Product Life Cycle Approach to Cascade Impaction Measurements
Chapter
First Online:
Abstract
Over the OIP life cycle (from development to commercial production, to the development of generic/follow-on products), APSD measurements are used extensively but for different purposes. The analytical and statistical approaches to the measurements and data analyses at these stages must therefore be different, depending on the specific questions pursued in a given situation. For some of those questions, full-resolution CIs are the instrument of choice. For others, an AIM system can provide all the needed information and support decision-making. This chapter describes how the utilization of specific measurement approaches changes over the product life cycle, and how the entire body of APSD data is interlinked to enable those transitions (e.g., by establishing correlations or by establishing typical profile parameters), thereby enhancing product knowledge, appropriate control, and comparisons between innovator and generic OIPs.
Keywords
Product Life Cycle Fine Particle Fraction Life Cycle Approach Clinical Batch Abbreviate Impactor Measurement
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References
- 1.European Medicines Agency (EMA) (2009) Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents. London, UK. CPMP/EWP/4151/00 Rev 1 Available at URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf. Visited 27 Sep 2012
- 2.European Directorate for the Quality of Medicines and Healthcare (EDQM). Preparations for inhalation: aerodynamic assessment of fine particles. (2012) Section 2.9.18—European Pharmacopeia [− Apparatus B in versions up to 4th edn 2002] Council of Europe, 67075 Strasbourg, FranceGoogle Scholar
- 3.European Medicines Agency (EMA) (2006) Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products. London, UK, EMEA/CHMP/QWP/49313/2005 Final. Accessed 20 Jan 2012 at: http://www.ema.europa.eu/pdfs/human/qwp/4931305en.pdf
- 4.Tougas TP, Christopher D, Mitchell JP, Strickland H, Wyka B, Van Oort M, Lyapustina S (2009) Improved quality control metrics for cascade impaction measurements of orally inhaled drug products (OIPs). AAPS PharmSciTech 10(4):1276–1285PubMedCrossRefGoogle Scholar
- 5.Mitchell JP, Newman SP, Chan H-K (2007) In vitro and in vivo aspects of cascade impactor tests and inhaler performance:a review. AAPS PharmSciTech. 8(4):article110. Available at URL: http://www.aapspharmscitech.org/articles/pt0804/pt0804110/pt0804110.pdf. Visited 30 June 2012
- 6.Mitchell JP, Dolovich MB (2012) Clinically relevant test methods to establish in vitro equivalence for spacers and valved holding chambers used with pressurized metered dose inhalers (pMDIs). J Aerosol Med Pulm Drug Deliv 25(4):217–242PubMedCrossRefGoogle Scholar
- 7.Usmani OS, Biddiscombe MF, Nightingale JA, Underwood SR, Barnes PJ (2003) Effects of bronchodilator particle size in asthmatic patients using monodisperse aerosols. J Appl Physiol 95(5):2106–2112PubMedGoogle Scholar
- 8.Usmani OS, Biddiscombe MF, Barnes PJ (2005) Regional lung deposition and bronchodilator response as a function of beta-2 agonist particle size. Am J Respir Crit Care Med 172(12):1497–1504PubMedCrossRefGoogle Scholar
- 9.Mitchell JP, Nagel MW, MacKay H, Avvakoumova VA, Malpass J (2009) Developing a “universal” valved holding chamber (VHC) platform with added patient benefits whilst maintaining consistent in vitro performance. In: Dalby RN, Byron PR, Peart J, Suman JD, Young PM (eds) Respiratory Drug Delivery-Europe 2009. Davis Healthcare International Publishing, River Grove, IL, pp 383–386Google Scholar
- 10.Newman SP, Chan H-K (2008) In vitro/in vivo comparisons in pulmonary drug delivery. J Aerosol Med Pulm Drug Deliv 21(1):77–84PubMedCrossRefGoogle Scholar
- 11.Tougas T, Christopher D, Mitchell J, Lyapustina S, Van Oort M, Bauer R, Glaab V (2011) Product lifecycle approach to cascade impaction measurements. AAPS PharmSciTech 12(1):312–322PubMedCrossRefGoogle Scholar
- 12.Mitchell JP, Newman SP, Chan H-K (2007) In vitro and in vivo aspects of cascade impactor tests and inhaler performance: a review. AAPS PharmSciTech 8(4): article 24. Accessed on 3 July 2012 at: http://www.aapspharmscitech.org/view.asp?art=pt0804110
- 13.Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens R, Conner D, Dissanayake S, Dolovich M, Doub W, Fuglsang A, Garcia-Arieta A, Golden M, Hermann R, Hochhaus G, Holmes S, Lafferty P, Lyapustina S, Nair P, O’Connor D, Parkins D, Peterson I, Reisner C, Sandell D, Singh GJP, Weda M, Watson P (2012) Equivalence considerations for orally inhaled products for local action—ISAM/IPAC-RS European Workshop Report. J Aerosol Med Pulm Drug Deliv 25(3):117–139PubMedCrossRefGoogle Scholar
- 14.Hegewald MJ, Crapo RO (2010) Pulmonary function testing. In: Mason RJ, Broaddus VC, Martin TR, King T Jr, Schraufnagel DMD, Murray JF, Nadel JA (eds) Murray and Nadel’s textbook of respiratory medicine, 5th edn. Saunders Elsevier, Philadelphia, PA, Chapter 24Google Scholar
- 15.Barnes PJ, Pedersen S, Busse WW (1998) Efficacy and safety of inhaled corticosteroids: new developments. Am J Respir Crit Care Med 157(3Pt2):S1–S53PubMedCrossRefGoogle Scholar
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