Effect of Inner Physical Properties on Powder Adhesion in Inhalation Capsules in Case of a High Resistance Device

Overview

Journal Exp Ther Med

Specialty Pathology

Date 2021 Oct 18

PMID 34659499

Authors

Hiroko Otake

Misa Minami

Mizuki Yamaguchi

Sawako Akiyama

Kazunori Inaba

Noriaki Nagai

Affiliations

Soon will be listed here.

Abstract

The inhalation performance of a dry powder inhaler (DPI) depends on the inhalation patterns of patients, inhalation particle characteristics and inhalation devices. In capsule-based DPIs, the capsule plays an important role in the dispersion of inhalation particles. The present study investigated the effects of inner physical properties of capsules on drug release from capsules-based DPIs with high resistance device. Atomic force microscopy (AFM) was used to evaluate the capsule physical properties, such as the capsule inner structure and surface potential, of three capsules with different compositions (G-Cap, PEG/G-Cap, and HPMC-Cap). As a model dry powder for capsule-based DPIs, the dry powder in Spiriva Inhalation Capsules containing tiotropium bromide was used. Inhalation performance was evaluated using a twin-stage liquid impinge and Handihaler (flow rate 30 l/min). The results indicated that the capsule inner surface presented with numerous valleys and mountains, regardless of the capsule type. Furthermore, the valley and mountain areas on the capsule inner surface showed a significantly higher or lower surface potential. Following inhalation of capsule-based DPIs, the drug remained in the valleys on the capsule inner surface; however, no significant difference was observed in the drug release from capsule and lung drug delivery. Therefore, inhalation performance in capsule-based DPIs when a high resistance device, such as Handihaler, is used at an appropriately flow rate is not markedly affected by the physical properties of the capsule inner surface due to capsule composition.

References

Bouwmeester C, Kraft J, Bungay K . Optimizing inhaler use by pharmacist-provided education to community-dwelling elderly. Respir Med. 2015; 109(10):1363-8. DOI: 10.1016/j.rmed.2015.07.013. View

Wauthoz N, Hennia I, Dejaeger B, Ecenarro S, Amighi K . Proposed algorithm for healthcare professionals based on product characteristics and in vitro performances in different use conditions using formoterol-based marketed products for inhalation. Int J Pharm. 2017; 530(1-2):415-429. DOI: 10.1016/j.ijpharm.2017.07.021. View

Horhota S, van Noord J, Verkleij C, Bour L, Sharma A, Trunk M . In Vitro, Pharmacokinetic, Pharmacodynamic, and Safety Comparisons of Single and Combined Administration of Tiotropium and Salmeterol in COPD Patients Using Different Dry Powder Inhalers. AAPS J. 2015; 17(4):871-80. PMC: 4476986. DOI: 10.1208/s12248-015-9751-7. View

Hira D, Koide H, Nakamura S, Okada T, Ishizeki K, Yamaguchi M . Assessment of inhalation flow patterns of soft mist inhaler co-prescribed with dry powder inhaler using inspiratory flow meter for multi inhalation devices. PLoS One. 2018; 13(2):e0193082. PMC: 5819805. DOI: 10.1371/journal.pone.0193082. View

Berkenfeld K, Lamprecht A, McConville J . Devices for dry powder drug delivery to the lung. AAPS PharmSciTech. 2015; 16(3):479-90. PMC: 4444630. DOI: 10.1208/s12249-015-0317-x. View

Saleem I, Diez F, Jones B, Kayali N, Polo L . Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels. Int J Pharm. 2015; 492(1-2):258-63. DOI: 10.1016/j.ijpharm.2015.07.034. View

Claus S, Weiler C, Schiewe J, Friess W . How can we bring high drug doses to the lung?. Eur J Pharm Biopharm. 2013; 86(1):1-6. DOI: 10.1016/j.ejpb.2013.11.005. View

Tonnis W, Lexmond A, Frijlink H, de Boer A, Hinrichs W . Devices and formulations for pulmonary vaccination. Expert Opin Drug Deliv. 2013; 10(10):1383-97. DOI: 10.1517/17425247.2013.810622. View

Cochrane M, Bala M, Downs K, Mauskopf J, Ben-Joseph R . Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique. Chest. 2000; 117(2):542-50. DOI: 10.1378/chest.117.2.542. View

10.

Weers J, Miller D . Formulation Design of Dry Powders for Inhalation. J Pharm Sci. 2015; 104(10):3259-88. DOI: 10.1002/jps.24574. View

11.

Chew N, Shekunov B, Tong H, Chow A, Savage C, Wu J . Effect of amino acids on the dispersion of disodium cromoglycate powders. J Pharm Sci. 2005; 94(10):2289-300. DOI: 10.1002/jps.20426. View

12.

Li H, Seville P, Williamson I, Birchall J . The use of amino acids to enhance the aerosolisation of spray-dried powders for pulmonary gene therapy. J Gene Med. 2004; 7(3):343-53. DOI: 10.1002/jgm.654. View

13.

Yang M, Chan J, Chan H . Pulmonary drug delivery by powder aerosols. J Control Release. 2014; 193:228-40. DOI: 10.1016/j.jconrel.2014.04.055. View

14.

Smith I, Bell J, Bowman N, Everard M, Stein S, Weers J . Inhaler devices: what remains to be done?. J Aerosol Med Pulm Drug Deliv. 2010; 23 Suppl 2:S25-37. DOI: 10.1089/jamp.2010.0853. View

15.

Bailey M, Gorman E, Munson E, Berkland C . Pure insulin nanoparticle agglomerates for pulmonary delivery. Langmuir. 2008; 24(23):13614-20. PMC: 2649680. DOI: 10.1021/la802405p. View

16.

Faulhammer E, Fink M, Llusa M, Lawrence S, Biserni S, Calzolari V . Low-dose capsule filling of inhalation products: critical material attributes and process parameters. Int J Pharm. 2014; 473(1-2):617-26. DOI: 10.1016/j.ijpharm.2014.07.050. View

17.

Lavorini F, Pistolesi M, Usmani O . Recent advances in capsule-based dry powder inhaler technology. Multidiscip Respir Med. 2017; 12:11. PMC: 5439154. DOI: 10.1186/s40248-017-0092-5. View

18.

Otake H, Okuda T, Okamoto H . Development of Spray-Freeze-Dried Powders for Inhalation with High Inhalation Performance and Antihygroscopic Property. Chem Pharm Bull (Tokyo). 2016; 64(3):239-45. DOI: 10.1248/cpb.c15-00824. View

19.

Coates M, Fletcher D, Chan H, Raper J . The role of capsule on the performance of a dry powder inhaler using computational and experimental analyses. Pharm Res. 2005; 22(6):923-32. DOI: 10.1007/s11095-005-4587-y. View

20.

Broeders M, Vincken W, Corbetta L . The ADMIT series--Issues in Inhalation Therapy. 7. Ways to improve pharmacological management of COPD: the importance of inhaler choice and inhalation technique. Prim Care Respir J. 2011; 20(3):338-43. PMC: 6549856. DOI: 10.4104/pcrj.2011.00062. View