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Current Materials Science

Editor-in-Chief

ISSN (Print): 2666-1454
ISSN (Online): 2666-1462

Review Article

A Concise Overview on Recent Advances in Pharmaceutical Aerosols and their Commercial Applications

Author(s): Raghav Mishra* and Radhika Agarwal

Volume 15, Issue 2, 2022

Published on: 02 December, 2021

Page: [125 - 141] Pages: 17

DOI: 10.2174/2666145414666211111102425

Price: $65

Abstract

Localized drug delivery to the respiratory system has become an increasingly successful and essential treatment strategy for several pulmonary diseases, including asthma, chronic abstractive disease, pneumonia, bronchitis, and cystic fibrosis. The rising incidence of respiratory diseases is a significant factor driving the worldwide market for respiratory inhaler devices.

The objective of this article is to present various aspects of pharmaceutical aerosols, including their types, components, fundamentals, in-process and finished product quality control tests based on pharmacopeial standards and specifications, and commercial utility considering the pharmaceutical aerosol dosage forms that have been patented from 2000 to 2020, along with a list of marketed pharmaceutical products.

Aerosol, collectively referred to as a pressurized device, operates by triggering an appropriate valve system with a continuous or metered dosage of tiny mist spray. It is used not only in the treatment of asthma and chronic obstructive pulmonary disease but also in the treatment of cancer, diabetes, migraine, angina pectoris, acute lung injury, bone disorders, tuberculosis, and many more. A multitude of different variables, including types and properties of propellants, active substances, containers, valves, actuators, spray patterns, valve crimping efficiency, and particle size of the aerosols, influence the therapeutic effectiveness of pharmaceutical aerosols.

Based on the current findings, distinct characteristics such as the elimination of first-pass metabolism, quick drug absorption, ease of therapy termination, as well as a larger surface area have attributed to the success of pharmaceutical aerosols.

Keywords: Pulmonary drug delivery system, aerosols, classification, evaluation, commercial utility, patents.

