Inhaled administration is an important non-injectable method of administration and is a common mode of administration in respiratory diseases such as asthma and chronic obstructive pulmonary disease. In recent years, benefiting from the rapid development of the biopharmaceutical industry, for some biotech drugs with relatively low oral bioavailability: such as peptides, proteins and nucleic acid drugs, inhalation is increasingly becoming an important way for local and systemic delivery. This book brings together some of the literature and application notes for the characterization of particles in the field of inhalation administration of Malvern, and is available to customers who are conducting inhalation studies!
The notes on Malvern Instruments related products covered in this article are as follows:
Mastersizer 3000/2000: Laser Particle Size Analyzer
Spraytec: Real-time spray particle size analyzer
Morphologi G3: Dry Particle Size Analyzer
FPIA-3000: Wet Particle Size Analyzer
Morphologi G3-ID: Particle Size, Particle and Chemical Composition Analyzer
If you need to refer to the full-text literature in the following directory, please send an email to: wendy. Thank you!
For more information on the instrument, visit the Malvern Instruments website at .
(1) Investigating bioequivalence of the API In metered dose inhaler formulations using the Morphologi G3
Using Morphologi G3 to study API bioequivalence in a metered dose formulation
The bioequivalence of APIs in MDI generics and original drugs was studied from the perspective of particle morphology, and it was discussed whether the difference in particle morphology was derived from the inherent differences in API materials or introduced in the formulation process.
(2) Aerosolization Analysis - Unlocking the Secrets of the Dry Powder Inhaler Plume
Atomization Analysis - unlocking the secret of dry powder inhalers
For dry powder inhalers, the particle size and rate of ejection of the drug determine its delivery and deposition; for example, whether the drug is deeply absorbed into the lungs or the upper respiratory tract, or swallowed through the throat. Therefore, detailed spray analysis, including component particle measurements, is a key part of the dry powder inhaler design process. This article will introduce the application of laser diffraction particle size analysis technology in the study of dry powder inhalants, the analysis of the factors affecting powder dispersion, and the case studies of how different excipients can improve the formulation performance.
(3) Laser diffraction and automated imaging: Complementary techniques for dry powder inhaler development
Laser Diffraction and Automated Imaging: A complementary technique for the development of dry powder inhalers
The main difficulty in developing dry powder inhalation formulations is how to disperse the drug into a suitable particle size range ( typically less than 5 microns). The first solution is to use "carriers" to improve flow and dispersion properties; Scheme 2 does not require a pharmaceutical carrier, the key to this approach is to minimize cohesion between API particles (typically less than 5 microns).
(4) Component specific particle characterisation of dry powder inhalable drug products
Particle characterization of specific components in dry powder inhalation formulations
The API particle size distribution (PSD) is the main indicator for determining whether a particle can reach the site of action and whether it can achieve the expected efficacy in a dry powder inhaler. The traditional method is to visually recognize the API particles in the formulation by a manual microscope, but this is very time consuming and subjective and accurate. This article will introduce a new technology combining Morphologi G3-ID automated imaging analysis with Raman spectroscopy, which can be analyzed by chemical identification and separation of target particles from dry powder inhaler (DPI) formulations, greatly improving measurement accuracy. And stability.
(5) Optimising dry powder inhaler drug delivery
Optimized dry powder inhalation
This paper discusses the particle size analysis of the components of the inhalation fog, the analysis of factors related to powder dispersion, and how different excipients affect formulation performance in the study of dry powder inhalation formulations.
(6) Understanding nasal drug delivery using the Malvern Spraytec
Intranasal administration using Spraytec
The jet pump in the nasal spray formulation is an important part of the overall system, acting to atomize the drug and accurately deliver a dose of the drug to the nasal cavity. Therefore, the performance of the spray is the key to assessing the performance of the nasal spray formulation. This article will describe the techniques used for spray characterization and discuss the importance of the conditions at which the drug is tested as similar as possible to the conditions at which the patient actually takes the drug.
