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Replace imported PH200

Solve the problem of splinter risk during replacement of imported PH200

Pressure adjustment

Westpint the client's PH200 formulation was optimized by appropriately increasing the fine particle fraction within the specified particle size distribution range. This modification fundamentally enhances the material's specific surface area, thereby creating more binding sites during tablet compression. As a result, the formulation demonstrates reduced sensitivity to lubricant effects (e.g., magnesium stearate), effectively mitigating capping risks at their root cause.

Moisture adjustment

Westpoint adjusted the hydrolysis and drying processes were adjusted to control moisture content at approximately 1%, while applying ~10 kN of main compression force to achieve the target tablet hardness of 50 N.

Disintegrating behavior adjustment

Westpoint adjusts the manufacturing process of PH101 based on the dissolution profile of the client's product, achieving similar disintegration and dissolution behavior to the reference listed drug (RLD), ultimately attaining matching dissolution curves.

Supply and cost

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