Backgrounder 3 – novalizer

Backgrounder 3
Novolizer®: significant advance in inhalation therapy for
improved asthma management
Following a symposium at last year’s European Respiratory Society congress Professor Peter Barnes (Imperial College, London) concluded that “Inhaled therapy is likely to remain predominant in the future and the type of inhaler is just as important as the class of drug in the long-term management of asthma Backgrounder 2 in this pack (The need for the ideal inhaler) described the drawbacks of many of the current inhaler systems and includes a list of requirements for an ‘ideal inhaler’. There is an urgent need to improve the delivery of asthma drugs to provide improved control of symptoms in this vast and growing global disease (see backgrounder 1). This backgrounder describes an innovative, new delivery device, NOVOLIZER® (MEDA), which has been specifically developed to meet the criteria for a significantly easier- to-use, easy-to-introduce and consistently effective inhaler (Figure 1). The new device uses a clear understanding of the modern physics of particle deagglomeration to deliver drug accurately and consistently to the lungs. [Figure 1 – Photograph of NOVOLIZER as in O’Connor B paper, page
S14 “The ideal inhaler” Resp Med 2004 (suppl A): S10-16.” highlighting
features of the devices with their benefits to patients and doctors]
What are the key problems in inhaler design that NOVOLIZER® is
designed to overcome?
Current inhalers suffer from a number of limitations including: • Poor drug deposition in the lungs• Inconsistent drug delivery both between doses and between devices• Lack of feedback mechanisms to reassure patients• Complex instructions and procedures• Need for high inspiration rates• Poor compliance rates The engineers and physicians who designed NOVOLIZER® aimed to address each of these significant limitations.
What is different about the design of NOVOLIZER®?
The device incorporates elegant design and engineering to deliver correct doses of drug time-after-time. Based on a clear understanding of the physical properties required for effective dry powder inhalation, NOVOLIZER® uses its unique, patented cyclone technology to separate the fine and coarse particles of the powdered drug. Actuation is made easy by selecting a low to medium level of inspiratory flow resistance – unlike other devices which require higher NOVOLIZER® incorporates an innovative flow trigger valve system which releases drug only if the inspiratory flow sufficient for correct lung deposition is achieved. The device has a minimum inspiratory flow rate threshold of only 35-50 L/min allowing use by a wide variety of patients.2 This mechanism overcomes the problems of poor patient inhalation technique and ensures Is the device reliable with consistent drug delivery?
The Viatris team worked in close co-operation with European academic centres to engineer an inhaler which effectively delivers the drug to the large and small airways – consistently, time-after-time. Within milliseconds of inhalation the flow of drug is evenly delivered in a clean stream of air into the large and small airways with minimal deposition in the mouth. The innovative refill system delivers up to 200 metered doses of drug from a replaceable cartridge. The refill system keeps costs down.
In vitro studies comparing budesonide fine particle doses have shown that compared with the Turbuhaler®, and at equal mean fine particle dose, there is more consistency of dose deposition with the NOVOLIZER®.3 The device has been extensively tested in real life clinical situations and the dose emitted. Handling of the device is not affected by temperature, humidity, long-term use (6 months with twice daily administration) or storage for up to 3 years. 3,4,5 These studies also compared inhalers from different batches and found no significant difference in performance.
How does the NOVOLIZER® compare with other inhalation devices?
Data from a randomised, cross-over study in which single doses of radiolabelled budesonide 200 µg were administered to healthy volunteers, showed low flow rate dependency for peripheral lung deposition with the NOVOLIZER®.6 When used optimally, there was greater drug deposition in the lungs as well as reduced deposition in the mouth with NOVOLIZER® In a number of randomised, controlled clinical trials designed to show equivalence, the efficacy of drugs delivered by NOVOLIZER® has been shown to be at least as good as other leading inhaler devices in terms of increasing FEV1, improvements in clinical symptoms and decline in albuterol use.7,8,9 Interestingly, patients preferred NOVOLIZER® to either the MDI or DPI (Turbuhaler®) used in these studies.
How does the patient know the dose has been delivered correctly?
Unlike other devices, NOVOLIZER® provides multiple, simple, feedback signals when correct inhalation has been achieved.2,10 Patients are able to see, hear and taste that they have received the accurate dose of asthma medication. For example, only when the correct inhalation has been achieved will an indicator on the unit change colour (the coloured window changes from red to green). At the same time the patient will hear a “click” if correct inhalation takes place. If you breathe inappropriately there is no colour change and no audible “click”. In addition, lactose added to the active ingredient provides a sweet taste to let patients know when the dose has been taken correctly. Meanwhile, a dose counter only moves forward when • Provide reassurance for patients that they have taken their dose • Aid compliance and allow compliance to be monitored by healthcare • Avoid the risk of accidental overdose or under-dosing. Is the NOVOLIZER® easy to use correctly?
