# Oral solid dose manufacturing (tablets and capsules)

Source: https://onco.cc/technologies/oral-solid-dose-manufacturing/  
OnCo record `oral-solid-dose-manufacturing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Most targeted cancer drugs are tablets. Turning a powder into a tablet that dissolves the same way every time is its own craft, and when patents end the same craft lets generic makers sell the drug for a fraction of the price.

## Summary

Oral solid dose manufacture blends the API with fillers, binders and disintegrants, granulates it (wet or dry), compresses tablets or fills capsules, and coats them, in batches of hundreds of thousands under 21 CFR 211 or EU GMP. For a kinase inhibitor the hard parts are poor solubility (handled with salt forms, amorphous dispersions or particle size control), content uniformity at low doses and the dissolution profile that the regulator ties to the clinical batches. Capecitabine, temozolomide, imatinib and almost every modern kinase inhibitor are made this way.

Generic entry depends on the same chemistry: a generic maker must show bioequivalence to the reference tablet in healthy volunteers and match its dissolution. When imatinib generics reached the United States in 2016 the price fell over the following years to a small fraction of the brand's, the clearest example of how oral generic manufacture changes access. Regulators worry about a different failure mode here than for injectables: nitrosamine and other impurities, and data integrity at plants inspected rarely. The FDA's inspection findings and warning letters to oral solid dose plants are public, and OnCo records them only as a class.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-17
- Tags: manufacturing-wave
- Principle: Formulation science (solubility, granulation, compression, coating) and dissolution control link the chemistry of an API to a tablet that behaves the same in every patient.
- Since: 1900
- Strengths: Cheap at scale and stable at room temperature; Patients take them at home; Generic pathway is well trodden
- Limitations: Poorly soluble APIs need enabling formulations; Bioequivalence studies still needed for each generic; Impurity findings can pull products from the market

## Sources

- 21 CFR Part 211: current good manufacturing practice for finished pharmaceuticals: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
- Wikipedia: https://en.wikipedia.org/wiki/Tablet_(pharmacy)

## Connected records

- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Targeted Therapy](https://onco.cc/fronts/targeted-therapy/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [GMP, inspections, Form 483s and warning letters](https://onco.cc/technologies/pharmaceutical-gmp-inspections/), [Small-molecule API synthesis](https://onco.cc/technologies/small-molecule-api-synthesis/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Imatinib](https://onco.cc/drugs/imatinib/), [Ondansetron](https://onco.cc/drugs/ondansetron/), [Temozolomide](https://onco.cc/drugs/temozolomide/)
- companies: [Amneal Pharmaceuticals](https://onco.cc/companies/amneal/), [Cipla](https://onco.cc/companies/cipla/), [Dr. Reddy's Laboratories](https://onco.cc/companies/dr-reddys/), [Intas Pharmaceuticals (Accord Healthcare)](https://onco.cc/companies/intas/), [Novartis](https://onco.cc/companies/novartis/), [Sandoz](https://onco.cc/companies/sandoz/), [Sun Pharmaceutical Industries](https://onco.cc/companies/sun-pharma/), [Teva Pharmaceuticals](https://onco.cc/companies/teva/), [Viatris](https://onco.cc/companies/viatris/)
- bottlenecks: [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)

---
JSON: https://onco.cc/api/v1/entities/oral-solid-dose-manufacturing.json