Release phenomena of insulin from an implantable device composed of a polyion complex of chitosan and sodium hyaluronate

Surini, Silvia; Akiyama, Hidero; Morishita, Mariko; Nagai, Tsuneji; Takayama, K.

doi:10.1016/s0168-3659(03)00196-2

Cited by 56 publications

(28 citation statements)

References 31 publications

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“…These results suggested that RSM-S successfully predicted the relationship between the causal factors (formulation characteristic and formulation factors) and pharmaceutical response variables. 6,7) These results indicated that an original optimal solution with acceptable characteristics (e.g., high skin permeability and good stability formulation) could be estimated with RSM-S.…”

Section: Prediction Of Response Variables and Simultaneous Optimizationmentioning

confidence: 81%

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Bootstrap Resampling Technique to Evaluate the Reliability of the Optimal Liposome Formulation: Skin Permeability and Stability Response Variables

Duangjit

Opanasopit

Rojanarata

et al. 2014

Biological & Pharmaceutical Bulletin

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A nonlinear response surface method incorporating multivariate spline interpolation (RSM-S) is a useful technique for the optimization of pharmaceutical formulations, although the direct reliability of the optimal formulation must be evaluated. In this study, we demonstrated the feasibility of using the bootstrap (BS) resampling technique to evaluate the direct reliability of the optimal liposome formulation predicted by RSM-S. The formulation characteristics (X n ), including vesicle size (X 1 ), size distribution (X 2 ), zeta potential (X 3 ), elasticity (X 4 ), drug content (X 5 ), entrapment efficiency (X 6 ), release rate (X 7 ), and the penetration enhancer (PE) factors as formulation factors (Z n ), with the type of PE (Z 1 ) and content of PE (Z 2 ) were used as causal factors of the response surface analysis. The intended responses were high skin permeability (flux, Y 1 ) and high stability formulation (drug remaining, Y 2 ). Based on the dataset obtained, the simultaneous optimal solutions were estimated using RSM-S. Leave-one-out-cross-validation showed satisfying reliability of the optimal solution. Concurrently, similar BS optimal solutions were estimated from the BS dataset that was generated from the original dataset through BS resampling at frequencies of 250, 500, 750, and 1000. The analysis and simulation indicated that X 4 , X 5 , and Z 2 were the prime factors affecting Y 1 and Y 2 . These findings suggest that this approach could also be useful for evaluating the reliability of an optimal liposome formulation predicted by RSM-S and would be beneficial for the pharmaceutical development of liposomes for transdermal drug delivery.Key words bootstrap; response surface; simultaneous optimal solution; transdermal drug delivery Optimization techniques using computer-based rationales to research and develop pharmaceutical formulations have recently become attractive and interesting. A non-linear response surface method incorporating multivariate spline interpolation (RSM-S) is a powerful method for pharmaceutical optimization.1) RSM-S has shown that the complex relationships between causal factors and response variables could be simply comprehended and that the simultaneous optimal solutions obtained would be stable and reproducible.2) Several intensive studies successfully developed novel pharmaceutical formulations using RSM-S (e.g., water-in-oil-water multiple emulsion of insulin for intestinal delivery, 3) sustained release of diltiazem tablets for oral delivery 4) and ultra-deformable liposome of meloxicam for transdermal delivery 5) ). RSM-S was determined to be a promising technique for formulation optimization.3-7) Simultaneously, it is considerable to evaluate the accuracy and reliability of each optimal formulation estimated by RSM-S. The leave-one-out-cross-validation (LOOCV) method was also employed. The LOOCV method can evaluate the generalization error of a given response surface.8) Moreover, the reliability of optimal formulation estimated by certain response surface can be directly ...

