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Properties of a Stable and Sustained-Release Formulation of Recombinant Human Parathyroid Hormone (rhPTH) with Chitosan and Silk Fibroin Microparticles.
Med Sci Monit. 2018 Oct 22; 24:7532-7540.MS

Abstract

BACKGROUND

Parathyroid hormone (PTH) is required for the maintenance of normal bone physiology. This study describes the properties of a sustained-release formulation of recombinant human PTH (rhPTH) using chitosan and silk fibroin microparticles as carriers for drug delivery, developed using a spray-drying method. MATERIAL AND

METHODS

Chitosan, silk fibroin, and chitosan/silk fibroin microparticles loaded with rhPTH were studied with scanning electron microscopy (SEM) to estimate the particle size and surface morphology. The in vitro release of rhPTH was used to assess the developed formulation. The effect of the spray-drying process was assessed by powder X-ray diffraction (PXRD) of the microparticles. Quantification of the released rhPTH was performed by enzyme-linked immune sorbent assay (ELISA). Fourier-transform infrared spectroscopy (FTIR) was used to determine the differences in the absorption frequency of samples.

RESULTS

Surface morphology of the final formulation showed the absence of pure crystals of chitosan and silk fibroin in the final formulation and FTIR demonstrated electrostatic interactions between chitosan and silk fibroin, which was supported by PXRD. The chitosan/silk fibroin microparticles loaded with rhPTH showed an entrapment efficiency (EE) that ranged from 60.36-72.99% with a 50% rhPTH release profile at pH 7.5 in 24 hours. There was no particle aggregation in blood and little hemolysis, indicating stability of the rhPTH-loaded microparticles.

CONCLUSIONS

A silk fibroin/chitosan microparticle formulation loaded with rhPTH was shown to be stable and to provide sustained-release of rhPTH, supporting a potential role of this formulation in the treatment of bone diseases including osteoporosis and bone fracture.

Authors+Show Affiliations

Department of Pharmacy, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China (mainland).Department of Radiology, Hospital of Wuhan University of Science and Technology, Wuhan, Hubei, China (mainland).Department of Environmental Hygiene and Occupational Medicine, School of Public Health, Hubei Province Key Laboratory of Occupational Hazard Identification and Control, Wuhan University of Science and Technology, Wuhan, Hubei, China (mainland).Department of Andrology, Jinling Hospital/Nanjing General Hospital Affiliated with Nanjing University School of Medicine, Nanjing, Jiangsu, China (mainland).Department of Environmental Hygiene and Occupational Medicine, School of Public Health, Hubei Province Key Laboratory of Occupational Hazard Identification and Control, Wuhan University of Science and Technology, Wuhan, Hubei, China (mainland).

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30345994

Citation

Lv, Bi-Hua, et al. "Properties of a Stable and Sustained-Release Formulation of Recombinant Human Parathyroid Hormone (rhPTH) With Chitosan and Silk Fibroin Microparticles." Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, vol. 24, 2018, pp. 7532-7540.
Lv BH, Tan W, Zhu CC, et al. Properties of a Stable and Sustained-Release Formulation of Recombinant Human Parathyroid Hormone (rhPTH) with Chitosan and Silk Fibroin Microparticles. Med Sci Monit. 2018;24:7532-7540.
Lv, B. H., Tan, W., Zhu, C. C., Shang, X., & Zhang, L. (2018). Properties of a Stable and Sustained-Release Formulation of Recombinant Human Parathyroid Hormone (rhPTH) with Chitosan and Silk Fibroin Microparticles. Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, 24, 7532-7540. https://doi.org/10.12659/MSM.911203
Lv BH, et al. Properties of a Stable and Sustained-Release Formulation of Recombinant Human Parathyroid Hormone (rhPTH) With Chitosan and Silk Fibroin Microparticles. Med Sci Monit. 2018 Oct 22;24:7532-7540. PubMed PMID: 30345994.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Properties of a Stable and Sustained-Release Formulation of Recombinant Human Parathyroid Hormone (rhPTH) with Chitosan and Silk Fibroin Microparticles. AU - Lv,Bi-Hua, AU - Tan,Wei, AU - Zhu,Chang-Cai, AU - Shang,Xuejun, AU - Zhang,Ling, Y1 - 2018/10/22/ PY - 2018/10/23/entrez PY - 2018/10/23/pubmed PY - 2019/1/4/medline SP - 7532 EP - 7540 JF - Medical science monitor : international medical journal of experimental and clinical research JO - Med. Sci. Monit. VL - 24 N2 - BACKGROUND Parathyroid hormone (PTH) is required for the maintenance of normal bone physiology. This study describes the properties of a sustained-release formulation of recombinant human PTH (rhPTH) using chitosan and silk fibroin microparticles as carriers for drug delivery, developed using a spray-drying method. MATERIAL AND METHODS Chitosan, silk fibroin, and chitosan/silk fibroin microparticles loaded with rhPTH were studied with scanning electron microscopy (SEM) to estimate the particle size and surface morphology. The in vitro release of rhPTH was used to assess the developed formulation. The effect of the spray-drying process was assessed by powder X-ray diffraction (PXRD) of the microparticles. Quantification of the released rhPTH was performed by enzyme-linked immune sorbent assay (ELISA). Fourier-transform infrared spectroscopy (FTIR) was used to determine the differences in the absorption frequency of samples. RESULTS Surface morphology of the final formulation showed the absence of pure crystals of chitosan and silk fibroin in the final formulation and FTIR demonstrated electrostatic interactions between chitosan and silk fibroin, which was supported by PXRD. The chitosan/silk fibroin microparticles loaded with rhPTH showed an entrapment efficiency (EE) that ranged from 60.36-72.99% with a 50% rhPTH release profile at pH 7.5 in 24 hours. There was no particle aggregation in blood and little hemolysis, indicating stability of the rhPTH-loaded microparticles. CONCLUSIONS A silk fibroin/chitosan microparticle formulation loaded with rhPTH was shown to be stable and to provide sustained-release of rhPTH, supporting a potential role of this formulation in the treatment of bone diseases including osteoporosis and bone fracture. SN - 1643-3750 UR - https://www.unboundmedicine.com/medline/citation/30345994/Properties_of_a_Stable_and_Sustained_Release_Formulation_of_Recombinant_Human_Parathyroid_Hormone__rhPTH__with_Chitosan_and_Silk_Fibroin_Microparticles_ L2 - https://www.medscimonit.com/download/index/idArt/911203 DB - PRIME DP - Unbound Medicine ER -