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Graphical Abstract
[1]
Dolovich MB, Dhand R. Aerosol drug delivery: Developments in device design and clinical use. Lancet 2011; 377(9770): 1032-45.
[http://dx.doi.org/10.1016/S0140-6736(10)60926-9] [PMID: 21036392]
[2]
Deb KP, Abed SN, Maher H, et al. Aerosols in pharmaceutical product development. In: Drug Delivery System. Boca Raton: Elsevier 2019; pp. 521-77.
[3]
Linda A. Aerosols. In: Remington Essentials of Pharmaceutics. 1st ed. London: Pharmaceutical Press 2013; pp. 633-50.
[4]
Ruzer LS, Harley NH. Medical and Pharmaceutical Aerosols. In: Ruzer LS, Harley NH, Eds. Aerosols Handbook. 2nd ed.. Boca Raton: CRC Press 2005; pp. 1-30.
[5]
Barr M. Aerosol dosage forms. J Am Pharm Assoc 1958; 19(11): 675-8.
[6]
Lahkar S, Das KM, Bora S. An overview on tea tree (Melaleuca alternifolia) oil. Int J Pharm Phytopharm Res 2013; 3(3): 250-3.
[7]
Geer RD. RSC Chemical Solutions 2011. Available from: www.southernaerosol.com (Accessed on December 20, 2020).
[8]
Kulkarni VS, Shaw C. Aerosols and nasal sprays. In: Essential Chemistry for Formulators of Semisolid and Liquid Dosages. San Diego: Academic Press 2016; pp. 71-97.
[http://dx.doi.org/10.1016/B978-0-12-801024-2.00006-6]
[9]
Kanig JL. Pharmaceutical aerosols. J Pharm Sci 1963; 52(6): 513-35.
[http://dx.doi.org/10.1002/jps.2600520603] [PMID: 13962236]
[10]
Davies RJ, D’Souza MF, Simmonds SP. Puffs per aerosol. BMJ 1972; 1(5793): 177-7.
[http://dx.doi.org/10.1136/bmj.1.5793.177] [PMID: 5007852]
[11]
Sciarra JJ. Pharmaceutical and cosmetic aerosols. J Pharm Sci 1974; 63(12): 1815-37.
[http://dx.doi.org/10.1002/jps.2600631202] [PMID: 4449012]
[12]
Pokar HG, Patel KR, Patel NM. Review on pharmaceutical aerosol. Int Pharm Sci 2012; 2(2): 58-66.
[13]
Lavorini F. The challenge of delivering therapeutic aerosols to asthma patients. ISRN Allergy 2013; 2013102418
[http://dx.doi.org/10.1155/2013/102418] [PMID: 23984095]
[14]
Phalen RF, Hinds WC, John W, et al. Rationale and recommendations for particle size-selective sampling in the workplace. Appl Ind Hyg 1986; 1(1): 3-14.
[http://dx.doi.org/10.1080/08828032.1986.10390436]
[15]
Soderholm SC. Proposed international conventions for particle size-selective sampling. Ann Occup Hyg 1989; 33(3): 301-20. https://pubmed.ncbi.nlm.nih.gov/2802448/
[PMID: 2802448]
[16]
Alexander K. Dosage forms and their routes of administration In: Hacker MP, Messer WS, Bachmann KA, Eds. Pharmacology: Principles and Practice. 1st ed.. San Diego: Academic Press 2009; pp. 9-29.
[http://dx.doi.org/10.1016/B978-0-12-369521-5.00002-6]
[17]
Kwok PCL, Chan HK. Electrostatics of pharmaceutical inhalation aerosols. J Pharm Pharmacol 2009; 61(12): 1587-99.
[http://dx.doi.org/10.1211/jpp.61.12.0002] [PMID: 19958580]
[18]
Cheng YS. Mechanisms of pharmaceutical aerosol deposition in the respiratory tract. AAPS PharmSciTech 2014; 15(3): 630-40.
[http://dx.doi.org/10.1208/s12249-014-0092-0] [PMID: 24563174]
[19]
Heyder JJ, Gebhart J, Rudolf G, Schille CF, Stahlhofen W. Deposition of particles in the human respiratory tract in the size range 0.005–15 μm. J Aerosol Sci 1986; 17(5): 811-25.
[http://dx.doi.org/10.1016/0021-8502(86)90035-2]
[20]
Kristin KI, Jacky AR, Martonen TB. Mechanism of particle deposition In: Ruzer LS, Harley NH, Eds. Aerosols handbook Measurement, Dosimetry and health effects. 1st ed.. Boca Raton: CRC Press 2005; pp. 76-95.
[21]
Remington JP, Gennaro AR. Aerosols. In: Remington JP, Gennaro AR, Eds. The Science & Practice of Pharmacy. 21st ed.. Philadelphia: Lippincott Williams and Wilkins 2006; Vol. 1: pp. 1000-17.
[22]
Abdo RW, Saadi N, Hijazi NI, Suleiman YA. Quality control and testing evaluation of pharmaceutical aerosols. In: Drug Delivery Systems. 1st ed. San Diego: Academic Press 2019; pp. 579-614.
[23]
Halatwala KYK, Shah D, Parikh R. Sublingual Spray: A boost to novel drug delivery system. Int J Pharm 2015; 5(4): 1144-8.
[24]
Parmar K, Patel MB. A review on sublingual spray: Novel drug delivery system. Int J Pharm Sci Res 2017; 8(11): 4533-9.
[25]
British Pharmacopoeia Commission British Pharmacopoeia. 8th ed. Great Britain: Stationery Office 2014.
[26]
Aerosols USP-NF. USP-NF. Aerosols, nasal spray, metered-dose inhalers and dry power inhalers. 2021. Available from: https://www.uspnf.com/notices/revision-general-chapter-aerosols-nasal-sprays-metered-dose-inhalers-and-dry-powder-inhalers (Accesses on: January 25, 2021).
