Generic Drug Development with VCM
From Reference Product to Generic Candidate in No Time
In generics development, the speed of reverse engineering a reference listed drug (RLD) defines the path to market. The VCM Platform is a benchtop instrument for fast milligram-scale prototyping of thermoplastic formulations. It helps teams move faster toward bioequivalence by enabling rapid screening of up to 10 formulations in under an hour with minimum process development.
Researchers can compare formulation variants sooner, identify promising candidates faster, and keep development moving toward Day 0. And because VCM works on a milligram scale, that speed does not come at the cost of unnecessary API use.
With strict timelines, competitive pressure, and the need to be market-ready, delays in bioequivalence-oriented development significantly impact timelines and first-to-market ambitions.
VCM Helps Generics Teams:
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Screen more different formulations with less API
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Reduce time spent on formulations unlikely to progress
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Move faster toward obtaining a biowaiver with reliable data
Fast-Track to Obtaining a Biowaiver
Reliable & Fast Stability and Dissolution Studies (USP 2)
VCM specimens yield reliable data for test-versus-reference comparisons. Each specimen takes only minutes to prepare with just a few milligrams of API, making it easy to compare more formulation options in a single day. For generics development, that means faster decisions, fewer material constraints, and a more efficient path toward biowaiver-relevant and ANDA-supporting data.
This makes VCM a practical tool for testing drug loads with different excipients and comparing formulations. Stability and dissolution studies with small, reproducible specimens support reference-product matching with little time and material commitment.
Replace Protected Formulations
with Ternary Mixtures
In this study, VCM was used to prepare ternary ASDs. The findings show that the release profile from a polymer mixture is the combination of the individual release profiles. A good example that proprietary formulations could possibly be replaced with a smart combination of two other excipients.
Directly Use VCM Specimens for Animal Studies
VCM specimens have been used in animal studies. After molding powder mixtures into defined ASD discs using the MeltPrep VCM Platform, the discs were milled and sieved to obtain a reproducible particle-size fraction. This material was then filled into gelatin capsules and used for both in vitro and in vivo assessment in mice.
Easy Scale-Up: Comparable to Manufacturing
Evaluate Earlier with a Clear Path to Manufacturing
The VCM platform has shown strong comparability with established manufacturing approaches such as hot melt extrusion (HME) and spray drying (SD), including comparable dissolution profiles between VCM specimens and HME or SD prototypes. This makes VCM a practical screening tool before moving to manufacturing.
More Insights with VCM
Detect Residual Crystallinity Down to 0.001%
VCM produces single-particle specimens with a defined geometry, making even the smallest traces of residual crystallinity visible. Using VCM-prepared samples, crystallinity can be visually detected down to 0.001%, helping confirm that an amorphous formulation is truly amorphous before starting analysis.
From Visual Insight to Prediction
​METT (Microscopic Erosion Time Test), developed by researchers at AbbVie, combines direct visualization with thermodynamic validation. A 50 mg ASD disc made with VCM is placed between two glass covers to create a controlled 2D dissolution setup.
During erosion, microscopic imaging makes phenomena such as phase separation and recrystallization directly visible, while thermodynamic modeling helps validate and explain these observations. Using this method, comparing formulations with increasing API content quickly identifies the polymer's maximum drug load.
See the Release Profile Before You Measure It
Visually tracking the dissolution of a VCM specimen under a microscope also allows you to predict the drug release profile (orange curve), which closely matches the final USPII dissolution results (blue).
