Intertek Launches Comprehensive Inhalation Product Development Services - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Intertek Launches Comprehensive Inhalation Product Development Services

Intertek announced that it is now offering comprehensive services for the development of orally inhaled and intranasal drug products (OINDPs) for both small molecules and biologics. This follows the company’s acquisition of Melbourn Scientific.

The services include formulation, analytical method development and validation, drug product physical characterization, chemistry, manufacturing and controls (CMC) support, stability studies and QC release testing. The company can also provide regulatory affairs consultancy, bioanalysis and extractables and leachables (E&Ls) studies for all types of inhalation medicine products.

There is an increasing demand for more user-friendly drug delivery products, such as OINDP, which can offer improved patient outcomes. The development of these products requires specialist capabilities and test facilities for techniques such as laser particle sizing, aerodynamic particle size distribution (APSD) by impaction (ACI, NGI), spray pattern/plume geometry and delivered dose assessment.

A key challenge in OINDP development is the control of E&Ls. With inhalation products that deliver the drug directly to the lungs, the rubber and plastic inhaler device components are in constant contact with the product formulation. Consequently, there is a potential for substances to leach from the device components into the drug product. Intertek can provide E&L studies supporting OINDP development.

Source: Intertek


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns

Click here