Preparing amorphous solid dispersion comprising ritlecitinib tosylate and one or more excipient used for treating severe alopecia areata, involves providing solution comprising ritlecitinib tosylate and excipients by dissolving in solvent followed by removing solvent, and recovering solid dispersion
	PAL S; PATHIVADA D
	2023-08-18
专利权人	DR REDDY'S LAB LTD (REDY-C)
申请日期	2023-08-18
专利号	IN202341055410-A
成果简介	NOVELTY - Preparing amorphous solid dispersion comprising ritlecitinib tosylate and one or more excipient, involves: (a) providing a solution comprising ritlecitinib tosylate and excipients by dissolving in a suitable solvent or mixture; (b) removing solvent from the solution; and (c) recovering the solid dispersion comprising ritlecitinib tosylate and excipients. USE - Method for preparing amorphous solid dispersion comprising ritlecitinib tosylate and one or more excipient used for the treatment of severe alopecia areata, rheumatoid arthritis, ulcerative colitis, Crohn's disease and vitiligo. No biological data given. ADVANTAGE - The method for preparing amorphous solid dispersion exhibits better processing or handling characteristics; improve dissolution profile or shelf-life; and improve stability and ease of manufacturing. DETAILED DESCRIPTION - INDEPENDENT CLAIMS are included for: 1. a crystalline form D1 of ritlecitinib tosylate, which has powder X-ray diffraction (PXRD) pattern having peaks at 5.65, 15.47, 18.45, 18.75, 21.77 and 28.34 ± 0.2° 2θ, or having additional peaks located at 20.7, 21.44, 22.99, 25.2, 28.9 and 29.66 ± 0.2° 2θ; 2. a process for preparing crystalline form D1 of ritlecitinib tosylate, which involves: (a) reacting ritlecitinib with a p-toluenesulfonic acid (PTSA) in a suitable solvent or mixture; (b) isolating crystalline form D1 of ritlecitinib tosylate; (c) optionally, drying the isolated product at suitable temperature; 3. a crystalline form DB1 of ritlecitinib, which has PXRD pattern having peaks at: 5.02, 15.07, 19.32, 21.20 ± 0.2° 2θ, or having additional peaks located at 10.02, 18.21, 25.25 and 26.01 ± 0.2° 2θ; or having additional peaks located at 26.7714, 28.54, 29.40, 29.91 and 30.41 ± 0.2° 2θ; 4. a process for preparing crystalline form DB1 of ritlecitinib, which involves: (a) reacting ritlecitinib tosylate with a suitable base in a suitable solvent or mixture; (b) isolating crystalline form DB1 of ritlecitinib; and (c) optionally, drying the isolated product at suitable temperature; 5. a process for preparation of amorphous solid dispersion comprising ritlecitinib and excipient, which involves: (a) providing a solution comprising ritlecitinib and excipients by dissolving in a suitable solvent or mixture; (b) removing solvent from the solution; and (c) recovering the solid dispersion comprising ritlecitinib and excipients; and 6. a process for preparation of amorphous form of ritlecitinib, which involves: (a) reacting ritlecitinib tosylate with a suitable base in a suitable solvent or mixture; (b) isolating amorphous form of ritlecitinib; and (c) optionally, drying the isolated product at suitable temperature.
IPC 分类号	A61K-031/4375 ; A61P-001/00 ; A61P-013/00 ; A61P-017/00 ; A61P-003/00 ; A61P-005/00 ; A61P-007/00 ; C07D-487/04
国家	印度
专业领域	医药卫生
语种	英语
成果类型	专利
文献类型	科技成果
条目标识符	http://119.78.100.226:8889/handle/3KE4DYBR/20766
专题	中国科学院新疆生态与地理研究所
作者单位	DR REDDY'S LAB LTD (REDY-C)
推荐引用方式 GB/T 7714	PAL S,PATHIVADA D. Preparing amorphous solid dispersion comprising ritlecitinib tosylate and one or more excipient used for treating severe alopecia areata, involves providing solution comprising ritlecitinib tosylate and excipients by dissolving in solvent followed by removing solvent, and recovering solid dispersion. IN202341055410-A[P]. 2023.

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