Enteric Coating Process Development
Control the release of your biologic by coating the intermediate drug product with protective layers called enteric coating. These coatings inhibit the release of your biotherapeutic in low pH environments where they are vulnerable to degradation and agglomeration.
Our team identifies the appropriate enteric coating for your biologic and prepares your processes to scale into commercial manufacturing. Incorporating this stage into your process development enhances the design of your oral dosage delivery system (coated tablet or capsule), improving efficacy of your final biotherapeutic product.
Go-To Coating Excipients
Our team often uses “off the shelf” coatings to improve oral dosage and targeted drug delivery because of the advantages in predictability, cost, and access. The following excipients are a few examples of the frequently requested coatings we apply to enhance delivery of your drug product formulations and prepare you for commercial-scale operations.
Hydroxypropyl methylcellulose (HPMC) capsules and tablets are among the most common coatings used to effectively deliver drug substances. Our team is knowledgeable in applying this excipient as well as its variations, helping you select the most suitable delivery for your biologic.
Hydroxypropyl Methylcellulose Phthalate (HPMCP) is a traditional coating agent used for tablets and granules that require dissolution at a higher pH (5.5+). Our team is knowledgeable in applying this excipient as well as its variations, helping you select the most suitable delivery for your biologic.
Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) is used during spray drying of tablets and multiparticulates and is increasingly applied during hot-melt extrusion. The dissolution of this polymer is pH dependent and most frequently applied to products requiring dissolution at a higher pH (6.0) or those with a more porous film. Our team is knowledgeable in applying this excipient as well as its variations, helping you select the most suitable delivery for your biologic.
The Eudragit family of coating polymers contain popular and well documented sets of excipients which are derived from methacrylic acid and methacrylic or acrylic esters. This group of coatings has a diverse set of characteristics (anionic, cationic, neutral) that enable API delivery throughout the GI tract.
Specialty Excipients
Our formulation scientists developed these excipients to solve unique coating problems. These products are formulated to improve process reliability, reduce cycle-times, and fortify functionality for enteric coating applications.
PlasACRYL®
PlasACRYL® is a 20% emulsion containing anti-tacking and plasticizing components that simplify the preparation of robust coating suspensions. It is commonly used with acrylic polymer coating systems for tablet and multiparticulate coating applications.
MarCoat™
MarCoat™ 125N is a natural, aqueous solution specifically designed to solve problems associated with natural ingredients in dietary supplements. It can be used in clear or pigmented coating systems at high solids levels, providing decreased processing times and superior performance.
PlasACRYL®
This specialty excipient is manufactured by our team and distributed globally by Evonik Corporation. PlasACRYL® is designed for synergistic use with EUDRAGIT® aqueous-based acrylic polymers.
- Enteric Coating
- Sustained-release Coating
- Drug Layering
- Tablets & Multiparticulates
- Simplified Coating Suspension Preparation – No High Shear Mixing
- 30% Shorter Cycle-Time Over Conventional Approaches
- Increased Process Reliability
- Reduced Multiparticulate Agglomeration
- Replacement For Talc and Additional Plasticizers
- Eliminates Sedimentation in Coating Equipment Tubing
- Prevents Spray Nozzle Clogs
- Aids In Reducing Tablet or Multiparticulate Cohesion
- Widely Accepted
- Plasticizer
- Anti-Tacking Agent
- Multiple Grades Available
MarCoat™
This specialty excipient is manufactured by our team and distributed globally by Evonik Corporation. The excipient has an all-natural enteric release and offers taste/odor masking, stability enhancement, and improved gloss and appearance.
- Taste & Odor Masking
- Seal Coating
- “Bleed Through” Prevention
- Stability Improvement
- Moisture Transmission Prevention
- Immediate Release Coating
- Enhancement of Tablet Elegance
- Organic Solvent Free
- Compatible with Other Coating Systems
- Widely Accepted, GRAS Ingredients
- Provides a High Gloss Film
- Improves Film Adhesion
- Low Viscosity
MarCoat™ is based on a dewaxed and decolorized shellac (dewaxed orange shellac), refined in a solvent extraction process. During this process the color is reduced by activated carbon. The chemical structure of shellac is not modified during the purification process.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.