+33 (0)1 41 19 21 99 | Tous les sites

TSI.com (0)

Life Sciences

|

Logiciel

Service

Contact

TSI.com
(0)

Menu

Generic Drug Development Equipment

One of the fastest ways to navigate the pharmaceutical approval process and generate positive cash flow is through the development of generic drugs. The USP and FDA offer blueprints, methods, and monographs that help accelerate regulatory acceptance. Popular generics include albuterol, fluticasone propionate, salmeterol, and combinations. The FDA also recently issued draft guidance for Beclomethasone Dipropionate, utilizing an IVIVC approach.
 

Beyond APSD and DDU tests, unique aspects of testing for Orally Inhaled and Nasal Drug Products (OINDPs) must be addressed. MSP, a Division of TSI, provides a complete range of equipment to perform essential tests such as dissolution, gravimetric analysis, spray force testing, and the “cold Freon” effect. These products are also available in the Copley catalog, offering comprehensive solutions for the unique demands of generic drug development.

Produits

Legacy Impactors

Legacy cascade impactors and impingers are used to replicate existing test methodologies, expand...

Voir le produit

Developing a generic inhalation product requires demonstrating equivalence to a reference listed drug (RLD) across device performance, aerosol metrics, and dose delivery. Our equipment portfolio aligns with these needs by providing repeatable test execution, robust sample preparation, and structured data analysis — core elements of credible bioequivalence packages.

How the Portfolio Supports Your Program

  • Bioequivalence-aligned testing: Use NGI and NGI Plus systems for aerodynamic particle size distribution, paired with validated sample extraction and quantitation workflows.
  • Delivered Dose Uniformity (DDU): Standardized setups for dose collection and DUSA shaking help support consistent sampling and extraction.
  • Automated actuation: Control stroke length, force, shake profile, and timing to reduce operator-to-operator variability and improve reproducibility.
  • Environmental conditioning: Benchtop chambers help maintain temperature and relative humidity conditions for device preparation and test stages.
  • Data analysis software: Calculate MMAD, GSD, FPF, and related metrics with reporting templates that support data integrity practices.

QbD and Method Lifecycle

Generic development programs benefit from QbD principles and structured method development. Our tools help:

  • Screen and rank formulations and device variables efficiently.
  • Establish design spaces and critical process parameters with higher confidence.
  • Transfer methods to QC laboratories with clear setup and execution steps.
  • Monitor performance during scale-up and commercialization.

Compliance Awareness

Pharmacopeial guidance such as USP <601> and Ph. Eur. 2.9.18 frame test design and data requirements. Our systems are designed to support these methods with fixtures, controlled actuation, and reproducible flow management. Software options can support 21 CFR Part 11 expectations through features like user roles, audit trails, and electronic signatures when properly configured within your validated environment.

Whether you are building foundational development data sets or preparing confirmatory runs before submission, the right mix of instrumentation and automation can help your team work faster and with higher repeatability — key advantages in a competitive generic market.


   close carousel