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Development and optimization of levodopa and benzylhydrazine orally disintegrating tablets by direct compression and response surface methodology.
Drug Dev Ind Pharm. 2020 Jan; 46(1):42-49.DD

Abstract

The number of Parkinson's disease (PD) patients with the advanced phase and motor fluctuations is increasing. The objective of this study is developing levodopa/benzylhydrazine orally disintegrating tablets (L/B ODTs), which would provide greater convenience and ease of use than conventional tablets for these patients. In the present study, the L/B ODTs were developed successfully with an optimized formulation using response surface methodology (RSM). The direct compression technology was employed for the preparation of L/B ODTs. Considerably shorter disintegration time and faster dissolution profile were obtained under the optimum formulation with microcrystalline cellulose 25.7%, cross-polyvinylpyrrolidone 6.22% and Sodium carboxymethyl starch 5.36%. The content uniformity (%) of levodopa and benzylhydrazine was 50 ± 1.4% and 14.25 ± 0.6%, respectively. Thickness, friability, hardness and wetting time were 2.8 ± 0.05 mm, 0.46 ± 0.21%, 5.42 ± 1.1 kp and 31.2 ± 2.1 s, respectively, and all of data well comply with the General Principles of the Chinese Pharmacopeia. Mannitol of 22% in formulation could bring a pleasant taste: sweet, cool and refreshing. Almost all the volunteers felt that the ODTs had good taste, no roughness, and no gritty feeling, indicating that the ODTs prepared had good palatability, so patients will have good compliance when taking medicine.

Authors+Show Affiliations

State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China. Department of Pharmaceutical Engineering, College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.State Key Laboratory Base for Eco-Chemical Engineering in College of Chemical Engineering, Qingdao University of Science and Technology, Qingdao, China.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31794271

Citation

Zhang, Yuanyuan, et al. "Development and Optimization of Levodopa and Benzylhydrazine Orally Disintegrating Tablets By Direct Compression and Response Surface Methodology." Drug Development and Industrial Pharmacy, vol. 46, no. 1, 2020, pp. 42-49.
Zhang Y, Li Z, Tang H, et al. Development and optimization of levodopa and benzylhydrazine orally disintegrating tablets by direct compression and response surface methodology. Drug Dev Ind Pharm. 2020;46(1):42-49.
Zhang, Y., Li, Z., Tang, H., Ren, W., Gao, X., Sun, Y., Zhao, Q. X., Wang, F., & Liu, J. (2020). Development and optimization of levodopa and benzylhydrazine orally disintegrating tablets by direct compression and response surface methodology. Drug Development and Industrial Pharmacy, 46(1), 42-49. https://doi.org/10.1080/03639045.2019.1698597
Zhang Y, et al. Development and Optimization of Levodopa and Benzylhydrazine Orally Disintegrating Tablets By Direct Compression and Response Surface Methodology. Drug Dev Ind Pharm. 2020;46(1):42-49. PubMed PMID: 31794271.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and optimization of levodopa and benzylhydrazine orally disintegrating tablets by direct compression and response surface methodology. AU - Zhang,Yuanyuan, AU - Li,Zewen, AU - Tang,Hui, AU - Ren,Wenjie, AU - Gao,Xin, AU - Sun,Yangjian, AU - Zhao,Qiu Xiang, AU - Wang,Fanye, AU - Liu,Junhong, Y1 - 2020/01/20/ PY - 2019/12/4/pubmed PY - 2019/12/4/medline PY - 2019/12/4/entrez KW - Levodopa KW - benzylhydrazine KW - direct compression KW - orally disintegrating tablets (ODTs) KW - response surface methodology SP - 42 EP - 49 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 46 IS - 1 N2 - The number of Parkinson's disease (PD) patients with the advanced phase and motor fluctuations is increasing. The objective of this study is developing levodopa/benzylhydrazine orally disintegrating tablets (L/B ODTs), which would provide greater convenience and ease of use than conventional tablets for these patients. In the present study, the L/B ODTs were developed successfully with an optimized formulation using response surface methodology (RSM). The direct compression technology was employed for the preparation of L/B ODTs. Considerably shorter disintegration time and faster dissolution profile were obtained under the optimum formulation with microcrystalline cellulose 25.7%, cross-polyvinylpyrrolidone 6.22% and Sodium carboxymethyl starch 5.36%. The content uniformity (%) of levodopa and benzylhydrazine was 50 ± 1.4% and 14.25 ± 0.6%, respectively. Thickness, friability, hardness and wetting time were 2.8 ± 0.05 mm, 0.46 ± 0.21%, 5.42 ± 1.1 kp and 31.2 ± 2.1 s, respectively, and all of data well comply with the General Principles of the Chinese Pharmacopeia. Mannitol of 22% in formulation could bring a pleasant taste: sweet, cool and refreshing. Almost all the volunteers felt that the ODTs had good taste, no roughness, and no gritty feeling, indicating that the ODTs prepared had good palatability, so patients will have good compliance when taking medicine. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/31794271/Development_and_optimization_of_levodopa_and_benzylhydrazine_orally_disintegrating_tablets_by_direct_compression_and_response_surface_methodology L2 - http://www.tandfonline.com/doi/full/10.1080/03639045.2019.1698597 DB - PRIME DP - Unbound Medicine ER -
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