Fidaxomicin dry suspension and preparation method thereof
By preparing a fenadine dry suspension and adding antioxidants and other excipients, the problem of fenadine self-oxidation was solved, resulting in improved stability and efficacy, making it suitable for patients with dysphagia.
CN121421971APending Publication Date: 2026-01-30ZHUOHE PHARM GRP CO LTD
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Patent Information
- Application Number
- CN202511691932.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-11-18
- Publication Date
- 2026-01-30
AI Technical Summary
Technical Problem
Fidamycin is prone to auto-oxidation, which affects product quality, and existing technologies are unable to effectively solve this problem.
Method used
Fidamycin dry suspension is prepared by adding the antioxidant butylated hydroxytoluene (BHT) and other excipients such as microcrystalline cellulose, sucrose, sodium carboxymethyl starch, and xanthan gum, and through steps such as pulverization, granulation, and drying to prevent drug auto-oxidation.
Benefits of technology
The prepared fenadine dry suspension has good stability, is suitable for patients with dysphagia, has good drug dissolution and absorption, improves efficacy, and reduces oxide formation.
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Figure CN121421971A_ABST
Abstract
The invention discloses a fidaxomicin dry suspension and a preparation method thereof. The fidaxomicin dry suspension is prepared from the following components in percentage by weight: 1%-90% of fidaxomicin, 1%-90% of microcrystalline cellulose, 1%-25% of cane sugar, 0.001%-5% of butylated hydroxytoluene, 0.01%-25% of carboxymethyl starch sodium, 0.05%-25% of xanthan gum and 0.01%-0.15% of artificial sweet orange essence. Fidaxomicin is used as a main drug, microcrystalline cellulose is used as a suspending aid and filler, sucrose is used as a suspending aid and corrigent, butylated hydroxytoluene is used as an antioxidant, carboxymethyl starch sodium is used as a disintegrating agent, xanthan gum is used as a suspending aid, and artificial sweet orange essence is used as an aromatic. According to the fidaxomicin dry suspension and the preparation method thereof, a high-quality ratio is set, various detection results of the prepared fidaxomicin dry suspension are excellent on the premise that the taste of the medicine is guaranteed, particularly, the content of related substances is low, the dissolution is similar to that of the original research, the medicine effect of the fidaxomicin can be well exerted, and the effective rate of the medicine is improved.
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