[27]
Uddin M, Mamun A, Rashid M, Asaduzzaman M. In-process and finished products quality control tests for pharmaceutical capsules according to Pharmacopoeias. J Pharm Res Int 2015; 9(2): 1-9.
[28]
Lachman L, Liberman HA, Kanig LJ. Pharmaceutical aerosols. In: The theory and practice of Industrial Pharmacy. 3rd ed. Philadelphia: Lea & Febiger 1986; pp. 589-618.
[29]
Lachmann L, Libermann HA. Pharmaceutical aerosols. In: The theory and practice of industrial pharmacy Spl. Indian ed.. India: CBS Publishers 2009; pp. 770-803.
[30]
Apiou-Sbirlea G, Newman S, Fleming J, et al. Bioequivalence of inhaled drugs: Fundamentals, challenges and perspectives. Ther Deliv 2013; 4(3): 343-67.
[http://dx.doi.org/10.4155/tde.12.161] [PMID: 23442081]
[31]
Salunkhe AA, Jagtap VKA, Usman R, Nagaich U. Pharmaceutical aerosols. In: Text Book Of Industrial Pharmacy 1 For B Pharmacy 5 Sem Indian ed. India: S. Vikas and company 2019 pp. 227-46.
[32]
Lipp MM, Sung JC. Cationic dry powders U.S. Patent 9,433,576, 2016.
[33]
Allosery K, Depla E, Huber M, et al. Methods of treating Respiratory Syncytial Virus (RSV) infections WIPO Patent 2,016,055,656, 2015.
[34]
Yadidi K. Dry powder formulation for inhalation U.S. Patent 20,160,022,705, 2015.
[35]
Lin HY. Inhalation type pharmaceutical composition for the treatment of arthritis. U.S. Patent 9,339,456, 2015.
[36]
Smutney CC, Leone-Bay A, Galarza JM, Munoz H, Martin GR, Grant ML. Inhalable aerosol compositions and methods. U.S. Patent 20,150,283,069, 2013.
[37]
Cipolla DC, Gonda I. Inhaled surfactant modified liposomal formulations providing both an immediate and sustained release profile. U.S. Patent 20,150,110,855, 2014.
[38]
Klinman DM, Ivins B, Verthelyi D. Method of preventing infections from bioterrorism agents with immunostimulatory CpG Oligonucletides. U.S. Patent 8,481,055, 2010.
[39]
Charan C, Dwivedi S. Antibiotic formulations, Unit doses, Kits, Methods. U.S. Patent 20,120,247,462, 2012.
[40]
Kjems J, Howard KA, Besenbacher F, Andersen MO. Dehydrated chitosan nanoparticles. U.S. Patent 20,110,033,547, 2008.
[41]
Renzi P, Zemzoumi K. Antisense oligonucleotides for treating allergy and neoplastic cell proliferation. U.S. Patent 20,120,065,249, 2011.
[42]
Bosch HW, Ostrander KD, Cooper ER. Aerosols comprising nanoparticle drugs WIPO 2,000,027,363 1999.
[43]
Schultz RK, Schultz DW, Moris RA. Suspension aerosol formulations. U.S. Patent 7,105,152, 1995.
[44]
Clearman JF, Chiou JJ, Williams DD, Casey WJ, Gentry TL, Squires WC. Aerosol delivery article. U.S. Patent 5,099,861, 1990.
[45]
Crowder TM, Hickey AJ, Warden JA. Dry Powder Inhalers Australian Patent 2,003,228,963 2003.
[46]
Knight JV, Gilbert B, Waldrep JC, Koshkina N, Wellen CW. Small particle liposome aerosols for delivery of Anti-Cancer drugs. TWI 1998; 224: 509.
[47]
Cipolla DC, Blanchard J. Concentrated, inhalable ciprofloxacin formulation. U.S. Patent 9,545,401, 2011.
[48]
Surber MW. Aerosol Pirfenidone and Pyridone analog compound and uses thereof. U.S. Patent 20,200,306,264, 2020.
[49]
Hoekman JD, Rodney JY. Circumferential aerosol device for delivering drugs to olfactory epithelium and brain. E.P. Patent 2,605,816, 2011.
[50]
Patton JS, Patton RS, Kuo MC, Ivri Y. Preservative free insulin formulations. U.S. Patent 20,180,353,714, 2018.
[51]
Gonda I. Nicotine formulations, kits and systems and methods for their use WIPO Patent 2,008,069,970 2007.
[52]
Taylor MK. Pharmaceutical formulations WIPO Patent 2,006,076,222 2006.
[53]
Paire M, Peipe MP, Meade CJ. Pharmaceutical compositions based on anticholinergics and NK1-Receptor Antagonists. U.S. Patent 6,696,042, 2003.
[54]
Joh B, Gadek T. Aerosolized lfa-1 antagonist to be used for topical treatment of immune related disorders. JP Patent 2,017,141,310, 2017.
[55]
Surber MW, Bostian KA, Dudley MN, Lomovskaya O, Griffith DC. Aerosolized Fluoroquinolones and uses thereof. U.S. Patent 7,838,532, 2006.
[56]
Calander S, Friberg C, Myrman M, Nilsson T. Combined doses of Tiotropium and Fluticasone. A.U. Patent 2,004,246,990, 2004.
[57]
Zeng XM. An inhalable medicament comprising Tiotropium. P.T. Patent 2,606,891, 2012.
[58]
Lipp MM, Sung JC. Dry powder formulations and methods for treating pulmonary diseases. A.U. Patent 2,010,229,668, 2010.
[59]
Gonda I. Systems and methods for effecting cessation of Tobacco Use. U.S. Patent 8,689,803, 2012.
[60]
