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AERx Drug Delivery System

Advances in Pulmonary Drug Delivery:

Prepared By: Shaikh Mohd. Saif. M Pharm II Sem HKCOP

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Pulmonary drug delivery : Introduction

Pulmonary route have been used to treat various respiratory diseases for centuries.

Ancient inhalation therapies included the use of leaves from plants, vapors from aromatic plants, balsams, and myhrr. However, around the turn of the 19th century, with the invention of liquid nebulizers.

In the 1920s adrenaline was introduced as a nebulizer solution, in 1925 nebulizer porcine insulin was used in experimental studies in diabetes,

In 1956 the pressured metered dose inhaler (pMDI) was introduced and so on……………………………..

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CHALLENGES IN PULMONARY DRUG DELIVERY

Low Efficiency of inhalation systemAerosol system should have to produce optimum size particles because they are too small, they will be exhaled. If the particles are too large, they affects on the oropharynx and larynx.(0.5-1mm)

Less drug mass per puffTo get adequate effect with the pulmonary drug delivery practicaldelivery of many drug which require milligram doses but With mostexisting systems, the total amount of drug per puff delivered to thelower respiratory tract is too low less than 1000 mcg.

Poor formulation stability for drugMost traditional drugs are crystalline, in the case of corticosteroids,and highly moisture sensitive drugs are unstable.

Improper dosing reproducibilityReason for Poor dosing reproducibility like worseningof diseases’, problem in device, un stabality of formulation.

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Depend upon generation of aerosol new technologies areClassified into four groups.

Systems that force the liquid through a nozzle ‐ Respimat , AERxTM, MedSpray

Systems that use a vibrating mesh or perforated plate ‐ Aerodose. TouchsprayTM technology.

Systems that use electrohydrodynamic breakup to generate the aerosol‐ MysticTM (Battelle)

Systems that apply condensation to generate the aerosol

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AERx™ :

The AERx® pulmonary delivery system combines precise control of aerosol particle size with regulation of the patient’s inhalation flow rate to achieve maximal efficiency of drug delivery to the lungs.

The AERx system consists of two components:

• AERx Strip® dosage packet

• one of the AERx system delivery devices.

AERx Device

AERx Strip

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Generations of AERx™ systems

AERx First-Generation Hand-Held Delivery Devices

AERx first-generation inhalation delivery systems are sophisticated electromechanical devices that were designed to achieve superior efficiency and precision required for applications such as Type 1 and Type 2 diabetes management with inhaled insulin, represented by the product AERx iDMS previously licensed to Novo Nordisk.

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AERx Second-Generation Delivery Device: AERx Essence®

AERx Essence is a small, palm-size all-mechanical device. The AERx Essence system offers a level of performance (efficiency and reproducibility) close to the first generation AERx system, but in a small, light and low-cost package.

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Component of AERx™Drug Loaded Strip Nozzel area

Drug loaded cavity

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Advantages of strips :

Single use, disposable aerosol nozzle avoids clogging

300 – 450 μm sized nozzle holes per strip drilled with precision by laser Blister for 50 μL liquid dose (max 1ml) Efficient, scalable dosage packet manufacture and nozzle drilling processes

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AERx™ Device

Synchronizes aerosol delivery with start of inhalation Emitted Dose ≈ 57% of the dose loaded into the Strip Fine Particle Fraction (at or below 4.95 μm) ≈ 90% Simple to operate, palm-sized, portable Weight: 6.5 oz (185 gm) Aerosol extrusion time: 2.5 seconds Easy to clean: just hold device under running water No maintenance Low cost

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Advantages of AERx™

Liquid formulation Fast development

Unit dose disposable packetSuperior aerosol performance

Breath control Consistent dose delivery

Data capture Enhances therapy compliance

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Chronic bronchitis and emphysema drugs

Antibodies

Gene therapies

Asthma drugs

Hematopoetic factors

Human growth factors

Future Opportunities

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References:

1) RECENT ADVANCES IN PULMONARY DRUG DELIVERY SYSTEM: A REVIEW, SIRAJ SHAIKH*1, SAYYED NAZIM1, International journal of aplllied pharmaceutics, ISSN- 0975-7058 Vol 2, Issue 4, 2010

2) www.aradigm.com

3) (http://www.aapspharmsci.org)

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