Abstract：
:Current pharmacopeial methods for in vitro orally inhaled product (OIP) performance testing were developed primarily to support requirements for drug product registration and quality control. In addition, separate clinical studies are undertaken in order to quantify safety and efficacy in the hands of the patient. However, both laboratory and clinical studies are time-consuming and expensive and generally do not investigate either the effects of misuse or the severity of the respiratory disease being treated. The following modifications to laboratory evaluation methodologies can be incorporated without difficulty to provide a better linkage from in vitro testing to clinical reality: (1) examine all types of OIP with patient-representative breathing profiles which represent normal inhaler operation in accordance with the instructions for use (IFU); (2) evaluate OIP misuse, prioritizing the importance of such testing on the basis of (a) probability of occurrence and (b) consequential impact in terms of drug delivery in accordance with the label claim; and (3) use age-appropriate patient-simulated face and upper airway models for the evaluation of OIPs with a facemask. Although it is not necessarily foreseen that these suggestions would form part of future routine quality control testing of inhalers, they should provide a closer approximation to the clinical setting and therefore be useful in the preparation for in vivo studies and in improving guidance for correct use.
journal_name
AAPS PharmSciTechjournal_title
AAPS PharmSciTechauthors
Mitchell JP,Suggett J,Nagel Mdoi
10.1208/s12249-016-0543-xsubject
Has Abstractpub_date
2016-08-01 00:00:00pages
787-804issue
4issn
1530-9932pii
10.1208/s12249-016-0543-xjournal_volume
17pub_type
杂志文章,评审abstract：:Nanotechnology is having a significant impact in the drug delivery systems and diagnostic devices. As most of the nanosystems are intended to be administered in vivo, there is a need for stability models, which could simulate the biological environment. Instability issues could lead to particle aggregation and in turn...
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journal_title：AAPS PharmSciTech
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journal_title：AAPS PharmSciTech
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journal_title：AAPS PharmSciTech
pub_type： 杂志文章,评审
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journal_title：AAPS PharmSciTech
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journal_title：AAPS PharmSciTech
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journal_title：AAPS PharmSciTech
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journal_title：AAPS PharmSciTech
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journal_title：AAPS PharmSciTech
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journal_title：AAPS PharmSciTech
pub_type： 杂志文章,评审
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journal_title：AAPS PharmSciTech
pub_type： 杂志文章
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