Arp J, Keegstra J, Goller MI. Dry Powder Inhaler EP3079744B1 2018.
[61]
Jones CE. Combination of Fluticasone Propionate, Umeclidinium and Salmeterol xinafoate for use in the treatment of inflammatory or respiratory tract diseases. U.S. Patent 9795561, 2013.
[62]
Kieckbusch T. System for treating chronic obstructive pulmonary disease. A.U. Patent 2,013,100,007, 2013.
[63]
Cavallion P, Llorca N, Louis O, Rosier P. Pharmaceutical aerosol formulation. U.S. Patent 7,521,042, 2003.
[64]
Sawant R, Parab S. Stable Aerosol pharmaceutical formulations. U.S. Patent 20,070,286,814, 2006.
[65]
Geller DE, Kesser KC. The I-neb adaptive aerosol delivery system enhances delivery of α1-antitrypsin with controlled inhalation. J Aerosol Med Pulm Drug Deliv 2010; 23(Suppl. 1): S55-9.
[http://dx.doi.org/10.1089/jamp.2009.0793] [PMID: 20373910]
[66]
de Boer AH, Hagedoorn P, Frijlink HW. The choice of a compressor for the aerosolisation of tobramycin (TOBI) with the PARI LC PLUS reusable nebuliser. Int J Pharm 2003; 268(1-2): 59-69.
[http://dx.doi.org/10.1016/j.ijpharm.2003.09.004] [PMID: 14643977]
[67]
Brand P, Schulte M, Wencker M, et al. Lung deposition of inhaled alpha1-proteinase inhibitor in cystic fibrosis and alpha1-antitrypsin deficiency. Eur Respir J 2009; 34(2): 354-60.
[http://dx.doi.org/10.1183/09031936.00118408] [PMID: 19251783]
[68]
Fischer A, Stegemann J, Scheuch G, Siekmeier R. Novel devices for individualized controlled inhalation can optimize aerosol therapy in efficacy, patient care and power of clinical trials. Eur J Med Res 2009; 14(Suppl. 4): 71-7.
[http://dx.doi.org/10.1186/2047-783X-14-S4-71] [PMID: 20156730]
[69]
Purucker ME, Rosebraugh CJ, Zhou F, Meyer RJ. Inhaled fluticasone propionate by diskus in the treatment of asthma: A comparison of the efficacy of the same nominal dose given either once or twice a day. Chest 2003; 124(4): 1584-93.
[http://dx.doi.org/10.1378/chest.124.4.1584] [PMID: 14555594]
[70]
Dell SD, Bola SS, Foty RG, Marshall LC, Nelligan KA, Coates AL. Provocative dose of methacholine causing a 20% drop in FEV1 should be used to interpret methacholine challenge tests with modern nebulizers. Ann Am Thorac Soc 2015; 12(3): 357-63.
[http://dx.doi.org/10.1513/AnnalsATS.201409-433OC] [PMID: 25575246]
[71]
Ari ME, Orun UA, Karademir S, et al. Pulmonary vasoreactivity testing with inhaled iloprost in children with pulmonary hypertension related to congenital heart disease. Turk J Thorac Cardiovasc Surg 2015; 23(2): 222-8.
[http://dx.doi.org/10.5606/tgkdc.dergisi.2015.10333]
[72]
Pascual S, Feimer J, De Soyza A, et al. Preference, satisfaction and critical errors with Genuair and Breezhaler inhalers in patients with COPD: A randomised, cross-over, multicentre study. NPJ Prim Care Respir Med 2015; 25(25): 15018.
[http://dx.doi.org/10.1038/npjpcrm.2015.18] [PMID: 25927321]
[73]
Yoshiyama Y, Yazaki T, Arai M, Asai K, Kanke M. The nebulization of budesonide suspensions by a newly designed mesh nebulizer. Respirat Drug Deliv 2002; VIII: 487-9.
[74]
Carreira Geralde M, Kassab G, Inada NM, Kurachi C, Bagnato VS. PDI using nebulized indocyanine green for pneumonia treatment. In: Endoscopic Microscopy XIII. San Francisco, California, United States 2018; p. 10470.
[http://dx.doi.org/10.1117/12.2291987]
[75]
Barry PW, O’Callaghan C. An in vitro analysis of the output of salbutamol from different nebulizers. Eur Respir J 1999; 13(5): 1164-9.
[http://dx.doi.org/10.1034/j.1399-3003.1999.13e37.x] [PMID: 10414421]
[76]
Chandel A, Goyal AK, Ghosh G, Rath G. Recent advances in aerosolised drug delivery. Biomed Pharmacother 2019; 112(108601)108601
[http://dx.doi.org/10.1016/j.biopha.2019.108601] [PMID: 30780107]
[77]
Patel AR, Vavia PR. Nanotechnology and pharmaceutical inhalation aerosols. Indian J Exp Biol 2007; 45(2): 166-74.
[PMID: 17375556]
[78]
Sugunan A, Dutta J. Nanoparticles for nanotechnology. J Phys Sci Idea 2004; 4(1-2): 50-7.
[79]
Anne H, Grietge M, Frijlink HW. Pulmonary drug delivery: Delivery to and through the lung. In: Drug Targeting. Federal Republic of Germany: Wiley-Vch 2001.
[80]
CISION PR Newswire. Global Nanotechnology in Drug Delivery markets, 2020-2027 with profiles of 43 industry players. Available from: https://www.prnewswire.com/news-releases/global-nanotechnology-in-drug-delivery-markets-2020-2027-with-profiles-of-43-industry-players-301067245.html (Accessed on: Aug 10, 2021).

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