Opadry® AMB II
高性能防潮型薄膜包衣系统
这是首个完全配方的基于聚乙烯醇（PVA）的速释包衣系统，不含聚乙二醇（PEG），具备卓越的防潮性能，同时兼具高生产效率、低杂质水平和优异的成膜外观。
High Performance Moisture Barrier Film Coating
release (IR) film coating systems provide essential protection and are especially useful when tablets are removed from their original packaging.
Opadry® amb II, high performance moisture barrier film coating is the first fully formulated PVA-based immediate release system without polyethylene glycol (PEG) that delivers the three-fold advantage of high productivity, low impurity levels and a superior tablet finish.
Guard your tablets from moisture over a longer period of time.
Superior Coating Productivity
Opadry amb II provides the perfect balance of barrier protection, time savings in production and ease-of-use.
- One step dry powder - ready to use in 45 minutes
- High productivity - low viscosity
Faster coating and significantly more moisture protection with Opadry amb III
Fig 3. On-Tablet WVTR 40ºC / 75% RH, 4% WG
Typical 48" Pan Coating
Proven Product Protection
The rate and level of moisture uptake provides a measureable indicator into the performance of moisture barrier film coatings. Opadry amb II films were characterized
using a novel on-tablet testing method.1 As shown in Figure 1, the rate of moisture uptake compared to uncoated tablets demonstrates the superior in-use functionality of this coating.
Fig 1. Moisture Uptake
Reliable Barrier
On-tablet analysis proves that coating with Opadry amb II at the recommended 4% weight gain offers the most reliable and consistent moisture barrier performance (See Figure 2).
Fig 2. Effect of Film Coating Weight Gain
*Conventional pans must be outfitted with spray equipment
Low Impurity Levels
Opadry amb II is formulated without PEG to reduce potential interaction with sensitive drugs. Studies of the Opadry amb II powder show:
- Formic acid and formaldehyde residues exhibited no measurable increase after six months accelerated stability (40°C/75%RH)
- Peroxide levels remained undetectable after twelve months (30°C/65%RH)
Glossy Finish and Well-Defined Logo
Tablets coated with Opadry amb II create a high gloss finish with distinctly defined logos
- Available in clear and pigmented formulas
- Approved for pharmaceutical use
