The Most Ordinary Product in Medicine Has the Least Forgiving File.
Regulatory strategy for tablets and capsules — dissolution, bioequivalence, and the lifecycle changes that decide whether a franchise stays compliant.
A Tablet Is a Delivery System That Has to Work in Every Stomach.
Oral solids look like the simplest thing pharma makes and behave like anything but. The drug has to survive compression, disintegrate on schedule, dissolve in a fluid whose pH you do not control, cross a membrane, and arrive at a concentration within a narrow band — batch after batch, for decades, from a plant running millions of units a day.
Which is why dissolution is the most consequential test in the category. It is your only routine in vitro window onto in vivo performance, the method that justifies your specification, and the thing that decides whether a post-approval change needs a new bioequivalence study or a paragraph. Programs that treat dissolution method development as a QC chore pay for it every time they touch the formulation.
Dissolution is the only routine test that looks, indirectly, at what the body will see.
Two Properties Decide How Much Clinical Work You Owe.
The Biopharmaceutics Classification System crosses solubility with permeability. Where your molecule lands governs formulation risk, bioequivalence strategy, and whether a biowaiver is even on the table.
The easy case. Rapid dissolution can support a biowaiver — bioequivalence argued in vitro rather than in subjects.
Absorption is permeability-limited. Biowaivers are possible under tighter conditions; excipient effects matter more than formulators expect.
Dissolution-limited — the interesting one. Formulation is doing real work, and an IVIVC, if you can build one, becomes a strategic asset.
Poorly soluble and poorly permeable. Expect enabling formulation, and expect to earn every bioequivalence result in vivo.
The class is a strategy document, not a label. Class I with a validated rapid-dissolution method can turn a post-approval change into an in vitro comparison. Class II without an IVIVC turns the same change into a clinical study. We establish the class and build the dissolution method to match — before the formulation locks, because afterwards it is an archaeology project.
Millions of units a day. Content uniformity is a statistical promise you keep every shift.
SUPAC Decides Whether Your Site Transfer Costs a Letter or a Clinical Study.
An oral solid product will outlive its original excipient suppliers, its granulation equipment, and often its manufacturing site. Each of those changes gets classified by level under the SUPAC framework — and the level determines the evidence: dissolution comparison at the low end, in vivo bioequivalence at the high end. The difference between those two outcomes is millions of dollars and a year.
This is where ICH Q12 earns its keep in this category more than any other. Established conditions and a post-approval change management protocol let you pre-negotiate the evidence for changes you know are coming. We build that framework while the file is open, because the alternative is a decade of supplements written under commercial pressure.
What an Oral Solid Program Plans Around.
Three levers in the most mature category in pharma.
Solubility crossed with permeability. Decides your formulation risk and whether biowaivers exist for you.
The method that justifies your specification and prices every future change. Build it deliberately.
How a change is classified — the difference between a dissolution comparison and a bioequivalence study.
Six Failure Modes We Are Brought In to Prevent.
Nothing here is exotic. All of it is expensive.
A dissolution method that discriminates nothing
A method that passes everything, including batches it should have caught — and cannot support a single post-approval change.
Biowaiver assumed, not earned
A Class I claim without the solubility and rapid-dissolution data to hold it, and a bioequivalence study appearing late.
Scale-up changes the dissolution profile
Granulation that behaves differently at commercial scale, discovered after the pivotal batches.
Excipient supplier swapped quietly
A grade change treated as procurement, when it moved the profile and triggered a SUPAC level nobody assessed.
Content uniformity at the edge
A blend that meets the limit on good days — and generates investigations forever on the others.
No Q12 framework for a 20-year product
Every future change a full supplement, because established conditions were never defined.
Oral Solid Leadership That Knows What the Change Will Cost.
Our leads have developed discriminating dissolution methods, argued biowaivers, and moved products between sites without a clinical study.
“Your dissolution method is the price list for the next twenty years of changes. Most companies write it once, quickly, and pay for that forever.”
The discipline we bring to tablets, capsules, and modified-release products.
Developing an Oral Solid? Build the Dissolution Method Like It Is Load-Bearing.
Bring senior CMC leadership in before the formulation locks — it is the last cheap moment.
Senior-led. Embedded in your team. No junior hand-offs.