Particle Size Measurements from Orally Inhaled and Nasal Drug Products

2021 ◽  
Vol 34 (6) ◽  
pp. 325-345
Author(s):  
Jolyon P. Mitchell
Keyword(s):  
Particle Size ◽  
Drug Products ◽  
Nasal Drug Products

Higher Yield and Quality through Particle Identification

2008 ◽  
Vol 51 (2) ◽  
pp. 55-65
Author(s):  
O. Valet ◽  
M. Lankers
Keyword(s):  
Rapid Determination ◽  
Particle Identification ◽  
Manufacturing Processes ◽  
Data Sets ◽  
Drug Products ◽  
Particulate Contamination ◽  
Yield And Quality ◽  
Analytical Result ◽  
Nasal Drug Products

The sources of particulate contamination are often not easy to identify. To control manufacturing processes, the measurement of particle concentration and size is necessary and has been routinely performed for many years. Technology has been developed to increase the information available for the immediate evaluation of particles. The method analyzes airborne particles or particles isolated from liquids automatically according to their number, size, and chemical composition.1,2 The analysis of thousands of particles enables users to locate the major sources of contamination in various manufacturing processes. The analytical tool provides rapid determination of particulate contamination, thus allowing for a quick, efficient response. Over time, the ability to compare analytical result data sets assists in detecting trends and implementing the appropriate quality management. Routine use of the technology contributes to ongoing supervision and optimization of production processes. This study reports on the use of the technology to analyze foreign particles associated with oral, inhalable, and nasal drug products (OINDP), parenterals, and coronary stents. Applications for troubleshooting and identifying latent contamination sources are discussed through several examples.

Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations

2008 ◽  
Vol 25 (4) ◽  
pp. 727-739 ◽  
Author(s):  
Daniel L. Norwood ◽  
Diane Paskiet ◽  
Michael Ruberto ◽  
Thomas Feinberg ◽  
Alan Schroeder ◽  
...  
Keyword(s):  
Best Practices ◽  
Drug Products ◽  
Nasal Drug Products

Risk Management for Materials and Components Used in Orally Inhaled and Nasal Drug Products

2015 ◽  
Vol 33 (1) ◽  
pp. 1-17 ◽  
Author(s):  
Cheryl L. M. Stults ◽  
Gaby Reckzuegel ◽  
Arthur Bailey ◽  
Jonathan Petersen ◽  
Lisa Dick ◽  
...  
Keyword(s):  
Risk Management ◽  
Drug Products ◽  
Nasal Drug Products

Design and Evaluation of Eudragit RS-100 based Itraconazole Nanosuspension for Ophthalmic Application

2020 ◽  
Vol 12 ◽  
Author(s):  
Pravin Pawar ◽  
Anita Duduskar ◽  
Swati Waydande
Keyword(s):  
Particle Size ◽  
Zeta Potential ◽  
Entrapment Efficiency ◽  
Xrd Analysis ◽  
Water Soluble ◽  
Particle Size Range ◽  
Corneal Permeability ◽  
Eudragit Rs ◽  
Drug Products ◽  
32 Factorial Design

Background: Poor water soluble compounds are difficult to develop as drug products using conventional formulation techniques. Objective: In the present study, the potential of Eudragit RS-100 nanosuspension as a new vehicle for the improvement of the delivery of drugs to the intraocular level was investigated. Methods : Solvent evaporation technique has been employed for nanosuspension preparation. Surfactant concentration and drug to polymer ratio has been optimized using 32 factorial design to achieve desired particle size, entrapment efficiency and percent permeation responses as dependent variables. All the formulations were characterized for particle size, zeta potential, polydispersity index (PDI), Fourier transform infrared spectroscopy (FTIR), Differential scanning calorimetery (DSC), X-ray diffraction (XRD) analysis, viscosity, antifungal study and Transmission electron microscopy (TEM). Secondly, itraconazole eye drop was prepared by using sulfobuty ether-β-cyclodextrin and comparatively studied its antifungal efficacy. Results: The nanosuspension had a particle size range of 332.7-779.2nm, zeta potential +0.609-16.3, entrapment efficiency 61.32±1.36%-76.34±2.04%. Ex vitro corneal permeability study showed that optimized Itraconazole nanosuspension produced higher permeation as compared to market formulation and Itraconazole eye drop. Moreover, optimized nanosuspension was found as more active against Candida albicans & Aspergillus flavus compared to market formulation and Itraconazole eye drop. Conclusion: The nanosuspension approach could be an ideal, promising approach to increases the solubility and dissolution of Itraconazole.

Reduction of Particle Size of Drug Substance for Low-Dose Drug Products

2008 ◽  
pp. 205-222 ◽  
Author(s):  
Christopher L. Burcham ◽  
Paul C. Collins ◽  
Daniel J. Jarmer ◽  
Kevin D. Seibert
Keyword(s):  
Particle Size ◽  
Low Dose ◽  
Drug Substance ◽  
Drug Products

scholarly journals Fast Screening Methods for the Analysis of Topical Drug Products

Processes ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 397
Author(s):  
Margarida Miranda ◽  
Catarina Cardoso ◽  
Carla Vitorino
Keyword(s):  
Particle Size ◽  
High Performance ◽  
In Vitro Release ◽  
Physicochemical Characteristics ◽  
Drug Analysis ◽  
Reversed Phase ◽  
Screening Methods ◽  
Drug Products ◽  
Rp Hplc

Considering the recent regulatory requirements, the overall importance of in vitro release testing (IVRT) methods regarding topical product development is undeniable, especially when addressing particulate systems. For each IVRT study, several hundreds of samples are generated. Therefore, developing rapid reversed-phase high-performance liquid chromatography (RP-HPLC) methods, able to provide a real-time drug analysis of IVRT samples, is a priority. In this study, eight topical complex drug products exhibiting distinct physicochemical profiles were considered. RP-HPLC methods were developed and fully validated. Chromatographic separations were achieved on a XBridgeTM C18 (5 µm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher® 100 RP-18 (5 µm particle size, 125 mm × 4.6 mm) at 30 °C, under isocratic conditions using UV detection at specific wavelengths. According to the physicochemical characteristics of each drug, different mobile phases were selected. Irrespective of the drug (hydrocortisone, etofenamate, bifonazole, clotrimazole, acyclovir, tioconazole, clobetasol, and diclofenac) and formulation, retention time values did not exceed 6.5 min. All methods were linear, specific, precise, and accurate at the intraday and interday levels, robust, and stable. These were successfully applied to establish product-specific IVRT profiles, thus providing a key database useful for topical pharmaceutical manufacturers.

scholarly journals Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference

2015 ◽  
Vol 17 (5) ◽  
pp. 1305-1311 ◽  
Author(s):  
Guenther Hochhaus ◽  
Craig Davis-Cutting ◽  
Martin Oliver ◽  
Sau L. Lee ◽  
Svetlana Lyapustina
Keyword(s):  
University Of Florida ◽  
Drug Products ◽  
Nasal Drug Products
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