Accelerated in vitro release testing of implantable PLGA microsphere/PVA hydrogel composite coatings

Shen, Jie; Burgess, Diane J.

doi:10.1016/j.ijpharm.2011.10.020

Cited by 68 publications

(50 citation statements)

References 48 publications

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“…For PLGA-H, there is not a range of constant energy activation throughout the entire process of thermal degradation. Previous studies presented activation energy of 115 kJ.mol -1 for bulk PLGA 50:50 [18] , 116 kJ.mol -1 for dexamethasone loaded PLGA microspheres 33 indicating that the activation energy value found for PLGA-Mag is close to that demonstrated in these studies. In a general way, both PLGA-H and PLGA-Mag show higher values of activation energy than those of PLGA-R.…”

Section: Resultssupporting

confidence: 85%

Study of Thermal Degradation of PLGA, PLGA Nanospheres and PLGA/Maghemite Superparamagnetic Nanospheres

et al. 2015

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Poly(glycolide-co-lactide) (PLGA) nanospheres containing magnetic materials have been extensively studied because of its biomedical applications. Therefore, it is very important to know thermal properties of these materials in addition to other physical properties. Thermal degradation activation energy (E α ) of PLGA nanospheres with maghemite entrapment (PLGA-Mag), PLGA nanospheres (hollow spheres) (PLGA-H) obtained by an emulsion method and unprocessed PLGA (PLGA-R) were calculated by isoconversional Vyazovkin method based on data of TG analysis in order to evaluate modifications in thermal behavior caused by nanospheres obtainment process or by maghemite entrapment. Both hydrodynamic diameter in the range of 200-250 nm and polydispersity index lower than 0.3 are considered satisfactory. Thermal degradation of PLGA-R begins at higher temperatures than those of PLGA-H and PLGA-Mag, but processed samples presented increase in thermal stability, which was greater before processing by emulsion and in the presence of the magnetic materials. PLGA-Mag presents superparamagnetic behavior at room temperature.

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Section: Resultssupporting

confidence: 85%

Study of Thermal Degradation of PLGA, PLGA Nanospheres and PLGA/Maghemite Superparamagnetic Nanospheres

et al. 2015

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“…Accelerated in vitro release testing based on elevated temperature has been successfully used as a fast quality control tool for PLGA based parenteral dosage forms (such as microspheres and implants) (D'Souza et al, 2014;Shen and Burgess, 2012a;Zolnik et al, 2006). Elevated temperature can accelerate PLGA polymer erosion (Zolnik et al, 2006), as well as enhance polymer mobility and thereby drug diffusion (Duda and Zielinski, 1996).…”

Section: Discussionmentioning

confidence: 99%

A reproducible accelerated in vitro release testing method for PLGA microspheres

Shen

Lee

Choi

et al. 2016

International Journal of Pharmaceutics

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The objective of the present study was to develop a discriminatory and reproducible accelerated in vitro release method for long-acting PLGA microspheres with inner structure/porosity differences. Risperidone was chosen as a model drug. Qualitatively and quantitatively equivalent PLGA microspheres with different inner structure/porosity were obtained using different manufacturing processes. Physicochemical properties as well as degradation profiles of the prepared microspheres were investigated. Furthermore, in vitro release testing of the prepared risperidone microspheres was performed using the most common in vitro release methods (i.e. sample-andseparate and flow through) for this type of product. The obtained compositionally equivalent risperidone microspheres had similar drug loading but different inner structure/porosity. When microsphere particle size appeared similar, porous risperidone microspheres showed faster microsphere degradation and drug release compared with less porous microspheres. Both in vitro release methods investigated were able to differentiate risperidone microsphere formulations with differences in porosity under real-time (37°C) and accelerated (45°C) testing conditions. Notably, only the accelerated USP apparatus 4 method showed good reproducibility for highly porous risperidone microspheres. These results indicated that the accelerated USP apparatus 4 method is an appropriate fast quality control tool for long-acting PLGA microspheres (even with porous structures). Graphical Abstract*

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“…Many explore the concepts (3)(4)(5), instrumentation (6)(7)(8)(9)(10)(11), or processes (12-15) used to characterize the drug product for the purpose of setting QC specifications. Those that are directly comparable to the efforts presented here are limited due to the physicochemical characteristics of the contents of the developmental formulation.…”

Section: Characterization Of the In Vitro Drug Exchange Profile Of A mentioning

confidence: 99%

“…During this phase, approximately twenty combinations of emulsifiers, surfactants, and acids in aqueous and organic based media were screened. Second, once a suitable medium was identified, both USP dissolution Apparatus 2 with the Distek topical drug cell and Apparatus 4 with the Sotax dialysis cell (7,10,11) were compared directly. Apparatus 2 with the Distek topical drug cell was determined to be best suited for this product and application.…”

Section: Characterization Of the In Vitro Drug Exchange Profile Of A mentioning

confidence: 99%

Characterization of the In Vitro Drug Exchange Profile of a Modified-Release Parenteral Solution for Veterinary Use

Priddy¹,

Roush²,

Bryson³

et al. 2017

Dissolution Technol.

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The release or exchange profile of an active pharmaceutical ingredient (API) from its carrier or formulation matrix is an important characteristic of a drug product, especially for that of a long-acting or modified-release formulation. The ability to measure this phenomenon in vitro assures that the product is manufactured using the intended quality of raw materials, including API and excipients, and that control of the overall compounding process is maintained. Developing and validating an in vitro drug exchange (IVDE) method that is capable of reproducibly demonstrating quality required addressing some fundamental challenges. Primarily, a suitable medium was identified to extract the API over a reasonable amount of time to generate a release profile, while also ensuring the API does not degrade in this medium during the exchange interval and brief storage prior to being assayed. Secondarily, a system and processes that can be used in a quality control (QC) laboratory setting to enable extraction, sampling, and quantitative measurement of the API exchanged from one medium (phase) into another was designed. The final challenge was the ability to differentiate high-quality drug product from others containing the same API in what could be a lesser quality, or perhaps even a completely different formulation. To meet the third objective, the method development strategy included comparison of the release profiles of the developmental product against numerous other formulations. These included a commercial product containing the same API in a different matrix, lab-scale batches containing the same API and excipients at variable concentrations, lab-scale batches containing similar or related excipients, and lab-scale batches containing degraded excipients. Statistical criteria were set to demonstrate that the method was capable of discriminating the IVDE profiles of the developmental formulation from all others. In addition, the same criteria were set for QC testing at release and real-time stability intervals to assure long-term quality of the drug product.

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Accelerated in vitro release testing of implantable PLGA microsphere/PVA hydrogel composite coatings

Cited by 68 publications

References 48 publications

Study of Thermal Degradation of PLGA, PLGA Nanospheres and PLGA/Maghemite Superparamagnetic Nanospheres

Study of Thermal Degradation of PLGA, PLGA Nanospheres and PLGA/Maghemite Superparamagnetic Nanospheres

A reproducible accelerated in vitro release testing method for PLGA microspheres

Characterization of the In Vitro Drug Exchange Profile of a Modified-Release Parenteral Solution for Veterinary Use

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