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Impact of Moisture Barrier Film Coating on Stability of Amoxicillin/Clavulanic Acid Tablets

Product Stability is Affected by Dosage Design and Manufacturing

While primary packaging and desiccants are considered a dosage form’s most significant defense from the environment, specialized film coatings such as Opadry® amb II, High Performance Moisture Barrier Film Coating, can provide further moisture protection, as demonstrated in the case study below.
Film coatings can protect sensitive compounds from temperature and humidity excursions prior to packaging including instances of bulk product storage, transport, or repackaging.

In-use product integrity testing ensures product quality prior to or after removal from primary packaging during temperature and humidity excursions, bulk storage, transport, or repackaging. There is often limited consideration given to storage conditions when the dosage form has been dispensed by the pharmacist, caregiver, or patient. Film coatings help to protect the integrity of the dosage form when removed from the primary packaging.

Part II: Accelerated Stability in Multiple Packaging Formats

A second case study was performed to determine the effects of Opadry amb II moisture barrier coating on the long-term (accelerated) stability for the same amoxicillin /clavulanic acid tablets. The uncoated and coated tablets were packaged in various commercial configurations including ACLAR blisters, aluminum foil blisters (AA), and HDPE bottles (with desiccant), all stored at 40°C/75% RH for six months.
After six months, tablets from all packaging formats met the USP amoxicillin assay limits (USP 90-120%). Opadry amb II coated tablets showed 5% more amoxicillin present compared to HPMC-coated and uncoated tablets. The impact of Opadry amb II film coating on the stability of clavulanic acid was significant.
Regardless of packaging formats, after six months accelerated stability, clavulanic acid levels fell below acceptable levels for the uncoated and HPMC-coated tablets. In comparison, all tablets coated with Opadry amb II, regardless of packaging, passed the USP assay for clavulanic acid. These results confirm coating with Opadry amb II maintained the integrity of the dosage form, while HPMC-coated and uncoated tablets failed.

Results confirm that Opadry amb II protects the integrity of moisture sensitive compounds beyond the primary packaging


Colorcon, from Core to Coating, Your Supplier of Choice

At Colorcon, we formulate, we innovate — and we focus our coatings and excipients exclusively for pharmaceutical and nutritional oral solid dosages.
That’s why, when you set out to select the right coating or excipient for your formulation, be sure to partner with the leading company that brings you innovative products plus specialized technical support when and where you need it.

Be confident with your choice.

Author: Colorcon
Website: www.colorcon.com