Inhaled Therapeutics using Dry Powder Inhalers (DPI) Scott Selig ‘19 Biomedical Engineering

Intro: Common Lung Diseases which compromise Airflow Asthma- inflamed airways and shortness of breathChronic Obstructive Pulmonary Disease (COPD)- inability to exhale normallyChronic Bronchitis- a type of COPD categorized by a chronic coughEmphysema- Lung damage prevents lungs from fully exhaling Cystic Fibrosis- genetic condition causing poor clearance of mucus from the bronchi "Lung Diseases: Types and Causes of Common Conditions." WebMD. Ed. Varnada Karriem-Norwood. WebMD, 23 Mar Web. 31 Oct

Intro: Problems with Medicating Targeted Area using an Inhaler Patient’s inability to administer dosage from device Patient’s shortness of breath Device’s limitations: variable delivered doses and inhaler design issues Jat, Kana Ram, Kamal Kumar Singhal, and Vishal Guglani. "Autohaler versus Metered-dose Inhaler with Spacer in Children with Asthma." Pediatr Allergy Immunol Pediatric Allergy and Immunology (2015): n. pag. Pubmed. Web. 31 Oct

Intro: Advantages of Dry Powder Inhalers (DPIs) Carrier particle’s high ability to disperseCarrier particle’s high drug yieldDevice’s drug dosage accuracyDevice’s reliability powder-inhaler-capsules Jat, Kana Ram, Kamal Kumar Singhal, and Vishal Guglani. "Autohaler versus Metered-dose Inhaler with Spacer in Children with Asthma." Pediatr Allergy Immunol Pediatric Allergy and Immunology (2015): n. pag. Pubmed. Web. 31 Oct

Method: Testing the Design of the Autohaler™ Observational Study of the interface of the device with patients 6 to 18 years of age - Compared dry powder inhaler (DPI) to metered dose inhaler (MDI) with spacer - Looked at the ability of the patient to correctly give the proper dosage - Looked at how easily the device was used Jat, Kana Ram, Kamal Kumar Singhal, and Vishal Guglani. "Autohaler versus Metered-dose Inhaler with Spacer in Children with Asthma." Pediatr Allergy Immunol Pediatric Allergy and Immunology (2015): n. pag. Pubmed. Web. 31 Oct Autohaler -multi-dose DPI _devices/MDIs/album/slides/airomir %20autohaler.html

Result: Testing the Design of the Autohaler™ The patients who used the breath actuated DPI (Autohaler) had better control of their asthma and received the desired dosage when needed with fewer dosage technical difficulties. Jat, Kana Ram, Kamal Kumar Singhal, and Vishal Guglani. "Autohaler versus Metered-dose Inhaler with Spacer in Children with Asthma." Pediatr Allergy Immunol Pediatric Allergy and Immunology (2015): n. pag. Pubmed. Web. 31 Oct

Method: Testing different blends of Lactose Coarse Carrier Particles with varying levels of Fine Lactose Muddle, Joanna, Darragh Murnane, Irene Parisini, Marc Brown, Clive Page, and Ben Forbes. "Interaction of Formulation and Device Factors Determine the In Vitro Performance of Salbutamol Sulphate Dry Powders for Inhalation." Journal of Pharmaceutical Sciences J. Pharm. -Three different blends of different grade lactose supplement with different levels of fine lactose were used -Using three different DPIs (Aeroliser, Handihaler, and Rotahaler), the different grades of lactose blends were tested for their in vitro particle distribution and drug deposition

Method: Testing different blends of Lactose Coarse Carrier Particles with varying levels of Fine Lactose Muddle, Joanna, Darragh Murnane, Irene Parisini, Marc Brown, Clive Page, and Ben Forbes. "Interaction of Formulation and Device Factors Determine the In Vitro Performance of Salbutamol Sulphate Dry Powders for Inhalation." Journal of Pharmaceutical Sciences J. Pharm.

Method: Testing different Dry Powder Formulations Muddle, Joanna, Darragh Murnane, Irene Parisini, Marc Brown, Clive Page, and Ben Forbes. "Interaction of Formulation and Device Factors Determine the In Vitro Performance of Salbutamol Sulphate Dry Powders for Inhalation." Journal of Pharmaceutical Sciences J. Pharm. Sympatec laser diffraction to determine particle size and shape

Results: Testing different Dry Powder Formulations Jat, Kana Ram, Kamal Kumar Singhal, and Vishal Guglani. "Autohaler versus Metered-dose Inhaler with Spacer in Children with Asthma." Pediatr Allergy Immunol Pediatric Allergy and Immunology (2015): n. pag. Pubmed. Web. 31 Oct (a) LH200 (b) ML001 (c) ML006 (white) Aeroliser (black) Handihaler (stripes) Rotahaler

Result: Testing different Dry Powder Formulations The amount of fine lactose added to the varying types of coarse lactose tended to increase fine particle fraction (FPF), directly relating to an increase in drug deposition. Jat, Kana Ram, Kamal Kumar Singhal, and Vishal Guglani. "Autohaler versus Metered-dose Inhaler with Spacer in Children with Asthma." Pediatr Allergy Immunol Pediatric Allergy and Immunology (2015): n. pag. Pubmed. Web. 31 Oct

Discussion: Pulmatrix iSperse™ - iSperse is an alternative to traditional dry powder lactose bases, which can be mixed with a variety of different medications - The powder is primarily a calcium salt base claimed to be easily dispersible and very dense, resulting in high yield of drug deposition in the lungs Lipp, Michael M., and Jean C. Sung. Respirably Dry Powder Comprising Calcium Lactate, Sodium Chloride and Leucine. Patent 8,992, Mar Print.

Any questions? [1] "Lung Diseases: Types and Causes of Common Conditions." WebMD. Ed. Varnada Karriem-Norwood. WebMD, 23 Mar Web. 31 Oct [2] Jat, Kana Ram, Kamal Kumar Singhal, and Vishal Guglani. "Autohaler versus Metered-dose Inhaler with Spacer in Children with Asthma." Pediatr Allergy Immunol Pediatric Allergy and Immunology (2015): n. pag. Pubmed. Web. 31 Oct [3] Muddle, Joanna, Darragh Murnane, Irene Parisini, Marc Brown, Clive Page, and Ben Forbes. "Interaction of Formulation and Device Factors Determine the In Vitro Performance of Salbutamol Sulphate Dry Powders for Inhalation." Journal of Pharmaceutical Sciences J. Pharm. Sci (2015): Pubmed. Web. 31 Oct [4] Holz, Olaf, H. Biller, M. Mueller, K. Kane, M. Rosano, J. Hanrahan, D. L. Hava, and J. M. Hohlfeld. "Efficacy and Safety of Inhaled Calcium Lactate PUR118 in the Ozone Challenge Model - a Clinical Trial." BMC Pharmacology and Toxicology BMC Pharmacol Toxicol 16.1 (2015): n. pag. Web. 31 Oct [5] Lipp, Michael M., and Jean C. Sung. Respirably Dry Powder Comprising Calcium Lactate, Sodium Chloride and Leucine. Patent 8,992, Mar Print.