The NOVOLIZER® has low-to-medium airflow resistance making it available for use by most asthma patients including children, older adults and other patients who make have limited inspiratory flow.2 Patients normally learn to use the device in less than five minutes and therefore it has high patient acceptance.7 Three simple steps allow consistent delivery of drug time-after- 3. Inhale deeply and hold breath for a few seconds (Figure 2) [Figure 2. Include series of 3 photographs from detail aid titled “simple,
breath-actuated inhalation”]
Many manufacturers claim that their device is easy to use, but NOVOLIZER® is proven to be easy to use correctly. A post-marketing surveillance study in 3057 patients showed that NOVOLIZER® delivered budesonide therapy effectively to significantly improve asthma symptoms (median total symptom score decreased from 8 to 2 on a 15 point scale) and improve lung function (PEFR increased from 5 l/s to 6.3 l/s, median FEV1 increased from 2250 ml to 2700 ml).11 An overwhelming majority of patients were satisfied with the new control features of the device and 90% of those who had used other devices before rated the feedback mechanisms of NOVOLIZER® as better or much better. Compliance in the study was assessed by physicians as good or Is NOVOLIZER® really suitable for children?
The simple instructions for use and low inspiratory flow requirement mean that NOVOLIZER® is ideal for use in children with asthma. In a study of 137 children with asthma, all of those over the age of six were able to perform correct inhalation manoeuvres with the NOVOLIZER® significantly in excess of the peak inspiratory flow required for actuation.12 The study also showed that 84% of children under six were able to generate sufficient peak inspiratory flow to operate the device. The feedback mechanisms incorporated in the NOVOLIZER® are of particular value in children as they allow accurate identification of successful and unsuccessful attempts. The innovative design of NOVOLIZER® means that under-dosing or over-dosing are virtually References
1. Barnes PJ. Decision making in asthma therapy – what is important in clinical practice? (Editorial overview). Respiratory Med 2004; 98:S1-3.
2. Kohler D. The Novolizer: overcoming inherent problems of other dry powder inhalers. Respir Med 2004;98 (Suppl A): S17-21.
3. Munzel U, Marschall K, Fyryns B, Wedel M. Variability of budesonide fine particle dose emitted through two multidose dry powder inhalers. Poster presented at the European Respiratory Society Annual 4. Mueller S, Fyrnys B. Development of formoterol fumarate dehydrate powder for inhalation delivered through a multidose dry powder inhaler. Eur Respir J 2004; Suppl 45: 582S (abstract P3575).
5. Mueller S, Fyrnys B. In use performance of formoterol fumarate dehydrate for inhalation delivered through a multidose dry powder inhaler. Eur Respir J 2003; Suppl 45: 473S (abstract P2985).
6. Newman SP, Pitcairn GR, Hirst PH et al. Scintigraphic comparison of budesonide deposition from two dry powder inhalers. Eur Respir J 7. Chuchalin AG, Kremer HJ, Metzenauer P et al. Clinical equivalence trial on budesonide delivered either by the Novalizer multidose dry powder inhaler or the Turbuhaler in asthmatic patients. Respiration 8. Kunkel G, Metzenauer P, Hoesch S et al. Comparison of a formoterol multiple dose dry powder inhaler with a formoterol single dose dry powder inhaler in patients with moderate to severe asthma. Eur Respir J 2004; 24 (Suppl 48): 260s (abstract P1708).
9. Kunkel G, Chuchalin AG. Therapeutic equivalence of the Sofotec Novolizer to established standard devices in COPD and asthma. Curr Opin Pulm Med 2001; 7 (Suppl 1): S15-17.
10. Virchow JC. Guidelines versus clinical practice: which therapy and which device? Respir Med 2004; 98 (Suppl B): S28-34.
11. Möller M, Fritsche D, Rivera D, Libertus H. Improvement of asthma therapy by a novel budesonide multidose dry powder inhaler. Arzneim- Forsch/Drug Res 2003; 53 (8): 562-7.
12. Vogelberg C, Kremer H-J, Ellers-Lenz B et al. Clinical evaluation of the peak inspiratory flow generated by asthmatic children through the Novolizer. Respir Med 2004; 98 (10): 924-31.



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