Impact of Moisture Barrier Film Coating on Stability of Amoxicillin/Clavulanic Acid Tablets
Product stability is affected by all elements of solid dosage development and manufacturing including core formulation, excipient choice, manufacturing conditions, packaging and end use storage conditions. Film coating can protect tablets from environmental factors such as moisture, light, or oxygen while presenting the opportunity to improve product identification and patient compliance.
Impact of Moisture Barrier Film Coating on Stability of Amoxicillin/Clavulanic Acid Tablets
Amoxicillin and clavulanic acid are combined to produce an antibiotic with an increased spectrum of action against some amoxicillin-resistant bacteria. Due to the high sensitivity of clavulanic acid to moisture, this combination was selected to investigate the moisture protection properties of Opadry amb II. This antibiotic combination product is typically coated with an hypromellose (HPMC) based film coating.
Part I: In-Use Product Integrity
The in-use stability of an uncoated amoxicillin / clavulanic acid dosage form was compared against similar tablets coated using a standard HPMC- based film coating and Opadry amb II aqueous moisture barrier coating.
Uncoated and coated tablets were removed from their primary packaging and transferred to a typical consumer-use tablet organizer and stored for the prescribed ten-day regimen at 25°C/60% RH. On each day, tablets were removed from the organizer and assayed according to the USP method for each drug component.
Results showed significant degradation of the clavulanic acid for uncoated and HPMC-coated tablets. At the end of the ten-day dose regimen, amoxicillin levels were shown to have decreased by 20% of the initial amount, but still within the USP assay specification of 90-120%. In contrast, clavulanic acid levels were totally depleted at the end of ten days; however, tablets coated with Opadry amb II maintained acceptable levels.
Application of the Opadry amb II coating resulted in improved tablet stability, even when removed from the primary packaging.
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Author: Colorcon
Website: www.colorcon.com
