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Metformin hydrochloride (BCS class III) is freely soluble in aqueous media. Alogliptin benzoate (BCS class I) is sparingly soluble in water from pH 3-11 and particle size was demonstrated to have no effect on dissolution profile. Nonetheless, a specification for alogliptin benzoate is included to ensure the particle size distribution falls within a justified range. Excipients were chosen to maximise hardness, reduce friability, and maximise disintegration and dissolution time but also based on their compatibility with the active substances, which were also shown to be mutually stable.
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Metformin hydrochloride (BCS class III) is freely soluble in aqueous media. Alogliptin benzoate (BCS class I) is sparingly soluble in water from ...

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