INHALATION DRUG DELIVERY ARTICLES
A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices
Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.
INHALATION DRUG DELIVERY VIDEOS
Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).
As orally inhaled drug delivery grows to encompass novel therapies and diverse molecule sizes, CDMOs are rising to meet the demand for specialized knowledge and scalable manufacturing capabilities.
See how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.
Dry powder capsules offer a compact, portable means for patients to receive treatment. Examine the challenges of dry powder formulation and unlock the potential of high-dose inhaled medications.
INHALATION DRUG DELIVERY RESOURCES
-
![Computational Science: Disruption In Biopharma Discovery]( "Formulation Research Strategy For Discovery- Stage New Drug Candidates")
Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.
-
![GettyImages-1069859094-IV-bag-intravenous]( "Mitigating Hidden Risks: Extractables And Leachables")
Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.
-
![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
-
![GettyImages-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
-
![GettyImages-1148337130 product pathway]( "Using 505(B)(2) To Streamline Approval Of Combination Products")
In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
-
![GettyImages-1266602356-Powder Inhaler Patient]( "Intranasal Drug Product Development—From Formulation To Scale-Up Manufacturing")
Explore the key advantages of intranasal drug delivery, including its potential to rapidly treat conditions like migraines and headaches, and deliver medications directly to the brain.
-
![iStock-146792998-capsule-powder-pill]( "Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development")
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
INHALATION DRUG DELIVERY SOLUTIONS
-
![Blow Fill Seal Packaging]( "Blow-Fill-Seal Packaging Systems For Large Volume Nebulizers And Humidifiers")
Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.
-
![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
-
![GettyImages-871317164-inhalation-inhaler]( "Designed For Inhalation: Pulmonary And Nasal Delivery")
Our newly expanded in-house capabilities span clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays.
-
![GettyImages-1354171846-lab-research-development]( "End-To-End Drug Development, Analytical Testing, & Fill/Finish")
August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.
-
![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
-
![iStock-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
-
![OFM]( "Pharmaceutical Filling System For Non-Injectable Products: Ophthalmic, Nasal Sprays, Syrups: OFM")
OFM automatic filling and closing machines are designed for pharmaceutical formulations, such as syrups, ophthalmic products, and nasal sprays either in glass or plastic containers.
-
![PharmaceuticalRespiratory]( "Pharmaceutical Respiratory Drug Packaging Equipment")
Weiler Engineering offers blow/fill/seal packaging machines to cover virtually every segment of the respiratory therapy marketplace – from simple inhalation solutions to complex delivery systems for deep lung and nasal applications.
-
![iStock-493302504-scientist-lab-development]( "Pre-Formulation And Material Sciences")
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
-
![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
