FORMULATION: Preformulation and Reformulation
September 1, 2017
INTEGRATED ANALYTICAL LABORATORIES' technical partners provide years of practical experience in developing accelerated and sustained release profiles for a variety of therapies and delivery systems.
IAL's services span the development cycle from pre-formulation thru Phase 1 clinical supply manufacture. We offer extensive capabilities in transdermal, transmucosal and implantable formulation and technology development. Combined with our regulatory and analytical development expertise, this permits rapid, effective formulation screening, and accelerated product development to pre-clinical and clinical stages.
Coordination yields technical, time and cost advantages
We closely coordinate formulation and analytical development so that we can evaluate the stability of a compound in long-term storage, accelerated, compatibility, and forced degradation studies. Extensive evaluation of a compound's degradation mechanisms provides critical knowledge in designing the appropriate formulation and analytical methods.
We perform in-vitro skin and transmucosal permeation studies and evaluate critical physiochemical data, which are critical for development of transdermal and transmucosal drug delivery systems. We also generate critical data to support regulatory filings for these dosage forms, or to support legal patent litigation cases.
A phased approach to formulation
Our partners have invented and developed numerous delivery mechanisms for transdermal, transmucosal and implantable therapeutics, so we are able to combine practical experience with analytical insight in a phased approach to move your product into the clinic faster. This approach helps to control development costs and improve timelines as unworkable formulations reach go/no-go milestones early in the process.
- Evaluate and determine project feasibility
- Evaluate pre-formulation alternatives
- Design and perform initial commercialization services
Consider IAL if you are planning to reformulate utilizing the 505 (b) (2) submission pathway to create a more effective delivery system for your drug product. We will thoroughly evaluate your project and offer guidance, and can propose a rational approach, with realistic costs and timelines.
Contact us today to obtain more information on our formulations services.