Impact of Excipients Blending on Sugar-Stabilized Therapeutic Proteins
Publish place: Journal of Medicinal and Chemical Sciences، Vol: 7، Issue: 6
Publish Year: 1403
نوع سند: مقاله ژورنالی
زبان: English
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شناسه ملی سند علمی:
JR_JMCH-7-6_002
تاریخ نمایه سازی: 10 تیر 1403
Abstract:
Sugars have long been used as stabilizing excipients for protein-based therapeutics during the development and production process. Incorporating stabilizing agents, such as sucrose and trehalose into dry formulations is a common strategy approved by the US FDA. However, single-sugar formulations may not be sufficient for diverse medicinal products, necessitating the blending of excipients to improve stability, dissolution, and patient acceptability. Our goal is to comprehensively understand the impact of excipients, focusing on the impact of various sugar types on formulation stability, and to explore the effectiveness of incorporating additional excipients such as amino acids, surfactants, and polyols, to further enhance protein stability.The review begins with an overview of sugars’ used in proteins stabilization and the blending of excipients. It discusses the limitation of single-sugar formulations and explores alternatives such as oligo- or polysaccharides. The mechanism underlying sugar and excipient combinations is elucidated, emphasizing the benefits of blending multiple excipients for stabilizing therapeutic protein. Our findings demonstrate that excipients blending presents a promising strategy for improving the stability of sugar-stabilized therapeutic proteins. Combining sugars with other excipients such as amino acids and polyols effectively enhances formulation stability. Optimization of excipients ratios and quantities is crucial for achieving the desired stability profile for each specific protein. Considering the impact of excipients on stabilization is essential in therapeutic proteins development. Employing blends of various excipients in different ratios and quantities ensures appropriate stability and functionality of the protein formulations.
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Authors
Cynthia Marisca Muntu
Laboratory of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Indonesia, Depok ۱۶۴۲۴, West Java, Indonesia
Christina Avanti
Department of Pharmaceutics, Faculty of Pharmacy, Universitas Surabaya, Surabaya ۶۰۲۹۳, East Java, Indonesia
Hayun Hayun
Laboratory of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Universitas Indonesia, Depok ۱۶۴۲۴, West Java, Indonesia
Silvia Surini
Laboratory of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Indonesia, Depok ۱۶۴۲۴, West Java, Indonesia
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