How to Make Pill Coatings That Keep Medicine Stable Over Time
A method for coating pills with a specific plasticized acrylic polymer that ensures the medicine releases at a steady, predictable rate, even after sitting on a shelf for months.
Patent Number
US 5639476
Status
Active
Filing Date
June 2, 1995
Grant Date
June 17, 1997
Expiration
~June 2015 (estimated)
Claims
15
Assignee
Euro Celtique SA
Inventors
Frank Pedi, Jr., Benjamin Oshlack, Mark Chasin
Citations
1092 forward · 48 backward
What it covers
This patent describes a way to coat medicine-filled substrates, like beads or tablets, with a special acrylic polymer dispersion. The core mechanism involves curing the coated pill at a temperature above the polymer's glass transition temperature for 24 to 60 hours. This process stabilizes the coating, ensuring that the rate at which the medicine dissolves in the body remains consistent even after the pill has been stored in hot and humid conditions. By achieving this stability, the manufacturer guarantees that the drug release profile does not shift by more than 15% after a month of accelerated storage.
What it doesn't cover
- —Does not cover coatings made from polymers other than ammonio-methacrylate copolymers.
- —Does not cover formulations that are not cured at a temperature above the polymer's glass transition temperature.
- —Does not cover coatings that do not include a permeability-enhancing agent or pore-former.
- —Does not cover immediate-release medications that do not require a controlled release profile.
The clever bit
The innovation is the specific curing process—heating the coated pill above its glass transition temperature for a long duration—which forces the polymer particles to fuse into a stable, uniform film that resists environmental degradation.
Why it matters
This technology was essential for the commercial success of long-acting opioid analgesics, such as OxyContin. By ensuring that the drug release rate remained stable during storage, manufacturers could reliably market pills intended to provide pain relief over 12 or 24 hours. The patent became a cornerstone of the pharmaceutical industry's ability to produce consistent, extended-release oral dosage forms.
Real-world examples
- 1.OxyContin extended-release tablets
- 2.Various 12-hour and 24-hour controlled-release opioid medications
- 3.Extended-release analgesic beads in capsules
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US 5639476 · 2026