Oral Dosage Form Development
Develop your biologic oral dosage formulation for optimal stability and delivery to the appropriate target site with support from our team. Oral delivery is an emerging route of administration for biologics effective against disorders of the gastrointestinal tract. A major challenge in this work is maintaining the active form of the biologic drug as it passes through the low pH environment of the stomach. Our team is skilled in protecting oral solids using functional coatings that are resistant to acidic environments and designed to release your biotherapeutic upon entry into the intestines.
Our team uses reliable methods to determine the key attributes of your biologic (pI, molecular weight, quaternary structure) and the processes to support successful formulation, scale up, and patient acceptability. With experts spanning preformulation development through commercialization, we provide a comprehensive perspective to developing oral biologic dosage formulations fit for your unique application.
Oral Dosage Forms
We offer multiple strategies to ensure appropriate delivery of your biologic to the target site. In many cases, the solid dosage forms are coated with a functional excipient that protects the biotherapeutic in the low pH environment of the stomach and dissolves at a higher pH to release your biologic.
- Enteric Coated
- Mini-tablets
- Extruded Spheres
- Drug Layered/Coated Spheres
- Powders For Reconstitution
- Immediate Release
- Sustained Release
- Delayed Release
- Enteric Coated
- Powder
- Capsules
- API-in-Capsule
- Multi-Particulates
- Over-Encapsulated
- Banded
- Immediate Release
- Sustained Release
- Delayed Release
- Enteric Coated
- Bi-Layer
- Orally Disintegrating
- Sublingual and Chewable
- Immediate Release
- Sustained Release
- Delayed Release
- Pediatric
- Fixed Dose Combinations
- Immediate Release
- Sustained Release
- Delayed Release
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.