
  17. Skachilova S.Ya., Chuchalin A.G., Shilova E.V., Balaev T.A., Karavaeva A.N.. Faktory, vliyayushhie na respirabel`nuyu frakciyu ingalyacionnyh protivoastmaticheskih preparatov. Razrabotka i registraciya lekarstvennyh sredstv, 2013; 2: 41–45. [Skachilova S. Ya., Chuchalin A.G., Shilova E.V., Balaev T.A., Karavaeva A.N. Factors affecting on respirable fraction of inhaled anti-asthmatic drugs. Development and registration medicinal drugs, 2013; 2: 41–45] (in Russian).
  18. Avdeev S.N., Aysanov Z.R., Arhipov V.V. i soavt. Atmosfera. Pul`monologiya i allergologiya, 2013; 2: 15–23. [Avdeev S.N., Aisanov Z.R., Archipov V.V. et al. The atmosphere. Pulmonology and allergology, 2013; 2: 15–23] (in Russian).
  19. Stepanyan I.E`. Spiriva® Respimat – preparat novogo pokoleniya. Rossiyskiy medicinskiy zhurnal, 2012; 6: 324–328. [Stepanuan I.E., Spiriva® Respimat is a drug of a new generation. Russian medical journal, 2012; 6: 324–328] (in Russian).
  20. Laube B.L., Janssens H.M., de Jongh F.H. What the pulmonary specialist should know about the new inhalation therapies. Eur. Respir. J., 2011, v. 37: 1308–1331.
  21. Hadder R., Pavia D., Lee A., Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft MistTM Inhaler in COPD. Int. J. Chron. Obstruct. Pulmon. Dis., 2011, vol. 6: 245–251.
  22. Perechen` zhiznenno neobhodimyh i vazhneyshih lekarstvennyh preparatov na 2015 god. Utverzhden Pravitel`stvom RF 30.12.2014 №2782-r. [The list of vital and essential medicines, approved by the Government Order of Russian Federation dat 30.12.2014 № 2782-r] (in Russian).
  23. American Academy of Pediatrics. «Inactive» Ingredients in Pharmaceutical Products: Update (Subject Review). Pediatrics, 1997; vol. 99: 268.
  24. Vesa T.H., Marteau P., Korpela R. Lactose intolerance. J. Am. Coll. Nutr., 2000; vol. 19 (2 Suppl): 165–175.
  25. Knight L., Fletcher J. Growth of Candida albicans in saliva: stimulation by glucose associated with antibiotics, corticosteroids, and diabetes mellitus. J. Infect. Dis., 1971; 123(4): 371–377.
  26. Vogt F.C. The incidence of oral candidiasis with use of inhaled corticosteroids. Ann. Allergy., 1979; vol. 43 (4): 205–210.
  27. Asmus M.J., Sherman J., Hendeles L. Bronchoconstrictor additives in bronchodilator solutions. J. Allergy. Clin. Immunol., 1999 Aug; 104(2 Pt 2): 53–60.
  28. Rukovodstvo po bezopasnosti vspomogatel`nyh veshhestv (Excipients Safety Guide). CPMC, USA, 463/00. 2003. [Excipients Safety Guide. CPMC, USA, 463/00. 2003] (in Russian).
  29. Handbook of Pharmaceutical Excipients (ed. by: Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn) UK, USA. Pharmaceutical Press and American Pharmacists Association. Electronic version. 2009.