An acotiamide hydrochloride tablet and a production method thereof

CN117398355BActive Publication Date: 2026-06-05NANJING HEALTHNICE PHARMACEUTICAL CO LTD +3
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
NANJING HEALTHNICE PHARMACEUTICAL CO LTD
Filing Date
2023-09-22
Publication Date
2026-06-05

AI Technical Summary

Technical Problem

Existing technologies for preparing acotitam hydrochloride tablets suffer from problems such as unstable crystal form, incomplete dissolution, high impurity content, and safety issues. Furthermore, the strong static electricity generated during the pulverization process can cause the rollers to stick.

Method used

A three-stage control method was used to control the particle size distribution of the active components, and a composite antistatic agent and anti-sticking agent were used in combination with wet granulation and fluidized bed drying technology to prepare an acotilamide hydrochloride composition. The process included steps such as pulverization, mixing, granulation, drying and sizing, and particle size and temperature were controlled to ensure stability and dissolution.

Benefits of technology

The method achieves high crystal stability, complete dissolution, low impurity content, and good safety of acotiamide hydrochloride tablets, while ensuring smooth process operation and reducing energy consumption and static electricity issues during the pulverization process.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

The present application relates to a kind of hydrochloric acid acotiamide tablets and its production method, the composition includes active component hydrochloric acid acotiamide hydrate, composite antistatic agent, anti-adhesive, disintegrant, binder and lubricant, the active component hydrochloric acid acotiamide is trihydrate, the particle size distribution of active component used is as follows: D10 <5 μm, D50 5~20 μm, D90 20~60 μm.Using the preparation process of the present application, the effect of completely removing static electricity can be basically achieved, ensuring the uniformity of mixing and the smooth progress of subsequent process;In addition, due to the hydrophilic effect of lactose, the dissolution of the product in water and hydrochloric acid medium can be improved.
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