Measuring and testing – Sampler – sample handling – etc. – With constituent separation
Reexamination Certificate
2011-05-03
2011-05-03
Noland, Thomas P (Department: 2856)
Measuring and testing
Sampler, sample handling, etc.
With constituent separation
C073S864340
Reexamination Certificate
active
07934434
ABSTRACT:
An apparatus and method are provided for collection and analysis of dry powder inhaler products to determine foreign particulate matter found therein. The apparatus includes a collection chamber that communicates directly with the mouthpiece of a dry powder inhaler device. The collection chamber is used to both collect product samples, as well as to mix the samples with a diluent that places the active pharmaceutical components and excipients in solution, while the foreign particulate matter remains suspended. Analysis of a sample is preferably conducted by light obscuration wherein a probe is inserted directly within the collection chamber of the apparatus. An integral magnetic stir-bar incorporated within the apparatus eliminates the need to transfer the collected sample to a secondary vessel for mixing or analysis.
REFERENCES:
patent: 5232808 (1993-08-01), Bonser et al.
patent: 2005/0025755 (2005-02-01), Hedrick et al.
patent: 60249676 (1985-12-01), None
“FORADIL® AEROLIZER®” Medication Guide, Copyright 2006, Novartis Parmaceuticals Corporation, 8 pages.
“How to Use The FORADIL AEROLIZER”, available at http://www.foradil.us/, printed Nov. 8, 2007, pp. 1-2.
Blanchard et al., “Best Practices for Managing Quality and Safety of Foreign Particles in Orally Inhaled and Nasal Drug Products, and an Evaluation of Clinical Relevance”, Pharm. Res. 24(3), 2007, pp. 471-479.
Blanchard et al., “Foreign Particles Testing in Orally Inhaled and Nasal Drug Products”, Pharmaceutical Research, vol. 21, No. 12, Dec. 2004, pp. 2137-2147.
Castaldo “Identification of Foreign Particles Below 10 Microns Key to Inhaled Drug Quality”, Pharmaceutical Processing, available at http://www.pharmpro.com/, printed Aug. 9, 2007, pp. 1-3.
D'Abreu-Hayling “Quality by Design and Risk Management Approaches to Foreign Particles in OINDP”, Respiratory Drug Delivery 2006, pp. 640-642.
Hart “Proposal for Foreign Particles Testing in orally Inhaled and Nasal Drug Products”, Respiratory Drug Delivery IX, 2004, pp. 521-524.
Kreher et al., “Foreign Particle Characterization in Inhalation Drug Products: A Critical Comparison of Methods and Techniques”, Respiratory Drug Delivery IX, Palm Springs, CA, 2004, pp. 373-376.
Neiman et al., “A Critical Comparison: Particle Counting With Light Obscuration and Automated Raman Microscopy”, Respiratory Drug Delivery 2006, pp. 529-532.
Neiman et al., “Development of an Integrated Measurement System for Foreign Particles Testing in OINDP Based on IPAC-RS Recommendations”, RDD Europe 2005, pp. 181-184.
Pilewski et al., “Determination of Foreign Particulate Matter in Metered Dose Inhalers by Light Obscuration”, Respiratory Drug Delivery IX, Palm Springs, CA, 2004, available at www.rddonline.org.
Valet et al., “Method for Foreign Particles Counting and Identification in a Cellulose Containing Suspension of a Nasal Spray”, Respiratory Drug Delivery Europe 2007, pp. 325-328.
Valet et al., “Qualification of the Particle Explorer System for Foreign Particles Counting and Identification in a Dry Powder Inhaler Product Based on IPAC-RS Recommendations”, Respiratory Drug Delivery 2006, pp. 761-764.
Vicens et al., “System for Measuring the Performance of Microscopic Particle Analyzers”, Respiratory Drug Delivery 2006, pp. 433-435.
Shelton Christopher M.
Stephens Timothy J.
Noland Thomas P
Pharmaceutical Product Development, Inc.
Sheridan & Ross P.C.
LandOfFree
Apparatus and method for analysis of dry powder inhaler... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Apparatus and method for analysis of dry powder inhaler..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Apparatus and method for analysis of dry powder inhaler... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2620498