Preparing and evaluating delivery systems for proteins

Jørgensen, Lene; Moeller, Eva Horn; Weert, Marco van de; Nielsen, Hanne Mørck; Frøkjær, Sven

doi:10.1016/j.ejps.2006.05.008

Cited by 72 publications

(38 citation statements)

References 76 publications

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“…In the processes of formulation and sustained release, proteins are subjected to a series of instability mechanisms such as hydrolysis, deamidation, acid-or enzyme-catalyzed degradation, and irreversible conformation changes including unfolding, aggregation, and adsorption on polymers (11,17). Among these mechanisms, irreversible conformation change is the mechanism lacking in peptides, and responsible for the deferred success to commercialize sustained-release protein dosage forms despite a number of sustained-release peptide drugs already being on the market.…”

Section: Chemical Basis Of Protein Denaturingmentioning

confidence: 99%

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Polymer-Based Sustained-Release Dosage Forms for Protein Drugs, Challenges, and Recent Advances

Jin

2008

AAPS PharmSciTech

111

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Abstract. While the concept of using polymer-based sustained-release delivery systems to maintain therapeutic concentration of protein drugs for extended periods of time has been well accepted for decades, there has not been a single product in this category successfully commercialized to date despite clinical and market demands. To achieve successful systems, technical difficulties ranging from protein denaturing during formulation process and the course of prolonged in vivo release, burst release, and incomplete release, to low encapsulation efficiency and formulation complexity have to be simultaneously resolved. Based on this updated understanding, formulation strategies attempting to address these aspects comprehensively were reported in recent years. This review article (with 134 citations) aims to summarize recent studies addressing the issues above, especially those targeting practical industrial solutions. Formulation strategies representative of three areas, microsphere technology using degradable hydrophobic polymers, microspheres made of water soluble polymers, and hydrophilic in vivo gelling systems will be selected and introduced. To better understand the observations and conclusions from different studies for different systems and proteins, physicochemical basis of the technical challenges and the pros and cons of the corresponding formulation methods will be discussed.

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Section: Chemical Basis Of Protein Denaturingmentioning

confidence: 99%

“…For fundamental discussions regarding stabilizing microencapsulated proteins, alleviating acidity generated from degradable polymers, and improving protein release kinetics from polymer-based sustained-release systems, some excellent earlier reviews are available (11)(12)(13)(14)(15)(16)(17)(18)(19)(20).…”

Section: Introductionmentioning

confidence: 99%

Polymer-Based Sustained-Release Dosage Forms for Protein Drugs, Challenges, and Recent Advances

Jin

2008

AAPS PharmSciTech

111

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“…The therapeutic activity of protein drug is well known to be highly dependent on their conformational structure, how to keep the structural integrity and active conformation of protein drug in the manufacturing processes of production, or shipping and long-term storage of products are the highlighted and critical issues [4,7]. Because the secondary structure is one of the most important conformational information for a protein, thus the secondary structure prediction and determination of proteins are the important events [10,20,25].…”

Section: Introductionmentioning

confidence: 99%

Different solid sample preparation methods affecting the spectral similarity of salmon calcitonin

Lin

Lee

2010

Spectroscopy

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Abstract. Salmon calcitonin (sCT) was selected as a model protein drug for investigating its structural similarity in the solid state by four sample preparation methods, such as tape, smeared, CaF 2 and film methods. The conformational changes of sCT in the solid state were estimated by using a second-derivative Fourier transform infrared (FT-IR) microspectroscopy. The tape method was acted as a standard reference.The value of correlation coefficient (r) for smeared method was higher than that of other method, indicating that a novel technique by smearing sCT powder on the surface of KBr pellet was the best optimal sample preparation method.

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“…[2] Emulsion gelation methods are most commonly used to prepare microspheres. [3,4] Diabetes mellitus (DM) is a chronic metabolic disorder affecting people worldwide, with significant morbidity and mortality caused by its micro-and macro-vascular complications, affecting various vital organs and structures in humans. [5] It has been estimated that by year 2030, the diabetic population will rapidly increase from 21.7 million to 79.4 million in India.…”

Section: Introductionmentioning

confidence: 99%

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Sharma

2017

AJP

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Aim: The aim of the research work was formulation and evaluation of sodium alginate beads containing voglibose for the effective use in the treatment of hyperglycemia. Materials and Methods: The gel beads containing oil were prepared by gentle mixing or homogenizing oil and water phase, containing sodium alginate, which was then extruded into calcium chloride solution to produce gel beads. Optimization: The effects of types of oil, and its proportions, on the morphology and release characteristics were optimized. A variety of oils were used to study the effect on the sustaining property of the formed beads. Results and Discussion: The oil entrapped calcium alginate gel beads showed sustained release. Scanning electron photomicrographs demonstrated minute oil globules on the beads and also throughout the inner surface of the beads. The beads also showed floating behavior depending on the type of the oils used.

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Preparing and evaluating delivery systems for proteins

Cited by 72 publications

References 76 publications

Polymer-Based Sustained-Release Dosage Forms for Protein Drugs, Challenges, and Recent Advances

Polymer-Based Sustained-Release Dosage Forms for Protein Drugs, Challenges, and Recent Advances

Different solid sample preparation methods affecting the spectral similarity of salmon calcitonin

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