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Section: Prediction Of Response Variables and Simultaneous Optimizationmentioning

confidence: 81%

“…RSM-S was determined to be a promising technique for formulation optimization. [3][4][5][6][7] Simultaneously, it is considerable to evaluate the accuracy and reliability of each optimal formulation estimated by RSM-S. The leave-one-out-cross-validation (LOOCV) method was also employed.…”

mentioning

confidence: 99%

Bootstrap Resampling Technique to Evaluate the Reliability of the Optimal Liposome Formulation: Skin Permeability and Stability Response Variables

Duangjit

Opanasopit

Rojanarata

et al. 2014

Biological & Pharmaceutical Bulletin

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“…There have been great progresses in implant devices for protein delivery (115)(116)(117)(118)(119)(120). Mohl and Winter developed a triglyceride implant aiming for sustained protein (115,116).…”

Section: Implantable Devices For Protein Deliverymentioning

confidence: 99%

“…Integrating hydroxypropyl-β-cyclodextrin into the matrices proved to stabilize IFNα-2a and led to a higher and faster protein release due to solubilizing effects. Surini et al designed an implantable controlled-release system based on a polyion complex device composed of chitosan and sodium hyaluronate for protein delivery (117). Insulin release from chitosan-hyaluronate pellets was markedly influenced by both the change in the polymer mixing ration and the total pellet weight, whereas the compression pressure did not affect the release profile significantly.…”

Section: Implantable Devices For Protein Deliverymentioning

confidence: 99%

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

Jin

2008

AAPS PharmSciTech

112

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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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“…More recently, the protein was bioengineered for use in biomaterials as three-dimensional porous scaffolds for tissue engineering (Kim et al, 2005), coating material for sustained drug release (Wang et al, 2007a;Bayraktar et al, 2005) and microspheres for encapsulation as drug carrier systems (Wang et al, 2007b) and films (Hofmann et al, 2006) for controlled drug delivery. On the other hand, hyaluronic acid (HA), a naturally occurring lubricous biopolymer, is an attractive building block for novel biocompatible and biodegradable biomaterials with potential applications in drug delivery (Surini et al, 2003;Luo et al, 2000;Simon et al, 1997) and tissue engineering (Park et al, 2002). HA has been used in the production of artificial blood vessel and artificial skin (Choi et al, 1999;Nishida et al, 1993), whereas electrical sensitive behavior of chitosan/hyaluronic acid polyelectrolyte complexes (PEC) has been found promising for the electric current mediated drug delivery systems (Kim et al, 2003).…”

Section: Introductionmentioning

confidence: 99%

pH- and electro-responsive characteristics of silk fibroin–hyaluronic acid polyelectrolyte complex membranes

Malay

Batıgün

Bayraktar

2009

International Journal of Pharmaceutics

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a b s t r a c t pH-responsiveness of recently developed silk fibroin (SF) and hyaluronic acid (HA) polyelectrolyte complex (PEC) membranes and their potential use in electro-responsive drug release systems were investigated. PEC membranes were prepared within a narrow pH window (3.0-3.5) for a SF-HA weight ratio of 20 and they were characterized by Atomic Force Microscopy in addition to characterization studies previously reported by our group. Swelling kinetics of the membranes was studied for a pH window of 2.5-7.4 and cyclic swelling test was performed to determine the pH-responsiveness of the membranes. It was shown that membranes swelled more in alkaline conditions and responded to variations in pH of the medium. Electric-stimuli assisted drug permeation and release studies were performed with a custom-made diffusion cell under both passive condition and electric field applied in pulsatile fashion. The instantaneous flux raised as the current was applied and then declined when the current application was terminated, and this process was repeated on subsequent applications. SF-HA complex membranes were found promising for the electric-stimuli-sensitive release of a high molecular weight and charged model drug for a membrane-permeation controlled formulation.

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Release phenomena of insulin from an implantable device composed of a polyion complex of chitosan and sodium hyaluronate

Cited by 56 publications

References 31 publications

Bootstrap Resampling Technique to Evaluate the Reliability of the Optimal Liposome Formulation: Skin Permeability and Stability Response Variables

Bootstrap Resampling Technique to Evaluate the Reliability of the Optimal Liposome Formulation: Skin Permeability and Stability Response Variables

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

pH- and electro-responsive characteristics of silk fibroin–hyaluronic acid polyelectrolyte complex membranes

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