The Effects of Accelerated Temperature-Controlled Stability Systems on the Release Profile of Primary Bile Acid-Based Delivery Microcapsules.

Armin Mooranian,Edan Johnston,Hani Al-Salami,Thomas Foster,Susbin Raj Wagle,Daniel Walker,Corina Mihaela Ionescu,Melissa Jones,Bozica Kovacevic,Louise Carey,Jacqueline Chester,Momir Mikov

doi:10.3390/pharmaceutics13101667

Armin Mooranian, Edan Johnston + Show 10 more

Open Access

https://doi.org/10.3390/pharmaceutics13101667

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Abstract

Introduction: Bile acid-based drug encapsulation for oral delivery has been recently explored in our laboratory and has shown to be beneficial in terms of drug-targeted delivery and release profile, but stability at various temperatures has not previously been examined; hence, this is the aim of this study. Methods: Various types of bile acid-based microcapsules containing the drug metformin were produced and tested for accelerated temperature-controlled profiles, as well as morphology, elemental composition, drug content, resilience, floatability, wettability and release profiles at various pH values. Results: Accelerated temperature-controlled analysis showed negligible effects on morphology, size, or shape at very low temperatures (below 0 °C), while higher temperatures (above 25 °C) caused alterations. Drug contents, morphology and elemental composition remained similar, while wettability and the release profiles showed formulation-dependent effects. Discussion and Conclusion: Results suggest that bile acid-based microcapsules containing metformin are affected by temperature; hence, their shelf life is likely to be affected by storage temperature, all of which have a direct impact on drug release and stability profiles.

Highlights

Bile acid-based drug encapsulation for oral delivery has been recently explored in our laboratory and has shown to be beneficial in terms of drug-targeted delivery and release profile, but stability at various temperatures has not previously been examined; this is the aim of this study
Metformin (M, 98%), sodium alginate (SA, 99%), chenodeoxycholic acid (CDCA, 99%) and Poloxamer 407 were purchased from Sigma Chemical Co
Temperature-induced changes have a great impact due to the implications for the preparation and storage conditions of capsules before use, as well as ensuring precise delivery of drugs [42,43]. These results indicate that the incorporation of CDCA improves the stability of microcapsules depending on formulation

Summary

Introduction

Bile acid-based drug encapsulation for oral delivery has been recently explored in our laboratory and has shown to be beneficial in terms of drug-targeted delivery and release profile, but stability at various temperatures has not previously been examined; this is the aim of this study. Methods: Various types of bile acid-based microcapsules containing the drug metformin were produced and tested for accelerated temperature-controlled profiles, as well as morphology, elemental composition, drug content, resilience, floatability, wettability and release profiles at various pH values. If temperature variations cause alterations to bile acid-based microcapsules, shelf life is likely to be affected, which would have an impact on both release and stability, an important consideration in the ongoing development of these microcapsules. Accelerated temperature-controlled stability systems are an important tool in quality control and design of formulations for microencapsulated compounds [3].

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Results

Conclusion