(7) Complementary techniques for nasal spray analysis
Nasal spray preparation analysis supplementary technology
The introduction of laboratory methods for comparative studies in the FDA guidance document "Bioequivalence (BE) and bioavailability (BA) studies for nasal sprays and nasal aerosols for local action" highlights the advantages and importance of in vitro testing for nasal spray formulations. . The essence of this method is to obtain BA/BE study data by measuring the parameters related to the efficacy and comparing the products with the existing clinical data. This article will introduce two independent but complementary analytical techniques: the first is image analysis technology, which can characterize API (raw drug) suspended in nasal spray preparation; the second is laser diffraction particle size analysis technology, suitable for A detailed study of particle size measurement and spray kinetics of spray droplets was performed.
(8) From actuation to deposition: Particle sizing techniques for characterizing nasal drug delivery systems
From Triggering to Deposition: Particle Size Analysis Techniques for Characterizing Nasal Delivery Systems
The FDA guidance document "Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action" (April 2003) highlights the use of laser diffraction techniques to measure the particle size distribution of nasal sprays and nasal aerosols. The smaller particle size distribution should be reviewed by multiple stages of impact. This article elaborates on how these two complementary technologies and their synergistic applications provide valuable information for nasal characterization.
(9) Laser diffraction and automated imaging - complementary techniques for nasal spray development
Laser diffraction technology can be used to measure the droplet size of spray droplets, while imaging or microscopy is a common method for analyzing API in suspension systems. If there are excipient particles in the suspension system that are similar in morphology to the API, the situation will be compared. complex. This article reviews how laser diffraction (Spraytec), automated imaging combined with Raman spectroscopy (Morphologi G3-ID) for nasal spray product development.
(10) Morphologi G3 Application - API Particles in Nasal Spray Formulations (MRK1194-01)
Morphologi G3 Application - API Particle Characterization in Nasal Spray Formulations
This article describes how to characterize API particles in nasal sprays using a particle size automatic analysis system.
(11) Guidance for method development determination of the API particle size distribution in Nasal Sprays using the Morphologi G3
(12) Method validation for nasal spray measurements
Particle size is an important parameter in the bioavailability and bioequivalence studies of nasal sprays because the particle size of the spray droplets affects their deposition location in the nasal passages. To achieve good nasal deposition while minimizing the risk of droplets entering the lungs, the optimal particle size range is 20-150 microns. Therefore, it is very important to select a suitable droplet size analysis technique and to evaluate the repeatability and intermediate precision of the test method. This article will provide a brief description of the verification of nasal spray measurement methods and provide guidance to meet validation requirements.
(13) Monitoring Nasal Spray Tail-Off using the Malvern Spraytec
Use Spraytec to monitor the attenuation of nasal sprays
This article describes the use of a Spraytec spray particle size analyzer to monitor the change in particle size of each droplet of the nasal spray formulation. The results can be used to assess the reproducibility of the spray particle size distribution within the use of the nasal spray formulation. Alternatively, it can be used to assess changes in the output of the spray decay phase to assess its effect on dosing.
(14) Automation of Manual QC analysis of Nasal Spray on the Morphologi G3
Automating nasal spray QC analysis with Morphologi G3
The FDA has clear nasal spray quality control program requirements and documentation. The size of the spray particle sprayed by the jet pump is an important parameter that is clearly required to be controlled. It is usually measured by laser diffraction. In addition, some nasal spray formulations must be quality controlled to determine the proportion of active particles and smaller particle size active particles that may be present in the sample. Often, these tasks are performed by manual microscopy, which is time consuming and labor intensive, and requires skilled analysts to identify particles that meet the conditions. In addition, this method may be subject to manual deviation or fatigue. Automating these programs with Morphologi® G3 not only shortens the analysis time but also reduces the subjective impact of the analysis.
(15) Characterizing oversized particles in drugs for inhalation
Characterization of oversized particles in inhaled formulations
The particle size of the inhaled preparation is an important guarantee for the safe and effective absorption of the drug. Therefore, the identification, characterization and elimination of oversized particles in inhaled formulations and other drug suspensions are important.
(16) Particle characterization of inhalation drug suspensions on the FPIA-3000
Particle characterization of inhalation formulation suspensions using FPIA-3000
In the production of inhaled formulation suspensions, the elimination of large particle size particles in the drug substance is important to ensure the effectiveness of the drug. The Sysmex FPIA-3000 Flow Particle Size and Image Analyzer can be used to monitor the production process of inhalation formulation suspensions to identify large particles from any source in the process to improve the process.
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